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TABLE OF CONTENTS
INDEX TO FINANCIAL STATEMENTS

Table of Contents

As filed with the Securities and Exchange Commission on November 10, 2015

Registration No. 333-             


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



SurgiQuest, Inc.
(Exact Name of Registrant as Specified in Its Charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
  3841
(Primary Standard Industrial
Classification Code Number)
  20-4678848
(IRS Employer
Identification Number)

488 Wheelers Farms Road
Milford, Connecticut 06461
(203) 799-2400

(Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices)



Kurt Azarbarzin
President and Chief Executive Officer
488 Wheelers Farms Road
Milford, Connecticut 06461
(203) 799-2400
(Name, address, including zip code, and telephone number, including area code, of agent for service)



With copies to:
Marc D. Jaffe
Wesley C. Holmes
Ryan K. deFord
Latham & Watkins LLP
885 Third Avenue
New York, New York 10022
(212) 906-1200
      Michael A. Hedge
Damien A. Grierson
K&L Gates LLP
1 Park Plaza
Twelfth Floor
Irvine, California 92614
(949) 253-0900



Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, please check the following box.    o

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer o   Accelerated filer o   Non-accelerated filer ý
(Do not check if a smaller reporting company)
  Smaller reporting company o



CALCULATION OF REGISTRATION FEE

       
 
Title of each Class of
Securities to be Registered

  Proposed Maximum
Aggregate Offering Price(1)(2)

  Amount of
Registration Fee(3)

 

Common Stock, par value $0.001 per share

  $75,000,000   $7,552.50

 

(1)
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended (the "Securities Act").
(2)
Includes offering price of any additional shares that the underwriters have the option to purchase to cover over-allotments, if any.
(3)
Calculated pursuant to Rule 457(o) under the Securities Act based on an estimate of the proposed maximum aggregate offering price.




The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

   


Table of Contents

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion, dated November 10, 2015

                    Shares

SURGIQUEST, INC.  
LOGO

Common Stock

$             per share


SurgiQuest, Inc. is offering                           shares.

We anticipate that the initial public offering price will be between $             and $             per share.

This is our initial public offering and no public market currently exists for our shares.

Proposed         trading symbol: "             ."



This investment involves risks. See "Risk Factors" beginning on page 13.

We are an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012, and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

             
   

 

 

Per Share

 

Total

 

Initial public offering price

  $               $                

Underwriting discount(1)

  $               $                

Proceeds, before expenses, to SurgiQuest, Inc. 

  $               $                
   
(1)
See "Underwriting" for additional information regarding underwriting compensation.

We have granted to the underwriters an option to purchase up to                                        additiona l shares of common stock from us at the public offering price, less the underwriting discount, for 30 days after the date of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the shares of common stock to investors on or about                    , 2015.

Piper Jaffray   Stifel
Canaccord Genuity

   

The date of this prospectus is                           , 2015.


LOGO


Table of Contents


TABLE OF CONTENTS

 
  Page  

Prospectus Summary

    1  

Risk Factors

    13  

Special Note Regarding Forward-Looking Statements

    55  

Industry and Other Data

    56  

Use of Proceeds

    57  

Dividend Policy

    58  

Capitalization

    59  

Dilution

    62  

Selected Financial Data

    64  

Management's Discussion and Analysis of Financial Condition and Results of Operations

    66  

Business

    84  

Management

    116  

Executive Compensation

    122  

Certain Relationships and Related Party Transactions

    139  

Principal Stockholders

    142  

Description of Capital Stock

    145  

Shares Eligible for Future Sale

    151  

Material U.S. Federal Income Tax Consequences to Non-U.S. Holders

    154  

Underwriting

    159  

Legal Matters

    168  

Experts

    168  

Where You Can Find More Information

    168  

Index to Financial Statements

    F-1  



Through and including             , 2015 (25 days after the commencement of this offering), all dealers effecting transaction in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.

We use our registered trademarks, AirSeal and SurgiQuest, and our unregistered trademark, Low Impact, in this prospectus. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and trade names.

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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock and it is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. You should read this entire prospectus carefully, especially the "Risk Factors" section and our financial statements and the related notes appearing at the end of this prospectus, before making an investment decision.

As used in this prospectus, unless the context otherwise requires, references to "we," "us," "our," "our company" and "SurgiQuest" refer to SurgiQuest, Inc.

Company Overview

We are a commercial stage global medical technology company that is revolutionizing Minimally Invasive Surgery with AirSeal, our proprietary surgical access management system that we believe offers significant clinical benefits for patients and economic benefits for healthcare providers. We refer to the combination of our proprietary AirSeal technology and the surgical procedures that they enable as Low Impact Surgery. We believe Low Impact Surgery enables a wider range of surgical procedures to be performed with less invasive surgical access, thereby broadening the population of patients for whom Minimally Invasive Surgery, or MIS, may be applicable. As of September 30, 2015, more than 1,600 AirSeal systems were deployed in over 700 institutions worldwide, and we believe AirSeal disposable devices have been used in more than 340,000 surgical procedures worldwide since 2011. Quarterly sales of AirSeal disposables have grown from less than 4,000 disposables sets during the three months ended March 30, 2012 to more than 44,000 disposables sets during the three months ended September 30, 2015; and more than 135,000 disposables sets were sold during the 9 months ended September 30, 2015.

Over the past 25 years, abdominal surgery has evolved from highly invasive open procedures to MIS approaches, which include techniques such as laparoscopic and robotic-assisted laparoscopic surgery. MIS relies on the creation of working space in the abdominal cavity to facilitate the manipulation of surgical instruments and the visualization of the surgical site by endoscopic cameras. This is done through the inflation and distension of the abdominal cavity using carbon dioxide, or CO2, under pressure. This process is known as insufflation and the resulting state of insufflation is referred to as pneumoperitoneum. It is critical that pneumoperitoneum remains stable throughout the procedure. However, fluctuations in intra-abdominal pressure can be caused by surgical suction, smoke evacuation, specimen removal, trocar dislodgement, moving the patient, applying pressure to the patient's body or over-pressurizing the surgical cavity after a loss of pneumoperitoneum. Conventional access devices, comprising trocars, insufflators and insufflation tubing, are designed to create and maintain pneumoperitoneum. Trocars are tubular devices inserted through a patient's abdominal wall that allow the passage of thin telescopes, tissue grasping/dissecting/retracting instruments, tissue cauterizing devices for bleeding control, sutures, clips and other prosthetic devices to remove or repair bodily tissue. Insufflators are pressure regulators that are used to inflate a patient's abdomen with gas to create a working space for the surgeon to remove or repair tissue. Insufflation tubing takes the gas from the pressure regulator and connects it to a trocar so that gas may enter and inflate the patient's abdomen to create the working space. However, these devices have numerous limitations which result in challenges in maintaining stable pneumoperitoneum. These limitations include intermittent pressure monitoring, delayed response to pressure changes and the inability to prevent loss of pneumoperitoneum during standard instrument exchange, use of suction, smoke evacuation or specimen removal. Conventional access devices also do not include integrated management of surgical smoke caused by thermal energy-based devices commonly used during surgery, which obstructs the view of the surgical field and poses potential health hazards for operating room occupants. The

 

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combination of these limitations contributes to an environment in which intra-abdominal pressure often fluctuates between levels so low that the surgical working space collapses and so high that it can cause harm to the patient. Surgeries using conventional access devices may also require more invasive access in order to accommodate the safe removal of contaminated or cancerous surgical specimens from the body.

We believe our AirSeal technology represents the first major innovation in minimally invasive surgical access since the introduction of the modern trocar. The AirSeal system replaces trocars that rely on mechanical valves to create and maintain pneumoperitoneum with a valve-free access port that has no moving parts. AirSeal instead employs a proprietary gaseous barrier to provide real-time sensing of intra-abdominal pressure, which enables dynamic adjustment of intra-abdominal pressure to maintain stable pneumoperitoneum. AirSeal also includes automatic and continuous smoke evacuation to provide a clear and constant field of vision. Accordingly, the improved surgical conditions enabled by AirSeal allow surgeons to perform MIS procedures with a more stable and less rigid state of pneumoperitoneum, and at approximately 50% lower intra-abdominal pressures than are typically used with conventional access devices. Laparoscopy performed at lower pressure has been clinically demonstrated to contribute to lower post-operative pain, reduced reliance on post-operative pain medication and shorter length of hospital stay. While we have not yet completed a clinical study comparing both AirSeal and conventional insufflation at low pressure, several studies have been completed comparing AirSeal at low pressure versus conventional insufflation at standard pressure. In these studies, AirSeal at low pressure did not demonstrate the challenges typically associated with conventional insufflation at low pressure (which include increased operating and a greater requirement to raise intra-abdominal pressure from low to standard levels). In addition, we believe AirSeal simplifies pulmonary ventilation and hemodynamic management by the anesthesiologist, enabling a minimally invasive approach in patients who have more complicated diseases and are traditionally poor candidates for MIS.

The AirSeal system has received clearance from the U.S. Food and Drug Administration, or FDA, pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act. The cleared indications for use are (i) in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke; (ii) to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke; and (iii) to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. In addition, the trocar of the AirSeal system is indicated for use with or without visualization of the surgical site by endoscopic cameras. Typically, our customers are reimbursed for surgical procedures utilizing our devices through bundled payments, rather than receiving direct reimbursement for the cost of the AirSeal system components. Our customers accept the bundled payments as reimbursement for all associated costs of the surgical procedure, including the products and supplies used. Facility and physician reimbursement levels can vary according to the type of surgical procedure performed, the setting in which the surgical procedure was performed (e.g., hospital inpatient or outpatient departments), the clinical condition of the patient and other factors.

We have sponsored numerous post-market clinical studies within several surgical specialties to assess the clinical benefits of our AirSeal system for its cleared indications, and we are aware of five third-party studies of our system. All of these studies assessed the AirSeal system for its currently cleared indications for use. While we believe that these data support the benefits of the AirSeal system, the studies have certain limitations, such as the fact that some of these clinical studies were not designed as prospective, randomized trials and some of these clinical studies enrolled fewer than 100 patients. In addition, some of the data we present on reduced pressure laparoscopy comes from clinical

 

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studies not assessing, and unrelated to, the AirSeal system. Further, we lack long-term clinical data on the safety and efficacy of our AirSeal system.

We have developed and maintain a portfolio of intellectual property to protect our technologies, which included 76 issued patents, of which 30 were issued U.S. patents, and 65 patent applications pending globally, of which 26 were patent applications pending in the United States, as of November 1, 2015. We continue to invest in the research and development necessary to design, develop and commercialize new surgical solutions that leverage our technologies to enable less invasive surgical techniques.

We currently market and sell our products in the United States and internationally through a multi-channel sales organization comprised of sales managers, direct sales representatives, clinical education specialists and distributors. The majority of our revenues are generated from sales to hospital customers through our direct sales representatives. Our sales professionals have extensive training and experience in promoting, marketing and selling advanced laparoscopic technologies. We expect to continue to make investments in our global sales organization by increasing the number of our direct sales representatives and broadening our relationships with distributor partners.

For the years ended December 31, 2013 and 2014, our total revenue was $19.1 million and $30.2 million, respectively, and our net losses were $8.3 million and $14.8 million, respectively. For the nine months ended September 30, 2014 and 2015, our total revenue was $20.6 million and $34.7 million, respectively, and our net losses were $11.4 million and $15.1 million, respectively.

Market Opportunity

According to reports by Millennium Research Group, approximately 33 million abdominal surgical procedures are expected to be performed in 2015 in major markets worldwide, of which approximately 10 million are currently addressable by our technology, representing an annual global opportunity for approximately $2 billion of AirSeal disposables. In 2015, approximately 15 million additional procedures are expected to be performed through more invasive conventional open surgical approaches in our target markets worldwide. We believe a significant number of these procedures can be performed with MIS approaches as continued development and increased adoption of techniques that leverage our technologies enable less traumatic access and improved surgical control.

We believe one of the most advanced forms of MIS is robotic-assisted laparoscopic surgery, which combines the benefits of minimally invasive ports with the enhanced dexterity, accuracy and surgical control provided by a robot. There were approximately 570,000 robotic-assisted laparoscopic procedures performed worldwide in 2014. We believe AirSeal is currently the leading surgical access management system used in robotic-assisted MIS procedures globally. We intend to leverage our strong relationships with surgeons that perform robotic-assisted procedures using AirSeal to further penetrate the larger general laparoscopic procedure market and ultimately become the standard of care for surgical access utilized by surgeons worldwide.

Limitations of Conventional Access Devices

Conventional access devices are comprised of three components: trocars, insufflators and insufflation tubing. The limitations of conventional access devices result in several challenges that adversely impact the clinical outcomes and healthcare economics of MIS procedures, including:

      Unintended Loss of Intra-abdominal Pressure.    Loss of intra-abdominal pressure can occur at critical times during a laparoscopic procedure utilizing conventional access devices. Many factors contribute to the loss of pneumoperitoneum, including tears in the mechanical valves, trocar dislodgement, the use of standard suction inside the pressurized body cavity and the venting of surgical smoke. Loss of intra-abdominal pressure results in

 

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        reduced or total loss of visibility of the surgical field and compromised working space. The potential consequences of losing pneumoperitoneum include conversion to open surgery, excessive blood loss, longer operating times, prolonged recovery times, higher post-operative pain and even death.

      Unintended Spikes in Intra-abdominal Pressure.    Significant rises in intra-abdominal pressure above target levels are known as spikes in pneumoperitoneum. Pressure spikes can be induced by the surgeon exerting external pressure on the body cavity during trocar replacement or when maneuvering the patient or from over pressurization of the cavity from conventional insufflators after a loss of pneumoperitoneum. Conventional trocars do not automatically vent gas when the cavity is overpressurized. Significant pressure spikes can have serious cardiovascular consequences including pulmonary embolism, tachycardia and death. Due to the intermittent pressure monitoring and simple on/off mechanics of conventional insufflators, there may be a dangerous delay before intra-abdominal pressure returns to the target level.

      Impact of a High Level of Intra-abdominal Pressure.    Conventional insufflators require surgeons to insufflate the abdominal cavity to pressures ranging from 12mmHg to 15mmHg. This elevation of intra-abdominal pressure has a negative impact on pulmonary compliance, hemodynamics and renal function in laparoscopic surgery. Clinical studies have shown that these pressure levels are associated with numerous side-effects, including post-operative pain, opioid use and extended length of hospital stay, all of which negatively impact hospital profitability.

      Challenging Management of Surgical Smoke.    Surgical smoke is typically vented through the trocar into the operating room, which frequently leads to a loss of pneumoperitoneum because it involves the sudden removal of large volumes of gas from the body. In addition, surgical smoke can expose operating room occupants to potential biohazards.

      Limited Ability for Specimen Removal.    Surgeons must often break specimens down into smaller pieces to allow them to fit through the mechanical valves of a conventional trocar. This may result in the release of unwanted material, such as cancerous tissue and fluids into the body cavity. The mechanical valves of trocars can also trap specimens, making them more difficult to extract from the body.

      Conventional Trocar Design.    Conventional trocars are ports through which cameras and instruments are inserted into the body to visualize the surgical site and perform surgery, respectively. Conventional trocars rely on mechanical valves to create a physical barrier to maintain pneumoperitoneum. These mechanical valves limit the size, shape and number of instruments and prosthetic materials that may be inserted or withdrawn through them. In addition, the mechanical valves themselves cause friction with the instruments inserted through them, hindering the ability to add or remove instruments or surgical specimens through the trocar, contributing to the risk of trocar dislodgement and reducing the surgeon's tactile feedback when engaging tissues and organs. Conventional trocars also incorporate a type of valve called a stopcock which manually controls the flow of gas into or out of the trocar. Stopcocks have small diameters that limit the rate of gas inflow required to maintain stable pneumoperitoneum in the event of significant air leaks or when surgeons use standard suction to clear the surgical field. We believe the limitations of conventional trocar design commonly result in longer procedure times and complications from instability of pneumoperitoneum.

 

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Our Solution

We have developed AirSeal, the first and only integrated surgical access management system to address the limitations associated with conventional access devices, to provide improved clinical outcomes for patients and economic benefits for healthcare providers. The components of our proprietary AirSeal system are the AirSeal Valve-Free Access Port, Intelligent Flow System (iFS) unit and the AirSeal Filtered Tube Set (FTS). We believe Low Impact Surgery provides the following benefits as compared to conventional access devices:

      Stable, Less Rigid State of Pneumoperitoneum.    AirSeal combines sophisticated real-time management of intra-abdominal pressure with a valve-free trocar that uses a proprietary gaseous pressure barrier to maintain pneumoperitoneum and dynamically responds to any pressure increases or decreases in real time.

      Lower Pressure Procedures.    AirSeal enables procedures to be performed at up to 50% lower intra-abdominal pressure than conventional MIS procedures by decreasing fluctuation in intra-abdominal pressure and reducing the pressure spikes and drops associated with conventional insufflation that make lower pressure techniques, such as those achievable by the AirSeal system, more challenging to perform. The benefits of lower intra-abdominal pressure have been clinically demonstrated to include significantly reduced post-operative shoulder pain, need for post-operative pain medication and faster recovery times.

      Integrated and Continuous Smoke Evacuation.    AirSeal continuously evacuates smoke from the abdominal cavity, providing uninterrupted visibility of the surgical field and reducing the risks of exposure to pathogen-laden surgical smoke among operating room occupants, while simultaneously maintaining stable pneumoperitoneum.

      Intact Specimen Removal.    AirSeal access ports are valve-free, enabling surgeons to extract larger specimens without having to dissect them inside the body. We believe that intact specimen removal saves procedure time and reduces the risk of spreading unwanted material, such as cancerous tissue, inside the body cavity.

      Improved Surgical Ergonomics.    AirSeal's patented valve-free access ports enable frictionless insertion or withdrawal of multiple small diameter instruments of both circular and non-circular geometries, implants, sutures and specimens without the risk of losing pneumoperitoneum.

      Faster Procedure Times.    AirSeal has been clinically demonstrated to result in faster average operating times in various types of laparoscopic and robotic-assisted laparoscopic procedures.

Our Strategy

Our goal is to establish AirSeal as the standard of care for every laparoscopic and robotic-assisted laparoscopic procedure worldwide, increase the number of surgeries that can be performed with less invasive surgical approaches and broaden the population of patients for which MIS procedures may be applicable. To accomplish this goal, we are employing the following strategies:

      Leverage our leading position in robotic-assisted MIS to establish Low Impact Surgery as the standard of care for laparoscopic procedures. Surgeons that perform robotic-assisted laparoscopy are typically the opinion leaders in laparoscopic surgery. We believe AirSeal is already the leading access technology utilized in robotic-assisted MIS. We intend to leverage our strong relationships with surgeons that perform robotic-assisted surgery to further penetrate into the larger general laparoscopic procedure market and ultimately become the standard of care in access technology.

 

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      Expand our sales organization to support growth.    We intend to expand our highly-trained direct sales organization and broaden our relationships with distributor partners to facilitate further adoption among existing hospital customers and broaden awareness of Low Impact Surgery in new hospitals.

      Leverage our AirSeal technology to enable Low Impact Surgery for procedures not currently performed using a minimally invasive approach.    We intend to continue leveraging our AirSeal technology and extending the benefits of Low Impact Surgery to broader patient populations, including patients typically treated with surgical procedures performed via open access.

      Deliver cost-effective solutions that extend the clinical and economic benefits of our AirSeal to high-volume laparoscopic procedures.    We intend to leverage the improved surgical working conditions and clinical outcomes enabled by AirSeal, and the less invasive access provided by our proprietary line of Low Impact micro-laparoscopic instruments to enable hospitals to perform higher volume procedures such as laparoscopic cholecystectomy more cost effectively.

      Conduct further clinical studies documenting the clinical and economic benefits of Low Impact Surgery.    We intend to continue to invest in further clinical studies in order to support the publication of peer reviewed articles that validate the clinical and economic benefits of Low Impact Surgery.

      Selectively pursue opportunities to enhance our product offerings.    We intend to continue to expand applications of our AirSeal technology and vigorously protect those innovations through patent applications. We may also opportunistically pursue the licensing or acquisition of complementary products and technologies to strengthen our market position or improve product margins.

Risks Associated with Our Business

Our business is subject to numerous risks, including:

      If we are unable to convince hospital facilities to approve the use of our devices, our sales may decrease;

      We must demonstrate to surgeons and hospitals the merits of our devices to facilitate greater adoption of our devices;

      Our ability to sell our devices at prices necessary to support our current business strategies depends on demonstrating that the benefits of devices incorporating our AirSeal technology outweigh the increased cost of such devices compared to other surgical access methods;

      We have a history of net losses, expect to incur net losses in the future and may never achieve or sustain profitability;

      Our business and products are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business;

      The safety and efficacy of some of our products is not yet supported by long-term clinical data, which could limit sales, and our products might therefore prove to be less safe or effective than initially anticipated; and

      If we are unable to adequately protect our proprietary technology or maintain issued patents that are sufficient to protect our intellectual property, others could compete against

 

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        us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.

Our Corporate Information

We were incorporated under the laws of the state of Delaware in November 2005. Our principal executive offices are located at 488 Wheelers Farms Road, Milford, Connecticut 06461, and our telephone number is (203) 799-2400. Our website address is www.surgiquest.com. The information contained in, or accessible through, our website does not constitute part of this prospectus.

Implications of Being an Emerging Growth Company

As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an "emerging growth company" as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012. An "emerging growth company" may take advantage of exemptions from some of the reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

      being permitted to present only two years of audited financial statements in addition to any required unaudited interim financial statements and only two years of related Management's Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

      not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;

      reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

      exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the closing of this offering. However, if certain events occur prior to the end of such five-year period, including if we become a "large accelerated filer" as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, our annual gross revenue exceeds $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

We have elected to take advantage of certain of the reduced disclosure obligations in this prospectus and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have irrevocably elected not to avail ourselves of this exemption and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

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THE OFFERING

Common stock offered by us

           shares

Common stock to be outstanding after this offering

 

             shares (or             shares, if the underwriters exercise in full their option to purchase additional shares).

Option to purchase additional shares

 

The underwriters have a 30-day option to purchase up to             additional shares of common stock.

Use of proceeds

 

We estimate that our net proceeds from our issuance and sale of              shares of our common stock in this offering will be approximately $              million (or approximately $              million if the underwriters exercise in full their option to purchase additional shares), based on an assumed initial public offering price of $              per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering as follows: (i) $             to expand our sales and marketing efforts relating to our U.S. and international sales presence; (ii) $             to continue to invest in our research and development program; (iii)  $             to continue clinical research documenting the benefits of our technology; (iv) $             to satisfy a royalty buyout obligation to IP Technologies, LLC triggered by this offering; and (v) the balance for working capital and general corporate purposes. We may also use a portion of our net proceeds to acquire and invest in complementary products, technologies or businesses; however, we currently have no agreements or commitments to complete any such transaction. See "Use of Proceeds."

Directed share program

 

At our request, the underwriters have reserved up to shares of common stock, or approximately         % of the shares of common stock offered by this prospectus, for sale, at the initial public offering price, to our directors, officers, employees and other parties associated with us. The number of shares of common stock available for sale to the general public will be reduced by the number of directed shares purchased by participants in the program. Any reserved shares that are not so purchased will be offered by the underwriters to the general public on the same terms as the other shares of our common stock offered by this prospectus.

 

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Risk factors

 

See "Risk Factors" and the other information included in this prospectus for a discussion of factors you should consider carefully before deciding to invest in our common stock.

Proposed               symbol

 

"             "

The number of shares of our common stock to be outstanding after this offering is based on 15,808,998 shares of our common stock outstanding as of September 30, 2015, after giving effect to the conversion of shares of our redeemable convertible preferred stock outstanding as of September 30, 2015 into an aggregate of 14,400,960 shares of our common stock upon the closing of this offering, and excludes:

      1,101,060 shares of common stock issuable upon exercise of stock options outstanding and exercisable as of September 30, 2015, at a weighted-average exercise price of $0.97 per share;

      472,515 shares of common stock issuable upon the exercise of outstanding warrants as of September 30, 2015, at a weighted-average exercise price of $3.85 per share; and

                     shares of our common stock reserved for future issuance under our 2015 Incentive Award Plan, or the 2015 Plan, which will become effective prior to the closing of this offering.

Unless otherwise indicated, this prospectus reflects and assumes the following:

      the automatic conversion of all outstanding shares of our redeemable convertible preferred stock into 14,400,960 shares of common stock, which will occur upon the closing of this offering;

      no exercise of outstanding options or warrants after September 30, 2015;

      the filing of our seventh amended and restated certificate of incorporation and the adoption of our amended and restated bylaws, which will occur upon the closing of this offering; and

      no exercise by the underwriters of their option to purchase additional shares of our common stock.

 

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SUMMARY FINANCIAL DATA

The following tables set forth, for the periods and as of the dates indicated, our summary financial data. The statement of operations data for the years ended December 31, 2013 and 2014 are derived from our audited financial statements appearing elsewhere in this prospectus. The balance sheet data as of September 30, 2015 and the statement of operations for the nine months ended September 30, 2014 and 2015 are derived from our unaudited condensed financial statements appearing elsewhere in this prospectus. We have prepared the unaudited condensed financial statements on the same basis as the audited financial statements, and the unaudited financial data include, in our opinion, all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair presentation of our financial position and results of operations for these periods. Our historical results are not necessarily indicative of our future results and our operating results for the nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015 or any other interim periods or any future year or period. You should read the following information together with our financial statements and the related notes included elsewhere in this prospectus and the sections of this prospectus entitled "Selected Financial Data" and "Management's Discussion and Analysis of Financial Condition and Results of Operations."

 

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  Year Ended December 31,   Nine Months Ended September 30,  
 
  2013   2014   2014   2015  
 
   
   
  (Unaudited)
 
 
  (In thousands, except per share and share amounts)
 

Statement of operations data:

                         

Revenues

  $ 19,102   $ 30,249   $ 20,601   $ 34,733  

Cost of goods sold

    11,052     16,031     10,874     16,232  

Gross profit

    8,050     14,218     9,727     18,501  

Selling, general and administrative expenses

    12,978     23,622     17,194     27,522  

Research and development expenses

    2,029     2,909     2,194     2,950  

    15,007     26,531     19,388     30,472  

Operating loss

    (6,957 )   (12,313 )   (9,661 )   (11,971 )

Other (expense) income:

   
 
   
 
   
 
   
 
 

Interest expense

    (909 )   (2,146 )   (1,580 )   (1,823 )

Interest income

    12     31     24     17  

Other (expense) income, net

    (414 )   (388 )   (221 )   (1,363 )

Total other (expense) income, net

    (1,311 )   (2,503 )   (1,777 )   (3,169 )

Net loss

    (8,268 )   (14,816 )   (11,438 )   (15,140 )

Cumulative preferred stock dividends

    (1,978 )   (2,156 )   (1,612 )   (2,481 )

Preferred stock accretion              

    (5,256 )   (5,292 )   (3,981 )   (6,583 )

Net loss attributable to common shareholders

  $ (15,502 ) $ (22,264 ) $ (17,031 ) $ (24,204 )

Per share data:

                         

Basic and diluted net loss per share attributable to common stockholders(1)

  $ (13.45 ) $ (18.03 ) $ (13.92 ) $ (17.38 )

Weighted average outstanding common shares used in computing net loss per share attributable to common stockholders:

                         

Basic and diluted(1)

    1,152,665     1,235,111     1,223,091     1,392,759  

Pro forma basic and diluted net loss per share attributable to common stockholders (unaudited)(2)

        $           $    

Weighted average outstanding common shares used in computing pro forma net loss per share attributable to common stockholders:

                         

Basic and diluted (unaudited)(2)

                         

(1)
See Note 3 to our financial statements included elsewhere in this prospectus for an explanation of the method used to calculate the historical basic and diluted net loss per share attributable to common stockholders.

(2)
The unaudited pro-forma weighted average outstanding common shares used in computing pro-forma net loss per share attributable to stockholders (basic and diluted) has been prepared to give the effect of automatic conversion of all outstanding shares of convertible preferred stock into 14,400,960 shares of common stock.

 

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  As of September 30, 2015
(Unaudited)
(In thousands)
 
 
  Actual   Pro Forma(1)   Pro Forma
As Adjusted(2)(3)
 

Balance sheet data:

                   

Cash and cash equivalents

  $ 7,840   $                 $    

Total assets

    28,359              

Current liabilities

    16,543              

Total debt less unamortized discounts

    24,950              

Total stockholders' deficit

    (106,472 )            

(1)
The pro forma balance sheet data give effect to the automatic conversion of all outstanding shares of our redeemable convertible preferred stock into 14,400,960 shares of common stock upon the closing of this offering.

(2)
In addition to the pro forma adjustments set forth in footnote 1, gives further effect to the sale by us of             shares of common stock in this offering at an assumed initial public offering price of $         per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(3)
Each $1.00 increase (decrease) in the assumed initial public offering price of $         per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total stockholders' deficit by approximately $          million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares in the number of shares offered by us, at the assumed initial public offering price per share of $             , which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total stockholders' deficit by approximately $          million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma and pro forma as adjusted information discussed above is illustrative only and will change depending on the actual initial public offering price and other terms of our initial public offering determined at pricing.

 

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RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our financial statements and the related notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations," before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Risks Related to our Business and Strategy

If we are unable to convince hospital facilities to approve the use of our devices, our sales may decrease.

In the United States, in order for surgeons to use our devices, the hospital facilities where these surgeons treat patients will typically require us to receive approval from the facility's value analysis committee, or VAC. VACs typically review the comparative effectiveness and cost of medical devices used in the facility. The makeup and evaluation processes for VACs vary considerably, and it can be a lengthy, costly and time-consuming effort to obtain approval by the relevant VAC. For example, even if we have an agreement with a hospital system for purchase of our devices, in most cases, we must obtain VAC approval by each hospital within the system to sell at that particular hospital. Additionally, hospitals typically require separate VAC approval for each specialty in which our device is used, which may result in multiple VAC approval processes within the same hospital even if such device has already been approved for use by a different specialty group. We often need VAC approval for each different device to be used by the surgeons in that specialty. In addition, hospital facilities and group purchasing organizations, or GPOs, which manage purchasing for multiple facilities, may also require us to enter into a purchasing agreement and satisfy numerous elements of their administrative procurement process, which can also be a lengthy, costly and time consuming effort. If we do not receive access to hospital facilities in a timely manner, or at all, via these VAC and purchasing contract processes, or otherwise, or if we are unable to secure contracts on commercially reasonable terms in a timely manner, or at all, our operating costs will increase, our sales may decrease and our operating results may be harmed. Furthermore, we may expend significant effort in these costly and time-consuming processes and still may not obtain VAC approval or a purchase contract from such hospitals or GPOs.

We must demonstrate to surgeons and hospitals the merits of our devices to facilitate greater adoption of our devices.

Surgeons play a significant role in determining the devices used in the operating room and in assisting in obtaining approval by the relevant VAC. Our devices have higher upfront costs than conventional access devices, so educating surgeons on the benefits of our devices compared to conventional access devices requires a significant commitment by our marketing team and sales organization. Surgeons and hospitals may be slow to change their practices because of familiarity with existing devices, perceived risks arising from the use of new devices, lack of experience using new devices, lack of clinical data supporting the benefits of such devices or the cost of new devices. There may never be widespread adoption of our devices by surgeons and hospitals. If we are unable to educate surgeons and hospitals about the advantages of devices incorporating our AirSeal technology, as compared to surgical methods which do not incorporate this technology, we may face challenges in obtaining approval by the relevant VAC, and we will not achieve significantly greater market acceptance of our devices, gain

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momentum in our sales activities, significantly grow our market share or grow our revenue and our business and financial condition will be adversely affected.

Our ability to sell our devices at prices necessary to support our current business strategies depends on demonstrating that the benefits of a device incorporating our AirSeal technology outweigh the increased cost of such devices compared to other surgical access methods.

Hospital and other healthcare provider customers that purchase our devices typically bill various third-party payors to cover all or a portion of the costs and fees associated with the surgical procedures in which our devices are used and bill patients for any deductibles or copayments. Supplies used in surgery, such as our devices, are typically not separately reimbursed by third-party payors, but are rather included in the overall reimbursement for the procedure involved. Because there is no separate reimbursement for medical devices and supplies used in surgical procedures, the additional cost associated with the use of our devices can impact the profit margin of the hospital or surgery center where the surgery is performed. If reimbursement is inadequate, hospitals may choose to use less expensive instruments or devices that do not include our AirSeal technology. Some of our target customers may be unwilling to adopt our devices in light of the additional associated cost. Our success depends on our ability to convince such cost-restricted customers that the potential benefits of using our devices, such as AirSeal outweigh the additional cost of such devices.

We are an early, commercial-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.

We are an early, commercial-stage company and have a limited operating history. We began our operations in 2006 and began a commercial launch of our AirSeal products in 2009. Our limited commercial operating history may make it difficult to evaluate our current business and predict our future performance. Any assessment of our profitability or prediction about our future success or viability is subject to significant uncertainty. We have encountered and will continue to encounter risks and difficulties frequently experienced by early, commercial-stage companies in rapidly evolving industries. If we do not address these risks successfully, it could have a material adverse effect on our revenue, results of operations and business.

We have a history of net losses, expect to incur net losses in the future and may never achieve or sustain profitability.

We have historically incurred substantial net losses, including net losses of $15.1 million for the nine months ended September 30, 2015, $14.8 million for the year ended December 31, 2014 and $8.3 million for the year ended December 31, 2013. As of September 30, 2015, we had an accumulated deficit of $106.1 million. We expect our losses to continue in the near term as a result of increased commercialization costs, increased cost of goods sold, including manufacturing costs and research and development expenses. These losses have had, and will continue to have, an adverse effect on our working capital, total assets and stockholders' deficit. Because of the numerous risks and uncertainties associated with our commercialization efforts, we are unable to predict when we will become profitable, and we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our inability to achieve and subsequently sustain profitability could have a material adverse effect on our results of operations and business.

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Our independent registered public accounting firm has identified a material weakness in our internal control over financial reporting that, if not properly remediated, could result in material misstatements in our financial statements in future periods.

Although we did not engage our independent registered public accounting firm to conduct an audit of our internal control over financial reporting, in connection with the audit of our consolidated financial statements as of and for the years ended December 31, 2014 and 2013, our independent registered public accounting firm informed us that they identified a material weakness relating to our internal control over financial reporting under standards established by the PCAOB. The PCAOB defines a material weakness as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. A deficiency in internal control exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis.

The material weakness identified by our independent registered public accounting firm related to adjustments made in connection with their audit of our financial statements due to our accounting department's lack of depth and technical accounting knowledge necessary to properly account and report on complex accounting matters. We are evaluating a number of actions to remediate this material weakness. We cannot assure you when we will remediate such weakness, nor can we be certain of whether additional actions will be required or the costs of any such actions.

We may need to take additional measures to fully mitigate these issues, and the measures we have taken, and expect to take, to improve our internal controls may not be sufficient to address the issues identified, to ensure that our internal controls are effective or to ensure that the identified material weakness or other material weaknesses or deficiencies will not result in a material misstatement of our annual or interim financial statements. In addition, other material weaknesses or deficiencies may be identified in the future. If we are unable to correct material weaknesses or deficiencies in internal controls in a timely manner, our ability to record, process, summarize and report financial information accurately and within the time periods specified in the rules and forms of the SEC will be adversely affected. This failure could negatively affect the market price and trading liquidity of our common stock, cause investors to lose confidence in our reported financial information, subject us to civil and criminal investigations and penalties, and generally materially and adversely impact our business and financial condition.

We operate in a highly competitive market segment. If our competitors are better able to market and develop devices than we are able to market or develop devices, our business will be adversely impacted.

The MIS access device industry is highly competitive. Our success depends, in part, upon our ability to maintain a competitive position in the development of technologies and devices for MIS access. Any device we develop will have to compete for market acceptance and market share. We believe that the primary competitive factors in the MIS access device market segment are clinical safety and effectiveness, price, surgeon experience and comfort with use of particular MIS access devices, reliability and durability, ease of use, device support and service, salesforce experience and relationships. We face significant competition in the United States and internationally in the MIS access device market, and we expect the intensity of competition will increase over time. Surgeons and hospitals typically use MIS access devices, and if we cannot convince surgeons and hospitals of the benefits of using our devices in addition to, or as an alternative to, other MIS access devices, or, of the benefits of using our products instead of using competing products, our business may be harmed. Some

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of our main competitors include Stryker Corporation, Karl Storz Endoscopy-America, Inc., Olympus Corporation and Richard Wolf Medical Instruments Corporation (insufflators); Ethicon Endo-Surgery, LLC (a subsidiary of Johnson & Johnson), Covidien plc and Applied Medical Resources Corporation (trocars); numerous generic manufacturers of insufflation tubing; and other general surgical instrument companies that supply MIS access devices. Many of the companies developing or marketing competing products enjoy several competitive advantages, including:

      more established sales and marketing programs and distribution networks;

      long established relationships with surgeons and hospitals;

      contractual relationships with customers;

      products that have already received approval from the relevant VACs;

      greater financial and human resources for product development, sales and marketing;

      greater name recognition;

      the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives; and

      greater experience in and resources for conducting research and development, clinical studies, manufacturing, preparing regulatory submissions, obtaining regulatory clearance or approval for products and marketing approved products.

Our competitors may develop and patent processes or devices earlier than us, obtain regulatory clearance or approvals for competing devices more rapidly than us or develop more effective or less expensive devices or technologies that render our technology or devices obsolete or less competitive. We also face fierce competition in recruiting and retaining qualified sales, scientific and management personnel. If our competitors are more successful than us in these matters, our business may be harmed.

Substantially all of our revenue is generated from our AirSeal system.

We generate substantially all of our revenue from the commercialization of the AirSeal system, and we expect this to continue for the foreseeable future. Customers may decide not to purchase the AirSeal system, or our customers may decide to cancel orders due to changes in treatment offerings, research and product development plans, adverse clinical outcomes, difficulties in obtaining coverage or reimbursement for our devices, complications with manufacturing or utilization of similar technology developed by other parties, all of which are circumstances outside of our control.

Furthermore, demand for the AirSeal system may not increase as quickly as we predict, and we may be unable to increase our revenue levels as we expect. Even if we succeed in increasing adoption of these systems by surgeons, hospitals and other healthcare providers, maintaining and creating relationships with our existing and new customers and developing and commercializing new features or indications for these systems, we may not be able to generate sufficient revenue to achieve profitability.

The loss of members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and salespeople could adversely affect our business.

Our future success depends on our ability to recruit, train, retain and motivate key personnel, including members of our senior management team, our research and development personnel, science and engineering staff, laboratory staff, sales teams and marketing personnel. The individual and

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collective efforts of these employees will be important as we continue to develop our AirSeal products and additional products, and as we expand our commercial activities. We do not maintain fixed-term employment contracts or key man life insurance with any of our employees, other than our CEO. Competition for highly-skilled and qualified personnel is intense. Our growth depends, in particular, on attracting, retaining and motivating highly trained sales personnel with the proper scientific or business backgrounds. We face competition from universities and public and private research institutions in recruiting highly scientific personnel. In addition, we may need additional employees at our facilities to meet demand for our products as we grow our sales and marketing operations. Because of the complex and technical nature of our products and the dynamic industry in which we compete, any failure to attract, train, retain and motivate highly qualified personnel could materially harm our operating results and growth prospects.

If we are unable to maintain and expand our network of direct sales representatives and distributors, we may not be able to generate anticipated sales.

We currently market and sell our products in the United States and internationally through a multi-channel sales organization comprised of sales managers, direct sales representatives, clinical education specialists and distributors. The vast majority of our revenues are generated from sales to hospital customers through our direct sales representatives and distributors. Our operating results are directly dependent upon the sales and marketing efforts of not only our direct sales representatives, but also our distributors. We may not be successful in maintaining strong relationships with our distributors. If our direct sales representatives or distributors fail to adequately promote, market and sell our products, our sales could significantly decrease.

We face significant challenges and risks in managing our geographically dispersed distribution network and retaining the individuals who make up that network. Our distributors may not be able to successfully market and sell our products and may not devote sufficient time and resources to support the marketing and selling efforts that enable the products to develop, achieve or sustain market acceptance in their respective jurisdictions. Additionally, in some international jurisdictions, we rely on our distributors to manage the regulatory process, and we are dependent on their ability to do so effectively.

If any of our direct sales representatives were to leave us, our sales could be adversely affected. If a direct sales representative were to depart and be retained by one of our competitors, we may be unable to prevent them from helping competitors solicit business from our existing customers, which could further adversely affect our sales. Because of the intense competition for their services, we may be unable to recruit or retain additional qualified direct sales representatives to work with us. Failure to hire or retain qualified direct sales representatives would prevent us from expanding our business and generating sales.

As a result of our reliance distributors, we may be subject to disruptions and increased costs due to factors beyond our control, including labor strikes, third-party error and other issues. If the services of any of these distributors become unsatisfactory, including the failure of such distributors to properly train surgeons and clinicians in the use of our products, we may experience delays in meeting our customers' product demands and we may not be able to find a suitable replacement on a timely basis or on commercially reasonable terms. Any failure to deliver products in a timely manner may damage our reputation and could cause us to lose current or potential customers.

As we launch new products and increase our marketing efforts with respect to existing products, we will need to expand the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled direct sales representatives

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with significant technical knowledge in various areas. If we fail to train new hires adequately, or if we experience high turnover in our sales force in the future, new hires may not become as productive as may be necessary to maintain or increase our sales.

If we are unable to expand our sales and marketing capabilities domestically and internationally, we may not be able to effectively commercialize our products, which would adversely affect our business, results of operations and financial condition.

Our manufacturing operations are dependent upon third-party suppliers, making us vulnerable to supply problems and price fluctuations, which could harm our business.

We rely on a number of suppliers who manufacture certain components of our devices. We do not have long-term supply agreements with most of our suppliers, and, in many cases, we purchase finished goods on a purchase order basis. Our suppliers may encounter problems during manufacturing for a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction and environmental factors, any of which could delay or impede their ability to meet our demand. Our reliance on these third-party suppliers also subjects us to other risks that could harm our business, including:

      some of our suppliers are smaller and may not be able to weather sustained downturns;

      we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;

      price fluctuations due to a lack of long-term supply arrangements with our suppliers for components or finished goods;

      our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of our devices or cause delays in shipment;

      we may have difficulty locating and qualifying alternative suppliers;

      switching components or suppliers may require device redesign and possibly premarket submission to the FDA;

      the failure of our suppliers to comply with strictly enforced regulatory requirements, which could result in disruption of supply or increased expenses;

      the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may affect the supplier's ability to deliver components or finished goods to us in a timely manner; and

      our suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.

If our third-party suppliers are unable to deliver us quality products in a timely manner, our results of operations could be adversely impacted.

We rely on single-source suppliers for certain of our components and materials and may not be able to find replacements or immediately transition to alternative suppliers.

We rely on World of Medicine AG to manufacture our iFS unit. An interruption in our commercial operations could occur if we encounter delays or difficulties in securing this product, and if we cannot then obtain an acceptable substitute. If we are required to transition to a new third-party manufacturer for our iFS unit, we believe that there are only a few other manufacturers that are currently capable of

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manufacturing the device. Any such interruption could harm our reputation, business, financial condition and results of operations.

Furthermore, if we are required to change the manufacturer of a critical component of our products or the assembly manufacturer of our unfinished goods, we will be required to verify that the new manufacturer maintains facilities, procedures and operations that comply with our quality and applicable regulatory requirements, which could further impede our ability to manufacture our products in a timely manner. We currently do not carry inventory for components for more than 3 months at any given time. Transitioning to a new supplier could be time-consuming, and may result in interruptions in our operations and product delivery. The occurrence of any of these events could harm our ability to meet the demand for our products in a timely manner or cost-effectively.

We may not be able to secure alternative equipment and materials and utilize such equipment and materials without experiencing interruptions in our workflow. If we should encounter delays or difficulties in securing, reconfiguring or revalidating the equipment and components we require for our devices, our reputation, business, financial condition and results of operations could be negatively impacted.

Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.

Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point transport of our products to our customers and for tracking of these shipments. Should a carrier encounter delivery performance issues such as loss, damage or destruction of any systems, it would be costly to replace such systems in a timely manner and such occurrences may damage our reputation and lead to decreased demand for our products and increased cost and expense to our business. In addition, any significant increase in shipping rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters or other service interruptions affecting delivery services we use would adversely affect our ability to process orders for our products on a timely basis.

We bear the risk of warranty claims on our devices.

We bear the risk of warranty claims on the AirSeal iFS unit, to the extent that they exceed warranty coverage provided by our suppliers. If warranty claims result in material liabilities, our business, financial condition and results of operations could be harmed.

We generate a significant portion of our revenue internationally and are subject to various risks relating to our international activities which could adversely affect our operating results.

We currently have significant international operations. Doing business internationally involves a number of difficulties and risks, including:

      required compliance with existing and changing foreign healthcare and other regulatory requirements and laws, such as those relating to patient privacy, security of patient information and/or handling of bio-hazardous waste;

      required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act, or FCPA, and U.K. Bribery Act, privacy and data security requirements, labor laws and anti-competition regulations;

      export or import restrictions;

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      various reimbursement and insurance regimes;

      laws and business practices favoring local companies;

      longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;

      political and economic instability;

      potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;

      foreign exchange controls;

      difficulties and costs of staffing and managing foreign operations; and

      difficulties protecting or procuring intellectual property rights.

As we expand internationally, our results of operations and cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates. Our expenses are denominated in the currencies in which our operations are located, which is in the United States. If the value of the U.S. dollar increases relative to foreign currencies in the future, in the absence of a corresponding change in local currency prices, our future revenue could be adversely affected as we convert future revenue from local currencies to U.S. dollars.

If we are unable to manage these risks effectively, our business, operating results and prospects could suffer.

We may face product liability claims that could result in costly litigation and significant liabilities, and we may not be able to maintain adequate product liability insurance.

Our business exposes us to the risk of product liability claims that are inherent in the testing, manufacturing and marketing of medical devices. This risk exists even if a device is cleared or approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority. Manufacturing and marketing of our commercial devices and clinical testing of our devices under development, may expose us to product liability and other tort claims. Furthermore, surgeons may misuse our devices or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk of product liability. If our devices are misused or used with improper technique, we may become subject to costly litigation by our customers or their patients. Regardless of the merit or eventual outcome, product liability claims may result in:

      significant litigation costs;

      distraction of management's attention from our primary business;

      impairment of our business reputation;

      heightened regulatory scrutiny of our devices by FDA and foreign regulatory agencies;

      the inability to commercialize our devices;

      decreased demand for our devices or devices in development, if cleared or approved;

      device recall or withdrawal from the market;

      withdrawal of clinical trial participants;

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      substantial monetary awards to patients or other claimants; or

      loss of revenue.

Although we have, and intend to maintain, liability insurance, the coverage limits of our insurance policies may not be adequate, and one or more successful claims brought against us may have a material adverse effect on our business and results of operations. If we are unable to obtain insurance in the future at an acceptable cost or on acceptable terms with adequate coverage, we will be exposed to significant liabilities.

We may not be able to gain the support of leading hospitals and key opinion leaders, which may make it difficult to establish our AirSeal products as a standard of care and may limit our revenue growth and ability to achieve profitability.

Our strategy includes developing relationships with surgeons, key opinion leaders and leading hospitals in the medical, surgical and related fields. If such potential users do not conclude that our AirSeal products are clinically effective enough to displace current technology, or if we encounter difficulty promoting adoption or establishing our AirSeal products as a standard of care in the surgical field, our business could be significantly affected.

Consolidation among our customers and in the healthcare industry as a whole could lead to demands for price concessions or to the exclusion of some suppliers such as us from certain of our markets, which could have an adverse effect on our business, results of operations or financial condition.

Because healthcare costs have risen significantly over the past decade, numerous initiatives and reforms initiated by legislators, regulators and third-party payors to curb these costs have resulted in a consolidation trend in the healthcare industry to aggregate purchasing power. As the healthcare industry consolidates, competition to provide products and services to industry participants has become and will continue to become more intense. This in turn has resulted and will likely continue to result in greater pricing pressures and the exclusion of certain suppliers, including us, from important market segments as GPOs, independent delivery networks and large single accounts continue to use their market power to consolidate purchasing decisions for hospitals. We expect that market demand, government regulation, third-party coverage and reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure on the prices of our products and may adversely impact our business, results of operations or financial condition.

Our future capital needs are uncertain, and we may need to raise additional funds in the future.

We believe that our existing cash, together with cash receipts from the sales of our products and the net proceeds from this offering, will be sufficient to meet our anticipated cash requirements for at least the next 24 months. However, we may need to raise substantial additional capital to:

      expand our product offerings;

      expand our sales and marketing infrastructure;

      increase our manufacturing capacity;

      fund our operations;

      fund our additional clinical studies; or

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      continue our research and development activities.

Our future funding requirements will depend on many factors, including:

      commercial market acceptance of our products;

      the cost and timing of establishing sales, marketing and distribution capabilities;

      the cost of our research and development activities;

      the ability of healthcare providers to obtain coverage and adequate reimbursement by third-party payors for procedures using our products;

      our ability to obtain any necessary approvals or clearances from regulatory authorities to market our products;

      the cost and timing of any necessary regulatory approvals or clearances;

      the cost of goods associated with our products;

      the effect of competing technological and market developments; and

      the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for products, although we currently have no commitments or agreements to complete any such transactions.

We may not be able to acquire additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or additional equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay, reduce the scope of or eliminate some or all of our development programs.

If we do not have, or are not able to obtain, sufficient funds, we may be required to delay development or commercialization of our products or license to third parties the rights to commercialize our products or technologies that we would otherwise seek to commercialize ourselves. We also may have to reduce marketing, customer support or other resources devoted to our products or cease operations. Any of these factors could harm our operating results.

Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.

As of December 31, 2014, we had federal net operating loss carryforwards, or NOLs, of $58.8 million, which are available to offset future taxable income, if any, through 2019. Under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an "ownership change" is subject to limitations on its ability to utilize its NOLs to offset future taxable income. We may have already experienced one or more ownership changes. Depending on the timing of any future utilization of our carryforwards, we may be limited as to the amount that can be utilized each year as a result of such previous ownership changes. In addition, future changes in our stock ownership, including this or future offerings, as well as other changes that may be outside of our control, could result in additional ownership changes under Section 382 of the Code. Our NOLs

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may also be impaired under similar provisions of state law. Furthermore, we may not be able to generate sufficient taxable income to utilize our NOLs before they expire. We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless or negligent conduct or other unauthorized activities that violate: (1) U.S. laws and FDA regulations, and the laws and regulations of other similar foreign regulatory bodies, including those laws and regulations that require the reporting of true, complete and accurate information, including financial and operating data, to regulatory bodies; (2) manufacturing standards; or (3) healthcare fraud and abuse laws and regulations in the United States and similar foreign fraudulent misconduct laws. Compliance with these laws and regulations may impact, among other things, our activities with principal investigators and research subjects, as well as our sales, marketing and education programs. In particular, the promotion, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent misconduct, including fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation.

It is not always possible to identify and deter misconduct by employees and other third parties. The precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Any of these actions or investigations could result in substantial costs to us, including legal fees, and divert the attention of management from the operation of our business.

Our long-term growth depends on our ability to develop and commercialize additional devices.

The medical device industry is highly competitive and subject to rapid change and technological advancements. Therefore, it is important to our business that we continue to enhance our device offerings and introduce new devices. Developing new devices is expensive and time-consuming and could divert management's attention away from our core business. Even if we are successful in developing additional devices, the success of any new device offering or enhancements to existing devices will depend on several factors, including our ability to:

      properly identify and anticipate surgeon and patient needs;

      develop and introduce new devices or device enhancements in a timely manner;

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      develop an effective and dedicated sales and marketing team;

      avoid infringing upon the intellectual property rights of third-parties;

      demonstrate, if required, the safety and efficacy of new devices with data from preclinical studies and clinical trials;

      obtain the necessary regulatory clearances or approvals for new devices or device enhancements;

      be fully FDA-compliant with marketing of new devices or modified devices;

      provide adequate training to potential users of our devices; and

      receive adequate coverage and reimbursement for procedures performed with our devices.

If we are unsuccessful in developing and commercializing additional devices in other areas, our ability to increase our revenue may be impaired.

New technologies, techniques or products could emerge that might offer better combinations of price and performance than the products and services that we plan to offer. Existing markets for our intended surgical devices are characterized by rapid technological change and innovation. It is critical to our success that we anticipate changes in technology and customer requirements and physician, hospital and healthcare provider practices. It is also important that we successfully introduce new, enhanced and competitive products to meet our prospective customers' needs on a timely and cost-effective basis. At the same time, however, we must carefully manage our introduction of new products. If potential customers believe that such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available. We may also continue to offer older obsolete products as we transition to new products, and we may not have sufficient experience managing product transitions. If we do not successfully innovate and introduce new technology into our anticipated product lines or successfully manage the transitions of our technology to new product offerings, our revenue, results of operations and business could be adversely impacted.

Our competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, industry standards, distribution reach or customer requirements. We anticipate that we will face strong competition in the future as current or future competitors develop new or improved products and as new companies enter the market with novel technologies.

If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our devices and, as a result, there will be an adverse impact on our business until we are able to secure a new facility.

Our facility and equipment would be costly to replace and could require substantial lead time to repair or replace. The facility may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, flooding, fire, vandalism and power outages, which may render it difficult to operate our business for some period of time. While we have taken precautions to safeguard our facilities, any inability to operate our business during such periods could lead to the loss of customers or harm to our reputation. We also possess insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all.

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If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected.

The efficient operation of our business depends on our information technology systems. We rely on our information technology systems to effectively manage:

      sales and marketing, accounting and financial functions;

      inventory management;

      engineering and product development tasks; and

      our research and development data.

Our information technology systems are vulnerable to damage or interruption from:

      earthquakes, fires, floods and other natural disasters;

      terrorist attacks and attacks by computer viruses or hackers;

      power losses; and

      computer systems, or Internet, telecommunications or data network failures.

We do not have redundant systems. The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition.

If we fail to properly manage our anticipated growth, our business could suffer.

We have been growing rapidly in recent periods and have a relatively short history of operating as a commercial company. We intend to continue to grow and may experience periods of rapid growth and expansion. Future growth will impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth will place a strain on our administrative personnel, information technology systems and other operational infrastructure. Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals. To achieve our revenue goals, we must continue to hire, train, retain and motivate skilled personnel.

In order to manage our operations and growth we will need to continue to improve our operational and management controls, reporting and information technology systems and financial internal control procedures. If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer.

We must also successfully increase production output to meet expected customer demand. In the future, we may experience difficulties with production yields, quality control, component supply and shortages of qualified personnel, among other problems. These problems could result in delays in product availability and increases in expenses. Any such delay or increased expense could adversely affect our ability to generate revenues.

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Our business is subject to seasonal fluctuations.

Our business is subject to seasonal fluctuations in that our sales are typically lower during the summer months and winter holidays due to the timing of MIS procedures. As a result, our financial results for any single quarter or for periods of less than a year are not necessarily indicative of the results that may be achieved for a full fiscal year.

We face risks and potential liabilities related to handling hazardous materials and other regulations governing environmental safety.

Our operations are subject to complex and stringent environmental, health, safety and other governmental laws and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these regulations include, among other things, our use of hazardous materials and the generation, transportation and storage of waste. We may not be in material compliance with these regulations at all times. Existing laws and regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether retroactively or prospectively. Such revisions, reinterpretations or new law and regulations may have a negative effect on our business and results of operations. It is also impossible to completely eliminate the risk of accidental environmental contamination or injury to individuals. In such an event, we could potentially be liable for any damages that result, which could adversely affect our business.

Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.

We may acquire other businesses, products or technologies as well as pursue strategic alliances, joint ventures, technology licenses or investments in complementary businesses. We have not made any acquisitions to date, and, as such, our ability to do so successfully is unproven. Any of these potential transactions could be material to our financial condition and operating results and expose us to many risks, including:

      disruption in our relationships with future customers or with current or future partners or suppliers as a result of such a transaction;

      unanticipated liabilities related to acquired companies;

      difficulties integrating any acquired personnel, technologies and operations into our existing business;

      diversion of management time and focus from operating our business to transaction integration challenges;

      increases in our expenses and reductions in our cash available for operations and other uses;

      possible write-offs or impairment charges relating to acquired businesses; and

      inability to develop a sales force for any additional products.

Foreign acquisitions involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures and languages, currency risks and the particular economic, political and regulatory risks associated with certain countries.

Also, the anticipated benefit of any acquisition may not materialize. Future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent

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liabilities or amortization expenses or write-offs of goodwill, any of which could harm our financial condition.

Provisions of our debt instruments may restrict our ability to pursue our business strategies.

Our credit facilities require us, and any debt instruments we may enter into in the future may require us, to comply with various covenants that limit our ability to, among other things:

      convey, lease, sell, transfer, assign or otherwise dispose of assets;

      change the nature or location of our business;

      complete mergers or acquisitions;

      incur indebtedness;

      encumber certain of our assets;

      pay dividends or make other distributions to holders of our capital stock (other than dividends paid solely in common stock);

      make certain specified investments;

      change certain key management personnel; and

      engage in material transactions with our affiliates.

These restrictions could inhibit our ability to pursue our business strategies. If we default under our credit facilities, and such event of default was not cured or waived, our lenders may terminate commitments to lend and cause all amounts outstanding with respect to the debt to be due and payable immediately, which in turn could result in cross defaults under other debt instruments. Our assets and cash flow may not be sufficient to fully repay borrowings under all of our outstanding debt instruments if some or all of these instruments are accelerated upon a default.

We may incur additional indebtedness in the future. The debt instruments governing such indebtedness could contain provisions that are as, or more, restrictive than our existing debt instruments. If we are unable to repay, refinance or restructure our indebtedness when payment is due, the lenders could proceed collection against the collateral granted to them to secure such indebtedness or force us into bankruptcy or liquidation.

Economic or business instability may have a negative impact on our business.

Continuing concerns over U.S. health care reform legislation, geopolitical issues and government stimulus programs in the United States and other countries have contributed to volatility for the global economy. If the economic climate worsens, our business, including our access to patient samples and the addressable market for our products that we may successfully develop, as well as the financial condition of our suppliers and our commercial third-party payors, could be adversely affected, resulting in a negative impact on our business, financial condition and results of operations. In the event of an economic slowdown, investment in bioinformatics and genetic research and development may also experience a corresponding slowdown.

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Risks Related to Government Regulation

The safety and efficacy of some of our products is not yet supported by long-term clinical data, which could limit sales, and our products might therefore prove to be less safe or effective than initially anticipated.

Our products that we market in the United States are regulated as medical devices by the FDA and have received premarket clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or the FDCA. In the 510(k) clearance process, before a device may be marketed the FDA must determine that a proposed device is "substantially equivalent" to a legally-marketed "predicate" device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (preamendments device), a device that was originally on the U.S. market pursuant to an approved premarket approval, or PMA, application and later downclassified, or a 510(k)-exempt device. This process is typically shorter and generally requires the submission of less supporting documentation than the FDA's PMA process and does not always require long-term clinical studies.

In the European Economic Area, or EEA, manufacturers of medical devices are required by the Medical Devices Directive to collect post-marketing clinical data in relation to their CE marked medical devices. Post-market surveillance includes the conduct of post-market clinical follow-up studies permitting manufacturers to gather information concerning quality, safety or performance of medical devices after they have been placed on the market in the EU. All information collected as part of the post-market surveillance process must be reviewed, investigated and analyzed on a regular basis in order to determine whether trending conclusions can be made concerning the safety or performance of the medical device and decisions must be taken in relation to the continued marketing of medical devices currently on the market. We expect to incur ongoing costs to comply with these post-market clinical obligations in all CE accepting countries and other EEA markets for so long as we continue to market and sell products in those markets. We anticipate that these costs will be immaterial going forward.

Given the foregoing regulatory environment in which we operate, we lack the breadth of published long-term clinical data supporting the safety and efficacy of our products and the benefits they offer that might have been generated if they had been authorized for marketing pursuant to the PMA process. For these reasons, surgeons and other clinicians may be slow to adopt our products, we may not have comparative data that our competitors have or are generating, and we may be subject to greater regulatory and product liability risks. Further, future patient studies or clinical experience may indicate that use of our products does not improve patient outcomes. Such results would slow the adoption of our products by surgeons, would significantly reduce our ability to achieve expected sales and could prevent us from achieving and maintaining profitability.

If future patient studies or clinical testing do not support our belief that our products are advantageous, market acceptance of our products could fail to increase or could decrease and our business could be harmed. Moreover, if future results and experience indicate that our products cause unexpected or serious complications or other unforeseen negative effects, we could be subject to mandatory product recalls, suspension or withdrawal of FDA or other governmental clearance or approval or CE Certificates of Conformity, significant legal liability or harm to our business reputation.

If we choose to, or are required to, conduct additional studies, such studies or experience could reduce the rate of coverage and reimbursement by both public and private third-party payors for procedures that are performed with our products, slow the market adoption of our products by physicians, significantly reduce our ability to achieve expected revenues and prevent us from becoming profitable.

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If we or our suppliers fail to comply with the FDA's Quality System Regulation, our manufacturing operations could be delayed or shut down and our sales could suffer.

Our manufacturing processes and those of our third-party suppliers are required to comply with the FDA's Quality System Regulation, or QSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our devices. Furthermore, we are required to verify that our suppliers maintain facilities, procedures and operations that comply with our quality and applicable regulatory requirements. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. We are also subject to similar state requirements and licenses. If we or our suppliers and contract manufacturers are found to be in violation of the QSR or comparable regulatory requirements, our operations could be disrupted and our manufacturing interrupted. Failure to take adequate and prompt corrective action in response to an adverse inspection could result in, among other things, a partial or total shut-down of our manufacturing operations, significant fines, consent decrees, injunctions, untitled letters, warning letters, injunctions, customer notifications or repair, replacement, refunds, recall, detention or seizure of our products, suspension of marketing clearances and approvals, seizures or recalls of our devices, operating restrictions, refusal to grant export approval for our products, refusing or delaying our requests for 510(k) clearance or PMA approval of new products or modified products, withdrawing 510(k) clearances or PMA approvals that have already been granted and criminal prosecutions, any of which would cause our business to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our devices and cause revenues to decline.

Many of our customers are required to comply with the federal Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and implementing regulation affecting the transmission, security and privacy of health information, and failure to comply could result in significant penalties.

Numerous federal and state laws and regulations, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, and the Health Information Technology for Economic and Clinical Health Act, or the HITECH Act govern the collection, dissemination, security, use and confidentiality of health information that identifies specific patients. HIPAA and the HITECH Act require our surgeon and hospital customers to comply with certain standards for the use and disclosure of health information within their companies and with third parties. The Privacy Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information by health plans, health care clearinghouses and certain health care providers, referred to as Covered Entities, and the business associates with whom Covered Entities enter into service relationships pursuant to which individually identifiable health information may be exchanged. Notably, whereas HIPAA previously directly regulated only these Covered Entities, the HITECH Act makes certain of HIPAA's privacy and security standards also directly applicable to Covered Entities' business associates. As a result, both Covered Entities and business associates are now subject to significant civil and criminal penalties for failure to comply with Privacy Standards and Security Standards.

HIPAA requires Covered Entities (like many of our customers) and business associates to develop and maintain policies and procedures with respect to protected health information that is used or disclosed, including the adoption of administrative, physical and technical safeguards to protect such information. The HITECH Act expands the notification requirement for breaches of patient-identifiable health information, restricts certain disclosures and sales of patient-identifiable health information and provides for civil monetary penalties for HIPAA violations. The HITECH Act also increased the civil

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and criminal penalties that may be imposed against Covered Entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions. Additionally, certain states have adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA.

We are not currently required to comply with HIPAA or the HITECH Act because we are neither a Covered Entity nor a business associate. However, in administering our warranties and complying with FDA required device tracking, we do regularly handle confidential and personal information similar to that which these laws seek to protect. We also occasionally encounter hospital customers who pressure us to sign Business Associate Agreements, or BAAs, although, to date, we have refused, given that we do not believe we are business associates to such Covered Entities under HIPAA or the HITECH Act. If the law or regulations were to change or if we were to agree to sign a BAA, the costs of complying with the HIPAA standards are burdensome and could have a material adverse effect on our business. In addition, under such situations there would be significant risks and financial penalties for us if we were then found to have violated the laws and regulations that pertain to Covered Entities and business associates.

Any new legislation or regulation in the area of privacy and security of personal information, including personal health information, could also adversely affect our business operations. If we do not comply with existing or new applicable federal or state laws and regulations related to patient health information, we could be subject to criminal or civil sanctions and any resulting liability could adversely affect our financial condition.

In addition, countries around the world have passed or are considering legislation that would impose data breach notification requirements and/or require that companies adopt specific data security requirements. If we experience a data breach that triggers one or more of these laws, we may be subject to breach notification obligations, civil liability and litigation, all of which could also generate negative publicity and have a negative impact on our business. For additional discussion of the data privacy laws and regulations applicable to us, see "Business — Government Regulation — Federal, State, and Foreign Fraud and Abuse, Data Privacy and Security and Physician Payment Transparency Laws."

Healthcare policy changes, including recent federal legislation to reform the U.S. healthcare system, may have a material adverse effect on us.

In March 2010, President Obama signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or PPACA. Among other things, PPACA:

      requires certain medical device manufacturers to pay a sales tax equal to 2.3% of the price for which such manufacturer sells its medical devices. This excise tax has resulted in an increase in the tax burden on our industry, and if any efforts we undertake to offset the excise tax are unsuccessful, the increased tax burden could have an adverse effect on our results of operations and cash flows;

      establishes a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such research;

      implements payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the

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        coordination, quality and efficiency of certain healthcare services through bundled payment models; and

      establishes an Independent Payment Advisory Board that will submit recommendations to reduce Medicare spending if projected Medicare spending exceeds a specified growth rate, any of which may adversely affect numerous aspects of our business.

In addition, other legislative changes have been proposed and adopted in the United States since the PPACA was enacted. On August 2, 2011, under the Budget Control Act of 2011 payments to Medicare providers are cut under a sequestration process by 2% each year relative to baseline spending through 2021. This policy was subsequently extended through 2024. In the Protecting Access to Medicare Act, the sequestration policy was frontloaded for the year 2024 such that Medicare providers would be cut 4% in the first half of 2024 and 0% in the second half of 2024. Due to subsequent legislative amendments to the statute, these cuts will remain in effect through 2024 unless additional Congressional action is taken. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare devices and services, which could result in reduced demand for our devices or additional pricing pressures. For additional discussion of healthcare reform see "Business — Healthcare Reform."

Our devices may in the future be subject to recalls or voluntary market withdrawals that could harm our reputation, business and financial results.

Manufacturers may, on their own initiative, initiate actions, including a non-reportable market withdrawal or a reportable product recall, for the purpose of correcting a material deficiency, improving device performance or other reasons. Additionally, the FDA and similar foreign governmental authorities have the authority to require the recall of commercialized devices in the event of material deficiencies or defects in the design, manufacture or labeling in the event that a product poses an unacceptable risk to health. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious adverse health consequences or death. Manufacturers may, under their own initiative, conduct a device notification to inform surgeons of changes to instructions for use or of a deficiency, or of a suspected deficiency, found in a device. A government-mandated recall or voluntary recall by us or one of our distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or other issues. Recalls, which include certain notifications and corrections as well as removals, of any of our devices, could divert managerial and financial resources and could have an adverse effect on our financial condition, harm our reputation with customers and reduce our ability to achieve expected revenues.

Further, under the FDA's Medical Device Reporting regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Any adverse event involving our products could result in future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions, such as inspection, mandatory recall or other enforcement action. Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.

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Moreover, depending on the corrective action we take to redress a product's deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals or clearances for the device before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, withdrawals or clearances or approvals or civil or criminal fines. We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our products in the future.

Legislative or regulatory reforms in the United States or Europe may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to produce, market or distribute our products after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of medical devices or the reimbursement thereof. In addition, the FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our devices. For example, in response to industry and healthcare provider concerns regarding the predictability, consistency and rigor of the 510(k) clearance process, the FDA initiated an evaluation, and in January 2011, announced several proposed actions intended to reform the clearance process. In addition, as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, Congress reauthorized the Medical Device User Fee Amendments with various FDA performance goal commitments and enacted several "Medical Device Regulatory Improvements" and miscellaneous reforms, which are further intended to clarify and improve medical device regulation both pre- and post-clearance or approval. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to manufacture, market or distribute our devices or future products. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

      additional testing prior to obtaining clearance or approval;

      changes to manufacturing methods;

      recall, replacement or discontinuance of our systems or future products; or

      additional record keeping.

Any of these changes could require substantial time and cost and could harm our business and our financial results.

In September 2012, the European Commission published proposals for the revision of the EU regulatory framework for medical devices. The proposal would replace the EU Medical Devices Directive and the Active Implantable Medical Devices Directive with a new regulation (the Medical Devices Regulation). Unlike the Directives that must be implemented into national laws, the Regulation would be directly applicable in all EEA Member States and so is intended to eliminate current national differences in regulation of medical devices.

In October 2013, the European Parliament approved a package of reforms to the European Commission's proposals. Under the revised proposals, only designated "special notified bodies" would be entitled to conduct conformity assessments of high-risk devices. These special notified bodies will

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need to notify the European Commission when they receive an application for a conformity assessment for a new high-risk device. The European Commission will then forward the notification and the accompanying documents on the device to the Medical Devices Coordination Group, or MDCG (a new, yet to be created, body chaired by the European Commission, and representatives of EEA Member States), for an opinion. These new procedures may result in a longer or more burdensome assessment of our new products.

We are subject to federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material adverse effect on our business.

Our operations are, and will continue to be, directly and indirectly affected by various federal, state or foreign healthcare laws, including, but not limited to, those described below. These laws include:

      the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal fines of up to $25,000, imprisonment of up to five years, civil penalties under the Civil Monetary Penalties Law of up to $50,000 for each violation, plus three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000 for each claim submitted, plus three times the amounts paid for such claims and exclusion from participation in the Medicare and Medicaid programs;

      the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent. Suits filed under the False Claims Act, known as "qui tam" actions, can be brought by any individual on behalf of the government and such individuals, commonly known as "whistleblowers," may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, the government may impose penalties of not less than $5,500 and not more than $11,000, plus three times the amount of the damages that the government sustains due to the submission of a false claim and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

      the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary's decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

      HIPAA, as amended by the HITECH Act, and their respective implementing regulations, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per

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        violation and/or imprisonment. State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages up to $25,000 per violation on behalf of residents of his or her state. HIPAA also imposes criminal penalties for fraud against any healthcare benefit program and for obtaining money or property from a healthcare benefit program through false pretenses and provides for broad prosecutorial subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense. Significantly, the HIPAA provisions apply not only to federal programs, but also to private health benefit programs. HIPAA also broadened the authority of the U.S. Office of Inspector General of the U.S. Department of Health and Human Services to exclude participants from federal healthcare programs;

      the federal physician sunshine requirements under the PPACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and teaching hospitals and ownership and investment interests held by physicians and their immediate family members. Manufacturers are required to submit reports to CMS by the 90th day of each calendar year. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for "knowing failures") for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations; and

      analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third- party payor, including commercial insurers; state laws that require device companies to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Any failure by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations could result in substantial penalties or restrictions on our ability to conduct business in those jurisdictions, and our results of operations and financial condition could be materially and adversely affected.

The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our business activities, including our relationships with surgeons and other healthcare providers, some of whom recommend, purchase and/or prescribe our devices, and our distributors, could be subject to challenge under one or more of such laws. For additional discussion of the healthcare laws and regulations applicable to us, see "Business — Government Regulation — Federal, State, and Foreign Fraud and Abuse, Data Privacy and Security and Physician Payment Transparency Laws."

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental

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health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from the operation of our business.

We could be negatively impacted by violations of global anti-bribery laws, including the U.S. Foreign Corrupt Practices Act.

Certain anti-bribery laws, including the FCPA or the UK Bribery Act of 2010 prohibit covered entities from offering, promising, authorizing or giving anything of value, directly or indirectly, to foreign officials or other commercial parties with the intent to influence the recipient's act or decision, to induce action or inaction in violation of lawful duty or for the purpose of improperly obtaining or retaining business or other advantages. In addition, the FCPA imposes recordkeeping and internal controls requirements on publicly traded corporations and their foreign affiliates.

As a significant portion of our revenue is, and we expect will continue to be, from countries outside the United States, we are subject to the risk that we, our employees, or any third parties such as sales agents and distributors acting our behalf in foreign countries may take action determined to be in violation of applicable anti-corruption laws, including the FCPA.

Any violations of these laws, or even allegations of such violations, can lead to an investigation, which could disrupt our operations, involve significant management distraction, lead to significant costs and expenses, including legal fees, and could result in a material adverse effect on our business, prospects, financial condition or operations. We could also suffer severe penalties, including criminal and civil penalties, disgorgement and other costly remedial measures.

Although we have implemented a program designed to ensure our employees and distributors comply with the FCPA and other anti-bribery laws, this program may not prevent all potential violations of the FCPA and other anti-corruption laws. Similarly, our books and records and internal control policies and procedures do not guarantee that we will, in all instances, comply with the accounting provisions of the FCPA.

The misuse or off-label use of our devices may harm our image in the marketplace, result in injuries that lead to product liability suits or result in costly investigations and FDA sanctions if we are deemed to have engaged in such promotion, any of which could be costly to our business.

Our products have been cleared by the FDA for specific uses. Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of a medical device for a use that has not been cleared or approved by FDA, or "off-label" use. We train our marketing and direct sales force to not promote our products for uses outside of the FDA-cleared indications for use. For example, our AirSeal iFS unit is cleared for the indication to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. It is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. Physicians may use our products off-label, as the FDA does not restrict or regulate a physician's choice of treatment within the practice of medicine. As such, we cannot prevent a physician from using our products off-label, when in the physician's independent professional medical judgment he or she deems it appropriate. There may be increased risk of injury to patients if physicians attempt to use our devices off-label. Furthermore, the use of our devices for indications other than those cleared by the FDA or approved by any foreign regulatory body may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.

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If the FDA or any foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

Our business and products are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business.

Our products are medical devices that are subject to extensive regulation by FDA in the United States and by regulatory agencies in other countries where we plan to do business. Government regulations specific to medical devices are wide-ranging and govern, among other things:

      device design, development and manufacture;

      laboratory, preclinical and clinical testing, labeling, packaging, storage and distribution;

      pre-market clearance and approval;

      record-keeping;

      device marketing, promotion and advertising, sales and distribution; and

      post-marketing surveillance, including reporting of deaths and serious injuries and recalls and correction and removals.

The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales.

In the United States, before we can market a new medical device, or a new use of, new claim for or significant modification to an existing product, we must first receive either clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or FDCA or approval of a PMA application from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is "substantially equivalent" to a legally-marketed "predicate" device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (preamendments device), a device that was originally on the U.S. market pursuant to a PMA application and later downclassified or a 510(k)-exempt device. To be "substantially equivalent," the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence. In the PMA process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices. Products that are approved through a PMA application generally need FDA approval before they can be modified. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k). Either process can be expensive, lengthy and unpredictable. The FDA's 510(k) clearance process usually takes from three to 9 months,

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but can last longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time the application is filed with the FDA. In addition, a PMA generally requires the performance of one or more clinical trials. Despite the time, effort and cost, we cannot assure you that any particular device will be approved or cleared by the FDA. Any delay or failure to obtain necessary regulatory approvals could harm our business. Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations on certain uses for the device, which may limit the market for the device.

In the United States, we have obtained 510(k) premarket clearances from the FDA to market our products for certain indications. For example, our AirSeal iFS unit is cleared for the indication to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. It is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. An element of our strategy is to continue to upgrade our products, add new features and expand the cleared indications for our products. We expect that certain of these modifications may require new 510(k) clearance; however, future modifications may be subject to the substantially more costly, time-consuming and uncertain PMA process. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we had expected, product introductions or modifications could be delayed or canceled, which could cause our sales to decline.

The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:

      we may not be able to demonstrate to the FDA's satisfaction that the product or modification is substantially equivalent to the proposed predicate device or safe and effective for its intended use;

      the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; and

      the manufacturing process or facilities we use may not meet applicable requirements.

In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations or take other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared product on a timely basis. For example, in response to industry and healthcare provider concerns regarding the predictability, consistency and rigor of the 510(k) clearance process, the FDA initiated an evaluation, and in January 2011, announced several proposed actions intended to reform the 510(k) clearance process. The FDA intends these reform actions to improve the efficiency and transparency of the clearance process, as well as bolster patient safety. In addition, as part of FDASIA enacted in 2012, Congress reauthorized the Medical Device User Fee Amendments with various FDA performance goal commitments and enacted several "Medical Device Regulatory Improvements" and miscellaneous reforms, which are further intended to clarify and improve medical device regulation both pre- and post-clearance and approval. Some of these proposals and reforms could impose additional regulatory requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance or restrict our ability to maintain our current clearances.

Even after we have obtained the proper regulatory clearance or approval to market a product, we have ongoing responsibilities under FDA regulations. The failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as:

      warning letters;

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      fines;

      injunctions;

      civil penalties;

      termination of distribution;

      recalls or seizures of products;

      delays in the introduction of products into the market;

      total or partial suspension of production;

      refusal to grant future clearances or approvals;

      withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of devices; and

      in the most serious cases, criminal penalties.

Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and harm our reputation, business, financial condition and results of operations.

In order to sell our products in member countries of the EEA our products must comply with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC). Compliance with these requirements is a prerequisite to be able to affix the Conformité Européene, or CE, mark to our devices, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a Member State of the EEA to conduct conformity assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues a certificate following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance and that any claims made about the performance and safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence. We favorably concluded the relevant assessments of conformity with the EU Medical Devices Directive and obtained the right to affix the CE mark to our products in 2008. If we fail to remain in compliance with applicable European laws and directives, we would not be able to continue to affix the CE mark to these systems, which would prevent us from selling them within the EEA.

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We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market and sell our devices.

We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.

We currently market our products internationally and intend to expand our international marketing. International jurisdictions require separate regulatory approvals and compliance with numerous and varying regulatory requirements. For example, we intend to continue to seek regulatory clearance to market our primary products in Brazil and other key markets. The approval procedures vary among countries and may involve requirements for additional testing, and the time required to obtain approval may differ from country to country and from that required to obtain FDA clearance or approval.

Clearance or approval by the FDA does not ensure approval or certification by regulatory authorities in other countries or jurisdictions, and approval or certification by one foreign regulatory authority does not ensure approval or certification by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval or certification process may include all of the risks associated with obtaining FDA clearance or approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals or certifications and may not receive necessary approvals to commercialize our products in any market. If we fail to receive necessary approvals or certifications to commercialize our products in foreign jurisdictions on a timely basis, or at all, our business, results of operations and financial condition could be adversely affected.

Modifications to our devices may require new 510(k) clearances or approvals of PMAs or may require us to recall or cease marketing our devices until clearances or approvals are obtained.

Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture, requires a new 510(k) clearance or, possibly, approval of a PMA. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review any manufacturer's decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. We have made modifications to our products in the past and have determined based on our review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances or PMA approvals were not required. We may make similar modifications or add additional features in the future that we believe do not require a new 510(k) clearance or approval of a PMA. If the FDA disagrees with our determination and requires us to submit new 510(k) notifications or PMA applications for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.

Furthermore, the FDA's ongoing review of the 510(k) clearance process may make it more difficult for us to make modifications to our previously cleared products, either by imposing more strict requirements on when a new 510(k) notification for a modification to a previously cleared product must be submitted, or applying more onerous review criteria to such submissions. For example, the FDA is currently reviewing its guidance describing when it believes a manufacturer is obligated to submit a new 510(k) for modifications or changes to a previously cleared device. The FDA is expected to issue revised guidance to assist device manufacturers in making this determination. It is unclear whether the FDA's approach in this new guidance will result in substantive changes to existing policy and practice regarding the assessment of whether a new 510(k) is required for changes or modifications to existing devices. The FDA continues to review its 510(k) clearance process, which

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could result in additional changes to regulatory requirements or guidance documents, which could increase the costs of compliance or restrict our ability to maintain current clearances.

If coverage and reimbursement from third-party payors for procedures using our products significantly decline, surgeons, hospitals and other healthcare providers may be reluctant to use our products and our sales may decline.

In the United States, healthcare providers who purchase our products generally rely on third-party payors, principally Medicare, Medicaid and private health insurance plans, to pay for all or a portion of the cost of our products in the procedures in which they are employed. Because there is often no separate reimbursement for instruments and supplies used in surgical procedures, the additional cost associated with the use of our products can impact the profit margin of the hospital or surgery center where the surgery is performed. Some of our target customers may be unwilling to adopt our products in light of the additional associated cost. Further, any decline in the amount payors are willing to reimburse our customers for the procedures using our products may make it difficult for existing customers to continue using, or adopt, our products and could create additional pricing pressure for us. We may be unable to sell our products on a profitable basis if third-party payors deny coverage or reduce their current levels of reimbursement.

To contain costs of new technologies, governmental healthcare programs and third-party payors are increasingly scrutinizing new and even existing treatments by requiring extensive evidence of favorable clinical outcomes. Surgeons, hospitals and other healthcare providers may not purchase our devices if they do not receive satisfactory reimbursement from these third-party payors for the cost of the procedures using our devices.

In addition to uncertainties surrounding coverage policies, there are periodic changes to reimbursement. Third-party payors regularly update reimbursement amounts and also from time to time revise the methodologies used to determine reimbursement amounts. This includes annual updates to payments to physicians, hospitals and ambulatory surgery centers for procedures during which our products are used. Because the cost of our products generally is recovered by the healthcare provider as part of the payment for performing a procedure and not separately reimbursed, these updates could directly impact the demand for our products. An example of payment updates is the Medicare program's updates to hospital and physician payments, which are done on an annual basis using a prescribed statutory formula. With respect to physician payments, in the past, when the application of the formula resulted in lower payment, Congress has passed interim legislation to prevent the reductions. In April 2015, however, the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA, was signed into law, which repealed and replaced the statutory formula for Medicare payment adjustments to physicians. MACRA provides a permanent end to the annual interim legislative updates that had previously been necessary to delay or prevent significant reductions to payments under the Medicare Physician Fee Schedule. MACRA extended existing payment rates through June 30, 2015, with a 0.5% update for July 1, 2015 through December 31, 2015, and for each calendar year through 2019, after which there will be a 0% annual update each year through 2025. In addition, MACRA requires the establishment of the Merit-Based Incentive Payment System, beginning in 2019, under which physicians may receive performance-based payment incentives or payment reductions based on their performance with respect to clinical quality, resource use, clinical improvement activities and meaningful use of electronic health records. MACRA also requires Centers for Medicare & Medicaid Services, or CMS, beginning in 2019, to provide incentive payments for physicians and other eligible professionals that participate in alternative payment models, such as accountable care organizations, that emphasize quality and value over the traditional volume-based fee-for-service model. It is unclear what impact, if any, MACRA will have on our business and

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operating results, but any resulting decrease in payment may result in reduced demand for our products.

Moreover, some healthcare providers in the United States have adopted or are considering a managed care system in which the providers contract to provide comprehensive healthcare for a fixed cost per person. Healthcare providers may attempt to control costs by authorizing fewer surgical procedures or by requiring the use of the least expensive devices available. Additionally, as a result of reform of the U.S. healthcare system, changes in reimbursement policies or healthcare cost containment initiatives may limit or restrict coverage and reimbursement for our products and cause our revenue to decline.

Outside of the United States, reimbursement systems vary significantly by country. Many foreign markets have government-managed healthcare systems that govern reimbursement for laparoscopic procedures. Additionally, some foreign reimbursement systems provide for limited payments in a given period and therefore result in extended payment periods. If adequate levels of reimbursement from third-party payors outside of the United States are not obtained, international sales of our devices may decline. For additional discussion of coverage and reimbursement, see "Business — Coverage and Reimbursement."

Our relationships with physician consultants and investors could be subject to additional scrutiny from regulatory enforcement authorities and could subject us to possible administrative, civil or criminal sanctions.

Federal and state laws and regulations impose restrictions on our relationships with physician consultants, owners and investors. We have entered into consulting agreements with physicians or physician-owned companies, including some agreements in which we have provided stock, or stock options as compensation in certain physician consulting agreements. We could be adversely affected if regulatory agencies were to interpret our financial relationships with these physicians or hospital employees who may be in a position to influence the ordering of and use of our products for which governmental reimbursement may be available as being in violation of applicable laws. If our relationships with physicians or hospital employees in a position to influence the ordering or use of our products are found to be in violation of the laws and regulations that apply to us, we may be required to restructure the arrangements and could be subject to administrative, civil and criminal penalties including exclusion from participation in government healthcare programs, imprisonment and the curtailment or restructuring of our operations, any of which could negatively impact our ability to operate our business and our results of operations.

Risk Factors Related to Our Intellectual Property

If we are unable to adequately protect our proprietary technology or maintain issued patents that are sufficient to protect our intellectual property, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.

Our commercial success will depend in part on our success in continuing to obtain and maintain issued patents and other intellectual property rights, including trademarks, in the United States and elsewhere and protecting our proprietary technology. If we do not adequately protect our intellectual property and proprietary technology, competitors may be able to use our technology and erode or negate any competitive advantage that we may have, which could harm our business and our ability to achieve profitability.

We have a number of issued patents and pending patent applications in the United States which cover our AirSeal system which includes, among other products, the AirSeal Valve-Free Access Port, iFS unit

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and Multi-Lumen Filtered Tube Sets. Corresponding patents and patent applications have also been granted or are pending in Europe (United Kingdom, France and Germany), Brazil, Canada, Japan, China and Korea. Consequently, we expect to have patent coverage in the United States for key components of our AirSeal system including the AirSeal Valve-Free Access Port, until at least 2032, with possible extended coverage from pending applications should they be granted.

Our patents may not have, or our pending patent applications that mature into issued patents may not include, claims with a scope sufficient to protect the AirSeal system and our other products associated therewith. Other parties may have developed technologies that may be related or competitive to our approach and may have filed or may file patent applications and may have received or may receive patents that may overlap or conflict with our patent applications, either by claiming the same subject matter or by claiming subject matter that could dominate our patent position. The patent positions of medical device companies, including our own patent position, involve complex legal and factual questions and, therefore, the issuance, scope, validity and enforceability of any patent claims that we may obtain can be unpredictable.

Patents, if issued, may be challenged, deemed unenforceable, invalidated or circumvented. U.S. patents and patent applications may also be subject to interference proceedings, ex parte reexamination, inter partes review proceedings, post-grant review proceedings and challenges in district court. Patents may be subjected to opposition, post-grant review or comparable proceedings lodged in various foreign patent offices. These proceedings could result in either loss of a patent or denial of a patent application or loss or reduction in the scope of one or more of the claims of a patent or patent application. In addition, such proceedings may be costly. Thus, any patents that we own may not provide any protection against competitors. Furthermore, an adverse decision in an interference proceeding can result in a third party receiving the patent right sought by us, which in turn could affect our ability to further develop, market or otherwise commercialize our AirSeal system.

Furthermore, though an issued patent is presumed valid and enforceable, its issuance is not conclusive as to its validity or its enforceability, and it may not provide us with adequate proprietary protection or competitive advantages against competitors with similar products. Competitors may also be able to design around our patents. Other parties may develop and obtain patent protection for more effective technologies. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors, former employees and current employees. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the United States, and we may encounter significant problems in protecting our proprietary rights in these countries. If these developments were to occur, they could have a material adverse effect on our sales.

Our ability to enforce our patent rights depends on our ability to detect infringement by other parties. It is difficult to detect infringers who do not advertise the components of their products. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor's or potential competitor's product.

In addition, proceedings to enforce or defend our patents could put our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Such proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or otherwise unenforceable. If any of our patents covering our AirSeal system are invalidated or found unenforceable, our financial position and results of operations would be materially and adversely impacted. In addition, if a court found that valid, enforceable patents held by third parties covered our AirSeal system, our financial position and results of operations would also be materially and adversely impacted.

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The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:

      any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect the AirSeal system or any of our other products;

      any of our pending patent applications will issue as patents;

      we were the first to make the inventions covered by each of our patents and pending patent applications;

      we were the first to file patent applications for these inventions;

      others will not develop similar or alternative technologies that do not infringe our patents;

      any of our patents will be found to ultimately be valid and enforceable;

      any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties;

      we will develop additional proprietary technologies that are separately patentable; or

      that our commercial activities or products will not infringe upon the patents of others.

We rely upon unpatented trade secrets, unpatented know-how and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our employees and our collaborators and consultants. We also have agreements with our employees and selected consultants that obligate them to assign their inventions to us and have non-compete agreements with some, but not all, of our consultants. It is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement. Furthermore, if the employees and consultants who are parties to these agreements breach or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets through such breaches or violations. Further, our trade secrets could otherwise become known or be independently discovered by our competitors.

We may become dependent on obtaining access to third party intellectual property rights in the future.

We may be required to enter into one or more licenses to third party intellectual property that we find necessary or useful to our business, or that the third party owner asserts we are infringing. In such a case, even if we are successful in obtaining terms that are commercially reasonable, a future licensor might also allege that we have breached our license agreement and may accordingly seek to terminate our license with them, or may insist on the right to terminate such a license at will. If successful, any such termination could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to develop and commercialize a product, as well as harm our competitive business position and our business prospects.

We may be subject to litigation alleging we infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our products.

Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. Our business, products and methods could infringe the patents or other intellectual property rights of third parties.

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The medical device industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may allege that our AirSeal system or the use of that technology by our customers infringes patent claims or other intellectual property rights held by them or that we are employing their proprietary technology without authorization. Patent and other types of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain. Any claim relating to intellectual property infringement that is successfully asserted against us may require us to pay substantial damages, including treble damages and attorney's fees if we are found to be willfully infringing another party's patents, for past use of the asserted intellectual property and royalties and other consideration going forward if we are forced to take a license. In addition, if any such claim were successfully asserted against us and we could not obtain a license, we may be forced to stop manufacturing, selling or otherwise commercializing the AirSeal system or our other products.

Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court or redesign our products. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, intellectual property litigation or claims could force us to do one or more of the following:

      cease developing and selling or otherwise commercializing our AirSeal system;

      pay substantial damages for past use of the asserted intellectual property;

      obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all; and

      in the case of trademark claims, redesign or rename the AirSeal system or our other products to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming.

Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or other intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

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Obtaining and maintaining our patent protection depends on compliance with various procedures, document submission requirements, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The U.S. Patent and Trademark Office and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payments such as maintenance and annuity fee payments and other provisions during the patent procurement process as well as over the life span of an issued patent. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.

We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid, unenforceable or not infringed or may refuse to stop the other party from using the technology at issue on the grounds that our patent does not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly.

While increasingly rare in occurrence, interference proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome in such a proceeding could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

Issued patents covering our products could be found invalid or unenforceable if challenged in court.

If we initiated legal proceedings against a third party to enforce a patent covering our AirSeal system or our other products, the defendant could counterclaim that the patent covering our product is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge include alleged failures to meet any one of several statutory requirements, including lack of novelty, obviousness, indefiniteness or non-enablement. Grounds for unenforceability assertions include allegations that someone connected with prosecution of the patent intentionally withheld information material to patentability from the U.S. Patent and Trademark Office, or made a misleading statement during prosecution.

Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review and

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equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings. Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our products or competitive products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to validity, for example, it is possible that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product. Such a loss of protection would have a material adverse impact on our business.

We do not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.

Filing, prosecuting and defending patents on our products in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the patent laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, including those relating to medical devices, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.

If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

We have a number of registered trademarks and pending trademark applications, including AirSeal, in many of our markets, including in international markets. Our applications may not be allowed for registration, and our registered trademarks may not be maintained or enforced. In addition, opposition or cancellation proceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would. Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. Over the long term, if we are unable to establish

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name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

In 2011, the United States enacted wide-ranging patent reform legislation under the America Invents Act. Further, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain future patents, this combination of events has created uncertainty with respect to the value of our patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts and the U.S. Patent and Trademark Office, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents or future patents.

We may be subject to claims that we, our employees, consultants or third parties we engage to manufacture our products have wrongfully used, or disclosed alleged trade secrets of our competitors or are in breach of non-competition agreements with our competitors.

Many of our employees were previously employed at other medical device companies, including our potential competitors. We may be subject to claims that we, our employees, consultants or third parties have inadvertently or otherwise used or disclosed alleged trade secrets or proprietary information of these former employers or competitors. In addition, we may be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction for our management. If our defense to those claims fails, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any litigation or the threat thereof may adversely affect our ability to hire employees or contract with third parties. A loss of key personnel or their work product could have an adverse effect on our business, results of operations and financial condition

Risks Related to Our Common Stock and this Offering

After this offering, our executive officers, directors and principal stockholders, if they choose to act together, will continue to have the ability to control all matters submitted to stockholders for approval.

Upon the closing of this offering, our executive officers, directors and stockholders who owned more than 5% of our outstanding common stock before this offering and their respective affiliates will, in the aggregate, hold shares representing approximately       % of our outstanding voting stock. As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to our stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of ownership control may:

      delay, defer or prevent a change in control;

      entrench our management and the board of directors; or

      impede a merger, consolidation, takeover or other business combination involving us that other stockholders may desire.

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The significant concentration of stock ownership may negatively impact the price of our common stock due to investors' perception that conflicts of interest may exist or arise.

If you purchase shares of common stock in this offering, you will suffer immediate dilution of your investment.

The initial public offering price of our common stock will be substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our net tangible book value per share after this offering. To the extent shares subsequently are issued under outstanding stock options, you will incur further dilution. Based on an assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $             per share, representing the difference between our pro forma net tangible book value per share, after giving effect to this offering, and the assumed initial public offering price. In addition, purchasers of common stock in this offering will have contributed approximately       % of the aggregate price paid by all purchasers of our stock but will own only approximately       % of our common stock outstanding after this offering. For further information on this calculation, see the section entitled "Dilution."

Provisions in our seventh amended and restated certificate of incorporation and amended and restated bylaws under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our seventh amended and restated certificate of incorporation and our amended and restated bylaws that will become effective upon the closing of this offering may discourage, delay or prevent a merger, acquisition or other change in control of our company that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions include those establishing:

      a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

      no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

      the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on our board of directors;

      the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;

      the ability of our board of directors to alter our amended and restated bylaws without obtaining stockholder approval;

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      the required approval of the holders of at least two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our amended and restated bylaws or repeal the provisions of our seventh amended and restated certificate of incorporation regarding the election and removal of directors;

      a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

      the requirement that a special meeting of stockholders may be called only by the chief executive officer, the executive chairman, the president or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;

      advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders' meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer's own slate of directors or otherwise attempting to obtain control of us; and

      the requirement that the Court of Chancery of the State of Delaware be the sole and exclusive forum for derivative actions and other corporate claims unless we consent to an alternative forum in writing.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

An active trading market for our common stock may not develop.

Prior to this offering, there has been no public market for our common stock. The initial public offering price for our common stock will be determined through negotiations with the underwriters. Although we have applied to have our common stock approved for listing on             , an active trading market for our shares may never develop or be sustained following this offering. If an active market for our common stock does not develop, it may be difficult for you to sell shares you purchase in this offering at or above the initial public offering price or at all. The lack of an active market may also reduce the fair market value of your shares. An inactive market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.

The price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for purchasers of our common stock in this offering.

Our stock price is likely to be volatile. The stock market in general has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your common stock at or above the initial public offering price. The market price for our common stock may be influenced by many factors, including:

      actual or anticipated fluctuations in our financial condition and operating results;

      actual or anticipated changes in our growth rate relative to our competitors;

      competition from existing products or new products that may emerge;

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      development of new technologies that may address our markets and may make our technology less attractive;

      changes in physician, hospital or healthcare provider practices that may make our products less attractive;

      announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;

      developments or disputes concerning proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

      the recruitment or departure of key personnel;

      failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;

      actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

      variations in our financial results or those of companies that are perceived to be similar to us;

      changes to reimbursement levels by commercial third-party payors and government payors, including Medicare, and negative announcements relating to reimbursement levels;

      general economic, industry and market conditions; and

      the other factors described in this "Risk Factors" section.

In addition, the stock market in general and emerging growth companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. A certain degree of stock price volatility can be attributed to being a newly public company. These broad market and industry fluctuations may negatively impact the price or liquidity of our common stock, regardless of our operating performance.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

Our management will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. We intend to use the net proceeds from this offering as follows: (i) $             to expand our sales and marketing efforts relating to our U.S. and international sales presence; (ii) $             to continue to invest in our research and development program; (iii)  $             to continue clinical research documenting the benefits of our technology; (iv) $             to satisfy a royalty buyout obligation to IP Technologies, LLC triggered by this offering; and (v) the balance for working capital and general corporate purposes. We may also use a portion of our net proceeds to acquire and invest in complementary products, technologies or businesses; however, we currently have no agreements or commitments to complete any such transaction. However, our use of these proceeds may differ substantially from our current plans. The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business and cause the price of our common stock to decline. Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.

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Future sales of shares by existing stockholders could cause our stock price to decline.

If our existing stockholders sell, or indicate an intent to sell, substantial amounts of our common stock in the public market after the 180-day contractual lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline significantly and could decline below the initial public offering price. Based on 15,808,998 shares outstanding as of September 30, 2015 (after conversion all the redeemable convertible preferred stock), upon the completion of this offering, we will have             outstanding shares of common stock, assuming no exercise of outstanding options or warrants. Of these shares,              shares of common stock, plus any shares sold pursuant to the underwriters' option to purchase additional shares, will be immediately freely tradable, without restriction, in the public market.

After the lock-up agreements pertaining to this offering expire and based on             shares outstanding after this offering, an additional 15,808,998 shares will be eligible for sale in the public market. In addition, upon issuance, the 2,192,674 shares subject to outstanding options under our stock option plans and the             shares reserved for future issuance under our equity compensation plans will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Moreover, 180 days after the completion of this offering, holders of approximately 15,808,998 shares of our common stock, including 472,515 shares issuable upon exercise of our outstanding warrants, will have the right to require us to register these shares under the Securities Act of 1933, as amended, or the Securities Act, pursuant to our Investors' Rights Agreement. If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business. We also intend to register all shares of common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements described in the "Underwriting" section of this prospectus.

We are an "emerging growth company," and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an "emerging growth company," as defined in the JOBS Act, and may remain an emerging growth company until the earliest of (1) the end of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the end of the second fiscal quarter, (2) the end of the fiscal year in which we have total annual gross revenue of $1.0 billion or more during such fiscal year, (3) the date on which we issue more than $1.0 billion in non-convertible debt in a three-year period or (4) December 31, 2020, the end of the fiscal year following the fifth anniversary of the completion of this offering. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

      being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced "Management's Discussion and Analysis of Financial Condition and Results of Operations" disclosure;

      not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;

      not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a

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        supplement to the auditor's report providing additional information about the audit and the financial statements;

      reduced disclosure obligations regarding executive compensation; and

      exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We have taken advantage of reduced reporting burdens in this prospectus. In particular, in this prospectus, we have provided only two years of audited financial statements and have not included all of the executive compensation related information that would be required if we were not an emerging growth company. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be reduced or more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption and, therefore, we will be subject to the same new or revised accounting as other public companies that are not emerging growth companies.

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the             and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

We are evaluating these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Our management team has limited experience managing a public company.

Most members of our management team have limited experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of securities analysts and investors. These new obligations and constituents will require significant attention from our senior

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management and could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial condition and operating results.

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If no or few securities or industry analysts commence coverage of us, the trading price for our stock would be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our regulatory clearance timelines, clinical trial results or operating results fail to meet the expectations of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. Any future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. If we face such litigation, it could result in substantial costs and a diversion of management's attention and resources, which could harm our business.

If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

After the closing of this offering, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the stock market on which our common stock is listed. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. Commencing with our fiscal year ending December 31, 2016, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting in our Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. This will require that we incur substantial additional professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts.

Prior to this offering, we have never been required to test our internal control within a specified period, and, as a result, we may experience difficulty in meeting these reporting requirements in a timely manner.

We may identify weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no

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matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls, we may not be able to produce timely and accurate financial statements. If that were to happen, the market price of our stock could decline and we could be subject to sanctions or investigations by the stock exchange on which our common stock is listed, the Securities and Exchange Commission or other regulatory authorities.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements. All statements other than statements of historical facts contained in this prospectus, including statements regarding our future results of operations and financial position, business strategy, current and prospective products, their expected performance and impact on healthcare costs, regulatory clearance, reimbursement for our products, research and development costs, prospective collaborations, timing of regulatory filings, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this prospectus are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described under the sections in this prospectus entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this prospectus. These forward-looking statements are subject to numerous risks, including, without limitation, the following:

      our ability to demonstrate the merits of our technology platform to facilitate greater adoption among surgeons and hospitals;

      our ability to demonstrate that the benefits of our products outweigh the increased relative product cost compared to other surgical access methods;

      our ability to convince hospitals to approve our products for use;

      our status as an early, commercial-stage company and the difficulty of evaluating our business and predicting our performance;

      our history of net losses;

      our ability to compete in a highly competitive market segment;

      the possibility of losing senior management or failing to attract highly skilled personnel;

      our dependence upon third-party suppliers, which makes us vulnerable to supply problems and price fluctuations;

      the ability of our products to perform as expected;

      the risks associated with international activities;

      federal, state, and foreign regulatory requirements; and

      our ability to protect and enforce our intellectual property rights, including our proprietary rights in AirSeal.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances

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reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.


INDUSTRY AND OTHER DATA

We obtained the industry, statistical and market data in this prospectus from our own internal estimates and research as well as from industry and general publications and research, surveys and studies conducted by third parties. Industry publications, studies and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that each of these studies and publications is reliable, we have not independently verified statistical, market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source.

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USE OF PROCEEDS

We estimate that our net proceeds from our issuance and sale of             shares of our common stock in this offering will be approximately $          million (or approximately $          million if the underwriters exercise in full their option to purchase additional shares), based on an assumed initial public offering price of $         per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $         per share would increase (decrease) the net proceeds to us from this offering by approximately $          million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase (decrease) of 1.0 million in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $          million, assuming the assumed initial public offering price stays the same.

We currently expect to use the net proceeds from this offering as follows: (i) $         to expand our sales and marketing efforts relating to our U.S. and international sales presence; (ii) $         to continue to invest in our research and development program; (iii) $         to continue clinical research documenting the benefits of our technology; (iv) $         to satisfy a royalty buyout obligation to IP Technologies, LLC triggered by this offering and; (v) the balance for working capital and general corporate purposes. We may also use a portion of our net proceeds to acquire and invest in complementary products, technologies or businesses; however, we currently have no agreements or commitments to complete any such transaction.

Our expected use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds from this offering or the actual amounts that we will spend on the uses set forth above. The amounts and timing of our actual expenditures will depend on numerous factors, including the rate of adoption of our products, the progress, cost and results of product development and clinical research and trials, the expenses we incur in our sales and marketing efforts, the scope of research and development efforts and other factors described under "Risk Factors" in this prospectus, as well as the amount of cash used in our operations. We may find it necessary or advisable to use the net proceeds from this offering for other purposes, and we will have broad discretion in the application of the net proceeds.

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DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. In addition, our ability to pay cash dividends is currently prohibited by the terms of our Credit and Security Agreement. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects, the requirements of current or then-existing debt instruments and other factors our board of directors may deem relevant.

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of September 30, 2015:

      on an actual basis;

      on a pro forma basis to reflect (a) the automatic conversion of all outstanding shares of our redeemable convertible preferred stock into 14,400,960 shares of common stock upon the closing of this offering, (b) the filing of our seventh amended and restated certificate of incorporation immediately upon the closing of this offering and (c) the forgiveness of a loan to an executive officer in the amount of $330,154; and

      on a pro forma as adjusted basis to give further effect to our issuance and sale of                  shares of common stock in this offering at an assumed initial public offering price of $         per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma and pro forma as adjusted information below is illustrative only and our capitalization following the closing of this offering will depend on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes appearing at the end of this prospectus and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" section and other financial information contained in this prospectus.

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  As of September 30, 2015  
 
  Actual   Pro Forma   Pro Forma
As Adjusted
 
 
  (Unaudited)
  (Unaudited)
  (Unaudited)
 
 
  (In thousands, except share amounts)
 

Cash and cash equivalents

  $ 7,840   $     $    

Long-term debt, less current portion, net of discount

  $ 24,950   $   $  

Warrant liabilities

  $ 2,637   $     $    

Redeemable convertible preferred stock:

                   

Series A redeemable convertible preferred stock, $0.001 par value; 2,539,795 shares authorized, 2,487,556 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma or pro forma as adjusted

 
$

12,710
 
$

 
$

 

Series B redeemable convertible preferred stock, $0.001 par value; 2,882,703 shares authorized, 2,882,703 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma or pro forma as adjusted

   
30,178
   
   
 

Series C redeemable convertible preferred stock, $0.001 par value; 5,200,000 shares authorized, 4,812,560 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma or pro forma as adjusted;

   
26,154
   
   
 

Series D redeemable convertible preferred stock, $0.001 par value; 1,545,726 shares authorized, 1,491,054 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma or pro forma as adjusted

   
7,753
   
   
 

Series E redeemable convertible preferred stock, $0.001 par value; 2,448,430 shares authorized, 2,448,428 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma or pro forma as adjusted;

   
20,179
   
   
 

Total redeemable convertible preferred stock

    96,974          

Stockholders' deficit:

                   

Common stock, par value $0.001 per share; 20,000,000 shares authorized, 1,408,038 shares issued and outstanding, actual;             shares authorized, 15,806,926 shares issued and outstanding, pro forma;             shares authorized,             shares issued and outstanding, pro forma as adjusted

    1              

Preferred stock, par value $0.001 per share; no shares authorized, issued or outstanding, actual;                  shares authorized, no shares issued or outstanding, pro forma and pro forma as adjusted

                 

Additional paid-in-capital

                 

Receivable from executive

    (300 )        

Accumulated deficit

    (106,143 )            

Total stockholders' deficit

    (106,472 )            

Total capitalization

  $ 18,089   $     $    

(1)
Each $1.00 increase (decrease) in the assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of

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    each of cash and cash equivalents, additional paid-in-capital total stockholders' deficit and total capitalization by $          million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares in the number of shares offered by us at the assumed initial public offering price per share of $         , which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, additional paid-in-capital, total stockholders' deficit and total capitalization by $          million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

    The number of shares in the table above excludes:

      1,101,060 shares of common stock issuable upon exercise of stock options outstanding and exercisable as of September 30, 2015, at a weighted-average exercise price of $0.97 per share;

      472,515 shares of common stock issuable upon the exercise of outstanding warrants as of September 30, 2015 having a weighted-average exercise price of $3.85 per share; and

                   shares of our common stock reserved for future issuance under our 2015 Plan, which will become effective prior to the closing of this offering.

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share and the pro forma as adjusted net tangible book value per share of our common stock after this offering.

As of September 30, 2015, we had a historical net tangible book value of $(107.0) million, or $(75.99) per share of common stock. Our historical net tangible book value per share represents total tangible assets less total liabilities and redeemable convertible preferred stock, divided by the number of shares of our common stock outstanding as of September 30, 2015.

As of September 30, 2015, our pro forma net tangible book value would have been $(10.0) million or $(0.63) per share of our common stock. Our pro forma net tangible book value per share represents total tangible assets less total liabilities, divided by the number of shares of our common stock outstanding as of September 30, 2015, after giving effect to the automatic conversion of all outstanding shares of our redeemable convertible preferred stock into common stock upon the closing of this offering.

After giving further effect to our sale of             shares of common stock in this offering at an assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2015 would have been $              million, or $             per share. This amount represents an immediate increase in pro forma net tangible book value of $             per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of $             per share to new investors in this offering. We determine dilution by subtracting the pro forma as adjusted net tangible book value per share after this offering from the initial public offering price per share paid by new investors. The following table illustrates this dilution (without giving effect to any exercise by the underwriters of their option to purchase additional shares):

Assumed Initial public offering price per share

        $    

Historical net tangible book value per share as of September 30, 2015

  $ (75.99 )      

Increase in net tangible book value per share attributable to conversion of redeemable convertible preferred stock

  $ 75.36        

Pro forma net tangible book value per share as of September 30, 2015 before giving effect to this offering. 

  $ (0.63 )      

Increase in pro forma net tangible book value per share attributable to this offering

  $          

Pro forma as adjusted net tangible book value per share after this offering

        $    

Dilution in pro forma as adjusted net tangible book value per share to new investors participating in this offering

        $    

Each $1.00 increase (decrease) in the assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted net tangible book value per share after this offering by $             , and dilution in pro forma net tangible book value per share to new investors by $             , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase (decrease) of 1.0 million shares in the number of shares offered by us would increase (decrease) our pro forma as adjusted net tangible book value per share after this offering by $             per share and decrease (increase) the dilution to new investors by $             per

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share, assuming that the assumed initial public offering price remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

If the underwriters exercise their option to purchase additional shares of our common stock in full, the pro forma as adjusted net tangible book value after this offering would be $             per share, the increase in pro forma as adjusted net tangible book value per share would be $             and the dilution per share to new investors would be $             per share, in each case assuming an initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

The following table summarizes, on the pro forma as adjusted basis described above, as of September 30, 2015, the differences between the number of shares purchased from us, the total consideration paid to us in cash (in thousands) and the average price per share that existing stockholders and new investors paid. The calculation below is based on an assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 
   
   
  Total
Consideration
   
 
 
  Shares Purchased    
 
 
  Average Price
Per Share
 
 
  Number   Percent   Amount   Percent  

Existing stockholders

            % $         % $    

New investors participating in this offering

            % $         % $    

Total

            % $         % $    

Each $1.00 increase (decrease) in the assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) total consideration paid by new investors, total consideration paid by all stockholders and the average price per share paid by all stockholders by $             million, $             million and $             , respectively, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The foregoing tables and calculations are based on 15,808,998 shares of our common stock outstanding as of September 30, 2015, after giving effect to the conversion of shares of our redeemable convertible preferred stock outstanding as of September 30, 2015 into an aggregate of 14,400,960 shares of our common stock upon the closing of this offering, and exclude:

      1,101,160 shares of common stock issuable upon exercise of stock options outstanding and exercisable as of September 30, 2015, at a weighted-average exercise price of $0.97 per share; and

      472,515 shares of common stock issuable upon the exercise of outstanding warrants as of September 30, 2015 having a weighted-average exercise price of $3.85 per share; and

                     shares of our common stock reserved for future issuance under our 2015 Plan, which will become effective prior to the closing of this offering.

To the extent any of these outstanding options or warrants are exercised or new awards are granted under our equity compensation plans, there will be further dilution to new investors. If all of such outstanding options had been exercised as of September 30, 2015, the pro forma as adjusted net tangible book value per share after this offering would be $             , and total dilution per share to new investors would be $             .

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SELECTED FINANCIAL DATA

The following tables set forth, for the periods and as of the dates indicated, our selected financial data. The balance sheet and statement of operations data as of and for the years ended December 31, 2013 and 2014 are derived from our audited financial statements appearing elsewhere in this prospectus. The balance sheet data as of September 30, 2015 and the statement of operations data for the nine months ended September 30, 2014 and 2015 are derived from our unaudited condensed financial statements appearing elsewhere in this prospectus. We have prepared the unaudited condensed financial statements on the same basis as the audited financial statements, and the unaudited financial data includes, in our opinion, all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair presentation of our financial position and results of operations for these periods. Our historical results are not necessarily indicative of our future results and our operating results for the nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015 or any other interim periods or any future year or period. You should read the following information together with our financial statements and the related notes included elsewhere in this prospectus and the section of this prospectus entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations."

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  Year Ended December 31,   Nine Months Ended September 30,  
 
  2013   2014   2014   2015  
 
   
   
  (Unaudited)
 
 
  (In thousands, except per share and share amounts)
 

Statement of operations data:

                         

Revenues

  $ 19,102   $ 30,249   $ 20,601   $ 34,733  

Cost of goods sold

    11,052     16,031     10,874     16,232  

Gross profit

    8,050     14,218     9,727     18,501  

Selling, general and administrative expenses

    12,978     23,622     17,194     27,522  

Research and development expenses

    2,029     2,909     2,194     2,950  

    15,007     26,531     19,388     30,472  

Operating loss

    (6,957 )   (12,313 )   (9,661 )   (11,971 )

Other (expense) income:

                         

Interest expense

    (909 )   (2,146 )   (1,580 )   (1,823 )

Interest income

    12     31     24     17  

Other (expense) income, net

    (414 )   (388 )   (221 )   (1,363 )

Total other (expense) income, net

    (1,311 )   (2,503 )   (1,777 )   (3,169 )

Net loss

    (8,268 )   (14,816 )   (11,438 )   (15,140 )

Cumulative preferred stock dividends

    (1,978 )   (2,156 )   (1,612 )   (2,481 )

Preferred stock accretion

    (5,256 )   (5,292 )   (3,981 )   (6,583 )

Net loss attributable to common shareholders

  $ (15,502 ) $ (22,264 ) $ (17,031 ) $ (24,204 )

Per share data:

                         

Basic and diluted net loss per share attributable to common stockholders(1)

  $ (13.45 ) $ (18.03 ) $ (13.92 ) $ (17.38 )

Weighted average outstanding common shares used in computing net loss per share attributable to common stockholders:

                         

Basic and diluted(1)

    1,152,665     1,235,111     1,223,091     1,392,759  

(1)
See Note 3 to our financial statements included elsewhere in this prospectus for an explanation of the method used to calculate the historical basic and diluted net loss per share attributable to common stockholders.

 
  As of
December 31,
   
 
 
  As of
September 30,
2015
 
 
  2013   2014  
 
  (In thousands)
 
 
   
   
  (Unaudited)
 

Balance sheet data:

                   

Cash and cash equivalents

  $ 5,459   $ 6,072   $ 7,840  

Total assets

    13,912     18,949     28,359  

Current liabilities

    7,526     9,492     16,543  

Total debt less unamortized discounts

    8,177     24,703     24,950  

Total stockholders' deficit

  $ (65,640 ) $ (85,205 ) $ (106,472 )

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MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes included elsewhere in this prospectus. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. You should review the sections entitled "Special Note Regarding Forward-Looking Statements" and "Risk Factors" for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements.

Overview

We are a commercial stage global medical technology company that is revolutionizing MIS with AirSeal, our proprietary surgical access management system that we believe offers significant clinical benefits for patients and economic benefits for healthcare providers. We refer to the combination of our proprietary AirSeal technology and the surgical procedures that they enable as Low Impact Surgery. We believe Low Impact Surgery enables a wider range of surgical procedures to be performed with less invasive surgical access, thereby broadening the population of patients for whom MIS procedures may be applicable. As of September 30, 2015, more than 1,600 AirSeal systems were deployed in over 700 institutions worldwide, and we believe AirSeal disposable devices have been used in more than 340,000 surgical procedures worldwide since 2011. Quarterly sales of AirSeal disposables have grown from less than 4,000 disposables sets during the three months ended March 30, 2012 to more than 44,000 disposables sets during the three months ended September 30, 2015; and more than 135,000 disposables sets were sold during the 9 months ended September 30, 2015.

We generate revenue primarily through sales of our highly differentiated AirSeal system, which is comprised of the AirSeal Intelligent Flow System, or iFS unit, AirSeal Access Ports and AirSeal FTS. We believe our AirSeal technology represents the first major innovation in minimally invasive surgical access since the introduction of the modern trocar. The AirSeal system replaces trocars that rely on mechanical valves to create and maintain stable intra-abdominal pressure with a valve-free access port that has no moving parts that employs a proprietary gaseous barrier to provide real-time sensing of intra-abdominal pressure, which enables dynamic adjustment to maintain stable intra-abdominal pressure, combined with automatic and continuous smoke evacuation.

We believe that Low Impact Surgery enabled by AirSeal and our complementary family of micro-laparoscopic instruments enables a shift to performing MIS at lower insufflation pressures and with less invasive techniques that drive improved clinical outcomes for patients and favorable economics to the healthcare system. We intend to continue to invest in research and development activities to enhance the offerings of our AirSeal and other technologies and broaden their indications for use.

We currently market and sell our products in the U.S. and internationally. We invest substantial resources to educate surgeons around the world on the clinical advantages of Low Impact Surgery using AirSeal. Our U.S. sales organization engages in sales efforts and promotional activities focused on leading medical institutions and laparoscopic surgeons, including those that perform advanced robotic-assisted procedures. As of September 30, 2015, our U.S. sales organization consisted of 68 direct sales representatives, six clinical education specialists and two independent sales agencies. All of our sales in the U.S. are to hospital accounts. We expect to continue to expand our sales organization to further penetrate the laparoscopic procedural market and expand the market for minimally invasive procedures enabled by AirSeal. Outside the U.S., we currently sell our products through 28 distributors, which are managed by a general manager and five independent area directors.

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Our customers are reimbursed by governmental and private health insurers for procedures using our products pursuant to reimbursement codes specific to the setting in which the surgical procedure was performed (e.g., hospital inpatient or outpatient departments). No single domestic customer accounted for more than 5.0% of our domestic revenue during the year ended December 31, 2014 or the nine months ended September 30, 2015. During the year ended December 31, 2014, one international distributor in Japan accounted for approximately 11.0% of our global net revenues and for the nine months ended September 30, 2015, no customer represented more than 10% of global net revenues. We believe a key factor in being able to increase our revenues is convincing our customers of the clinical and economic benefit of our AirSeal system.

We outsource the manufacture of our AirSeal system and related single-use products through multiple third parties. We own the critical assembly and manufacturing tooling associated with the production of key components and finished goods. In most cases, we have redundant manufacturing capabilities for each of our products to ensure our inventory needs are met while maintaining high quality. However, we currently rely on a small number of limited source and sole source suppliers and we have not experienced any difficulty in locating and obtaining the materials necessary to meet demand for our products.

For the year ended December 31, 2013 and 2014 we generated revenues of $19.1 million and $30.2 million, respectively and had net losses of $8.3 million and $14.8 million, respectively. For the nine months ended September 30, 2014 and 2015 we generated revenues of $20.6 million and $34.7 million, respectively and had net losses of $11.4 million and $15.1 million, respectively. As of September 30, 2015, we had an accumulated deficit of $(106.1) million. We expect to continue to incur losses in the near term as we expend resources to expand our sales organization and invest in the development of new products.

Royalty Payments

In April 2006, we entered into an Assignment and License Agreement with IP Technologies, LLC. As part of the License Agreement, IP Technologies, LLC sold, assigned and transferred proprietary patents and patent applications to us so we could develop and commercialize products. In exchange for patents and patent applications, we agreed to pay IP Technologies, LLC an upfront fee, which we have recorded as an asset that is being amortized over the anticipated useful lives of the patents. In addition to the upfront fee, we also agreed to issue to IP Technologies, LLC shares of our common stock. As further consideration, we agreed to pay IP Technologies, LLC royalties on the net sales of any eligible products sold by us that utilized the acquired technology, subject to certain minimum royalty amounts.

The eligible products subject to royalty payments under the Assignment and License Agreement are the cannulae portions of our single-use access port devices. A cannula is the small tube that is inserted into the body cavity during procedures. One single use set that is used in every AirSeal procedure consists of a trocar and the AirSeal FTS; however, only the trocar portion of the set is eligible for royalty payments.

During November 2012, we amended the Assignment and License Agreement to reduce the royalties on net sales of any eligible products (subject to a minimum royalty), further clarify which products are considered eligible products under the agreement and add a royalty buyout provision. Under the royalty buyout provision, upon an initial public offering or a non-IPO liquidation event, we are required to make a buyout payment to IP Technologies, LLC. Upon that buyout payment, we will no longer be subject to the royalty expenses related to the sale of eligible products and we expect our margins to be favorably impacted. We estimate that this royalty buyout obligation will be approximately $             . See "Use of Proceeds."

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For the nine months ended September 30, 2015 and 2014 and the years ended December 31, 2014 and 2013, we incurred $0.4 million, $0.2 million, $0.3 million and $0.2 million, respectively, of cost of goods sold expenses related to the IP Technologies, LLC royalty agreement.

Components of Results of Operations

Revenues

We commenced sales of AirSeal family products in the United States in the second quarter of 2009 and outside the United States in the fourth quarter of 2009. Our AirSeal family of products have historically accounted for substantially all of our revenues. Our revenues include sales and rentals or leases of the AirSeal iFS unit and sales of single-use products and accessories, such as Access Ports and FTS. For the nine months ended September 30, 2015, approximately 67.9% of our revenues were derived from the sale of single-use products and 32.1% of our revenues were derived from our AirSeal iFS units. We anticipate our revenues will increase as we expand our sales force and marketing programs, increase awareness of our products and increase our number of installed base units and procedures performed with our iFS units and single-use products and accessories. We also expect that, in the future, our revenues will fluctuate on a quarterly basis due to a variety of factors, including seasonal fluctuations of elective surgical procedures during the summer months and holiday periods.

Cost of Goods Sold and Gross Margin

Cost of goods sold consists primarily of costs of finished products purchased from our third-party original equipment manufacturer or contract assembly manufacturer, sterilization, other costs to ready the product for shipment and freight.

Additionally, we pay a royalty equal to 3.0% of the revenue from the sale of cannulas related to our single-use product line. We will use a portion of the proceeds from this offering for a one-time buyout of our royalty obligations and therefore, we do not expect to have continuing royalty obligations after the completion of this offering, which will favorably impact our gross margin.

Our overall gross margin, which is calculated as revenues less cost of goods sold for a given period divided by revenues, may fluctuate in future periods primarily as a result of the uncertainty of potential pricing pressures in conjunction with entering into integrated delivery network contracts and volume discounts to our large international distributors, which may be partially offset by manufacturing cost decreases. The unpredictable variable mix of products sold with different gross margin will also cause fluctuations in overall gross margin.

Selling, General and Administrative Expenses

Our selling, general and administrative, or SG&A expenses consist primarily of salaries, bonuses, benefits, incentive and stock-based compensation for executive, finance, sales, legal, human resources, information technology and administrative personnel, including sales commissions. Other significant SG&A expenses include distributor commissions, clinical studies, conferences, trade shows, promotional activities, training and development, professional fees for legal and accounting services, consulting fees, insurance costs, facility costs and travel expenses.

We expect our SG&A expenses to increase in absolute dollars as we increase our headcount and expand our commercial infrastructure to both drive and support our planned revenue growth. In addition, we expect to incur increased general and administrative expenses such as additional insurance expenses, investor relations activities and other administrative and professional services in connection with becoming a public company, which may increase further when we are no longer able to rely on the "emerging growth company" exemption we are afforded under the JOBS Act.

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Research and Development Expenses

Our research and development, or R&D expenses primarily consist of clinical expenses, regulatory expenses, product development, consulting services, outside research activities, quality control and other costs associated with the development of our products and compliance. R&D expenses also include related personnel and consultant compensation and stock-based compensation expense.

We expect our R&D expenses to vary as different development projects are initiated and completed, including improvements to our existing products, expansions of our existing product lines and new product acquisitions. However, we generally expect these costs will increase in absolute terms over time as we continue to expand our product portfolio and add related personnel.

Other Income and Expenses

Our other income and expenses primarily consist of interest expense, as well as the cost associated with the re-measurement of the fair value of the liability associated with warrants for our redeemable preferred stock and write off of long lived assets.

Results of Operations

The following table sets forth our results of operations for the periods indicated:

 
  Nine Months Ended September 30,  
 
  2014   2015   $ Change   % Change  
 
  (Unaudited)
   
   
 
 
  (In thousands,
except percentages)

 

Statement of operations data:

                         

Revenues

  $ 20,601   $ 34,733   $ 14,132     68.6 %

Cost of goods sold

    10,874     16,232     5,358     49.3 %

Gross profit

    9,727     18,501     8,774     90.2 %

Selling, general and administrative expenses

    17,194     27,522     10,328     60.1 %

Research and development expenses

    2,194     2,950     756     34.5 %

    19,388     30,472     11,084     57.2 %

Operating loss

    (9,661 )   (11,971 )   (2,310 )   23.9 %

Other (expense) income:

                         

Interest expense

    (1,580 )   (1,823 )   (243 )   15.4 %

Interest income

    24     17     (7 )   (29.2 )%

Other (expense) income, net

    (221 )   (1,363 )   (1,142 )   516.7 %

Total other (expense) income, net

    (1,777 )   (3,169 )   (1,392 )   78.3 %

Net loss

  $ (11,438 ) $ (15,140 ) $ (3,702 )   32.4 %


 
  Nine Months Ended
September 30,
   
   
 
 
  2014   2015   $ Change   % Change  
 
  (Unaudited)
   
   
 
 
  (In thousands,
except percentages)

 

Revenues:

                         

Domestic revenue

  $ 13,918   $ 24,912   $ 10,994     79.0 %

International revenue

    6,683     9,821     3,138     47.0 %

Total revenues

  $ 20,601   $ 34,733   $ 14,132     68.6 %

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Comparison of Nine Months Ended September 30, 2014 and 2015

Revenues

Revenues increased $14.1 million, or 68.6%, from $20.6 million for the nine months ended September 30, 2014 to $34.7 million for the nine months ended September 30, 2015. This increase was primarily driven by a global increase in the sales volume of our AirSeal system products resulting from increased commercialization activities, including the expansion of our sales organization, expansion into the China market, increased marketing activities and growing evidence of the clinical and economic benefits of AirSeal system products.

Cost of Goods Sold and Gross Margin

Cost of goods sold increased $5.4 million, or 49.3%, from $10.9 million for the nine months ended September 30, 2014 to $16.2 million for the nine months ended September 30, 2015. This increase was primarily due to an increase in sales volume.

Gross margin for the nine months ended September 30, 2014 and 2015 was 47.2%, and 53.3%, respectively. This increase was primarily due to manufacturing cost reductions driven by improvements in product design as well as increasing volumes of single-use products.

Selling, General and Administrative Expenses

SG&A expenses increased $10.3 million, or 60.1%, from $17.2 million for the nine months ended September 30, 2014 to $27.5 million for the nine months ended September 30, 2015. This increase was primarily due to a $5.0 million increase in direct employee-related expenses for the global sales department, a $1.6 million increase in accounting costs related to the initial public offering, a $1.1 million increase in marketing costs, mostly attributable to clinical studies, a $1.0 million increase in professional services, a $0.8 million increase in indirect sales costs such as demonstration product, travel, meetings and vendor dues, a $0.6 million increase in personnel costs associated with developing the financial infrastructure required for reporting as a publicly traded corporation, and a $0.2 million increase in the federal excise tax due to increased sales.

Research and Development Expenses

R&D expenses increased $0.8 million, or 34.5%, from $2.2 million for the nine months ended September 30, 2014 to $3.0 million for the nine months ended September 30, 2015. This increase was primarily due to an increase in employee-related expenses and costs associated with the redesign of AirSeal single-use products to achieve manufacturing cost savings and compliance with FDA regulations.

Other (Expense) Income, net

Other (expense) income, net increased $(1.4) million, or 78.3%, from $(1.8) million for the nine months ended September 30, 2014 to $(3.2) million for the nine months ended September 30, 2015. This increase was primarily associated with the re-measurement of the fair value of the liability associated with warrants for our redeemable preferred stock and interest expense on our term and revolver loans, net of interest income on our cash balances.

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  2013   2014   $ Change   % Change  
 
  (In thousands,
except percentages)

 

Statement of operations data:

                         

Revenues

  $ 19,102   $ 30,249   $ 11,147     58.4 %

Cost of goods sold

   
11,052
   
16,031
   
4,979
   
45.1

%

Gross profit

    8,050     14,218     6,168     76.6 %

Selling, general and administrative expenses

    12,978     23,622     10,644     82.0 %

Research and development expenses

    2,029     2,909     880     43.4 %

    15,007     26,531     11,524     76.8 %

Operating loss

    (6,957 )   (12,313 )   (5,356 )   77.0 %

Other (expense) income:

                         

Interest expense

    (909 )   (2,146 )   (1,237 )   136.1 %

Interest income

    12     31     19     158.3 %

Other (expense) income, net

    (414 )   (388 )   26     (6.3 )%

Total other (expense) income, net

    (1,311 )   (2,503 )   (1,192 )   90.9 %

Net loss

  $ (8,268 ) $ (14,816 ) $ (6,548 )   79.2 %


 
  Year Ended December 31,    
   
 
 
  2013   2014   $ Change   % Change  
 
  (In thousands,
except percentages)

 

Revenues:

                         

Domestic revenue

  $ 12,829   $ 20,665   $ 7,836     61.1 %

International revenue

    6,273     9,584     3,311     52.8 %

Total revenues

  $ 19,102   $ 30,249   $ 11,147     58.4 %

Comparison of Year Ended December 31, 2013 and 2014

Revenues

Revenues increased $11.1 million, or 58.4%, from $19.1 million in 2013 to $30.2 million in 2014. This increase was primarily driven by a global increase in the sales volume of our AirSeal system products resulting from increased commercialization activities, including the expansion of our sales organization, increased marketing activities and growing evidence of the clinical and economic benefits of AirSeal system products.

Cost of Goods Sold and Gross Margin

Cost of goods sold increased $5.0 million, or 45.1%, from $11.1 million in 2013 to $16.0 million in 2014. This increase was primarily due to an increase in sales volume.

Gross margin for the years 2013 and 2014 was 42.1% and 47.0%, respectively. This increase was primarily due to newly launched product extensions within our technology platform with design improvements resulting in lower manufacturing costs.

Selling, General and Administrative Expenses

SG&A expenses increased $10.6 million, or 82.0%, from $13.0 million in 2013 to $23.6 million in 2014. This increase was primarily due to a $5.7 million increase in direct employee-related expenses

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for the global sales department, a $1.8 million increase in indirect sales costs such as demonstration product, travel, meetings and vendor dues, a $0.9 million increase in marketing costs, mostly attributable to clinical studies and consultants, a $0.6 million increase in executive compensation due to the hiring of a new Chief Commercialization Officer, a $0.4 million increase in recruiting costs associated with overall headcount increases, a $0.3 million increase in information technology expenses related to the implementation of our new enterprise resource planning system and a $0.3 million increase in professional services.

Research and Development Expenses

R&D expenses increased $0.9 million, or 43.4%, from $2.0 million in 2013 to $2.9 million in 2014. This increase was primarily due to an increase in employee-related expenses and costs associated with the redesign of AirSeal single-use products to achieve manufacturing cost savings and compliance with FDA regulations.

Other (Expense) Income, net

Other (expense) income, net increased $(1.2) million, or 90.9%, from $(1.3) million in 2013 to $(2.5) million in 2014. The increase was primarily due to the refinancing of our $11.0 million debt facility to a $20.0 million debt facility in May 2014, which was subsequently increased to $25.0 million in November 2014. We incurred $0.3 million in conjunction with early prepayment fees to the previous lender that increased interest expense in May 2014. In contrast, the expense related to the re-measurement of the fair value of our warrant liability decreased by $0.2 million during 2014.

Liquidity and Capital Resources

Since our inception, we have incurred significant Net Operating Losses, or NOLs, and anticipate that our losses will continue in the near term. We expect our operating expenses will continue to grow as we expand our operations. We will need to generate significant revenues to achieve profitability. We have funded our operations primarily with proceeds from the sales of preferred stock, borrowings under our term loans and sales of our products. To date, we have received gross proceeds from the sales of preferred stock totaling $66.0 million. We issued and sold preferred stock for aggregate gross proceeds of $20.0 million in March and May 2015, which was our most recent issuance and sale of preferred stock. All of our preferred stock is convertible to common stock at the option of the holder and will automatically convert upon the closing this offering. As of September 30, 2015, we had $22.0 million outstanding on our term loan and $3.0 million outstanding on our revolver loan.

At September 30, 2015, we had $7.8 million in cash and cash equivalents. We believe that our available cash on hand combined with cash receipts from the sale of our products and proceeds from this offering will be sufficient to satisfy our liquidity requirements for at least the next twenty-four months. However, the continued growth of our business, including the expansion of our sales force, marketing programs, business development and research and development activities, will significantly increase our expenses. In addition, the amount of our future sales is difficult to predict and actual sales may be not be in line with our forecasts. As a result, we may be required to seek additional funds in the future from public or private offerings of our capital stock, borrowings under term loans or other sources, subject to the restrictions under our term loan agreement.

Our historical cash outflows have primarily been associated with research and development related to obtaining FDA clearance and other global regulatory approvals for our AirSeal system, complying with the FDA's post-approval requirements, capital expenditures relating to production equipment and tooling, sales and marketing activities relating to commercialization and increases in working capital, including the purchase of inventory.

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The following table shows a summary of our cash flows provided by (used by) operating, investing and financing activities for the periods indicated:

 
  Year Ended December 31,   Nine Months Ended September 30,  
 
  2013   2014   2014   2015  
 
   
   
  (Unaudited)
 
 
  (In thousands)
 

Net cash used by operating activities

  $ (5,796 ) $ (12,687 ) $ (8,472 ) $ (16,295 )

Net cash used by investing activities

    (1,747 )   (2,882 )   (2,444 )   (1,857 )

Net cash provided by financing activities

    3,511     16,183     10,880     19,920  

Net increase (decrease) in cash and cash equivalents

  $ (4,032 ) $ 614   $ (36 ) $ 1,768  

Cash used by operating activities

The net cash used by operating activities increased $7.8 million from $8.5 million for the nine months ended September 30, 2014 to $16.3 million for the nine months ended September 30, 2015. The increase in cash used by operating activities for the first nine months of 2015 compared to the same period in 2014 was primarily the result of the increase in net loss of $3.7 million and a $5.2 million increase in the components of working capital, partially offset by a $1.1 million increase in warrant liabilities due to the increase in the fair value associated with warrants of our redeemable preferred stock. The components of working capital increased $4.6 million in the first nine months of 2015 due primarily to a $3.3 million increase in accounts receivable, a $1.7 million increase in inventory due to sales growth, a $1.4 million increase in prepaid expenses and other current assets due to capitalized IPO costs partially offset by a $1.3 million increase in accounts payable and a $0.7 increase accrued expenses.

The increase in net cash used by operating activities from 2013 to 2014 of $6.9 million was primarily associated with the increase in net loss of $6.5 million and an increase in accounts receivable due to sales growth.

Cash used by investing activities

The net cash used by investing activities was $2.4 million for the nine months ended September 30, 2014 and $1.9 million for the nine months ended September 30, 2015. For both periods, this included the purchase of assembly and manufacturing tooling for the production of our products.

The increase in net cash used by investing activities from 2013 to 2014 of $1.1 million was primarily associated with the purchase of production equipment for redesigned products and production efficiencies.

Cash provided by financing activities

Net cash provided by financing activities of $10.9 million and $19.9 million for the nine months ended September 30, 2014 and September 30, 2015, respectively, was primarily attributable to additional funds borrowed under our debt facility refinance in May 2014 and our $20.0 million Series E preferred stock financing in March and May 2015, respectively.

Net cash provided by financing activities of $16.2 million for the year ended December 31, 2014 was primarily attributable to funds borrowed under our credit facility.

Net cash provided by financing activities of $3.5 million for the year ended December 31, 2013 was primarily attributable to funds borrowed under our credit facility and the issuance of the second tranche of our Series D preferred stock.

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Our liquidity position and capital requirements are subject to a number of factors. For example, our cash inflow and outflow may be impacted by the following:

      the revenues generated by our AirSeal system and any other future products that we may develop and commercialize;

      the cost associated with expanding our sales force and marketing programs;

      the cost of clinical studies in support of our continued commercialization efforts;

      the cost associated with developing and commercializing our proposed products or technologies;

      the cost of obtaining and maintaining regulatory clearance or approval for our current or future products;

      the cost of ongoing compliance with regulatory requirements;

      expenses we incur in connection with potential litigation or governmental investigations;

      expenses we incur in connection with being a publicly traded company;

      anticipated or unanticipated capital expenditures; and

      unanticipated SG&A expenses.

Our primary short-term capital needs, which are subject to change, include expenditures related to:

      support of our commercialization efforts related to our current and future products;

      support of research validating the clinical and economic benefits of the AirSeal system;

      new product development efforts; and

      payment of monthly interest due under our term loan.

Although we believe the foregoing items reflect our most likely uses of cash in the short-term, we cannot predict with certainty all of our particular short-term cash uses or the timing or amount of cash used. If cash generated from operations is insufficient to satisfy our working capital and capital expenditure requirements, we may be required to sell additional equity or debt securities or obtain additional credit facilities. Additional capital, if needed, may not be available on satisfactory terms, if at all. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may include restrictive covenants. For a discussion of other factors that may impact our future liquidity and capital funding requirements, see "Risk Factors — Risks Related to our Business and Strategy."

Indebtedness

Fountain Leasing

On July 27, 2015, we entered into a Master Lease with Fountain Leasing 2013 LP for an equipment lease in the amount of $0.4 million. The lease calls for thirty-six monthly payments of $0.01 million with either a purchase option at the end of the lease term of $0.04 million or an extension of the term for an additional twelve months. The lease is collateralized by a security interest in the equipment.

Credit and Security Agreement

On May 29, 2014, we entered into a Credit and Security Agreement with MidCap Funding V Trust. The Credit and Security Agreement included a term loan in the amount of $17.0 million and a

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revolving loan in the amount of $3.0 million, which may be increased by up to $5.0 million, subject to certain conditions outlined in the Credit and Security Agreement. On November 6, 2014, we amended the Credit and Security Agreement to borrow an additional $5.0 million on the term loan. As of September 30, 2015, the amount outstanding under the Credit and Security Agreement was $25.9 million, which consisted of $22.0 million on the term loan, $3.0 million on the revolving loan and a $0.9 million terminal fee.

Depending on whether certain revenue thresholds are met, we have the option to elect to make interest-only payments until a date between July 1, 2015 and July 1, 2017. The maturity date of the Credit and Security Agreement will fall between June 1, 2018 and June 1, 2019 depending on the number of interest only extensions we have elected.

The $22.0 million term loan bears interest at a rate equal to an applicable LIBOR rate plus 7.5%, with a minimum floor for the applicable LIBOR rate of 0.5% per annum. The interest rate is currently 8.0% per annum. The $3.0 million revolving loan bears interest at a rate equal to an applicable LIBOR rate plus 5.5%, with a minimum floor for the applicable LIBOR rate of 0.5% per annum. The interest rate is currently 6.0% per annum. The weighted average interest rate for the period ended and the rate at December 31, 2014 for the term loan and revolving loan was 8.0% and 6.0%, respectively. The weighted average interest rate for the nine months ended and at September 30, 2015 and September 30, 2014 for the term loan and revolving loan was 8.0% and 6.0%, respectively.

A terminal payment equal to 4.0% of the total amount of the term loan is due when the loan matures. We are also required to pay an early termination fee of 1.0% of the total credit extensions if we chose to pay off the loans prior to the abovementioned maturity date.

The loans are secured by all of our tangible assets. The Credit and Security Agreement contains various negative and affirmative covenants, including certain restrictive covenants that limit our ability to transfer or dispose of certain assets, engage in new lines of business, change the composition of our management, merge with or acquire other companies, incur additional debt, create new liens and encumbrances, pay dividends or subordinated debt and enter into material transactions with affiliates, among others. It also contains financial reporting requirements, but no specific financial covenants. Proceeds from the $17.0 million term loan were used to pay off the outstanding balances and obligations under the Loan and Security Agreement.

Loan and Security Agreement

In September 2012, we entered into a Loan and Security Agreement with a lender for a term loan in the amount of $9.0 million. Of this amount, a $7.0 million term loan was funded upon the execution of the Loan and Security Agreement in September 2012, and the remaining $2.0 million term loan was funded in September 2013. The term loans were collateralized by a first-priority security interest in substantially all of our assets.

The $7.0 million term loan bore interest at a rate of 10.0% per annum and required 48 monthly installments as follows (i) commencing on November 1, 2012, nine monthly payments of interest only; (ii) commencing on August 1, 2013, three monthly payments of $0.1 million each, plus accrued interest; (iii) commencing on November 1, 2013, 36 monthly payments of $0.2 million each, plus accrued interest. We were also required to pay an upfront term loan commitment fee of $45,000 in connection with the $7.0 million term loan. A terminal payment fee equal to $0.2 million, which represented 3.0% of the total amount of the $7.0 million term loan, was due on October 1, 2016.

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The $2.0 million term loan bore interest at a rate of 10.69% per annum and required 48 monthly installments as follows (i) commencing on November 1, 2013, nine monthly payments of interest only; (ii) commencing on August 1, 2014, three monthly payments of $0.03 million each, plus accrued interest; (iii) commencing on November 1, 2014, 36 monthly payments of $0.05 million each, plus accrued interest. A terminal payment fee equal to $0.06 million, which represented 3.0% of the total amount of the $2.0 million term loan, was due on October 1, 2017.

The Loan and Security Agreement also made available a revolving loan of $2.0 million. The revolving loan included a swing arm feature that allowed any principal paid on the term loans in the subsequent twelve months from funding to be applied to the availability on the revolving loan to increase the overall revolving loan commitment. As of December 31, 2013, the total availability on the revolving loan was $2.2 million.

Interest on the revolving loan bore interest at a rate of 8.5% per annum and required us to pay an annual commitment fee equal to 1.0% of the revolving loan commitment. The revolving loan commitment fee was due on September 28, 2013 and each year thereafter on the anniversary of the revolving loan. At December 31, 2013, we had not borrowed any funds under the revolving loan. On May 29, 2014, we had $2.2 million outstanding on the line of credit. The proceeds from the Credit and Security Agreement were used to pay-off the outstanding balance of the revolving loan.

In connection with the Loan and Security Agreement, we issued a stock warrant to purchase 54,672 shares of Series D Preferred Stock at a cost of $5.03 per share, subject to adjustment as defined in the warrant agreement. The resulting debt discount was being amortized over four years, which was equal to the life of the applicable notes. During 2014, we wrote off the debt discount when the Loan and Security Agreement was paid in full.

Contractual Obligations and Commitments

The following table summarizes our contractual obligations and commitments as of December 31, 2014:

 
  Payments Due by Period  
 
  Total   Less than
1 year
  1 - 3 years   3 - 5 years   More than
5 years
 
 
  (In thousands)
 

Debt obligations(1)(2)

  $ 25,000   $ 1,833   $ 14,667   $ 8,500   $  

Interest and other payments related to debt(1)(2)

    4,624     1,878     2,495     251      

Operating lease obligations(3)

    78     78              

Total contractual obligations

  $ 29,702   $ 3,789   $ 17,162   $ 8,751   $  

(1)
The amortization of the term loan outstanding assumes that only the first interest-only extension of eight possible interest-only extensions, that in an aggregate effect may defer principle payments through June 30, 2017, has occurred.

(2)
In July 2015, we entered into a new lease for office furniture for our new office and laboratory space, such that our debt obligations reflected in the table above will increase by $73.0 thousand for less than 1 year, $366.1 thousand for 1-3 years and $0.0 thousand for 3-5 years following December 31, 2014. Our interest obligations reflected in the table above will increase by $13.5 thousand for less than 1 year, $35.8 thousand for 1-3 years and $0.0 thousand for 3-5 years following December 31, 2014.

(3)
In April 2015, we signed a lease agreement for office and laboratory space in Milford, Connecticut, such that our operating lease obligations reflected in the table above will increase by $46.1 thousand for less than 1 year, $1.9 million for 1-3 years, $1.5 million for 3-5 years and $0.0 million for more than 5 years following December 31, 2014.

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Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Quantitative and Qualitative Disclosure About Market Risk

We are exposed to market risks arising from transactions in the ordinary course of our business. These risks are primarily associated with interest rate fluctuations, as well as changes in our credit standing, based on the capital and credit markets, which are not predictable. We do not currently hold any instruments for trading purposes.

Our cash and cash equivalents include cash in readily available checking and money market accounts in financial institutions that are insured by the Federal Deposit Insurance Corporation up to $250,000. Changes in interest rates would not be expected to have a material impact on cash and cash equivalents; however, interest rate fluctuations would affect the amount of interest income that is earned.

The interest rates on our term loans and revolver loan are not fixed. They are subject to changes in the LIBOR rate, the Federal Funds Rate or the prime rate at Wells Fargo Bank, N.A. and are thus subject to exposure of interest rate changes. For the term and revolver loan facility, a hypothetical 10% increase in variable rates from the applicable rates at September 30, 2015 would not have an impact on interest expense, as LIBOR was more than 50.0% below the floor stipulated in the Credit and Security Agreement. We cannot predict market fluctuations in interest rates and their impact on our debt, nor can there be any assurance that long-term fixed-rate debt will be available at favorable rates, if at all. Consequently, future results may differ materially from estimated results due to adverse changes in interest rates or debt availability.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about our financial condition and results of operations that are not readily apparent from other sources. Actual results may differ from these estimates.

While our significant accounting policies are more fully described in Note 3 to our financial statements included in this prospectus, we believe that the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.

Revenue Recognition

Our revenues are primarily derived from the sale of the AirSeal Intelligent Flow System, or iFS, unit and related iFS single-use products. We currently market and sell products in the United States and other countries internationally through a multi-channel sales organization comprised of sales managers, direct sales representatives, clinical education specialists and distributors. The vast majority of our revenues are generated from sales to hospital customers through direct sales representatives and distributors. Virtually all these distributor arrangements are evidenced by contracts whereby we grant the distributor the exclusive right to market and sell certain products in a specified geographic territory. The contracts require written purchase orders for all product sales at which time pricing is

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determined for all products sold under the purchase order and no post sale pricing concessions are provided. The customers take title and bear the "risk of loss" at time of shipment or upon receipt, at which time we have no further performance obligations. We also warrant the products for twelve months from the date of delivery for material defects in design or workmanship. To date, the effect to us under the provisions of this arrangement of any replacements of product or refunds has been immaterial.

We only sell in markets where we have regulatory approval. We sell our products directly to hospitals in the United States and to distributors outside the United States. We recognize revenue when persuasive evidence of an arrangement exists, title and risk of loss has passed, delivery to the customer has occurred or the services have been fully rendered, as well as when the sales price is fixed or determinable and collectability is reasonably assured. Revenue is recognized at the net amounts expected to be received. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. We recognize revenue when title to the goods and risk of loss transfer to customers, as there are no remaining performance obligations that will affect the customer's final acceptance. None of the products that we sell come with an attached right of return, or contain subjective conditions which would prevent us from recognizing revenue. We offer rights of return in limited circumstances, generally on a discretionary basis when there is a legitimate product defect, which has historically been infrequent in nature and immaterial. As such, we do not currently provide for a return reserve.

Arrangements with customers may include multiple deliverables, including a lease as well as sale of products. In these arrangements, we allocate revenue to all deliverables based on their relative selling prices. We use a hierarchy to determine the selling price to be used for allocating revenue to deliverables: (a) vendor-specific objective evidence of fair value, or VSOE, (b) third-party evidence of selling price, or TPE and (c) best estimate of selling price, or BESP, which are determined as follows:

(a)
VSOE — It is common for the sale of iFS units to include multiple elements which have standalone value and qualify as separate units of accounting. These elements commonly include the sale of the unit(s) and single-use products. We determine VSOE based on its normal pricing and discounting practices for the specific product or service when sold separately. In determining VSOE, we require that a substantial majority of the selling prices for a product or service falls within a reasonably narrow pricing range. In addition, we consider the geographies in which the products or services are sold, major product and service groups, customer classification and other environmental or marketing variables in determining VSOE.

(b)
TPE — TPE exists only when we sell the deliverable separately and is based on competitor prices. We are unable to reliably determine what similar competitor products' selling prices are on a stand-alone basis. Therefore, we are typically not able to determine TPE.

(c)
BESP — BESP is an estimate based on our pricing practices, market conditions and other factors specific to us. We currently do not utilize BESP.

Once elements of an arrangement are separated into more than one unit of accounting, revenue is recognized for each separate unit of accounting based on the nature of the revenue as described above.

Changes in cost estimates and the fair values of certain deliverables could negatively impact our operating results. In addition, unforeseen conditions could arise over the contract term that may have a significant impact on our operating results.

Management judgments and estimates are made in connection with the determination of revenue to be recognized and the period in which it is recognized. If different judgments and estimates were utilized,

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the amount of revenue to be recognized and the period in which it is recognized could differ materially from the amounts reported.

Stock-Based Compensation

Stock-based compensation cost is measured at the date of grant based on the estimated fair value of the award, net of estimated forfeitures. We estimate the fair value of our stock-based awards to employees and directors using the Black-Scholes option pricing model. The grant date fair value of a stock-based award is recognized as an expense over the requisite service period of the award on a straight-line basis.

For equity instruments issued to individuals other than employees and directors, the award is recorded at fair value at the date of grant; however we re-measure the fair value of such instruments granted at each reporting period until the performance under the consulting arrangements is completed. The initial expense is recognized over the term of the service agreement or if an open ended assignment, over the standard vesting period indicated in the grant. To date this expense has been immaterial.

We recorded total non-cash stock-based compensation expense of $0.3 million and $0.2 million for the years ended December 31, 2014 and 2013, respectively, and $0.4 and $0.3 million for each of the nine months ended September 30, 2015 and 2014. At December 31, 2014 and September 30, 2015, we had $0.5 million and $1.5 million of total unrecognized employee stock-based compensation expense, related to stock option grants, respectively. As of December 31, 2014 and September 30, 2015, these costs will be recognized as expense over a weighted-average period of 2.84 and 3.17 years, respectively.

We expect to continue to grant stock options in the future, and, to the extent that we do, our actual stock-based compensation expense recognized in future periods will increase.

The Black-Scholes option pricing model requires the input of subjective assumptions, including the risk-free interest rate, expected dividend yield, expected volatility, expected term and the fair value of the underlying common stock on the date of grant, among other inputs. These estimates involve inherent uncertainties and the application of management's judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows:

      Risk-free interest rate — The risk-free interest rate is based on the yields of U.S. Treasury securities with a maturity similar to the expected term of the option in effect at the time of grant.

      Dividend yield — We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

      Expected volatility — As our common stock has never been publicly traded, the expected stock price volatility for our common stock is derived from the weighted average historical volatilities of publicly traded companies within our industry that we consider to be comparable to our business over a period approximately equal to the expected term for employee options. We intend to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of our own common stock share price becomes available.

      Expected term — The expected term represents the period that our stock-based awards are expected to be outstanding. We use the simplified method to determine the expected term,

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        which is calculated as the weighted average of midpoint between the time to vesting for each vesting period and the contractual life of the options.

      Fair value of our common stock — Because our stock was not publicly traded prior to this offering, we estimated the fair value of our common stock, as discussed below. Upon the completion of this offering, our common stock will be valued by reference to the publicly-traded price of our common stock.

In addition to the assumptions used in the Black-Scholes option pricing model, the amount of stock-based compensation expense we recognize in our financial statements includes an estimate of stock option forfeitures. We estimate our forfeiture rate based on an analysis of our actual forfeitures and will continue to evaluate the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover and other factors. Changes in the estimated forfeiture rate can have an impact on our stock-based compensation expense as the cumulative effect of adjusting the rate is recognized in the period the forfeiture estimate is changed. If a revised forfeiture rate is higher than the previously estimated forfeiture rate, an adjustment is made that will result in a decrease to the stock-based compensation expense recognized in the financial statements. If a revised forfeiture rate is lower than the previously estimated forfeiture rate, an adjustment is made that will result in an increase to the stock-based compensation expense recognized in our financial statements.

The fair value of our common stock is determined on each grant date by our management in accordance with Statement of Standards for Valuation Services No. 1 of the American Institute of Certified Public Accountants. Options to purchase shares of our common stock are intended to be granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant, based on the information known to us on the date of grant. Our assessments of the fair value of our common stock were performed using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation.

The valuations have been developed using significant judgment and taking into account numerous factors, including:

      external market conditions affecting the medical device industry;

      trends within the medical device industry;

      the superior rights and preferences of our preferred stock relative to our common stock at the time of each grant;

      our results of operations and financial position;

      our stage of development and business strategy;

      our ability to commercialize our product;

      the lack of an active public market for our common and our preferred stock; and

      the likelihood of achieving a liquidity event such as an initial public offering or sale of our company in light of prevailing market conditions.

Warrant Liabilities

In 2007 and 2008, we issued stock warrants to purchase 52,239 shares of Series A preferred stock. The warrants are immediately exercisable and expire ten years from the date of issuance. The exercise price of the warrants is $2.01 per share, subject to adjustment as defined in the warrant agreement.

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In 2011 we issued stock warrants to purchase 365,604 shares of Series C preferred stock. The warrants are immediately exercisable and expire between five and seven years from the date of issuance, as defined in each warrant agreement. The exercise price of the warrants is $3.95 per share, subject to adjustment as defined in the warrant agreements. In connection with the issuance of notes payable in 2012, we issued stock warrants to purchase 54,672 shares of Series D preferred stock. The warrants are immediately exercisable and expire ten years from the date of issuance. The exercise price of the warrants is $5.03 per share, subject to adjustment as defined in the warrant agreement.

We account for the warrants as a liability since they are separable instruments for the purchase of potentially redeemable stock. The liability is revalued at each reporting period and the change in fair value recognized as interest expense for warrants outstanding in connection with the issuance of debt that is still payable or other income (expense) if issued in connection with the issuance of preferred stock. The terms of all warrants provide for either gross or net settlement at the option of the holder.

Recent Accounting Pronouncements

In July 2015, the FASB issued Accounting Standards Update (ASU) No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory, or ASU 2015-11. The amendments in ASU 2015-11 require an entity to measure in scope inventory at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The amendments do not apply to inventory that is measured using last-in, first-out, or LIFO, the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out, or FIFO, or average cost. The pronouncement is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. We are currently evaluating the impact of this update.

In November 2014, the FASB issued Accounting Standards Update, or ASU, No. 2014-16, Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity, or ASU 2014-16. The update was issued to reduce the diversity under GAAP in the accounting for hybrid financial instruments issued in the form of a share. The update clarifies that an entity should consider all relevant terms and features in evaluating the nature of the host contract. Entities should also assess the substance of the relevant terms and features when considering how to weight them. The amendment is effective for fiscal years beginning after December 15, 2015, with early adoption permitted. Application to existing instruments is on a modified retrospective basis to all relevant prior periods. We are currently evaluating the impact of this update.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern, or ASU 2014-15. The amendments in ASU 2014-15 are intended to define management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. Under U.S. GAAP, financial statements are prepared under the presumption that the reporting organization will continue to operate as a going concern, except in limited circumstances. The going concern basis of accounting is critical to financial reporting because it establishes the fundamental basis for measuring and classifying assets and liabilities. Currently, GAAP lacks guidance about management's responsibility to evaluate whether there is substantial doubt about the organization's ability to continue as a going concern or to provide related footnote disclosures. This ASU provides guidance to an organization's management, with principles and definitions that are intended to reduce diversity in the timing and

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content of disclosures that are commonly provided by organizations today in the financial statement footnotes. The pronouncement is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. We are currently evaluating the impact of this update.

In May 2014, the Financial Accounting Standards Board the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, or ASU 2014-09, which stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for such goods or services. To achieve this core principle, an entity should apply the following steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract(s); (3) determine the transaction price(s); (4) allocate the transaction price(s) to the performance obligations in the contract(s); and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The guidance also requires advanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity's contracts with customers. For public business entities, ASU 2014-09 was originally effective for the fiscal year beginning January 1, 2017 using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a modified retrospective approach with the cumulative effect of initially adopting the standard recognized at the date of adoption (which includes footnote disclosures). In August, 2015, the FASB issued ASU 2015-14, Revenue From Contracts With Customers (Topic 606): Deferral of the Effective Date, that defers the effective date of the new revenue standard by one year (January 1, 2018 effective date). Reporting entities have the option to adopt the standard as early as the original January 1, 2017 effective date. We are currently evaluating the impact of this amendment on our financial position and results of operations.

Jumpstart Our Business Startups Act of 2012 (JOBS Act)

In April 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an "emerging growth company." As an "emerging growth company," we are electing not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards, and as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth public companies. Section 107 of the JOBS Act provides that our decision not to take advantage of the extended transition period is irrevocable. We have chosen to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an "emerging growth company" we are not required to, among other things, (i) provide an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (auditor discussion and analysis) and (iv) disclose certain executive compensation-related items, such as the correlation between executive compensation and performance and comparisons of the chief executive officer's compensation to median employee compensation. We may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of this offering. However, if certain events occur prior to the end of such five-year period, including if we become a "large accelerated filer," our annual gross revenue equals or exceeds $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

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The above listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by GAAP. There are also areas in which our management's judgment in selecting any available alternative would not produce a materially different result. Please see our audited financial statements and notes thereto included elsewhere in this prospectus, which contain accounting policies and other disclosures required by GAAP.

Controls and Procedures

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. GAAP. We have not performed an evaluation of our internal control over financial reporting, such as required by Section 404 of the Sarbanes-Oxley Act, nor have we engaged an independent registered public accounting firm to perform an audit of our internal control over financial reporting as of any balance sheet date or for any period reported in our financial statements. Presently, we are not an accelerated filer, as such term is defined by Rule 12b-2 of the Exchange Act, and therefore, our management is not presently required to perform an annual assessment of the effectiveness of our internal control over financial reporting. This requirement will first apply to our Annual Report on Form 10-K for the year ended December 31, 2016. Our independent registered public accounting firm will first be required to attest to the effectiveness of our internal control over financial reporting for our Annual Report on Form 10-K for the first year we are no longer an "emerging growth company" under the JOBS Act. In connection with our audit as of and for the years ended December 31, 2014 and December 31, 2013, our independent registered public accounting firm identified a material weakness in our internal control over financial reporting. See "Risk Factors — Risks Related to Our Business and Strategy — Our independent registered public accounting firm has identified a material weakness in our internal control over financial reporting that, if not properly remediated, could result in material misstatements in our financial statements in future periods" for a discussion of these matters.

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BUSINESS

We are a commercial stage global medical technology company that is revolutionizing Minimally Invasive Surgery with AirSeal, our proprietary surgical access management system that we believe offers significant clinical benefits for patients and economic benefits for healthcare providers. We refer to the combination of our proprietary AirSeal technology and the surgical procedures that they enable as Low Impact Surgery. We believe Low Impact Surgery enables a wider range of surgical procedures to be performed with less invasive surgical access, thereby broadening the population of patients for whom MIS procedures may be applicable. As of September 30, 2015, more than 1,600 AirSeal systems were deployed in over 700 institutions worldwide, and we believe AirSeal disposable devices have been used in more than 340,000 surgical procedures worldwide since 2011. Quarterly sales of AirSeal disposables have grown from less than 4,000 sets during the three months ended March 30, 2012 to more than 44,000 disposables sets during the three months ended September 30, 2015; and more than 135,000 disposables sets were sold during the 9 months ended September 30, 2015.

Over the past 25 years, abdominal surgery has evolved from highly invasive open procedures to MIS approaches, which include techniques such as laparoscopic and robotic-assisted laparoscopic surgery. According to Millennium Research Group, approximately 33 million abdominal surgical procedures are expected to be performed in 2015 in major markets worldwide, of which approximately 10 million are currently addressable by our technology, representing an annual opportunity for approximately $2 billion of AirSeal disposables. MIS has continued to evolve, incorporating surgical robots in its most advanced form. We believe robotic-assisted surgery combines the benefits of minimally invasive access to the body with the enhanced dexterity and surgical control provided by surgical robotics. Approximately 570,000 robotic-assisted surgical procedures were performed in 2014 worldwide. We believe AirSeal is the leading surgical access system used in robotic-assisted procedures globally.

MIS relies on the creation of working space in the abdominal cavity to facilitate the manipulation of surgical instruments and the visualization of the surgical site by endoscopic cameras. This is done through the inflation and distension of the abdominal cavity using CO2 under pressure. This process is known as insufflation and the resulting state of insufflation is referred to as pneumoperitoneum. It is critical that pneumoperitoneum remains stable throughout the procedure. However, fluctuations in intra-abdominal pressure can be caused by surgical suction, smoke evacuation, specimen removal, trocar dislodgement, moving the patient, applying pressure to the patient's body or over-pressurizing the surgical cavity after a loss of pneumoperitoneum. Conventional access devices, comprising trocars, insufflators and insufflation tubing, are designed to create and maintain pneumoperitoneum. However, these devices have numerous limitations which result in challenges in maintaining stable pneumoperitoneum. These limitations include intermittent pressure monitoring, delayed response to pressure changes and the inability to prevent loss of pneumoperitoneum during standard instrument exchange, use of suction, smoke evacuation or specimen removal. Conventional access devices also do not include integrated management of surgical smoke caused by thermal energy-based devices commonly used during surgery, which obstructs the view of the surgical field and poses potential health hazards for operating room occupants. The combination of these limitations contributes to an environment in which intra-abdominal pressure often fluctuates between levels so low that the surgical working space collapses and so high that it can cause harm to the patient. Surgeries using conventional access devices may also require more invasive access in order to accommodate the safe removal of contaminated or cancerous surgical specimens from the body. Accordingly, conventional access devices are associated with complications including errant cuts or burns, increased blood loss, longer operating times, more post-operative pain and prolonged recovery times which also lead to increased costs for the hospital.

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We believe that our AirSeal technology represents the first major innovation in minimally invasive surgical access since the introduction of the modern trocar. The AirSeal system replaces trocars that rely on mechanical valves to create and maintain pneumoperitoneum with a valve-free access port that has no moving parts. AirSeal instead employs a proprietary gaseous barrier to provide real-time sensing of intra-abdominal pressure, which enables dynamic adjustment of intra-abdominal pressure to maintain stable pneumoperitoneum. AirSeal also includes automatic and continuous smoke evacuation to provide a clear and constant field of vision. Accordingly, the improved surgical conditions enabled by AirSeal allow surgeons to perform MIS procedures with a more stable and less rigid state of pneumoperitoneum, and at approximately 50% lower intra-abdominal pressures than are typically used with conventional access devices. Laparoscopy performed at lower pressure has been clinically demonstrated to contribute to lower post-operative pain, reduced reliance on post-operative pain medication and shorter length of hospital stay. While we have not yet completed a clinical study comparing both AirSeal and conventional insufflation at low pressure, several studies have been completed comparing AirSeal at low pressure versus conventional insufflation at standard pressure. In these studies, AirSeal at low pressure did not demonstrate the challenges typically associated with conventional insufflation at low pressure (which include increased operating time and a greater requirement to raise intra-abdominal pressure from low to standard levels). In addition, we believe AirSeal simplifies pulmonary ventilation and hemodynamic management by the anesthesiologist, enabling a minimally invasive approach in patients who have more complicated diseases and are traditionally poor candidates for MIS.

The AirSeal system has received clearance from the U.S. Food and Drug Administration, or FDA, pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act. The cleared indications for use are (i) in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke; (ii) to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke; and (iii) to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. In addition, the trocar of the AirSeal system is indicated for use with or without visualization of the surgical site by endoscopic cameras. Typically, our customers are reimbursed for surgical procedures utilizing our devices through bundled payments, rather than receiving direct reimbursement for the cost of the AirSeal system components. Our customers accept the bundled payments as reimbursement for all associated costs of the surgical procedure, including the products and supplies used. Facility and physician reimbursement levels can vary according to the type of surgical procedure performed, the setting in which the surgical procedure was performed (e.g., hospital inpatient or outpatient departments), the clinical condition of the patient and other factors.

We have sponsored numerous post-market clinical studies within several surgical specialties to assess the clinical benefits of our AirSeal system for its cleared indications, and we are aware of five third-party studies of our system. All of these studies assessed the AirSeal system for its currently cleared indications for use. While we believe that these data support the benefits of the AirSeal system, the studies have certain limitations, such as the fact that some of these clinical studies were not designed as prospective, randomized trials and some of these clinical studies enrolled fewer than 100 patients. In addition, some of the data we present on reduced pressure laparoscopy come from clinical studies not assessing, and unrelated to, the AirSeal system. Further, we lack long-term clinical data on the safety and efficacy of the AirSeal system.

We have developed and maintain a portfolio of intellectual property to protect our technologies, which included 76 issued patents, of which 30 were issued U.S. patents, and 65 patent applications pending globally, of which 26 were patent applications pending in the United States, as of November 1, 2015.

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We continue to invest in the research and development necessary to design, develop and commercialize new surgical solutions that leverage our technologies to enable less invasive surgical techniques.

We currently market and sell our products in the United States and internationally through a multi-channel sales organization comprised of sales managers, direct sales representatives, clinical education specialists and distributors. Our sales professionals have extensive training and experience in promoting, marketing and selling advanced laparoscopic technologies. The majority of our revenues are from sales to hospital customers through our direct sales representatives. For the years ended December 31, 2013 and 2014, international sales represented approximately 32.8% and 31.7% of revenue, respectively. We expect to continue to make investments in our global sales organization by increasing the number of our direct sales representatives and broadening our relationships with distributor partners. We believe the continuing expansion of our global sales organization will provide us with significant opportunities for future growth as we increase the penetration of our technologies within the global laparoscopic procedure market and enable novel procedures.

For the years ended December 31, 2013 and 2014, our total revenue was $19.1 million and $30.2 million, respectively and our net losses were $8.3 million and $14.8 million, respectively. For the nine months ended September 30, 2014 and 2015, our total revenue was $20.6 million and $34.7 million, respectively and our net losses were $11.4 million and $15.1 million, respectively.

Industry Background

Evolution of Minimally Invasive Surgery

Over the past 25 years, abdominal surgery has evolved from the performance of highly invasive open procedures to those that use increasingly advanced forms of MIS. These procedures are also referred to as laparoscopic surgeries. MIS procedures utilize one or more small incisions through which ports, or trocars, are inserted into an insufflated abdomen. Small cameras, called endoscopes, and surgical instruments are placed through the trocars and used to visualize the surgical site and to perform surgery, respectively. MIS procedures are often associated with less surgical trauma and enable improved patient outcomes, faster recovery times, less post-operative pain and reduced scarring as compared to traditional open surgery. Although recent advances in MIS are enabling surgery through a natural orifice, such as the mouth, nose or anus, rather than an incision, a clear and stable operative field is still essential in these techniques. We believe one of the most advanced forms of MIS is robotic-assisted laparoscopic surgery, which combines the benefits of minimally invasive ports with the enhanced dexterity, accuracy and surgical control provided by a robot.

Market Opportunity

According to reports by Millennium Research Group, approximately 33 million abdominal surgical procedures are expected to be performed in 2015 in major markets worldwide, of which 10 million are currently addressable by our technology, representing an annual global opportunity for approximately $2 billion of AirSeal disposables. In 2015, approximately 15 million additional procedures are expected to be performed through more invasive conventional open surgical approaches in our target markets worldwide. We believe a significant number of these procedures can be performed with MIS approaches as continued development and increased adoption of techniques that leverage our technologies enable less traumatic access and improved surgical control.

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2015 Global Laparoscopic Procedures



GRAPHIC
 
GRAPHIC

We believe one of the most advanced forms of MIS is robotic-assisted laparoscopic surgery, which combines the benefits of minimally invasive ports with the enhanced dexterity, accuracy and surgical control provided by a robot. There were approximately 570,000 robotic-assisted laparoscopic procedures performed worldwide in 2014. We believe AirSeal is currently the leading surgical access management system used in robotic-assisted laparoscopic procedures globally. We intend to leverage our strong relationships with surgeons that perform robotic-assisted procedures using AirSeal to further penetrate the larger general laparoscopic procedure market and ultimately become the standard of care for surgical access utilized by surgeons worldwide.

Key Working Conditions that Enable Effective MIS Procedures

MIS procedures require certain working conditions in order to provide an environment in which surgery can be performed more effectively and efficiently, including stable pneumoperitoneum, clear and constant field of vision, controlled management of surgical smoke and sufficient access for intact specimen removal.

      Stable Pneumoperitoneum.    MIS procedures utilize small incisions to access the abdominal cavity. Accordingly, working space must be created within the abdominal cavity to enable visualization of the surgical field, access to specific tissues and organs and sufficient space to maneuver instruments and perform surgery. This space is created by inflating, or insufflating, the body cavity with CO2 to pressures typically ranging from 12mmHg to 15mmHg. The state of insufflation inside the abdominal cavity is referred to as pneumoperitoneum. It is critical that the pneumoperitoneum remain stable throughout the MIS procedure in order to maintain satisfactory space for visualization and manipulation of instruments.

      Clear and Constant Field of Vision.    As a result of the small incisions utilized during MIS, a surgeon has no direct view of the surgical site. Accordingly, it is critical that endoscopic cameras and endoscopes have a clear field of vision of the surgical site to ensure that instruments are maneuvered precisely and the patient's anatomy can be identified and manipulated accurately.

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      Controlled Management of Surgical Smoke.    Energy-based surgical instruments commonly used during most MIS procedures emit smoke as they ligate and seal tissue in the body cavity. Surgical smoke can include potential biohazards such as toxic gases, tissue material, blood fragments and other pathogens such as viruses. Surgical smoke obstructs intra-procedural visibility, can completely block the operating site from view and increases the risk of surgical trauma. The Association of Perioperative Registered Nurses recommends that surgical smoke be evacuated and filtered throughout the procedure, which typically requires the use of a separate smoke evacuation system.

      Sufficient Access for Specimen Removal.    During an MIS procedure, the removal of diseased or damaged organ or tissue specimens, including those for cancer staging, is often required. If the ability to remove the specimen is impeded, a larger surgical incision may be required in order to accommodate removal of the specimen without risk of fragmentation of diseased tissue inside the body which can lead to spread of disease.

Conventional Access Devices

Conventional access devices are designed to access the abdominal cavity in a minimally invasive manner and attempt to establish the safe working conditions described above for the performance of MIS procedures. The three devices used in combination to achieve this are: trocars, insufflators and insufflation tubing.

Trocars.

A trocar is a pointed shaft with a hollow circular tube that is inserted into the abdominal cavity during laparoscopic surgery. Conventional trocars incorporate small internal valves to create a mechanical seal through which to pass instruments to prevent pressurized CO2 from escaping the body. The mechanical valves that conventional trocars rely on to maintain pneumoperitoneum must be covered with lubricants in order to reduce friction with the instruments inserted and withdrawn through them. The majority of trocars are designed as single-use devices because these valves are subject to wear and tear. Conventional trocars also incorporate a type of valve called a stopcock which manually controls the flow of CO2 into or out of the trocar. Stopcocks have small diameters that may limit the rate of gas inflow below what is required to maintain stable pneumoperitoneum when suction is used or trocars are dislodged.

Insufflators.

Insufflators regulate the transfer of CO2 from a pressurized external source into the body and the release of gas from the body through the trocar with the goal of creating and maintaining stable pneumoperitoneum. Insufflators typically transfer CO2 for three seconds and then pause to monitor the intra-abdominal pressure for one second to determine if the intra-abdominal pressure is below or above the surgeon's specified level of pneumoperitoneum. The insufflator then adjusts by releasing gas or continuing to transfer CO2. The intermittent pressure monitoring and simple on/off mechanics of conventional insufflators often result in significant fluctuations of intra-abdominal pressure during the intervals of gas transfer and monitoring. In addition, while some insufflators advertise high flow-rate, the flow of gas through the trocar is limited by the diameter of conventional trocar stopcocks, regardless of insufflator flow-rate. Insufflators also do not dynamically respond to the changes in intra-abdominal pressure caused by the mechanical ventilation of the patient by the anesthesiologist.

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Insufflation Tubing.

Single-lumen, or single-channel, tubing connects conventional insufflators and trocars. Conventional tubing is unidirectional and can therefore only perform one action at a time, such as either transferring gas or providing a conduit for monitoring pressure.

Limitations of Conventional Access Devices

While MIS procedures are associated with many benefits, as described above, the limitations of conventional access devices result in several challenges that adversely impact the clinical outcomes and healthcare economics of MIS procedures, including:

      Unintended Loss of Intra-abdominal Pressure.    A noticeable drop in intra-abdominal pressure is referred to as a loss of pneumoperitoneum. Loss of pneumoperitoneum results in the collapse of the working space in the abdominal cavity that can lead to reduced or total loss of visibility of the surgical field and compromised working space. The potential consequences of losing pneumoperitoneum include conversion to open surgery, excessive blood loss, longer operating times, prolonged recovery times, higher post-operative pain and even death. Many factors contribute to loss of pneumoperitoneum, including tears in the mechanical valves, trocar dislodgment, the use of standard suction inside the pressurized body cavity during an MIS procedure and the venting of surgical smoke from the body cavity.

      Unintended Spikes in Intra-abdominal Pressure.    Significant rises in intra-abdominal pressure above target levels are known as spikes in pneumoperitoneum. Pressure spikes can be induced by the surgeon exerting external pressure on the body cavity during trocar replacement or when maneuvering the patient, or from over pressurization of the body cavity from conventional insufflators after a loss of pneumoperitoneum. Conventional trocars do not automatically vent gas when the cavity is overpressurized. Significant pressure spikes can have serious cardiovascular consequences including pulmonary embolism, tachycardia and death. Unfortunately, the intermittent pressure monitoring and simple on/off mechanics of conventional insufflators create a delay in detecting and responding to changes in intra-abdominal pressure, including these spikes. As a result, there may be a dangerous lag before intra-abdominal pressure returns to the target level, exposing the patient to unnecessary risk.

      Maintenance of a High Level of Intra-abdominal Pressure.    Conventional insufflators require surgeons to insufflate the abdominal cavity to pressures ranging from 12mmHg to 15mmHg to create and maintain an acceptable working space during MIS. Pneumoperitoneum requires the elevation of intra-abdominal pressure which, on its own, has a negative impact on pulmonary compliance, hemodynamics and renal function in laparoscopic surgery. Clinical studies have shown that these pressure levels are associated with numerous side-effects, including post-operative pain, opioid use and extended length of hospital stay, all of which negatively impact hospital profitability. These side effects can lead to increased post-anesthesia care unit, or PACU, time and its associated higher hospitalization costs and lower patient throughput.

      Challenging Management of Surgical Smoke.    Conventional management of surgical smoke includes simple venting of smoke through the trocar into the operating room, utilizing a separate smoke evacuation system or waiting for the smoke to be absorbed by the body before continuing with the procedure. Venting or evacuating smoke frequently leads to a loss of pneumoperitoneum because it involves the sudden removal of large volumes of gas from the body without real-time pressure monitoring and dynamic response from an insufflator. In addition, surgical smoke can expose operating room

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        occupants to potential biohazards. As a result, conventional management of surgical smoke leads to the need for additional equipment, longer procedure time or increased risk to the patient and operating room staff.

      Limited Ability for Specimen Removal.    Surgeons must often break specimens down into smaller pieces to allow them to fit through the mechanical valves of conventional trocars. This may result in the release of unwanted material, such as cancerous tissue, and fluids into the body cavity. The mechanical valves of trocars can also trap specimens, making them more difficult to extract from the body. Surgeries using conventional access devices may require more invasive surgical incisions to accommodate the safe removal of larger specimens.

      Conventional Trocar Design.    Conventional trocars rely on mechanical valves to create a physical barrier to maintain pneumoperitoneum while cameras and instruments are inserted, manipulated and withdrawn. These mechanical valves limit the size, shape and number of instruments and prosthetic materials that may be inserted or withdrawn through them. In addition, the mechanical valves themselves cause friction with the instruments inserted through them, hindering the ability to add or remove instruments or surgical specimens through the trocar, contributing to the risk of trocar dislodgement and reducing the surgeon's tactile feedback when engaging tissues and organs. Conventional trocars also incorporate a type of valve called a stopcock which manually controls the flow of gas into or out of the trocar. Stopcocks have small diameters that limit the rate of gas inflow below what is required to maintain stable pneumoperitoneum in the event of significant air leaks or when surgeons use standard suction to clear the surgical field. We believe the limitations of conventional trocar design commonly result in longer procedure times and complications from instability of pneumoperitoneum.

Although MIS procedures have enabled surgeries to be performed with less invasive access to the body, there remains a significant opportunity for abdominal access systems that enable continuous pressure sensing, dynamic responses to changes in intra-abdominal pressure to maintain consistent pneumoperitoneum, provide for integrated smoke evacuation and enable intact specimen removal. We further believe that advanced access technologies will enable MIS procedures to be performed safely at lower pneumoperitoneum pressures resulting in improved clinical outcomes for patients and enhanced profitability for providers.

Our Solution

We have developed AirSeal, the first and only integrated surgical access management system to address the limitations associated with conventional access devices, to provide improved clinical outcomes for patients and economic benefits for healthcare providers. The components of our proprietary AirSeal system are the AirSeal Valve-Free Access Port, Intelligent Flow System, or iFS unit and the AirSeal Filtered Tube Set, or FTS. We believe Low Impact Surgery provides the following benefits as compared to conventional access devices.

      Stable, Less Rigid State of Pneumoperitoneum.    AirSeal combines sophisticated real-time management of intra-abdominal pressure with a valve-free trocar that uses a proprietary gaseous pressure barrier to maintain unparalleled stability of pneumoperitoneum at the surgeon's target level. The pressure barrier created by AirSeal enables a less rigid state of pneumoperitoneum that dynamically responds to any increases or decreases in intra-abdominal pressure by adding or venting gas in real time to provide stable pneumoperitoneum. AirSeal utilizes a proprietary gas-flow manifold that enables significantly higher gas inflow rates than the stopcocks of conventional trocars and

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        maintains stable pneumoperitoneum even during significant air leaks or the use of standard suction.

      Lower Pressure Procedures.    AirSeal employs a combination of innovations that enables procedures to be performed at up to 50% lower intra-abdominal pressure than conventional MIS procedures. Because procedures performed with the AirSeal system see little fluctuation in intra-abdominal pressure, lower pressure techniques can be performed on a more routine basis. In addition to pressure spikes, conventional insufflation systems cause pressure drops which make lower pressure techniques more challenging to perform. Procedures performed with lower intra-abdominal pressure have been clinically demonstrated to reduce post-operative shoulder pain, decrease the need for post-operative pain medication and shorten recovery times. AirSeal's stable, less rigid state of pneumoperitoneum also results in less stress and pressure on the patient's diaphragm and upper organs during surgery and improves pulmonary and respiratory stability under anesthesia. We also believe the reduced pain and pulmonary and respiratory stability enabled by lower pneumoperitoneum pressures result in less post-operative monitoring and pain management in the PACU. We believe the reduction in PACU congestion enabled by procedures performed at lower pressure improves operating room efficiency.

      Integrated and Continuous Smoke Evacuation.    AirSeal continuously evacuates smoke from the abdominal cavity through our patented FTS connected to the iFS unit. The FTS incorporates a specialized 0.01 micron filter that captures and removes biohazardous particulates from the evacuated gas. Accordingly, our AirSeal system provides continuous visibility of the surgical field and reduces the risks to the patient and the surgical team of exposure to pathogen-laden smoke, while simultaneously maintaining stable pneumoperitoneum.

      Intact Specimen Removal.    AirSeal access ports are valve-free, enabling surgeons to extract larger specimens without having to dissect them inside the body. We believe intact specimen removal saves procedure time and reduces the risk of spreading unwanted material, such as cancerous tissue, inside the body cavity.

      Improved Surgical Ergonomics.    AirSeal's patented valve-free access ports enable frictionless insertion or withdrawal of multiple small diameter instruments of both circular and non-circular geometries, implants, sutures and specimens without the risk of losing pneumoperitoneum. In addition, our valve-free ports do not require any surgical lubricants or retain residue from blood or other fluids released during the MIS procedure, thereby preventing camera smudges that obscure the field of vision during the surgical procedure. Our line of micro-laparoscopic 3mm surgical instruments also have longer jaws and rigid shafts that feel and function like larger traditional 5mm instruments, enabling surgeons to perform less invasive procedures without changing the ergonomics or techniques to which they have been accustomed with larger, more invasive instruments.

      Faster Procedure Times.    AirSeal has been clinically demonstrated to result in faster average operating times in various types of laparoscopic and robotic-assisted laparoscopic procedures.

We believe that Low Impact Surgery enables improved clinical outcomes, better surgical control, faster operating times, higher patient safety, shorter recovery times and reduced post-operative pain as compared to MIS procedures performed with conventional access devices. As a result, we believe Low Impact Surgery offers compelling economic benefits to health care providers including reduced PACU time and its associated lower hospitalization costs and higher patient throughput. We believe our technologies enable a new generation of techniques that expand the surgical procedures that may be performed with less invasive surgical access, while offering improved clinical and economic benefits for patients, physicians and providers as compared to existing alternatives.

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Our Strategy

Our goals are to establish AirSeal as the standard of care for every laparoscopic and robotic-assisted laparoscopic procedure worldwide, increase the number of surgeries that can be performed with less invasive surgical approaches and broaden the population of patients for whom MIS procedures may be applicable. To accomplish these goals, we are employing the following strategies:

      Leverage our leading position in robotic-assisted MIS to establish Low Impact Surgery as the standard of care for laparoscopic procedures.    Surgeons that perform robotic-assisted laparoscopy are typically the opinion leaders in laparoscopic surgery. We believe AirSeal is already the leading access technology utilized in robotic-assisted MIS. We intend to leverage our strong relationships with surgeons that perform robotic-assisted surgery to further penetrate into the larger general laparoscopic procedure market and ultimately become the standard of care in access technology.

      Expand our sales organization to support growth.    We plan to continue to expand our highly-trained direct sales organization in the United States to help facilitate further adoption among existing hospital customers as well as broaden awareness of Low Impact Surgery in new hospitals. In addition, we have agreements with and are engaged in advanced discussions with the largest integrated delivery networks and group purchasing organizations in the United States regarding the adoption of AirSeal. We will also continue to make significant investments in our global distribution network to increase our penetration in existing markets and expand our geographic presence into new markets. We believe there remains significant opportunity for us to expand our global presence by hiring additional direct sales representatives, developing relationships with distributor partners in select markets and improving the productivity and efficiency of our sales force.

      Leverage our AirSeal technology to enable Low Impact Surgery for procedures not currently performed using a minimally invasive approach.    We intend to continue leveraging our AirSeal technology and extending the benefits of Low Impact Surgery to broader patient populations, including patients typically treated with open access surgical procedures. We will also further improve Low Impact Surgery with novel micro-laparoscopic instruments and access devices to enable new surgical approaches that combine standard laparoscopic techniques with less invasive access to further improve patient outcomes.

      Deliver cost-effective solutions that extend the clinical and economic benefits of AirSeal to high-volume laparoscopic procedures.    We intend to leverage the improved surgical working conditions and clinical outcomes enabled by AirSeal, and the less invasive access provided by our proprietary line of Low Impact micro-laparoscopic instruments to enable hospitals to perform higher volume procedures such as laparoscopic cholecystectomy more cost effectively.

      Conduct further clinical studies documenting the clinical and economic benefits of Low Impact Surgery.    We intend to invest in further clinical studies in order to support the publications of peer reviewed articles that validate the clinical and economic benefits of Low Impact Surgery.

      Selectively Pursue Opportunities to Enhance Our Product Offerings.    We intend to continue to innovate new applications of our AirSeal technology and vigorously protect those innovations through patent applications. We may also opportunistically pursue the licensing or acquisition of complementary products and technologies to strengthen our market position or improve product margins.

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Clinical Experience Regarding AirSeal's Benefits

There is a growing body of evidence that supports the clinical performance and economic benefits of our AirSeal system. Results of multiple studies assessing the benefits of the AirSeal system have been published in peer-reviewed articles and presented at international healthcare conferences. In addition, we are currently engaged in a variety of ongoing studies to continue to assess our clinical and economic benefits. The studies below illustrate findings pertaining to stable pneumoperitoneum, lower pressure surgery and economic benefits associated with our AirSeal system that we believe are consistent with the outcomes observed in published literature. Although the number of subjects of these studies is relatively small, the design of the studies nevertheless allowed for an assessment of statistical significance, and the results are both statistically significant and clinically relevant. "Statistical significance" means the likelihood that a result or relationship is caused by something other than random chance or error. Statistical significance is measured by a "p-value," which indicates the probability value that the results observed in a study were due to chance alone. The lower the p-value, the less likely that the results observed were due to chance alone. A p-value of less than 0.05 is generally considered "statistically significant," meaning that the probability of the results occurring by chance alone is less than five percent.

Clinical Data Suggesting AirSeal Enables a More Stable Pneumoperitoneum

In a 60-patient prospective randomized study, researchers at the University of California, Irvine compared the intra-procedural abdominal cavity pressure and associated physiologic effects during laparoscopic renal surgery of the AirSeal system and a conventional insufflation system. Patients were randomized to either the AirSeal system (Figure A) or conventional insufflation (Figure B), and pressure was measured eight times per second for the entirety of the procedure via a specialized pressure transducer. The researchers submitted their results for the first 28 patients to complete this trial for presentation at the 2014 annual meeting of the American Urological Association. In the interim analysis, researchers found that pneumoperitoneum was significantly more stable in the AirSeal group than in the conventional insufflation group.

The charts below demonstrate that AirSeal maintained pneumoperitoneum pressure at the specified range of 12mmHg to 18mmHg 98.5% of the time, whereas conventional insufflation was in range only 71% of the time (p<0.001). This clinical evidence demonstrates that AirSeal provides a more stable pneumoperitoneum when compared to conventional insufflation. Moreover, there were far fewer instances of temporary drops in pressure using AirSeal, and the recovery of the specified pressure range was accomplished without the corresponding spikes in pressure seen with conventional insufflation.

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GRAPHIC

        Figure A

GRAPHIC

        Figure B

The interim analysis also found a significantly lower mean arterial pressure within 20 minutes after insufflation in the AirSeal group, indicating the possibility of a reduced physiologic impact on cardiovascular function.

Clinical Data Associating Lower Intra-abdominal Pressure with Improved Clinical and Economic Outcomes

A meta-analysis of 22 randomized controlled trials, or RCTs, comparing 1,263 laparoscopic cholecystectomies performed utilizing conventional insufflation technologies (that did not utilize our products) at low pressure pneumoperitoneum of 7mmHg to 10mmHg versus standard pressure pneumoperitoneum of 12mmHg to 15mmHg were published in the July 2014 edition of The American

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Journal of Surgery. In this meta-analysis, low pressure pneumoperitoneum was associated with significantly reduced incidence and severity of pain, incidence of post-operative pain medication use and total pain medication requirements, and reduced hospital length of stay. Post-operative shoulder pain is thought to result from the stimulation of the phrenic nerve due to diaphragmatic irritation under pneumoperitoneum. Reduced intra-abdominal pressure has been shown in multiple clinical studies to reduce both the incidence and severity of post-operative shoulder pain. However, lower pressure procedures, all of which utilized conventional insufflation technologies, were also associated with significantly greater requirement for increasing pressure during the procedure in order to complete the procedure and significantly longer operative time.

      Incidence of Shoulder Pain.    From 10 RCTs, 81 out of 404 patients (20%) in the low pressure group complained of shoulder pain as compared with 153 of 402 patients (38%) in the standard pressure group. Low pressure pneumoperitoneum was associated with a significantly lower incidence of shoulder pain (p<0.001).

GRAPHIC

      Severity of Pain.    From 8 RCTs, the low pressure group had significantly lower pain scores compared with the standard pressure group at the intervals of zero to six hours (p=0.01), seven to 12 hours (p = 0.003) and 13 to 24 hours (p=0.02) time intervals.

      Incidence of Post-Operative Pain Medication Use.    Data from 6 RCTs indicated that low pressure pneumoperitoneum was associated with a significantly lower rate of analgesic use as compared to the standard pressure group (p=0.02).

GRAPHIC

      Total Post-Operative Pain Medication Requirements.    Data from 7 RCTs indicated that the low pressure group had significantly lower post-operative pain medication dosing requirements than the standard pressure group (p=0.003).

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      Length of Hospital Stay.    Patients in the low pressure group had a significant 0.27 day shorter length of hospital stay as compared to the standard pressure group (p=0.01).

      Requirement for Increased Pressure.    The low pressure group had a significantly greater requirement to increase pressure during the procedure in order to complete the procedure as compared to the standard pressure group (p<0.001).

      Operative Time.    Patients in the low pressure group had a significantly longer mean operating time (average 2.07 minutes longer) as compared to the standard pressure group (p<0.001).

The meta-analysis found that performing procedures at lower pneumoperitoneum pressures of 7mmHg to 10mmHg significantly reduced the incidence and severity of shoulder pain, medication use and hospital length of stay. However, the data also showed that lower pressure procedures in some instances resulted in the requirement to raise the intra-abdominal pressure during the procedure in order to complete it as well as a significantly increased procedure time. We believe the increased risk of raising pressure and longer procedure times resulting from lower pressure were due to the limitations of conventional access devices as described above, including unstable pneumoperitoneum and challenging smoke management both of which result in inadequate visibility of the surgical field.

A recently published report regarding an ongoing clinical quality improvement project by Surgical Momentum, a healthcare data analytics company, evaluated the post-operative impact among 106 patients undergoing laparoscopic ventral hernia repair using standard insufflation at 15mmHg (50 patients), standard insufflation at 15mmHg with a transversus abdominus plane, or TAP, peripheral nerve block (37 patients), and AirSeal at 8-10 mmHg with the same TAP block (19 patients). There were no statistically significant differences between treatment groups in patient age, gender, race, or BMI. Patients in the third treatment group, those undergoing laparoscopic ventral hernia repair with AirSeal and TAP peripheral nerve block, demonstrated statistically significant reductions in the percent of patients with no pain in PACU, PACU opioid use, PACU time, total opioid use, and length of stay compared to the other two treatment groups. In addition, 37% of patients in the AirSeal with TAP arm were treated as outpatients compared to those with standard insufflation without TAP block (2%, p-value 0.0003) and those with standard insufflation with TAP block (11%, p-value 0.03). Though outcomes from a clinical quality improvement project implemented in one local environment may not be the same in other environments due to variables including differences in specific surgeon skill and experience, we believe these findings support the potential benefits of the AirSeal System when used in combination with a TAP block.

 
  A   B   C   p values    
 
  S15 no
TAP Block
  S15 w/
TAP Block
  ALP w/
TAP Block
  A vs. B   A vs. C   B vs. C   Method

LOS

    4.4     3.4     1.6     0.1575     0.0001     0.0138   2-sided t-test

PACU Time

    163.5     163.9     83.4     0.9912     0.00004     0.0428   2-sided t-test

PACU MEQ

    11.2     10.5     3.6     0.6858     0.0002     0.0014   2-sided t-test

% Patients w/ No Pain in PACU

    20.0 %   11.0 %   63.0