S-1/A 1 forms-1a.htm

 

As filed with the Securities and Exchange Commission on July 26, 2022

 

Registration No. 333-265632

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

Amendment No. 1

to

FORM S-1

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

 

OPTMED, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of

incorporation or organization)

 

3842

(Primary Standard Industrial

Classification Code Number)

 

20-8866142

(I.R.S. Employer

Identification No.)

 

745 Fifth Avenue, Suite 500
New York, New York 10151
(646) 898-2004

 

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

 

Ervin Braun

Chief Executive Officer
OptMed, Inc.
745 Fifth Avenue, Suite 500
New York, New York 10151
(646) 898-2004

 

(Name, address, including zip code, and telephone number including area code, of agent for service)

 

Copies of all communications, including communications sent to agent for service, should be sent to:

 

Curt P. Creely, Esq.

Foley & Lardner LLP

100 North Tampa Street, Suite 2700

Tampa, Florida 33602

(813) 229-2300

Ross Carmel. Esq.

Philip Magri, Esq.

Carmel, Milazzo & Feil LLP

5 West 39th Street, 18th Floor

New York, NY 10018

(646) 838-1310

 

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

 

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, as amended (the “Securities Act”), check the following box. ☐

 

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. ☐

 

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. ☐

 

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. ☐

 

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

 

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
  Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

 

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 of 1933 or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 

 

 

The information in this preliminary 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 preliminary prospectus is not an offer to sell, and it is not soliciting an offer to buy, these securities in any state where the offer or sale is not permitted.

 

Subject to completion, dated July 26, 2022

 

PRELIMINARY PROSPECTUS

 

 

OptMed, Inc.

 

           Shares of Common Stock

 

This is an initial public offering of          shares of our common stock.

 

We currently estimate that the offering price will be between $         and $        per share. The final offering price of the shares will be determined by us and EF Hutton, division of Benchmark Investments, LLC, the representative of the underwriters in connection with this offering (the “Representative”), taking into consideration several factors as described between the underwriters and us at the time of pricing, including our historical performance and capital structure, prevailing market conditions, and overall assessment of our business. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the actual public offering price for our common stock and the warrants. See “Underwriting.”

 

Prior to this offering, there has been no public market for our common stock. We have applied to list our common stock on the Nasdaq Capital Market under the symbol “OMED”. We will not consummate this offering unless we receive approval from The Nasdaq Stock Market LLC (“Nasdaq”) to list our common stock.

 

We are an “emerging growth company,” as defined in Section 2(a)(19) of the Securities Act of 1933, as amended (the “Securities Act”), and a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have elected to comply with certain reduced public company reporting requirements. See “Prospectus Summary — Implications of Being an Emerging Growth Company and Smaller Reporting Company.”

 

Investing in our common stock involves risks. See “Risk Factors” beginning on page 9 to read about factors you should consider before buying shares of our common stock.

 

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission or other regulatory body has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

 

   Price to Public   Underwriting
Discounts and
Commissions (1)
   Proceeds, before expenses, to us (2) 
Per Share  $                $                     $                    
Total  $    $   $ 

 

(1)

Does not include additional compensation payable to the Representative. We have agreed to reimburse the Representative for certain expenses incurred relating to this offering. In addition, we will issue to the Representative a warrant to purchase the number of shares of our common stock equal to five percent (5%) of the aggregate number of shares of our common stock sold in this offering, excluding the Over-Allotment Option, for an exercise price of $          per share (110% of the offering price per share) (the “Representative’s Warrants”). Such warrants will be exercisable at any time and from time to time, in whole or in part, during the four and a half-year period commencing six (6) months from the effective date of this offering. See “Underwriting” for additional information regarding underwriting compensation.

   
(2) The amount of offering proceeds to us presented in this table does not give effect to any exercise of the: (i) Over-Allotment Option we have granted to the underwriters as described below, or (ii) the warrants being issued to the Representative in this offering.

 

This offering is being underwritten on a firm commitment basis. We have granted a 45-day option to the underwriters, exercisable one or more times in whole or in part, to purchase up to an additional 15% of the shares of common stock from us at the public offering price per share of common stock, less the underwriting discounts payable by us, solely to cover over-allotments, if any (the “Over-Allotment Option”).

 

The underwriters expect to deliver the securities against payment to the investors in this offering on or about            , 2022.

 

Sole Book-Running Manager

 

 

EF HUTTON,

division of Benchmark Investments, LLC

 

The date of this prospectus is           , 2022.

 

 

 

 

TABLE OF CONTENTS

 

  Page
   
MARKET AND INDUSTRY DATA ii
PROSPECTUS SUMMARY 1
RISK FACTORS 9
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 45
USE OF PROCEEDS 46
DIVIDEND POLICY 47
CAPITALIZATION 47
DILUTION 48
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 49
BUSINESS 60
MANAGEMENT 82
EXECUTIVE COMPENSATION 88
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS 93
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 94
DESCRIPTION OF CAPITAL STOCK 95
SHARES ELIGIBLE FOR FUTURE SALE 99
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR NON-U.S. HOLDERS OF OUR COMMON STOCK 101
UNDERWRITING 104
LEGAL MATTERS 108
EXPERTS 108
WHERE YOU CAN FIND MORE INFORMATION 108
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS F-1

 

i

 

 

Through and including         , 2022 (the 25th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

 

Neither we nor any of the underwriters have authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus, any amendment or supplement to this prospectus and any related 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 assurances as to the reliability of, any other information that others may give you. We are offering to sell, and seeking offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus or in any applicable free writing prospectus related thereto is current only as of its date, regardless of its time of delivery or any sale of shares. Our business, financial condition, results of operations and future prospects may have changed since that date.

 

For investors outside the United States: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside of the United States.

 

No person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities offered hereby or any matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

 

Copies of some of the documents referred to herein have been filed as exhibits to the registration statement of which this prospectus forms a part, and you may obtain copies of those documents as described in this prospectus under the heading “Where You Can Find More Information.”

 

MARKET AND INDUSTRY DATA

 

This prospectus includes estimates regarding market and industry data. Unless otherwise indicated, information concerning our industry and the markets in which we operate, including our general expectations, market position, market opportunity and market size, are based on our management’s knowledge and experience in the markets in which we operate, together with currently available information obtained from various sources, including publicly available information, industry reports and publications, surveys, our customers, trade and business organizations, and other contacts in the markets in which we operate. Certain information is based on management estimates, which have been derived from third-party sources, as well as data from our internal research, and are based on certain assumptions that we believe to be reasonable.

 

In presenting this information, we have made certain assumptions that we believe to be reasonable based on such data and other similar sources and on our knowledge of, and our experience to date in, the markets in which we operate. While we believe the estimated market and industry data included in this prospectus are generally reliable, such information, which is derived in part from management’s estimates and beliefs, is inherently uncertain and imprecise, and you are cautioned not to give undue weight to such estimates. Market and industry data are subject to change and may be limited by the availability of raw data, the voluntary nature of the data gathering process and other limitations inherent in any statistical survey of such data. In addition, projections, assumptions and estimates of the future performance of the markets in which we operate are necessarily subject to uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us. Accordingly, you are cautioned not to place undue reliance on such market and industry data or any other such estimates. The content of, or accessibility through, the sources and websites identified herein, except to the extent specifically set forth in this prospectus, does not constitute a portion of this prospectus and is not incorporated herein and any websites are an inactive textual reference only.

 

TRADEMARKS

 

The logos and other trade names, trademarks, and service marks of OptMed, Inc. appearing in this prospectus are the property of OptMed, Inc. Other trade names, trademarks, and service marks appearing in this prospectus are the property of their respective holders. Trade names, trademarks, and service marks contained in this prospectus may appear without the “®” or “™” symbols. Such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to those trade names, trademarks, and service marks.

 

ABOUT THIS PROSPECTUS

 

Throughout this prospectus, unless otherwise designated or the context suggests otherwise,

 

  all references to “OptMed,” the “Company,” the “registrant,” “we,” “our,” or “us” in this prospectus mean OptMed, Inc., a Delaware corporation, and its subsidiary;
     
  assumes a public offering price of $        per share, which is the midpoint of the $        to $        range of the offering price per share;
     
  “year” or “fiscal year” means the year ending December 31st;
     
  all dollar or $ references when used in this prospectus refer to United States dollars; and
     
  all references to the “Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder, and all references to the “Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

ii

 

 

 

PROSPECTUS SUMMARY

 

The following summary highlights selected information about our Company and this offering that is included elsewhere in this prospectus in greater detail. It does not contain all of the information that you should consider before investing in our common stock. Before investing in our common stock, you should read this entire prospectus carefully, including the information presented under the heading “Risk Factors” and in our consolidated financial statements and notes thereto.

 

In this prospectus, unless we indicate otherwise or the context requires, “OptMed,” the “Company,” the “registrant,” “we,” “our,” “ours” and “us” refer to OptMed, Inc.

 

Overview

 

We are a clinical-stage medical device company, incorporated in the State of Delaware in 2007, focused on the development and commercialization of novel surgical adhesives for the localized treatment of patients with external and internal wounds. Our proprietary technology platform is based on a chemistry called methylidene malonate (“MM212”), a biocompatible polymer originally designed for drug delivery which has been extensively tested for biocompatibility and adhesive properties in topical and internal applications. MM212-based surgical adhesives have unique versatile properties which include strong bonding properties, the ability to bond to tissues in wet environments, elastic properties and biocompatibility with human tissues. Our initial product candidates, BondEase® Topical Skin Adhesive (“BondEase”) and TearRepair Liquid Skin Protectant (“TearRepair”), are biocompatible tissue adhesives for topical applications. BondEase was designed as a topical adhesive for the closure of acute incision and laceration wounds and TearRepair was designed as a topical skin protectant for fragile and damaged skin, such as for skin tears of the elderly.

 

In December 2015, we received clearance from the U.S. Food and Drug Administration (“FDA”) to market BondEase in the United States. However, we have not yet started to market and sell BondEase, as we needed first to scale up its manufacturing process and make certain improvements to ease the delivery of the adhesive on the wound. We have now completed the scale up of the manufacturing process and the product improvements for BondEase, which included changes to the manufacturing process of the active component within the monomer formulation, the composition of the monomer and activator formulations, and changes to device design. We have evaluated the improved BondEase product and we believe it is substantially equivalent to the device that received FDA clearance because it has the same intended use as the original BondEase device and contains substantially the same technological characteristics as the original BondEase device, with minor design and composition differences. As a result, we believe that no additional animal studies or human clinical trials will be required by the FDA. We anticipate that we will file a new application with the FDA to obtain clearance to market BondEase in the United States within three months of the completion of this offering.

 

We are also planning to file an application with the FDA within three months of the completion of this offering to obtain clearance to market TearRepair in the United States. We are also at the early stage of development of our adhesive platform for two additional clinical indications to protect chronic wounds and to seal internal wounds and organ leakage. These two clinical applications are unique as there are currently no surgical adhesives approved for chronic wounds and very few adhesives approved for internal wounds, and we believe these few adhesives have serious shortcomings. We believe that our chemistry with unique mechanical performance in a wet environment and its safety profile could make these two clinical applications potential candidates for the treatment of chronic wounds, internal wounds and organ leakage.

 

Need for Surgical Adhesives

 

Over the past few decades, sutures have been the mainstay of surgical treatment. Sutures are fibers or strands used for connecting blood vessels or tissues together. Besides sutures, various other materials like microporous surgical tapes, clips and staples have also commonly been used in surgeries. These procedures are easy to handle, have high tensile strength, have no allergic or carcinogenic potential, and few sutures get absorbed in the body after serving their function. Despite having these advantages, sutures are very time-consuming, may result in leakages, wound detachment, tissue scarring and increased chances of infections during their removal. Therefore, the need for simpler, quicker and minimally invasive surgical procedures have necessitated the development of suture-less techniques.

 

Surgical adhesives are a class of biomaterial that adheres to tissue after its application and seals the tissue or wound. They also help in attaching medical devices to tissues and post-operative sealing of air or gas leakages through an incision. Ideally, surgical glue should possess strong binding strength and elasticity and should be easy to apply, biocompatible and biodegradable, which ultimately improves the wound healing process.

 

Current Treatments and Their Limitations

 

We believe an ideal tissue adhesive should have the following properties:

 

  strong adhesion to tissue, especially under wet conditions and an ability to form a watertight seal;
     
  biodegradability;

 

 

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  mechanical compliance with the underlying tissue, such as elasticity, which is important for applications such as lung sealants, where the size of the underlying tissue strongly varies over time; and
     
  low toxicity and minimal inflammatory response.

 

Although numerous adhesive technologies have been developed, only a handful have been approved by the FDA for clinical use. The main challenge is achieving adequate adhesion to soft tissues, especially when tissues are wet and under dynamic forces.

 

The two main classes of adhesive technologies developed to date are described below:

 

  Biologically-derived sealants, such as fibrin sealants, have advantages because they biodegrade rapidly after the wound is healed and the adhesive is no longer needed and, typically, do not lead to inflammation, foreign-body reactions, tissue necrosis or extensive fibrosis. But they also have disadvantages because they provide minimal bond strength and are, therefore, unsuitable for applications requiring resistance to high mechanical load and they also may be susceptible to viral contamination, given their animal origin.
     
  Synthetic tissue adhesives, such as cyanoacrylate tissue adhesives (for example, Dermabond, which was developed by Ethicon, Inc.), have advantages because of their rapid rate of polymerization and strong bonding to tissues. But they also have disadvantages, such as their inability to adhere properly to wet tissues, their potential to cause thermal damage and scarring to tissues through the heat generated during the curing process, their limited elasticity which limits their use on internal organs where the size of the underlying tissue strongly varies over time, such as lungs, and concerns over the cytotoxic or histotoxic effects of the by-products from the degradation process of the adhesive.

 

The main challenge toward designing a surgical sealant or adhesive is to achieve sufficient adhesion strength to the tissues in a wet environment without impairing the biocompatibility and tissue function. Unfortunately, biologically-derived sealants have strong biocompatibility attributes but have limited adhesion strength while the strong adhesion performance of synthetic tissue adhesives is diminished in wet environments, in addition to their poor elasticity, poor biocompatibility and poor degradation properties. As such, synthetic tissue adhesives have limited use in internal applications and are mostly used for topical skin applications. We believe an effective surgical glue needs to be strong, flexible, non-toxic, biodegradable and able to accommodate movement, yet there are no adhesives currently available that have all of those properties.

 

Our Surgical Adhesive Platform

 

The MM212 chemistry may be able to fill the gap caused by the limitations of both biologically-derived sealants and synthetic tissue adhesives as this chemistry matches most of the requirements for the ideal sealant, as follows:

 

  Strong adhesion to tissue, especially under wet conditions:
         
      MM212 has similar adhesion strength as synthetic adhesives and performs well in wet conditions.
         
  Biodegradability:
         
      For internal applications, tissue adhesives need to be able to biodegrade at a rate compatible with the rate of healing of the underlying tissue. We currently are not able to control the biodegradability of our adhesives and, in order to meet this property requirement, we have initiated a research program to make changes to our chemistry in order achieve control of the degradation process. However, as these requirements are only for internal applications, they do not apply to our TearRepair or BondEase products as they are topical applications.
         
  Mechanical compliance with the underlying tissue, such as elasticity, which is important for applications such as lung sealants, where the size of the underlying tissue strongly varies over time:
         
      MM212 has elastic properties as opposed to cyanoacrylates, which have been found to be brittle. Our internal in-vitro testing has shown elastic performance of polymerized MM212 which can expand and rapidly recover to its original size after multiple elongations to over 15% of its original size, while in our in-vitro tests in our laboratories we have not observed any measurable elasticity of cyanoacrylates.
         
  Low cytotoxicity and minimal inflammatory response:
         
      Biocompatibility testing to date has shown good results and may hold long term due to the safety of the main MM212 degradation by-products via hydrolysis, ethanol and glycolic acid although future formulation changes such as controlling degradation may alter biocompatibility properties.

 

 

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Our Pipeline

 

The following shows the development and regulatory status of our product candidates:

 

 

Our Strategy

 

Our mission is to advance the development and commercialization of our proprietary tissue adhesive platform based on the MM212 chemistry, to develop safe and effective adhesives for acute wounds, damaged skin, chronic wounds and internal wounds. We intend to achieve this through the following strategies:

 

  Secure FDA clearance and approval of our TearRepair device and start commercialization of TearRepair with our marketing partner, DermaRite Industries, LLC, a leading U.S. manufacturer and distributor of skin care, wound care, and nutritional supplements for healthcare facilities, including hospitals, nursing homes, hospice, and home care.
     
  Secure FDA clearance and approval of our scaled-up and improved version of BondEase and secure a marketing partner for the commercialization of BondEase.
     
  Advance our third product candidate for the treatment of chronic wounds into a proof-of-concept animal study in order to set up a meeting with the FDA to discuss the regulatory pathway for clearance and approval and requirements to human clinical trials.
     
  Continue the development of internal indications by customizing the formulation and delivery system of our adhesive and evaluating its performance in long term animal studies.
     
  Seek strategic collaborative relationships.

 

Indebtedness

 

To date, we have financed our operations, in part, through the issuance of unsecured debt to various investors, including our directors and officers and entities affiliated with our director and officers, which includes several series of promissory notes issued from March 2015 through July 2022 bearing interest at rates ranging from five percent (5%) to fifteen percent (15%), as well as promissory notes issued during 2019 at an original issue discount of thirty-five percent (35%) (collectively, the “Notes”). Approximately $4.0 million of the total principal and interest outstanding under the Notes will convert into           shares of our common stock upon the completion of this offering. Approximately $1.7 million of outstanding principal and interest relating to the Notes will be repaid in full with the proceeds of this offering, and we are currently in default with respect to the entire amount to be repaid.

 

We have also financed our operations, in part, through the issuance of senior secured loans (the “Senior Secured Loans”) from two lenders in the aggregate principal amount of $3,250,000. The Senior Secured Loans, which are secured by substantially all of our assets, were originally due on July 1, 2018 but have not been paid to date. The loans bear interest at a rate equal to 8% per annum, provided that the interest rate increased to 12% per annum as of July 1, 2019 per a notice of default and demand of payment for failure to make payments of interest when due. Each of the lenders has agreed to forbear on the balance of the Senior Secured Loans until the earlier of September 30, 2022 or the completion of this offering, and if we do not complete this offering by September 30, 2022, we will need to seek and obtain an additional forbearance through at least the actual closing of this offering, and there is no assurance that we will be able to obtain such additional forbearance. We intend to use a portion of the net proceeds from this offering to pay in full the balance of the Senior Secured Loans. The outstanding principal of $3,250,000 and accrued but unpaid interest of $1,426,685 as of March 31, 2022 under the Senior Secured Loans are convertible at the option of the lenders into an aggregate total of           shares of our common stock at a conversion price of $0.69 per share.

 

Additionally, beginning in 2014, a group of our directors, including Dr. Braun, Mr. Martin Sands, Mr. Steven Sands, and, at various times, certain other persons including Mr. Stone, a former director, now deceased (the “LOC Affiliates”), have made available to our Company a line of credit that is due 30 days after demand by the lender (the “Affiliate Line of Credit”). This line of credit bears interest at a rate of 5.25% per annum. By June 30, 2020, we had borrowed an aggregate of $867,000 and repaid $637,000 of the Affiliate Line of Credit. The principal balance of $230,000 plus $116,272 of accrued interest was assumed by Sterm Group, a partnership owned by the LOC Affiliates, under the terms of a loan agreement dated July 1, 2020 in the total amount of $346,272. Pursuant to the agreement, the loan bears interest at a rate of 5.25% per annum, payable within 30 days upon demand. On June 28, 2021, Sterm Group agreed to loan us $300,000 at a rate of 5.25% per annum, payable within 30 days upon demand. Installments totaling $280,000 were loaned to us by Sterm Group from June 30, 2021 to August 31, 2021. Approximately $380,687 of the total principal and interest outstanding under the loans to Sterm Group will convert into           shares of our common stock upon the completion of this offering. We anticipate that approximately $312,902 of the outstanding loan and accrued interest will be repaid in full with the proceeds of this offering.

 

As of March 31, 2022, our total outstanding indebtedness and accrued but unpaid interest was $10,842,865.

 

 

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Intellectual Property & Barriers to Entry

 

We own all the material intellectual property rights related to our platform and product candidate portfolio. As of March 31, 2022, our product and product candidate portfolio are protected by approximately 14 issued patents and 1 pending patent application worldwide with claims directed to composition of matter, adhesive delivery and method of use.

 

Recent Developments

 

We have recently completed the scaling up of the manufacturing process for the BondEase device and we have also completed testing to demonstrate that the improved BondEase device is equivalent to the BondEase device that was cleared by the FDA in December 2015. Within three months of the completion of this offering, we intend to submit this data in a new 510(k) application with the FDA to obtain marketing clearance in the United States for BondEase. We have also completed the development and testing of the TearRepair device, which is intended for the protection of damaged skin and skin tears of the elderly. Within three months of the completion of this offering, we intend to file a new 510(k) application with the FDA to obtain marketing clearance in the United States for TearRepair.

 

Effects of COVID-19 Pandemic

 

In December 2019, a novel strain of coronavirus (COVID-19) was reported to have surfaced in Wuhan, China, which has and is continuing to spread throughout China and other parts of the world, including the United States. On January 30, 2020, the World Health Organization declared the outbreak of COVID-19 a “Public Health Emergency of International Concern.” On January 31, 2020, U.S. Health and Human Services Secretary Alex M. Azar II declared a public health emergency for the United States to aid the U.S. healthcare community in responding to COVID-19, and on March 11, 2020, the World Health Organization characterized the outbreak as a “pandemic.”

 

The current COVID-19 pandemic has globally resulted in loss of life, business closures, restrictions on travel, and widespread cancellation of social gatherings. A significant outbreak of variants and subvariants of COVID-19 and other infectious diseases could adversely affect the economies and financial markets worldwide. The extent to which the COVID-19 pandemic impacts our business will depend on future developments, which are highly uncertain and cannot be predicted at this time, including:

 

  new information which may emerge concerning the severity of COVID-19 and its variants and subvariants;
     
  the duration and spread of the pandemic;
     
  regulatory actions taken in response to the pandemic, which may impact our offerings;
     
  other business disruptions that affect our workforce;
     
  the impact on capital and financial markets; and
     
  actions taken throughout the world, including in markets in which we operate, to contain the COVID-19 pandemic or treat its impact.

 

We have experienced difficulties in the procurement of raw materials, particularly during 2020, as a result of the prioritization of medical device suppliers of the provision of supplies for the production of vaccines against COVID-19. Furthermore, the spread of the virus may affect the operations of key governmental agencies, such as the FDA, which may delay the development or approval or clearance process for our product candidates. COVID-19 may also affect employees of third-party contract research organizations that we rely upon to carry out our clinical trials. The spread of COVID-19 and its variants and subvariants, or another infectious disease, could also negatively affect the operations of our partners, which could result in delays or disruptions in the supply of our product candidates.

 

In addition, the spread of COVID-19 has caused us to modify our business practices, including employee travel, employee work locations in certain cases, and cancellation of physical participation in certain meetings, events and conferences and further actions may be taken as required or recommended by government authorities or as we determine are in the best interests of our employees, customers and other business partners. We are monitoring the COVID-19 pandemic, and are taking steps in an effort to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and the governmental and community reactions thereto. See “Risk Factors—Risks Related to Our Business and Industry—We face risks related to health, pandemics, epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials.

 

Geopolitical Conditions

 

Recently, Russia initiated significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates, regional economies and the global economy. The situation remains uncertain, and while it is difficult to predict the impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs and impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

 

Summary of Risk Factors

 

There are a number of risks that you should understand before making an investment decision regarding this offering. These risks are discussed more fully in the section entitled “Risk Factors” following this prospectus summary. If any of these risks actually occur, our business, financial condition, or results of operations would likely be materially and adversely affected. In such case, the trading price of our common stock would likely decline, and you may lose all or part of your investment. These risks include, but are not limited to:

 

  We are a clinical-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance;
     
  We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses in for the foreseeable future and may never achieve or maintain profitability;
     
  If we fail to obtain additional financing on acceptable terms or at all, we may be unable to complete the development and commercialization of our product candidates;
     
  Even if we obtain regulatory approval or clearance of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community;
     
  Our near-term ability to generate product revenue is dependent on the success of one or more of our product candidates, which have not yet been commercialized;
     
  The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval or clearance of our product candidates;
     
  Our future success will largely depend on our ability to maintain and further grow clinical acceptance and adoption of our products, and we may be unable to adequately educate healthcare practitioners on the use and benefits of our products;
     
  Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery and development efforts;
     
  We may be unable to compete successfully against our existing or future competitors;
     
  Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business, results of operations and financial condition;
     
  Changes in existing third-party coverage and reimbursement may impact our ability to sell our products;
     
  Geopolitical conditions, including acts of war or terrorism could adversely affect our business;
     
  We face risks related to health, pandemics, epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials; and
     
  Other risks and factors listed under “Risk Factors,” “Cautionary Note Regarding Forward-Looking Statements” and elsewhere in this prospectus.

 

 

4

 

 

 

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

 

As a company with less than $1.07 billion in annual gross revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include:

 

  we are required to present only two years of audited financial statements and related management’s discussion and analysis of financial condition and results of operations in the registration statement of which this prospectus is a part;
     
  we are exempt from compliance with the requirement that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
     
  we are exempt from compliance with any requirement that the Public Company Accounting Oversight Board (the “PCAOB”) has adopted regarding communication of critical accounting matters and may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
     
  we are exempt from the “say on pay,” “say when on pay,” and “say on golden parachute” non-binding advisory vote requirements; and
     
  we can provide reduced disclosures about our executive compensation arrangements.

 

We currently intend to take advantage of each of the exemptions described above. It is possible, therefore, that some investors will find our common stock less attractive, which may result in a less active trading market for our common stock and higher volatility in our stock price.

 

We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the completion of this offering or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues are $1.07 billion or more; (ii) the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt securities; or (iii) the date on which we are deemed to be a “large accelerated filer,” which will occur as of the end of any fiscal year in which we (x) have an aggregate market value of our common stock held by non-affiliates of $700 million or more as of the last business day of our most recently completed second fiscal quarter, (y) have been required to file annual and quarterly reports under the Exchange Act for a period of at least 12 months and (z) have filed at least one annual report pursuant to the Exchange Act.

 

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We intend to take advantage of the benefits of this extended transition period. For risks related to our status as an emerging growth company, see “Risk Factors — Risks Related to Ownership of Our Common Stock — Taking advantage of the reduced disclosure requirements applicable to “emerging growth companies” may make our common stock less attractive to investors.”

 

We are also a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies. We will remain a smaller reporting company until the end of the fiscal year in which (1) we have a public common equity float of more than $250 million, or (2) we have annual revenues for the most recently completed fiscal year of more than $100 million and a public common equity float or public float of more than $700 million. We also would not be eligible for status as a smaller reporting company if we become an investment company, an asset-backed issuer or a majority-owned subsidiary of a parent company that is not a smaller reporting company.

 

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part 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 from what you might receive from other public reporting companies in which you hold equity interests.

 

Corporate Information

 

OptMed, Inc. is the registrant and the issuer of the common stock being sold in this offering. Our corporate headquarters is located at 745 Fifth Avenue, Suite 500, New York, New York 10151. Our telephone number is (646) 898-2004.

 

Our principal website address is www.optmed.com. The information contained on, or that can be accessed through, our website is deemed not to be incorporated in this prospectus or to be part of this prospectus. You should not consider information contained on our website to be part of this prospectus.

 

This prospectus includes trademarks, trade names and service marks owned by us. This prospectus also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus may appear without the ®, ™, or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights to these trademarks, trade names, and service marks. We do not intend our use or display of other parties’ trademarks, trade names, or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

 

5

 

 

 

OFFERING SUMMARY

 

Offered securities (1):           shares of our common stock (or         shares of our common stock if the underwriters exercise in full their option to purchase additional shares to cover over-allotments, if any).
     
Assumed public offering price: $        , the midpoint of the estimated $      to $      price range per share in this offering.
     
Over-Allotment Option:   The underwriters have an option to purchase up to            additional shares of common stock from us at the initial public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. The underwriters can exercise this option at any time within 45 days from the date of this prospectus.
     
Common stock outstanding before this offering (2):   42,286,342 shares
     
Common stock to be outstanding after this offering (3)(4):          shares (or          shares if the underwriters exercise their Over-Allotment Option in full)
     
Underwriters compensation:   In connection with this offering, the underwriters will receive an underwriting discount equal to 8% of the gross proceeds from the sale of common stock in the offering. We will also reimburse the underwriter for certain out-of-pocket actual expenses related to the offering and the Representative shall be entitled to a non-accountable expense allowance equal to one percent (1%) of the gross proceeds of the Offering.
     
    In addition, upon the closing of this offering, we have agreed to issue to the Representative warrants that will expire on the fifth anniversary of the commencement date of sales in this offering, entitling the Representative to purchase 5% of the number of shares of common stock sold in this offering, excluding the Over-Allotment Option. The registration statement of which this prospectus is a part also covers the Representative’s Warrants and the shares of common stock issuable upon the exercise thereof. See “Underwriting” for more information about underwriting compensation.
     
Use of proceeds:   We estimate that we will receive net proceeds from the sale of shares of our common stock in this offering of approximately $        million, assuming an initial public offering price of $        per share, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering to fund our product development and marketing activities, fund the repayment of our senior secured indebtedness and certain other indebtedness, and for general corporate and working capital purposes. Our management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of our management regarding the application of the proceeds. See “Use of Proceeds.”
     
Lock-up agreements:   We and our directors, officers and certain stockholders have agreed with the underwriters not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any shares of our common stock or securities convertible into shares of our common stock for a period of 180 days after the date of this prospectus. See “Underwriting—Lock-Up Agreements” on page 106 of this prospectus.
     
Dividend policy:   We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, for use in the operation of our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future. Investors should not purchase our common stock with the expectation of receiving cash dividends. See “Dividend Policy.”
     
Nasdaq listing and proposed trading symbol:   We have applied to list our common stock on the Nasdaq Capital Market under the symbol “OMED.” No assurance can be made that Nasdaq will approve our application to list our common stock. This offering is contingent on our common stock being listed on Nasdaq.
     
Transfer agent:  

[●]

     
Risk factors:   Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 9 of this prospectus for a discussion of factors you should carefully consider before investing in our common stock.

 

 

6

 

 

 

  (1) The actual number of shares we will offer and the actual price per share will be determined based on the actual public offering.
     
  (2) The number of shares of common stock to be outstanding immediately before this offering is based on shares of common stock outstanding as of July 15, 2022 and excludes:
     
  7,348,262 shares of common stock issuable pursuant to the exercise of outstanding stock options as of July 15, 2022 at a weighted-average exercise price of $         per share;
  13,132,567 shares of common stock issuable pursuant to the exercise of outstanding warrants as of July 15, 2022 at a weighted-average exercise price of $         per share;
  4,670,779 shares of common stock issuable pursuant to the conversion of shares of our Series A Convertible Preferred Stock (“Series A Preferred Stock”) outstanding as of July 15, 2022;
  4,609,430 shares of common stock issuable pursuant to the conversion of shares of our Series BB-1 Convertible Preferred Stock (“Series BB-1 Preferred Stock”) outstanding as of July 15, 2022;
  5,334,964 shares of common stock issuable pursuant to the conversion of shares of our Series BB-2 Convertible Preferred Stock (“Series BB-2 Preferred Stock”) outstanding as of July 15, 2022;
  Up to          shares of common stock issuable pursuant to the conversion of convertible notes outstanding as of July 15, 2022; and
  4,651,738 additional shares of common stock reserved for issuance under our 2022 Equity Compensation Plan.
     
  (3) The number of shares of our common stock that will be outstanding immediately after this offering is based on        shares of our common stock outstanding as of July 15, 2022, and reflects the conversion of         shares of our Series A Preferred Stock,         shares of our Series B Preferred Stock,         shares of our Series BB-1 Preferred Stock and         shares of our Series BB-2 Preferred Stock that will convert into shares of our common stock in connection with the completion of this offering (collectively, the “Preferred Stock Conversion”), and it also reflects the conversion of $        in aggregate principal and interest under outstanding convertible notes into an aggregate of         shares of common stock in connection with the completion of this offering (the “Note Conversion”). The number of shares of common stock to be outstanding after this offering excludes:
     
           shares of common stock issuable pursuant to the exercise of outstanding stock options as of        , 2022 at a weighted-average exercise price of $        per share;
           shares of common stock issuable pursuant to the exercise of outstanding warrants as of        , 2022 at a weighted-average exercise price of $       per share; and
           additional shares of common stock reserved for issuance under our 2022 Equity Compensation Plan.
     
  (4) Unless the context otherwise requires, the information in this prospectus assumes:
     
  a public offering price of $       per share, which is the midpoint of the range of the offering price per share;
  the Preferred Stock Conversion and Note Conversion occurs;
  no shares of common stock have been issued pursuant to the Representative’s Warrants;
  a        -to-        reverse split of our common stock effected on        , 2022; and
  no exercise of the Over-Allotment Option.

 

 

7

 

 

Summary Consolidated Financial Data

 

The following tables summarize our consolidated financial and other data. We have derived the summary consolidated statements of operations data for the years ended December 31, 2021 and 2020 from our audited consolidated financial statements included elsewhere in this prospectus. We derived our summary consolidated financial data as of March 31, 2022 and for the three months ended March 31, 2022 and 2021 from our unaudited consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future.

 

The following summary consolidated financial and other data should be read in conjunction with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus.

 

Consolidated Statement of Operations:

 

  

Three

Months Ended

March 31, 2022

  

Three

Months Ended

March 31, 2021

  

Year Ended

December 31,

2021

  

Year Ended

December 31,

2020

 
                 
Operating expenses                    
Research and development  $92,677   $459,515   $1,028,232   $902,726 
General and administrative   809,385    427,211    1,807,470    1,615,870 
                     
Total operating expenses   902,062    886,726    2,835,702    2,518,596 
                     
Operating loss   (902,062)   (886,726)   (2,835,702)   (2,518,596)
                     
Other income/expense                    
PPP Forgiveness   -    (108,225)   (108,225)   - 
Interest expense   248,618    773,193    1,599,272    997,153 
                     
Loss before provision for income taxes   (1,150,680)   (1,551,694)   (4,326,749)   (3,515,749)
                     
Provision (benefit) for income taxes   -    -    52,308    (131,844)
                     
Net loss   (1,150,680)   (1,551,694)   (4,379,057)   (3,383,905)
                     
Net loss attributable to non-controlling interest   (69,094)   (304)   (49,969)   (26,298)
                     
Net loss attributable to OptMed, Inc.  $(1,081,586)  $(1,551,390)  $(4,329,088)  $(3,357,607)

 

Consolidated Balance Sheets:

 

   March 31, 2022   December 31, 2021 
         
Assets    
Current assets          
Cash  $168,199   $6,968 
Prepaid expenses   413,372    458,411 
Deferred tax asset   195,014    200,224 
          
Total current assets   776,585    665,603 
          
Property and equipment, net   396,389    453,394 
           
Deferred offering costs   

82,915

    - 
          
Total assets  $1,255,889   $1,118,997 
          
Liabilities and Stockholders’ Deficit          
Current liabilities          
Accounts payable  $657,717   $462,704 
Bank overdraft   263,463    

277,052

 
Accrued expenses   3,273,469    3,196,424 
Due to shareholders   2,331,053    2,259,803 
Promissory notes   1,539,500    1,539,500 
Promissory notes - related party   457,250    457,250 
Convertible notes, net of debt discount   4,820,584    4,317,000 
Convertible notes - related party, net of debt discount   436,653    250,000 
           
Total current liabilities   13,779,689    12,759,733 
           
Long term liabilities   -    - 
           
Total other liabilities   -    - 
           
Total liabilities   13,779,689    12,759,733 
           
Commitments and contingencies          
           
Stockholders’ deficit          
Common stock, $0.0001 par value per share; 100,000,000 shares authorized; 42,276,340 and 42,276,340 issued and outstanding at March 31, 2022 and December 31, 2021, respectively   4,228    4,228 
Preferred stock Series A, $0.0001 par value per share; 6,000,000 shares authorized; 4,670,779 issued and outstanding at March 31, 2022 and December 31, 2021 (no liquidation preference)   467    467 
Preferred stock Series B, $0.0001 par value per share; 4,000,000 shares authorized; no shares issued and outstanding at March 31, 2022 and December 2021   -    - 
Preferred stock Series BB-1, $0.0001 par value per share 4,000,000 shares authorized; 3,841,512 issued and outstanding at March 31, 2022 and December 31, 2021 (liquidation preference of $3,199,979)   384    384 
Preferred stock Series BB-2, $0.0001 par value per share 4,446,174 shares authorized; 4,446,174 issued and outstanding at March 31, 2022 and December 31, 2021 respectively (liquidation preference of $2,000,003)   445    445 
Additional paid-in capital   30,933,590    30,665,974 
Accumulated deficit   (43,567,751)   (42,486,165)
           
Total stockholders’ deficit   (12,628,637)   (11,814,667)
           
Non-controlling interest   104,837    173,931 
           
Total liabilities and stockholders’ deficit  $1,255,889   $1,118,997 

 

8

 

 

RISK FACTORS

 

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes, before investing in our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and you could lose part or all of your investment. Some statements in this prospectus, including statements in the following risk factors, constitute forward-looking statements. Please refer to the section titled “Cautionary Note Regarding Forward-Looking Statements.”

 

Risks Related to Our Business and Industry

 

We are a clinical-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 a clinical-stage medical device company that was formed in 2007. We do not yet commercially sell any of our products and have not generated any revenue. Our operations to date have been limited to organizing and staffing our Company, business planning, raising capital, developing our technology, identifying potential product candidates, undertaking preclinical studies, and conducting clinical trials. If one of our product candidates receives regulatory approval or clearance, we will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. In addition, our limited operating history may make it difficult to evaluate our current business and predict our future performance. We will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields. If we do not address these risks successfully, our business will suffer.

 

We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses in for the foreseeable future and may never achieve or maintain profitability.

 

We are not profitable and have incurred significant losses in each period since our inception, including net losses of $4.3 million for the year ended December 31, 2021 and $3.4 million for the year ended December 31, 2020. For the three months ended March 31, 2022, we incurred net losses of $1.08 million. The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, the Company had an accumulated deficit of $43.6 million and $42.5 million as of March 31, 2022 and December 31, 2021, respectively, and used net cash in operating activities of $0.8 million and $2.0 million during the three months ended March 31, 2022 and year ended December 31, 2021, respectively. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after March 31, 2022.

 

To date, we have financed our operations primarily through private placements of our common stock, preferred stock, convertible loans, and loans. We have not commercialized any products and have never generated any revenue from product sales. We expect these losses to increase as we continue to incur significant research and development and other expenses related to our ongoing operations, seek regulatory approvals or clearances for our product candidates, scale-up manufacturing capabilities and hire additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems.

 

A critical aspect of our strategy is to invest significantly in our technology platform to improve the efficacy and safety of our product candidates. To become and remain profitable, we must develop and eventually commercialize products with significant market potential, which we may never achieve. Even if we succeed in commercializing one or more of these product candidates, we will continue to incur losses for the foreseeable future relating to our substantial research and development expenditures to develop our technologies. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital. Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period to period comparison of our results of operations may not be a good indication of our future performance. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of the Company and could impair our ability to raise capital, maintain our discovery and preclinical development efforts, expand our business or continue our operations and may require us to raise additional capital that may dilute your ownership interest. A decline in the value of our Company could also cause you to lose all or part of your investment.

 

9

 

 

We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors.

 

We have not generated any revenue from product sales, and do not anticipate generating any revenue from product sales until sometime after we have received regulatory approval or clearance for the commercial sale of a product candidate. Our ability to generate revenue and achieve profitability depends significantly on our success in many factors, including:

 

  completing research regarding, and nonclinical and clinical development of, our product candidates;
     
  obtaining regulatory approvals, clearances, and/or and marketing authorizations for product candidates for which we complete clinical trials;
     
  developing a sustainable and scalable manufacturing process for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure;
     
  launching and commercializing product candidates for which we obtain regulatory approvals, clearances, and/or marketing authorizations, either directly or with a collaborator or distributor;
     
  obtaining market acceptance of our product candidates as viable treatment options;
     
  addressing any competing technological and market developments;
     
  identifying, assessing, acquiring and/or developing new product candidates;
     
  negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;
     
  maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and
     
  attracting, hiring, and retaining qualified personnel.

 

Because of the numerous risks and uncertainties associated with medical device product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the FDA or other regulatory agencies, domestic or foreign, or other comparable foreign authorities, to perform preclinical studies or clinical trials in addition to those we currently anticipate, or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase and revenue could be further delayed.

 

Even if one or more of the product candidates that we develop is approved or cleared for commercial sale, we anticipate incurring significant costs associated with commercializing any approved or cleared product candidate. Our expenses could increase beyond expectations if we are required by the FDA or other regulatory agencies, domestic or foreign, to change our manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate. If we are successful in obtaining regulatory approvals or clearances to market one or more of our product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval or clearance, the accepted price for the product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of our treatable patients is not as significant as we estimate, the indication approved or cleared by regulatory authorities is narrower than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved or cleared. If we are not able to generate revenue from the sale of any approved or cleared products, we may never become profitable.

 

If we fail to obtain additional financing on acceptable terms or at all, we may be unable to complete the development and commercialization of our product candidates.

 

Our operations have required substantial amounts of cash since inception. We expect to continue to spend substantial amounts to continue the development of our product candidates. After we file 510(k) applications with the FDA for the regulatory clearance of our two most advanced products, BondEase and TearRepair, the FDA may request that we perform additional testing or provide additional information, including in-vitro testing or animal and human clinical trial data, which may require us to spend substantial amounts of cash and require substantial resources to perform. If we obtain clearance from the FDA to market the BondEase or TearRepair products or any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. We also expect to spend substantial amounts of cash to develop our early stage product candidates for the use of surgical adhesives for treatment of chronic wounds and internal applications. Furthermore, we expect to incur additional costs associated with operating as a public company in the United States.

 

As of March 31, 2022, we had $168,199 in cash. We estimate that our net proceeds from the offering will be approximately $           after deducting estimated underwriting discounts and commissions and the estimated transaction expenses payable by us. We expect to use the net proceeds from the offering to fund our product development and marketing activities, increase our capitalization and financial flexibility, to create a public market for our common stock and to facilitate our future access to the capital markets, and for general corporate and working capital purposes. We believe that such proceeds will be sufficient to fund our operations through at least 2023. However, changing circumstances may cause us to increase our spending significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control. We may require additional capital for the further development and commercialization of our product candidates and may need to raise additional funds sooner if we choose to pursue additional indications or geographies for our product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

 

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We cannot be certain that additional funding will be available on acceptable terms, or at all. Our ability to raise additional funding will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. In addition, our ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances regarding the COVID-19 pandemic and Russia’s recent invasion of Ukraine. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. Certain agreements may also be terminated if we are unable to meet the payment obligations under the agreements. We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.

 

Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

 

The loss of key personnel or the inability of replacements to quickly and successfully perform in their new roles could adversely affect our business.

 

We depend on the leadership and experience of our relatively small number of key executive management personnel, particularly our Chief Executive Officer, Dr. Ervin Braun, and our Chief Operating Officer and Chief Financial Officer, Mr. Alain Klapholz. The loss of the services of either of these key executives or any of our executive management members could have a material adverse effect on our business and prospects, as we may not be able to find suitable individuals to replace such personnel on a timely basis or without incurring increased costs, or at all. Furthermore, if we lose or terminate the services of one or more of our key employees or if one or more of our current or former executives or key employees joins a competitor or otherwise competes with us, it could impair our business and our ability to successfully implement our business plan. Additionally, if we are unable to hire qualified replacements for our executive and other key positions in a timely fashion, our ability to execute our business plan would be harmed. Even if we can quickly hire qualified replacements, we would expect to experience operational disruptions and inefficiencies during any transition. We believe that our future success will depend on our continued ability to attract and retain highly skilled and qualified personnel. There is a high level of competition for experienced, successful personnel in our industry. Our inability to meet our executive staffing requirements in the future could impair our growth and harm our business.

 

We may be unable to compete successfully against our existing or future competitors.

 

We operate in a highly competitive market characterized by rapid technological change. We compete with both alternative biologically-derived products and synthetic products based on efficacy, price, ease of use, reimbursement, customer support services and healthcare provider education. We may face competition from various industry participants, including medical device companies, pharmaceutical companies, biotechnology companies, academic institutions and government agencies, as well as private and public research institutions.

 

Our success depends, in part, on our ability to maintain a competitive position in the development of technologies and products for use by our customers. Many of the companies that may develop or market competing or alternative products may have competitive advantages when compared to us, including:

 

  greater financial and human resources for product development, sales and marketing;
     
  greater domestic and international name recognition and more product familiarity among physicians;
     
  broader and more established relationships with physicians, hospitals and third-party payors;
     
  broader product lines and the ability to offer lower prices or rebates or bundle products to offer greater discounts or incentives;
     
  a greater body of clinical data supporting the efficacy and safety of their products, and the ability and resources to continue to develop supportive clinical data;

 

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  broader intellectual property protection for their technology and products;
     
  broader and more established domestic and international sales and marketing and distribution networks; and
     
  more experience in conducting research and development, manufacturing, preparing regulatory submissions and obtaining regulatory clearance or approval for products, both in the United States and in foreign jurisdictions.

 

In addition to already marketed products, we also face competition from products that are or could be under development and that target the same applications as our products or applications that we may address in the future. Such product candidates may be developed by the above-mentioned entities and others, including pharmaceutical companies, biotechnology companies, academic institutions, government agencies and private and public research institutions. Our competitors may develop and patent processes or products earlier than we can, obtain regulatory clearance or approvals for competing products more rapidly than we can and develop more effective or less expensive products or technologies that render our technology or products obsolete or non-competitive. Despite the steps we have taken to maintain and protect our intellectual property, competitors may nevertheless attempt to or succeed in developing similar technologies. We also compete with other organizations in recruiting and retaining qualified scientific, sales and management personnel. If our competitors are more successful than us in these matters, we may be unable to compete successfully against our existing or future competitors.

 

With respect to our BondEase topical surgical adhesive for the closure of acute wounds, we will face direct and indirect competition from a number of competitors who have developed or are developing topical adhesives products for topical wound closure such as Ethicon, a subsidiary of Johnson and Johnson, Advanced Medical Solutions Group PLC, Chemence Medical, Inc., Adhezion Biomedical, LLC, Cryolife, Inc. Aesculap, Inc., and Glustich Inc.

 

With respect to our TearRepair topical adhesive for the protection of damaged skin and skin tears of the elderly population, we will face direct and indirect competition from a number of competitors who have developed or are developing topical adhesives products for Medline Industries, LP, and 3M Health Care, a subsidiary of 3M.

 

With respect to our surgical adhesive products currently in the research and development phase to be used as a seal for internal wounds and organ leakage, we will face direct and indirect competition from a number of competitors who have developed or are developing adhesives products for internal use products such as Ethicon, a Johnson & Johnson company, Baxter Inc., BD (Becton, Dickinson and Company), and Covidien Inc., a Medtronic Inc. company. The successful development of products is highly uncertain.

 

Successful development of products within our industry is highly uncertain and depends on numerous factors, many of which are beyond our control. Products that appear promising in the early phases of development may fail to reach the market for several reasons including:

 

  clinical study results that may show the product to be less effective than expected (e.g., the study failed to meet its primary endpoint) or to have unacceptable side effects;
     
 

failure to receive the necessary regulatory approvals or clearances or a delay in receiving such approvals or clearances. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis, or preparation of 510(k) application, or Pre-Market Approval (“PMA”) application, discussions with the FDA, and FDA request for additional preclinical or clinical data, or unexpected safety or manufacturing issues;

     
  manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the product uneconomical; and
     
  the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized.

 

Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or clearances. The length of time necessary to complete clinical studies and to submit an application for marketing approval or clearance for a final decision by a regulatory authority varies significantly from one product to the next and may be difficult to predict.

 

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Even if we are successful in getting market approval or clearance, commercial success of any of our product candidates will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. If government and other health care payors were not to provide adequate coverage and reimbursement levels for any of our products once approved or cleared, market acceptance and commercial success would be reduced.

 

Our near-term ability to generate product revenue is dependent on the success of one or more of our product candidates, which have not yet been commercialized.

 

Our near-term ability to generate product revenue is highly dependent on our ability to obtain regulatory approval or clearance of and successfully commercialize one or more of our product candidates. Our initial product candidates, the BondEase and TearRepair products, are tissue adhesives for topical applications. The BondEase product was designed as a topical adhesive for the closure acute incisional and laceration wounds and the TearRepair product was designed as a topical skin protectant for fragile and damaged skin such as skin tears of the elderly. In December 2015, we received clearance from the FDA to market BondEase in the United States. However, we have not yet started to commercialize BondEase, as we needed to first scale up its manufacturing process and to make certain modifications to improve the delivery of the adhesive on the wound. We have completed the manufacturing process and the product improvements for the BondEase product, and we are poised to file, within three months of the completion of this offering, a new application with the FDA to obtain clearance to market the modified version of BondEase in the United States. We are also planning to file, within three months of the completion of this offering, an application with the FDA to obtain clearance to market the TearRepair product in the United States. After review of our applications, the FDA may require us to perform additional in-vitro testing, animal studies, or human studies prior to clearing BondEase or TearRepair for marketing approval in the United States. The BondEase and TearRepair products will require additional regulatory review and approval or clearance in each jurisdiction in which we intend to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales. Before obtaining marketing approval from regulatory authorities for the sale of those of our product candidates which are still in the research and development phase and have not yet received marketing approval or clearance, we must conduct extensive clinical trials to demonstrate the efficacy of the product candidates. We cannot be certain that any of our product candidates will be successful in clinical trials and they may not receive regulatory approval or clearance even if they are successful in clinical trials.

 

Before we can generate any revenues from sales of our product candidates, we must complete the following activities for each of them, any one of which we may not be able to successfully complete:

 

  manage preclinical, manufacturing and clinical activities;
     
  obtain regulatory approval or clearance from the FDA and other comparable foreign regulatory authorities for our product candidates that have not yet received such approval;
     
  establish manufacturing relationships for the clinical and post-approval supply of the applicable product candidate in compliance with all regulatory requirements;
     
  build a commercial sales and marketing team, either internally or by contract with third parties;
     
  establish and maintain patent and trade secret protection or regulatory exclusivity for our product candidates;
     
  develop and implement marketing strategies for successful commercial launch of our product candidates, if and when approved or cleared;
     
  secure and maintain acceptance of our products, if and when approved or cleared, by patients, from the relevant medical communities and from third-party payors;
     
  compete effectively with other therapies;
     
  establish and maintain adequate health care coverage and reimbursement from third-party payors;
     
  ensure continued compliance with any post-marketing requirements imposed by regulatory authorities, including any required post-marketing clinical trials, that may be required by the FDA or comparable requirements in other jurisdictions to ensure the benefits of the product outweigh its risks;
     
  maintain continued acceptable safety profile of the product candidates following approval or clearance; and
     
  invest significant additional cash in each of the above activities.

 

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If we are unable to address one or more of these factors in a timely manner or at all, we could experience significant delays in the successful commercialization of, or an inability to successfully commercialize, our product candidates, which would materially harm our business. If we do not receive regulatory approvals or clearances for one or more of our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approvals or clearances to manufacture and market our product candidates, our revenues will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval or clearance and have commercial rights. If the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved.

 

Our business and sale of our products are subject to extensive regulatory requirements, including compliance with labelling, manufacturing and reporting controls. If we fail or are unable to timely obtain the necessary 510(k) clearances or Pre-Market Application approvals for new products or for the use of our products for additional indications, our ability to generate revenue could be materially harmed.

 

Our products are classified as medical devices and are subject to extensive regulation in the United States by the FDA and other federal, state and local authorities and by similar regulatory authorities in overseas jurisdictions. Government regulation of medical devices is meant to assure their safety and effectiveness, and includes regulation of, among other things:

 

  design, development and manufacturing;
     
  testing, labeling, including directions for use, processes, controls, quality assurance, packaging, storage, distribution, installation and servicing;
     
  preclinical studies and clinical trials;
     
  establishment registration and listing;
     
  product safety and effectiveness;
     
  marketing, sales and distribution;
     
  premarket approval and 510(k) clearance;
     
  recordkeeping procedures;
     
  advertising and promotion;
     
  corrections and removals and recalls; post-market surveillance, including reporting of deaths or serious injuries, and malfunctions that, if they were to recur, would be likely to cause or contribute to a death or serious injury; and
     
  product import and export.

 

In the United States, before we can market a new medical device, or a new use of, or claim for, an existing product, we must first receive either 510(k) clearance or PMA approval from the FDA, unless an exemption applies.

 

In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device. Substantial equivalence means that with respect to the proposed device being compared to the predicate device, the proposed device has the same intended use as the predicate device and the proposed device has the same technological characteristics as the predicate device, or has different technological characteristics but that the proposed device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. Clinical data are sometimes required to support substantial equivalence. The PMA pathway requires an applicant to demonstrate the safety and effectiveness of the device based, in part, on extensive data, including, but not limited to, technical, preclinical, 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 and also novel devices that remain in Class III. Products that are approved from a PMA application generally need FDA approval of a PMA supplement before they can be modified. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k). Both of these processes can be expensive and lengthy, and with respect to a PMA, can entail significant user fees, unless exempt. The FDA’s 510(k) clearance process usually takes from nine to twelve months, but may take significantly 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 longer, from the time the application is submitted to the FDA until an approval is obtained. The process of obtaining 510(k) clearances or PMA approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all.

 

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In the United States, we have received 510(k) clearance for our BondEase product indicated for the closure of topical incisions and lacerations. However, before we could commercialize our BondEase product we needed to scale up its manufacturing process and to make modifications to the BondEase product. We have completed the scale-up of the manufacturing process and product modifications for BondEase. We plan to file, within three months of the completion of this offering, a new 510(k) application with the FDA to obtain clearance to market the modified BondEase product in the United States. There is no assurance that the FDA will clear the new application or that it will not require us to conduct additional pre-clinical, animal clinical and human clinical testing before it considers our application for review. If the FDA requires us to go through a lengthier, more rigorous process for future products or modifications to existing products than expected, our product introductions or modifications could be delayed or cancelled, which could result in no future revenues or could cause our sales to decline. In addition, several of our product candidates will require the more costly, lengthy and uncertain PMA process. Further, even with respect to those future products where a PMA is not required, we cannot assure you that we will be able to obtain the 510(k) clearances with respect to those products. The FDA can delay, limit or deny 510(k) clearance or PMA approval of a device for many reasons, including:

 

  we may not be able to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended uses;
     
  the data from our preclinical 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.

 

While we have previously received FDA clearance for the indication of our BondEase product for the closure of topical incisional and laceration wounds, the manufacturing for that product was not commercially feasible and our new modified BondEase product may not be cleared by the FDA and the FDA may not clear additional indications that are necessary or desirable future successful commercialization of our products. Indeed, the FDA may refuse our requests for 510(k) clearance or premarket approval of new products, new intended uses or modifications to existing products.

 

From time to time, legislation is drafted and introduced in the United States that could significantly change the statutory provisions governing any regulatory approval or clearance that we receive in the United States. 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 products under development or impact our ability to modify our currently approved or cleared products on a timely basis.

 

If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect the commercialization of any of our product candidates may be delayed, our business will be harmed.

 

Elsewhere in this prospectus we have provided a number of timing estimates regarding the initiation of clinical trials and clinical development milestones, and the expected availability of data resulting from these trials for certain of our product candidates. We expect to continue to estimate the timing of these types of development milestones and our expected timing for the accomplishment of various other scientific, clinical, regulatory and other product development objectives. From time to time following the completion of this offering, we may publicly announce the expected timing of some of these events. However, the achievement of many of these milestones and events may be outside of our control. All of these timing estimations are based on a variety of assumptions we make which may cause the actual timing of these events to differ from the timing we expect, including:

 

  our available capital resources and our ability to obtain additional funding as needed;
     
  the rate of progress, costs and results of our clinical trials and research and development activities;
     
  our ability to identify and enroll patients who meet clinical trial eligibility criteria;
     
  our receipt of approvals or clearances by the FDA, European Medicines Agency, or EMA, and other regulatory authorities and the timing of these approvals;
     
  our ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates;
     
  the efforts with respect to the commercialization of our product candidates;
     
  the securing of costs related to, and timing issues associated with manufacturing our products and, if any of our product candidates are approved, associated with sales and marketing activities and the commercial manufacture of our product candidates; and
     
  circumstances arising from or relating to the COVID-19 pandemic and Russia’s recent invasion of Ukraine, including potential effects on the global supply chain, our manufacturers and the availability of raw materials needed for the research and development of our product candidates.

 

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If we fail to achieve announced milestones in the timeframes we expect, the commercialization of any of our product candidates may be delayed, and our business and results of operations may be harmed and our stock price may decline.

 

Failure to successfully identify, develop and commercialize additional products or product candidates could impair our ability to grow.

 

Although a substantial amount of our efforts will focus on the continued preclinical and clinical testing and potential approval or clearance of our product candidates in our current pipeline, we expect to continue to innovate and potentially expand our portfolio. Because we have limited financial and managerial resources, research programs to identify product candidates may require substantial additional technical, financial and human resources, whether or not any new potential product candidates are ultimately identified. Our success may depend in part upon our ability to identify, select and develop promising product candidates. We may expend resources and ultimately fail to discover and generate additional product candidates suitable for further development. All product candidates are prone to risks of failure typical of biotechnology product development, including the possibility that a product candidate may not be suitable for clinical development as a result of its harmful side effects, limited efficacy or other characteristics indicating that it is unlikely to receive approval by the FDA, the EMA and other comparable foreign regulatory authorities and achieve market acceptance. If we do not successfully develop and commercialize new product candidates we have identified and explored, our business, prospects, financial condition and results of operations could be adversely affected.

 

We face risks related to health, pandemics, epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials.

 

If a pandemic, epidemic or outbreak of an infectious disease occurs in the United States or worldwide our business may be adversely affected. The COVID-19 pandemic has impacted the global economy and may impact our operations, including the potential interruption of our clinical trial activities, regulatory reviews and our supply chain. For example, the COVID-19 pandemic may delay enrollment in our clinical trials due to prioritization of hospital resources toward the outbreak or other factors, and some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release clinical trial results and could delay our ability to obtain regulatory approval and commercialize our product candidates. We have experienced difficulties in the procurement of raw materials, particularly during 2020, as a result of the prioritization of medical device suppliers of the provision of supplies for the production of vaccines against COVID-19. Furthermore, the spread of the virus may affect the operations of key governmental agencies, such as the FDA, which may delay the development or approval process for our product candidates.

 

COVID-19 may also affect employees of third-party contract research organizations (“CROs”) that we rely upon to carry out our clinical trials. The spread of COVID-19, or another infectious disease, could also negatively affect the operations of our partners, which could result in delays or disruptions in the supply of our product candidates. In addition, we have taken precautionary measures, and may take additional measures, intended to help minimize the risk of the virus to our employees, including temporarily requiring certain employees to work remotely, suspending all non-essential travel worldwide for our employees, and discouraging employee attendance at industry events and in-person work-related meetings, which could negatively affect our business. In 2020, we were forced to suspend operations at our subsidiary in Spain for three weeks, and we re-opened the facility only with limited operations.

 

We cannot presently predict the extent to which current or future business shutdowns and disruptions may impact or limit our ability or the ability of any of the third parties with which we engage to conduct business in the manner and on the timelines presently planned. Any such impacts or limitations could have a material adverse impact on our business and our results of operation and financial condition. The ongoing COVID-19 pandemic may result in significant disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting from the continuing spread of COVID-19 and its variants and subvariants could materially affect our business and the value of our common stock.

 

A significant outbreak of other infectious diseases in the future also could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations.

 

To the extent the COVID-19 pandemic or a similar public health threat has an impact on our business, it is likely to also have the effect of heightening many of the other risks described in this “Risk Factors” section.

 

Geopolitical conditions, including acts of war or terrorism could adversely affect our business.

 

Our operations could be disrupted by acts of war, terrorist activity or other similar events, including the current or anticipated impact of military conflict and related sanctions imposed on Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations by the United States and other countries due to Russia’s recent invasion of Ukraine. It is not possible to predict the broader consequences of the conflict, including related geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates, regional economies and the global economy. The situation remains uncertain, and while it is difficult to predict the impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs and impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

 

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The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval or clearance of our product candidates.

 

In the United States, before we can market a new medical device, or a new use of, or claim for, an existing product, we must first receive either 510(k) clearance or PMA approval from the FDA, unless an exemption applies.

 

In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device. Substantial equivalence means that with respect to the proposed device being compared to the predicate device, the proposed device has the same intended use as the predicate device and the proposed device has the same technological characteristics as the predicate device, or has different technological characteristics but that the proposed device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. Clinical data are sometimes required to support substantial equivalence. The PMA pathway requires an applicant to demonstrate the safety and effectiveness of the device based, in part, on extensive data, including, but not limited to, technical, preclinical, 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 and also novel devices that remain in Class III. Products that are approved from a PMA application generally need FDA approval of a PMA supplement before they can be modified. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k). Both of these processes can be expensive and lengthy, and with respect to a PMA, can entail significant user fees, unless exempt. The FDA’s 510(k) clearance process usually takes from nine to twelve months, but may take significantly 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 longer, from the time the application is submitted to the FDA until an approval is obtained. The process of obtaining 510(k) clearances or PMA approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all.

 

As part of its marketing authorization process, the EMA may grant marketing authorizations on the basis of less complete data than is normally required, when, for certain categories of medicinal products, doing so may meet unmet medical needs of patients and serve the interest of public health. In such cases, it is possible for the Committee for Medicinal Products for Human Use, or CHMP, to recommend the granting of a marketing authorization, subject to certain specific obligations to be reviewed annually, which is referred to as a conditional marketing authorization. This may apply to medicinal products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention, or the medical diagnosis of seriously debilitating diseases or life-threatening diseases and those designated as orphan medicinal products.

 

A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

 

  the risk-benefit balance of the medicinal product is positive;
     
  it is likely that the applicant will be in a position to provide the comprehensive clinical data;
     
  unmet medical needs will be fulfilled; and
     
  the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

 

The granting of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete nonclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be used in emergency situations in response to public-health threats.

 

Conditional marketing authorizations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.

 

The granting of a conditional marketing authorization will allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case and will ensure that additional data on a product are generated, submitted, assessed and acted upon. Although we may seek a conditional marketing authorization for one or more of our product candidates by the EMA, the EMA or CHMP may ultimately not agree that the requirements for such conditional marketing authorization have been satisfied.

 

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Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.

 

The clinical trials of our product candidates are, and the manufacturing and marketing of our products will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals or clearances for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. In particular, because our product candidates are subject to regulation as medical devices. For example, response rates from the use of our product candidates may not be sufficient to obtain regulatory approval or clearance unless we can also show an adequate duration of response. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. The results of studies in one set of patients or line of treatment may not be predictive of those obtained in another. We expect there may be greater variability in results for products processed and administered on a patient-by-patient basis, as anticipated for our product candidates, than for “off-the-shelf” products. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the device industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

 

In addition, even if our clinical trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval or clearance. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

 

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Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or clearance, limit their commercial potential, or result in significant negative consequences.

 

As with most chemical adhesive products, use of our product candidates could be associated with side effects or adverse events, which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical trials.

 

The FDA or comparable foreign regulatory authorities could delay or deny approval or clearance of our product candidates for any or all targeted indications and negative side effects could result in a more restrictive label for any product that is approved or cleared. Side effects such as toxicity or other safety issues associated with the use of our product candidates could also require us or our collaborators to perform additional studies or halt development or sale of these product candidates.

 

If one or more of our product candidates receives marketing approval or clearance, and we or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, a number of potentially significant negative consequences could result, including:

 

  regulatory authorities may withdraw or limit their approvals of such products;
     
  regulatory authorities may require the addition of labeling statements, specific warnings or contraindications;
     
  we may be required to change the way such products are distributed or administered, or change the labeling of the products;
     
  the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products;
     
  we may decide to recall such products from the marketplace after they are approved;
     
  we could be sued and held liable for harm caused to individuals exposed to or taking our products; and
     
  our reputation may suffer.

 

In addition, adverse side effects caused by any products that may be similar in nature to our product candidates could delay or prevent regulatory approval or clearance of our product candidates, limit the commercial profile of an approved or cleared label for our product candidates, or result in significant negative consequences for our product candidates following marketing approval.

 

We believe that any of these events could prevent us from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing our product candidates, if approved or cleared, and significantly impact our ability to successfully commercialize our product candidates and generate revenues.

 

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

 

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

 

  the size and nature of the patient population;
     
  the patient eligibility criteria defined in the protocol;
     
  the size of the study population required for analysis of the trial’s primary endpoints;
     
  the proximity of patients to trial sites;

 

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  the design of the trial;
     
  our ability to recruit clinical trial investigators with the appropriate competencies and experience;
     
  clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating;
     
  our ability to obtain and maintain patient consents; and
     
  the risk that patients enrolled in clinical trials will not complete a clinical trial.

 

In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Because the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because our product candidates represent an alternative to more common alternatives for wound treatment, potential patients and their doctors may be inclined to use conventional products or treatment, rather than enroll patients in any future clinical trial.

 

Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.

 

Our future success will largely depend on our ability to maintain and further grow clinical acceptance and adoption of our products, and we may be unable to adequately educate healthcare practitioners on the use and benefits of our products.

 

Healthcare practitioners play a significant role in determining the course of a patient’s treatment and, ultimately, the type of product that will be used to treat the patient. As a result, our commercial success is heavily dependent on our ability to educate these practitioners on the use of our products in surgical soft tissue repair procedures and complex wound management. Acceptance and adoption of our products in our markets depends on educating healthcare practitioners as to the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products, including potential comparisons to our competitors’ products, and on training healthcare practitioners in the proper application of our products. If we are not successful in convincing healthcare practitioners of the merits and advantages of our products compared to our competitors’ products, they may not use our products and we will be unable to increase our sales and sustain growth or profitability.

 

Convincing healthcare practitioners to dedicate the time and energy necessary to properly train to use new products and techniques is challenging, and we may not be successful in these efforts. In particular, as healthcare resources are strained due to the ongoing COVID-19 pandemic, it may be more difficult to convince healthcare practitioners to commit their time and resources to learning to use a new product. If healthcare practitioners are not properly trained, they may use our products ineffectively, resulting in unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us. Accordingly, even if our products show superior benefits, safety or efficacy, based on head-to-head clinical trials, in comparison to alternative treatments, our success will depend on our ability to gain and maintain market acceptance for our products. If we fail to do so, our sales will not grow and our business, financial condition and results of operations will be adversely affected. We may not have adequate resources to effectively educate the medical community and our efforts may not be successful due to physician resistance or negative perceptions regarding our products.

 

Healthcare practitioners may be hesitant to change their medical treatment practices for the following reasons, among others:

 

  lack of experience with new technologies or other biologically-derived regenerative products;
     
  lack or perceived lack of evidence supporting additional patient benefits;
     
  perceived liability risks generally associated with the use of new products and procedures;
     
  limited or lack of availability of coverage and reimbursement within healthcare payments systems;

 

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  existing sole-source supply contracts with purchasing entities, such as hospital systems and group organizations, or GPOs, that do not use our products;
     
  limited or lack of available published clinical data;
     
  pressure to contain costs and use lower cost alternatives to our products;
     
  costs associated with the purchase of new products; and
     
  the time commitment that may be required for training to use new products or technologies.

 

In addition, we believe recommendations and support of our products by key opinion leaders are essential for market acceptance and adoption. If we do not receive support from such key opinion leaders or if long-term clinical data does not show the benefits of using our products, we may not achieve adequate commercial acceptance of our products.

 

The process of manufacturing our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities. If we encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved or cleared, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

 

The process of manufacturing our products is complex, highly-regulated and subject to multiple risks. The manufacture of our product candidates involves complex processes, and as a result of the complexities, the cost to manufacture our product candidates is high, and the manufacturing process is less reliable and is more difficult to reproduce than those of alternative products. Our manufacturing process will be susceptible to product loss or failure due to logistical issues. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. Further, as product candidates are developed through preclinical to late stage clinical trials towards approval or clearance and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

 

In addition, the manufacturing process for any products that we may develop is subject to FDA and foreign regulatory authority approval process, and we will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an ongoing basis. If we are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, we may not obtain or maintain the approvals or clearances we need to commercialize such products. Even if we obtain regulatory approval or clearance for any of our product candidates, there is no assurance that either we will be able to manufacture the product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval or clearance of our product candidate, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.

 

We rely on third parties to manufacture our clinical product supplies, and we intend to rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved or cleared. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices, or fail to maintain or achieve satisfactory regulatory compliance.

 

In October 2017, we formed Synkotech Biomaterials S.L. (“Synkotech”) located in Tarragona, Spain, as a joint-venture with Thasus Partners, a technical consulting company founded in December 2016 by specialists in all aspects of the synthesis, processing, formulating, packaging and intellectual property associated with highly reactive adhesive monomers. We own 66% of the equity and 52% of the profits of Synkotech. Synkotech built a state of the art manufacturing facility in a space of approximately 1,600 square feet. This facility’s goal was to scale up the manufacturing process of the MM212 chemistry, to produce BondEase and TearRepair products, the first devices that we intend to commercialize in the United States pending receipt of marketing clearance from the FDA. Synkotech also serves as a research and development facility to develop new clinical indications for our adhesive surgical platform. There are currently fourteen employees working at Synkotech. Synkotech is ISO-9001 and ISO-13485 certified and intends to comply with FDA requirements to manufacture medical devices.

 

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Our manufacturing facility may be used as our clinical-scale manufacturing and processing facility. This facility can manufacture or process our product on a very limited commercial scale and may not be able manufacture or process on a large commercial scale for any of our product candidates.

 

Although in the future we do intend to increase the output capability and the size of our own manufacturing facility, we may, in any event, never be successful in developing a manufacturing facility that is capable to meet our research and commercial needs. Our anticipated reliance on a single manufacturing facility with limited capacity exposes us to the following risks:

 

  We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and must be compliant with FDA regulations, which would require the set up of extensive quality systems, new testing, good manufacturing practices, or cGMP, and compliance inspections by the FDA. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products.
     
  Our manufacturing facility and potential third-party manufacturers might be unable to timely manufacture our products or produce the quantity and quality required to meet our clinical and commercial needs, if any.
     
  Future contract manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately.
     
  Our future contract manufacturers may not perform as agreed, may not devote sufficient resources to our products, or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our products.
     
  Manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with current cGMP if applicable and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.
     
  We may not own, or may have to share, the intellectual property rights to any improvements made by our future third-party manufacturers in the manufacturing process for our products.
     
  Our future third-party manufacturers could breach or terminate their agreement with us.
     
  Raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier, may not be available or may not be suitable or acceptable for use due to material or component defects.
     
  Disruptions in the supply chain, particularly with respect to chemical raw materials utilized in our development and manufacturing processes, could significantly delay our product development and have a detrimental effect on our ability to commercialize product candidates.
     
  Our contract manufacturers and critical reagent suppliers may be subject to inclement weather, as well as natural or man-made disasters.
     
  Our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.

 

Each of these risks could delay or prevent the completion of our clinical trials or the approval or clearance of any of our product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates. In addition, we will rely on third parties to perform certain specification tests on our product candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put at risk of serious harm and the FDA could place significant restrictions on our Company until deficiencies are remedied.

 

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The manufacture of our product candidates is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.

 

Manufacturers of medical products often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process (including the absence of contamination). These problems include logistics and shipping, difficulties with production costs and yields, quality control, including stability of the product, product testing, operator error, availability of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability failures or other issues relating to the manufacture of our product candidates will not occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide our product candidates to patients in clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical trials completely.

 

Our manufacturing facility may be unable to successfully scale up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing any approved or cleared product candidates.

 

We may be unable to successfully increase the manufacturing capacity for our product candidates in a timely or cost-effective manner, or at all, as needed for our development efforts or, if our product candidates are approved or cleared, our commercialization efforts. Quality issues may also arise during scale-up activities. If we are unable to successfully scale up the manufacture of our product candidates in sufficient quality and quantity, the development, testing, and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or clearance or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.

 

We rely and will rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval or clearance of or commercialize our product candidates.

 

We depend and will depend upon independent investigators and collaborators to conduct our clinical trials under agreements with universities, medical institutions, CROs, strategic partners, and others. We expect to have to negotiate budgets and contracts with CROs and trial sites, which may result in delays to our development timelines and increased costs.

 

We rely and will rely heavily on third parties over the course of our clinical trials, and as a result will have limited control over the clinical investigators and limited visibility into their day-to-day activities. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol and legal, regulatory, and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with good clinical practices, or cGCP, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these cGCP through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving or clearing our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the applicable cGCP regulations. In addition, our clinical trials must be conducted with medical device products produced under cGMP regulations and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval or clearance process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

 

Any third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed, or terminated and we may not be able to complete development of, obtain regulatory approval or clearance of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

 

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Any agreements governing our relationships with CROs or other contractors with whom we currently engage or may engage in the future may provide those outside contractors with certain rights to terminate a clinical trial under specified circumstances. If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

 

We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

 

We currently have no sales, marketing, or commercial product distribution capabilities and have no experience in marketing products. We intend to pursue collaborative arrangements regarding the sales and marketing of our products. Currently, we have entered into an exclusive distribution agreement in the United States, Canada and Mexico territories for our TearRepair product with DermaRite Industries, LLC, a United States manufacturer and distributor of skin care, wound care, and nutritional supplements. We have also entered into an exclusive distribution agreement, including subsequent amendments, for all our products with Jiangsu Synecoun Medical Technology Co., Ltd. for China, Hong Kong, Taiwan, Japan, South Korea and Indonesia territories. However, there can be no assurance that we will be able to establish or maintain such collaborative arrangements for our other products, or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates.

 

There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.

 

We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

 

We may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.

 

Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following:

 

  collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
     
  collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
     
  collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;

 

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  collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
     
  a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;
     
  collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
     
  disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;
     
  collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and
     
  collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property.

 

As a result, if we enter into collaboration agreements and strategic partnerships or license our products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition, and results of operations.

 

If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

 

We may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

 

  increased operating expenses and cash requirements;
     
  the assumption of additional indebtedness or contingent liabilities;
     
  assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;
     
  our inability to achieve desired efficiencies, synergies or other anticipated benefits from such acquisitions or strategic partnerships;
     
  the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
     
  retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;
     
  risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and
     
  our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

 

In addition, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.

 

We have significant debt and if we are unable to repay our debt when it comes due, our business, financial condition and results of operations could be materially harmed.

 

We have issued secured notes to H.B. Fuller Company and Pidilite, Inc. (the “Senior Lenders”) in the aggregate principal amount of $3.25 million, which are secured by substantially all of our assets (the “Collateral”) and originally became due on July 1, 2018 (the “Senior Secured Loans”). We are currently in default on the Senior Secured Loans, but the Senior Lenders have agreed to forbear from exercising any default-related rights and remedies against us until the earliest of: (i) September 30, 2022 and (ii) the date on which we complete our initial public offering. We will need to seek and obtain an additional forbearance on our Senior Secured Loans from our Senior Lenders in the event our initial public offering is not completed by September 30, 2022. In the event we do not successfully obtain an additional forbearance through the date of our initial public offering, the Senior Lenders may exercise their rights relating to default under the Senior Secured Loans, which would include proceeding against the Collateral, and our financial condition would be negatively affected and we may have to curtail or cease our operations altogether.

 

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In addition, we currently have outstanding unsecured loans in an aggregate amount, including principal and interest, of approximately $4.9 million (the “Unsecured Loans”). To date, we have not paid the outstanding balances under the Unsecured Loans as they have come due. Of the aggregate amount of the Unsecured Loans outstanding, approximately $1.9 million will be automatically converted into shares of our common stock in accordance with the terms of the Unsecured Loans, and a portion of the remaining Unsecured Loans will be converted into shares of our common stock at the option of the holders. As of March 31, 2022, our aggregate outstanding indebtedness and accrued but unpaid interest was $10,842,865. Although we plan to reduce our outstanding debt obligations by satisfying the Senior Secured Loans and a portion of the Unsecured Loans with a portion of the proceeds of this offering and converting a portion of the Unsecured Loans into shares of our common stock, our remaining outstanding indebtedness could have significant effects on our business by, among other things:

 

  limiting our ability to borrow additional amounts to fund working capital, capital expenditures, acquisitions, debt service requirements, execution of our growth strategy and other purposes;
     
  requiring us to dedicate a portion of our cash flows from operations to pay interest on our debt, which would reduce availability of our cash flows to fund working capital, capital expenditures, potential acquisitions, execution of our growth strategy and other general corporate purposes;
     
  making us more vulnerable to adverse changes in general economic, industry and competitive conditions, in government regulation and in our business by limiting our ability to plan for and react to changing conditions; and
     
  placing us at a competitive disadvantage compared with our competitors that have less debt.

 

We may not be able to generate sufficient cash flows from our operations to repay our past due and other indebtedness when it becomes due and to meet our other cash needs. If the holders of our past due indebtedness make demand for payment, or we are not able to pay our other debts as they become due, we will be required to pursue one or more alternative strategies, such as selling assets, refinancing or restructuring our indebtedness or selling additional debt or equity securities. We may not be able to refinance our debt, sell additional debt or equity securities or sell our assets on favorable terms, if at all, and if we must sell our assets, we may negatively affect our ability to generate revenue.

 

If we, our CROs or our contract manufacturing organizations (“CMOs”) use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

 

Our research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by us or third parties, such as CROs and CMOs. We and such third parties are subject to federal, state, and local laws and regulations in the United States governing the use, manufacture, storage, handling, and disposal of medical and hazardous materials. Although we believe that our and such third parties’ procedures for using, handling, storing, and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability or local, city, state, or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition, or results of operations.

 

Our internal computer systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.

 

Despite the implementation of security measures, our internal computer systems and those of our future CROs and other contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. Although to our knowledge we have not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on our third-party research institution collaborators for research and development of our product candidates and other third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.

 

Although we take reasonable steps to help protect confidential and other sensitive information from unauthorized access or disclosure, we also could be the target of phishing attacks seeking confidential information regarding our employees. Furthermore, while we have implemented data privacy and security measures in an effort to comply with applicable laws and regulations relating to privacy and data protection, some protected health information (“PHI”) and other personally identifiable information (“PII”) or confidential information may be transmitted to us by third parties, who may not implement adequate security and privacy measures, and it is possible that laws, rules and regulations relating to privacy, data protection, or information security may be interpreted and applied in a manner that is inconsistent with our practices or those of third parties who transmit PHI and other PII or confidential information to us.

 

To the extent we or these third parties are found to have violated such laws, rules or regulations or that any disruption or security breach were to result in a loss of, or damage to, our or our third-party vendors’, collaborators’ or other contractors’ or consultants’ data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability including litigation exposure, penalties and fines, we could become the subject of regulatory action or investigation, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed. Any of the above could have a material adverse effect on our business, financial condition, results of operations or prospects.

 

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If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

 

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial and management resources. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing any approved or cleared products, these claims could result in an FDA investigation of the safety and effectiveness of our products, our manufacturing processes and facilities (or the manufacturing processes and facilities of our third-party manufacturer) or our marketing programs, a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in:

 

  decreased demand for our products;
     
  injury to our reputation;
     
  withdrawal of clinical trial participants and inability to continue clinical trials;
     
  initiation of investigations by regulators;
     
  costs to defend the related litigation;
     
  a diversion of management’s time and our resources;
     
  substantial monetary awards to trial participants or patients;
     
  product recalls, withdrawals or labeling, marketing or promotional restrictions;
     
  loss of revenue;
     
  exhaustion of any available insurance and our capital resources;
     
  the inability to commercialize any product candidate; and
     
  a decline in our share price.

 

Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.

 

Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials. There is no assurance that our manufacturers will be successful in establishing a larger-scale commercial manufacturing process for our product candidates that achieves our objectives for manufacturing capacity and cost of goods. Even if we could otherwise obtain regulatory approval or clearance for any product candidate, there is no assurance that our manufacturers will be able to manufacture the product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product or to meet potential future demand. If our manufacturers are unable to produce sufficient quantities of the approved or cleared product for commercialization, our commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

 

Changes in existing third-party coverage and reimbursement may impact our ability to sell our products.

 

In the United States and markets in other countries, patients who are prescribed medical products for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Maintaining and growing sales of our products depends in large part on the availability of adequate coverage and reimbursement from third-party payors, including government programs such as Medicare and Medicaid, private insurance plans and managed care programs. Hospitals and other healthcare provider customers that purchase our products typically bill various third-party payors to cover all or a portion of the costs and fees associated with the procedures in which our products are used, including the cost of the purchase of our products. Medicare reimbursement for procedures using our products during an inpatient stay is generally made under a prospective payment system that is determined by a classification system known as the Medicare severity diagnosis-related groups, or MS-DRGs. The Centers for Medicare & Medicaid Services, or CMS, the agency responsible for administering the Medicare program, also includes payment for our products in Medicare payments for outpatient surgical procedures in ambulatory surgery centers or hospital outpatient departments. Our customers’ access to adequate coverage and reimbursement for the procedures performed with our products by government and private insurance plans is central to the acceptance of our current and future products. Changes in the amount third-party payors are willing to reimburse our customers for procedures using our products or our products themselves could create pricing pressures 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 payment, or if our costs of production increase faster than increases in reimbursement levels.

 

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Coverage decisions and payment amounts are established at the discretion of individual third-party payors. Many private payors, however, use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies. As the portion of the U.S. population over the age of 65 and eligible for Medicare continues to grow, we may be more vulnerable to coverage and reimbursement limitations imposed by CMS. While certain procedures using our products are currently covered by Medicare and other third-party payors, future action by CMS or other government agencies may diminish payments to physicians, outpatient centers and/or hospitals for covered services.

 

These bundled payments are subject to a two-tier system—one bundled payment for procedures that involve products whose cost exceeds a threshold amount (i.e., high cost products) and another bundled payment for procedures that involve low cost products below that designated threshold (i.e., low cost payments). Bundled payment rates are modified annually based on modifications to the threshold amounts and geographic adjustments.

 

In any case, these bundled payments are limited by dollar amount and may not cover the cost of our products used in a given surgical procedure. Moreover, coverage decisions are at the discretion of the Medicare contractors. As a result, we cannot be certain that the procedures performed with our products will be reimbursed at a cost-effective level or reimbursed at all.

 

Some third-party payors in the United States, including certain Medicare contractors and private health insurance companies, have developed policies that deny coverage for our products when used as wound care treatment for certain clinical indications such as lower extremity ulcers in a hospital outpatient facility, ambulatory surgery center or physician office. To support changes in these policies and expanded coverage, we may need to conduct prospective, randomized controlled clinical trials and present data from such trials to payors to demonstrate the medical necessity or cost effectiveness of our products for these indications.

 

While we are devoting considerable resources to such post-market clinical trials to support such additional coverage and reimbursement, there can be no assurance that coverage for our products will be expanded. In addition, those private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures performed with our products, though we cannot predict whether coverage will be sufficient or if there will be coverage at all. Failure to obtain favorable payor policies could have a material adverse effect on our business and operations.

 

Furthermore, the healthcare industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot be certain that the procedures performed with our products will be reimbursed at cost-effective levels. Nor can we be certain that third-party payors using a methodology that sets amounts based on the type of procedure performed, such as those utilized by Medicare and in many privately managed care systems, will view the cost of our products to be justified so as to incorporate such costs into the overall cost of the procedure. Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors in the future.

 

To the extent we sell our products internationally, market acceptance may depend, in part, upon the availability of coverage and reimbursement within prevailing healthcare payment systems. Reimbursement and healthcare payment systems in international markets vary significantly by country, and include both government-sponsored healthcare and private insurance. We may not obtain international coverage and reimbursement approvals in a timely manner, if at all. Our failure to receive such approvals would negatively impact market acceptance of our products in the international markets in which those approvals are sought.

 

Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business, results of operations and 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 create new companies with greater market 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 from important market segments as GPOs, independent delivery networks and large single accounts continue to use their market power to consolidate purchasing decisions for some of our customers. 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 could adversely impact our business, results of operations and financial condition.

 

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We have no experience selling, marketing or distributing products and currently have no internal marketing and sales force. If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.

 

We currently have no sales, marketing or distribution capabilities and have no experience as a company in the sale or marketing of pharmaceutical products. There can be no assurance that we will be able to market and sell our products in the United States or overseas. In order to commercialize any product candidates, we must build on a territory-by-territory basis marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. Therefore, with respect to the commercialization of all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If so, our success will depend, in part, on our ability to enter into and maintain collaborative relationships for such capabilities, such collaborators’ strategic interest in the products under development and such collaborators’ ability to successfully market and sell any such products.

 

If we are unable to enter into such arrangements when needed on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations. Further, to the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful.

 

To the extent that we decide not to, or are unable to, enter into collaborative arrangements with respect to the sales and marketing of our products, we may in the future need to establish an internal sales and marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates, which could be expensive, time-consuming and requiring significant attention of our executive officers to manage. Further, we may not have sufficient resources to allocate to the sales and marketing of our products.

 

Any failure or delay in the development of sales, marketing and distribution capabilities, through collaboration with one or more third parties or through internal efforts, would adversely impact the commercialization of any of our products that we obtain approval to market. As a result, our future product revenue will suffer and we may incur significant additional losses.

 

Risks Related to Government Regulation

 

The FDA regulatory approval and clearance processes are lengthy, time-consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval or clearance, if any, of our product candidates.

 

Before a new medical device or a new intended use for an existing product can be marketed in the United States, a company must first submit and receive either 510(k) clearance or premarketing approval from the FDA, unless an exemption applies. The typical duration to receive a 510(k) approval is approximately nine to twelve months from the date of the initial 510(k) submission and the typical duration to receive a PMA approval is approximately two years from the date of submission of the initial PMA application, although there is no guarantee that the timing will not be longer.

 

Surgical adhesives are classified in different categories depending on their clinical applications. Surgical adhesives intended for topical skin indications have been classified as Class I devices if they are intended as skin protectants and have been classified as Class II devices if they are intended to be used as tissue adhesive for the topical approximation of skin. As such our BondEase device was classified by the FDA as a Class II device as it is intended to be used as tissue adhesive for the topical approximation of skin. We believe that our TearRepair device will be classified as a Class I device as it is intended to be used as a skin protectant. Both our BondEase modified product and our TearRepair product will require a 510(k) clearance prior to marketing. In some instances, the 510(k) pathway for product marketing may be used with only proof of substantial equivalence in technology for a given indication with a lawfully marketed device (a “predicate device”). In other instances, the FDA may require additional human clinical trials to prove efficacy in addition to technological equivalence and basic safety. Whether human clinical trial data is provided or not, the FDA may decide to reject the substantial equivalence argument we present. If that happens, our device would be automatically designated as a Class III device and we would have to fulfill the more rigorous PMA requirements, or request a “de novo” reclassification of the device into Class I or II. Thus, although at this time we do not anticipate that we will be required to do so, it is possible that one or more of our planned products may require PMA approval or de novo reclassification.

 

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Surgical adhesives for internal applications are classified as Class III devices and will be required to be approved via the PMA approval process.

 

The FDA has designated tissue adhesives as Class III devices except for specific indications such as the closure of topical approximation of skin for surgical incisions, including laparoscopic incisions and simple traumatic lacerations that have easily approximated skin edges. As such, surgical adhesives for internal applications are classified as Class III devices and will be required to be approved via the PMA approval process. However, although the regulatory pathway in the U.S. for approval of the product for the treatment of chronic wounds that we are currently developing appears to be classified as a Class III device, we intend to request that the FDA grant a de novo classification request for the use of our surgical adhesive for chronic wounds indications which are topical wounds. In the United States, before we can market a new medical device, or a new use of, certain new claims for, or significant modifications to an existing product, we must first receive either clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA, de novo classification under Section 513(f) (2) of the FDCA, or approval of a PMA 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 (pre-amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-classified, a device that was de novo classified under section 513(f)(2) of the FDCA, 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 demonstrations. The de novo classification process for the use of our surgical adhesive for the treatment of chronic wounds may provide a pathway if we could demonstrate that our adhesive would provide reasonable assurance of safety and effectiveness for the treatment of chronic wounds, even though there are no legally marketed predicate devices for the use of topical of surgical adhesive for the treatment of chronic wounds. A de novo classification is a risk-based classification process through which devices are classified into Class I or Class II. Devices classified in response to a de novo classification request may be marketed and used as predicates for future premarket notification 510(k) submissions. However, if the FDA does not grant the chronic wound indication for our surgical adhesive a de novo classification, we will be required to file for approval via the PMA process where 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, preclinical, 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.

 

However, it is possible that the FDA will require us to file for approval via the PMA pathway for one or more of our planned products. In this case, the FDA is likely to require that randomized, controlled clinical trials be conducted before an application for approval can be filed. These are typically expensive and time consuming, and require substantial commitment of financial and personnel resources from the sponsoring company. These trials also entail significant risk, and the data that results may not be sufficient to support approval by the FDA or other regulatory bodies.

 

Furthermore, regulatory approval of a PMA or a 510(k) pathway is not guaranteed, and the filing and approval process itself is expensive and may take several years. The FDA also has substantial discretion in the approval and clearance process. Despite the time and expense exerted, failure may occur at any stage, and we could encounter problems that cause us to abandon or repeat clinical studies. The FDA can delay, limit, or deny approval of a future product for many reasons, including but not limited to:

 

  a future product may not be deemed to be safe and effective;
     
  FDA officials may not find the data from clinical and preclinical studies sufficient;
     
  the FDA may not approve our or our third-party manufacturer’s processes or facilities; or
     
  the FDA may change its approval policies or adopt new regulations.

 

If any products we may develop fail to demonstrate safety and efficacy in further clinical studies that may be required, or do not gain regulatory approval or clearance, our business and results of operations will be materially and adversely harmed.

 

Obtaining and maintaining regulatory approval or clearance of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

 

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval or clearance of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

 

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Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

 

Even if we receive regulatory approval or clearance of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

 

If our product candidates are approved or cleared, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

 

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, and comparable foreign regulatory authority, requirements, including ensuring that quality control and manufacturing procedures conform to current cGMP regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any 510(k), PMA, or other marketing application, and previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

 

Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS program as a condition of approval of our product candidates, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, we will have to comply with requirements including submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs, and cGCPs for any clinical trials that we conduct post-approval.

 

Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following among other things:

 

  restrictions on the manufacturing of the product, the approved manufacturers or the manufacturing process;
     
  restrictions on the labeling or marketing of a product;
     
  restrictions on product distribution or use;
     
  requirements to conduct post-marketing studies or clinical trials;
     
  withdrawal of the product from the market;
     
  product recalls;
     
  warning or untitled letters from the FDA or comparable notice of violations from foreign regulatory authorities;
     
  refusal of the FDA or other applicable regulatory authority to approve pending applications;
     
  supplements to approved applications;
     
  fines, restitution or disgorgement of profits or revenues;
     
  suspension or withdrawal of marketing approvals;
     
  suspension of any of our ongoing clinical trials;
     
  product seizure or detention or refusal to permit the import or export of products; and
     
  consent decrees, injunctions or the imposition of civil or criminal penalties.

 

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The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs and devices may be promoted only for the approved or cleared indications and in accordance with the provisions of the label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

 

Non-compliance with European Union (EU) requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply with the EU’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

 

The policies of the FDA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval or clearance of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval or clearance that we may have obtained and we may not achieve or sustain profitability.

 

Even if we obtain regulatory approval or clearance of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community.

 

Our products may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, and others in the medical community. Several factors will influence whether our product candidates are accepted in the market, including:

 

  the clinical indications for which our product candidates are approved;
     
  physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;
     
  the potential and perceived advantages of our product candidates over alternative treatments;
     
  the prevalence and severity of any side effects;
     
  any restrictions on concomitant us of other medications;
     
  product labeling or product insert requirements of the FDA or other regulatory authorities;
     
  limitations or warnings contained in the labeling approved by the FDA;
     
  the size of the market for such candidate, based on the size of the patient subsets that we are targeting, in their territories for which we gain regulatory approval and have commercial rights;
     
  the safety of the candidate as demonstrated through broad commercial rights;
     
  the adequacy of supply of our product candidates;
     
  the timing of market introduction of our product candidates as well as competitive products;
     
  the cost of treatment in relation to alternative treatments;
     
  the amount of upfront costs or training required for physicians to administer our product candidates;
     
  the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities;

 

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  the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities;
     
  support from patient advocacy groups;
     
  relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and
     
  the effectiveness of our sales and marketing efforts.

 

Our ability to negotiate, secure and maintain third-party coverage and reimbursement for our product candidates may be affected by political, economic and regulatory developments in the United States, the EU and other jurisdictions. Governments continue to impose cost containment measures, and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. These and other similar developments could significantly limit the degree of market acceptance of any product candidate of ours that receives marketing approval in the future.

 

Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.

 

We are and will be subject to stringent privacy laws, cybersecurity laws, regulations, policies and contractual obligations related to privacy and security, and changes in such laws, regulations, policies or how they are interpreted or changes in related contractual obligations could adversely affect our business.

 

We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, processing, storage and use of personally-identifying information including comprehensive regulatory systems in the U.S. and EU, which, among other things, impose certain requirements relating to the privacy, security and transmission of personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. Failure to comply with any of these laws and regulations by us or third parties to whom we contract certain types of work (like clinical trials) could result in enforcement action against us or such third parties, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

 

There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information. In particular, regulations promulgated pursuant to the US federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, establish privacy and security standards that limit the use and disclosure of individually identifiable health information and require the implementation of administrative, physical and technological safeguards to protect the privacy of PHI and ensure the confidentiality, integrity and availability of electronic PHI. Determining whether PHI has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.

 

If we are unable to properly protect the privacy and security of PHI or other personal, sensitive, or confidential information in our possession, we could be found to have breached our contracts. Further, if we fail to comply with applicable privacy laws, including applicable HIPAA privacy and security standards, we could face significant administrative, civil and criminal penalties. Enforcement activity can also result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal and outside resources. In addition, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents. In addition to the risks associated with enforcement activities and potential contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to our policies, procedures and systems.

 

In the EU, we may be subject to the General Data Protection Regulation (GDPR) which went into effect in May 2018 and imposes obligations on companies that operate in our industry with respect to the processing of personal data and the cross-border transfer of such data. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and policies. If our or our partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.

 

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The GDPR may also impose additional compliance obligations relating to the transfer of data between us and our subsidiaries or other business partners. For example, the European Court of Justice recently invalidated the EU-U.S. Privacy Shield as a basis for transfers of personal data from the EU to the U.S. and raised questions about the continued validity of one of the primary alternatives to the EU-U.S. Privacy Shield, namely the European Commission’s Standard Contractual Clauses. Some customers or other service providers may respond to these evolving laws and regulations by asking us to make certain privacy or data-related contractual commitments that we are unable or unwilling to make. This could lead to the loss of current or prospective customers or other business relationships.

 

While we continue to address the implications of the recent changes to EU data privacy regulations, data privacy remains an evolving landscape at both the domestic and international level, with new regulations coming into effect and continued legal challenges, and our efforts to comply with the evolving data protection rules may be unsuccessful. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices. We must devote significant resources to understanding and complying with this changing landscape. Failure to comply with laws regarding data protection would expose us to risk of enforcement actions taken by data protection authorities in the EU and elsewhere and carries with it the potential for significant penalties if we are found to be non-compliant. Similarly, failure to comply with federal and state laws in the United States regarding privacy and security of personal information could expose us to penalties under such laws. Any such failure to comply with data protection and privacy laws could result in government-imposed fines or orders requiring that we change our practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect our business. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects.

 

Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.

 

Successful sales of our product candidates, if approved, depend on the availability of adequate coverage and reimbursement from third-party payors. In addition, because our product candidates represent new approaches to treat cancer and other immune-related diseases, we cannot accurately estimate the potential revenue from our product candidates.

 

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance.

 

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs, devices, and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

  a covered benefit under its health plan;
     
  safe, effective and medically necessary;
     
  appropriate for the specific patient;
     
  cost-effective; and
     
  neither experimental nor investigational.

 

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our products. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our product candidates. Because our product candidates have a higher cost of goods than conventional therapies, and may require long-term follow up evaluations, the risk that coverage and reimbursement rates may be inadequate for us to achieve profitability may be greater.

 

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We intend to seek approval or clearance, as applicable, to market our product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for our product candidates and may be affected by existing and future health care reform measures.

 

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

 

We are exposed to the risk of fraud, misconduct or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with applicable laws and regulations of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. If we obtain FDA approval or clearance of any of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent 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, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials, which could result in significant regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other parties, and the precautions we take to detect and prevent this activity 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 significant fines or other sanctions.

 

Our relationships with prescribers, purchasers, third-party payors and patients will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

 

Although we do not currently have any products on the market, upon commercialization of our device candidates, if approved or cleared, we will be subject to additional health care statutory and regulatory requirements and oversight by federal and state governments in the United States as well as foreign governments in the jurisdictions in which we conduct our business. Physicians, other health care providers and third-party payors will play a primary role in the recommendation, prescription and use of any product candidates for which we obtain marketing approval. Our future arrangements with such third parties may expose us to broadly applicable fraud and abuse and other health care laws and regulations that may constrain our business or financial arrangements and relationships through which we market, sell and distribute any products for which we may obtain marketing approval. Restrictions under applicable domestic and foreign health care laws and regulations include, but are not limited to, the following:

 

  the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, 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 a federal health care program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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  US federal false claims, false statements and civil monetary penalties laws, including the US False Claims Act, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; actions may be brought by the government or a whistleblower and may include an assertion that a claim for payment by federal health care programs for items and services which results from a violation of the federal Anti-Kickback Statue constitutes a false or fraudulent claim for purposes of the False Claims Act;
     
  Federal health care statutes, including 18 U.S.C. § 1347, impose criminal and civil liability for executing a scheme to defraud any health care benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
     
  analogous state and foreign laws and regulations relating to health care fraud and abuse, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving health care items or services reimbursed by non-governmental third-party payors, including private insurers;
     
  the Foreign Corrupt Practices Act and other anti-corruption laws and regulations pertaining to our financial relationships and interactions with foreign government officials;
     
  the US federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act,” which requires manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS, information related to physician payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as the ownership and investment interests of physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year;
     
  analogous state and foreign laws that require pharmaceutical companies to track, report and disclose to the government and/or the public information related to payments, gifts, and other transfers of value or remuneration to physicians and other health care providers, marketing activities or expenditures, or product pricing or transparency information, or that require pharmaceutical companies to implement compliance programs that meet certain standards or to restrict or limit interactions between pharmaceutical manufacturers and members of the health care industry;
     
  the US federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under federal health care programs;
     
  HIPAA, which imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses and their business associates that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and
     
  state and foreign laws that govern the privacy and security of health information in certain circumstances, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

 

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act (“ACA”), among other things, amends the intent requirement of the federal Anti-Kickback and criminal healthcare fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation. Moreover, the ACA provides that 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.

 

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Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and 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 significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, 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. In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. If any of the physicians or other health care providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from federal health care programs.

 

Risks Related to Intellectual Property

 

We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our products or product candidates.

 

We anticipate that we will file additional patent applications both in the United States and in other countries, as appropriate. However, we cannot predict:

 

  if and when any patents will issue;
     
  the degree and range of protection any issued patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;
     
  whether others will apply for or obtain patents claiming aspects similar to those covered by our patents and patent applications; or
     
  whether we will need to initiate litigation or administrative proceedings to defend our patent rights, which may be costly whether we win or lose.

 

Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.

 

In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce, and any other elements of our product discovery and development processes that involve proprietary know-how, information, or technology that is not covered by patents. Trade secrets, however, may be difficult to protect. We seek to protect our proprietary processes, in part, by entering into confidentiality agreements with our employees, consultants, outside scientific advisors, contractors, and collaborators. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, outside scientific advisors, contractors, and collaborators might intentionally or inadvertently disclose our trade secret information to competitors. In addition, competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, or misappropriation of our intellectual property by third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.

 

Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery and development efforts.

 

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the U.S. Patent and Trademark Office (“USPTO”) or oppositions and other comparable proceedings in foreign jurisdictions. Recently, due to changes in U.S. law referred to as patent reform, procedures including inter parties review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of challenge to our patents in the future.

 

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Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our product candidates. As the biotechnology and medical device industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.

 

We may not be able to protect our intellectual property rights throughout the world.

 

Filing, prosecuting, maintaining and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can have a different scope and strength than do those in the United States. To date, in addition to the United States, we have filed patent applications in Brazil, Canada, China, Europe (via European Patent Office, or EPO), and India; however, these applications and resulting patents were allowed to lapse due to the reallocation of financial resources and, as such, we have no applications pending in foreign countries. In addition, the laws of some foreign countries, such as China, Brazil, Russia, and India, do not protect intellectual property rights to the same extent as federal and state 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 against importation of infringing products is challenging or legal remedies are insufficient. These products may compete with our products and our patents or other intellectual property rights may not be effective or adequate to prevent them from competing.

 

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult in those jurisdictions for us to stop the infringement or misappropriation of our patents or other intellectual property rights, or the marketing of competing products in violation of our proprietary rights. Proceedings to enforce our patent and other intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Furthermore, such proceedings could put our patents at risk of being invalidated, held unenforceable, or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims of infringement or misappropriation 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 or license.

 

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

 

Competitors may infringe our patents or the patents of our licensors. To cease such infringement or unauthorized use, we may be required to file patent infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding or a declaratory judgment action against us, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceeding could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

 

Interference or derivation proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to, or the correct inventorship of, our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and 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. Litigation, interference, or derivation proceedings may result in a decision adverse to our interests and, even if we are 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. In addition, there could 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 substantial adverse effect on the price of our common stock.

 

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Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign authority.

 

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. 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, inter parties review, post-grant review, and equivalent proceedings in foreign jurisdictions, such as opposition or derivation proceedings. Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity of our patents, for example, we cannot be certain that there is no invalidating prior art of which we, our patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business.

 

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

 

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves, both technological and legal complexity, and is therefore costly, time-consuming, and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, 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 and patents that we might obtain in the future. For example, in, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to naturally-occurring substances are not patentable. Although we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents.

 

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

 

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. Although we have not used such confidential and proprietary information in developing our product candidates and technology platform, we may be subject to claims that we or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

 

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

 

Although we are not currently experiencing any claims challenging the inventorship of our patents or ownership of our intellectual property, we may in the future be subject to claims that former employees, collaborators, or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. 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.

 

Risks Relating to Ownership of Our Common Stock

 

There is no existing market for our common stock and an active, liquid trading market for our common stock may not develop following this offering.

 

Prior to this offering, there has been no public market for our common stock. We have applied to have our common stock listed on the Nasdaq Capital Market. However, there can be no assurances that our listing application will be approved, or even if approved, that an active trading market for our common stock will develop or be sustained. If an active market for our common stock does not continue to develop or is not sustained, it may be difficult for investors to sell their shares of our common stock without depressing the market price and investors may not be able to sell their shares at all. An inactive market may also impair our ability to raise capital by selling our securities and may impair our ability to acquire other businesses, applications, or technologies using our securities as consideration, which, in turn, could materially adversely affect our business and the market price of your shares of our common stock.

 

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The market price of our common stock may be highly volatile, and you may not be able to resell your shares at or above the initial public offering price.

 

If our listing application is approved, the market price of our common stock following this offering is likely to be highly volatile, may be higher or lower than the initial public offering price and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. These fluctuations could cause you to lose all or part of your investment in our common stock since you might be unable to sell your shares at or above the price you paid in this offering. The following factors, in addition to other factors described in this “Risk Factors” section and included elsewhere in this prospectus, may have a significant impact on the market price of our common stock:

 

  our operating and financial performance, quarterly or annual earnings relative to similar companies;
     
  publication of research reports or news stories about us, our competitors or our industry, or positive or negative recommendations or withdrawal of research coverage by securities analysts;
     
  the public’s reaction to our press releases, our other public announcements and our filings with the SEC;
     
  announcements by us or our competitors of acquisitions, business plans or commercial relationships;
     
  any major change in our board of directors or senior management;
     
  additional sales of our common stock by us, our directors, executive officers or principal stockholders;
     
  adverse market reaction to any indebtedness we may incur or securities we may issue in the future;
     
  short sales, hedging and other derivative transactions in our common stock;
     
  exposure to capital market risks related to changes in interest rates, realized investment losses, credit spreads, equity prices, and foreign exchange rates;
     
  our creditworthiness, financial condition, performance, and prospects;
     
  our dividend policy and whether dividends on our common stock have been, and are likely to be, declared and paid from time to time;
     
  perceptions of the investment opportunity associated with our common stock relative to other investment alternatives;
     
  regulatory or legal developments;
     
  changes in general market, economic, and political conditions;
     
  conditions or trends in our industry, geographies or customers;
     
  changes in accounting standards, policies, guidance, interpretations or principles; and
     
  threatened or actual litigation or government investigations.

 

In addition, broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance, and factors beyond our control may cause our stock price to decline rapidly and unexpectedly. In addition, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Litigation of this type could result in substantial costs and diversion of management’s attention and resources, which could have a material adverse effect on our business, financial condition, results of operations or prospects. Any adverse determination in litigation could also subject us to significant liabilities.

 

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Investors purchasing common stock in this offering will experience immediate and substantial dilution as a result of this offering and any future equity issuances.

 

The initial public offering price of our common stock will be substantially higher than the pro forma net tangible book value per share of our outstanding common stock (after giving effect to the Preferred Stock Conversion and Note Conversion) prior to completion of this offering. Accordingly, if you purchase our common stock in this offering, you will pay substantially more for your shares than the amounts paid by our existing stockholders for their shares and you will suffer immediate dilution of approximately $         per share in pro forma net tangible book value of our common stock. In addition, if the underwriters exercise their Over-Allotment Option to purchase additional shares from us, or if we issue additional equity securities in the future, investors purchasing shares of common stock in this offering will experience additional dilution. See “Dilution.”

 

We have broad discretion over the use of the net proceeds from this offering and it is possible that we will not use them effectively.

 

We cannot specify with any certainty the particular uses of the net proceeds that we will receive from this offering. Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these proceeds effectively could adversely affect our business, results of operations and financial condition. Pending their use, we may invest our proceeds in a manner that does not produce income or that loses value. Our investments may not yield a favorable return to our investors and may negatively impact the price of our common stock.

 

Our executive officers and directors, and their affiliated entities, own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

 

Upon consummation of this offering (based on shares outstanding as of            , 2022), our executive officers and directors, together with entities affiliated with such individuals, will beneficially own approximately           % of our common stock (approximately           % if the underwriters’ Over-Allotment Option is exercised in full). Accordingly, these stockholders may, as a practical matter, continue to be able to exert substantial control of the Company after this offering. This concentration of ownership could delay or prevent a change in control of the Company.

 

There can be no assurances that our shares once listed on Nasdaq will not be subject to potential delisting if we do not continue to maintain the listing requirements of Nasdaq.

 

We have applied to list our shares of common stock on Nasdaq under the symbol “OMED.” Nasdaq has rules for continued listing, including, without limitation, minimum market capitalization and other requirements. Failure to maintain our listing (i.e., being de-listed from Nasdaq), would make it more difficult for stockholders to sell our common stock and more difficult to obtain accurate price quotations on our common stock. This could have an adverse effect on the price of our common stock. Our ability to issue additional securities for financing or other purposes, or otherwise to arrange for any financing we may need in the future, may also be materially and adversely affected if our common stock is not traded on a national securities exchange.

 

If we cannot satisfy, or continue to satisfy, the initial listing requirements and other rules of Nasdaq, our securities may not be listed or may be delisted, which could negatively impact the price of our securities and your ability to sell them.

 

Even if our securities are listed on Nasdaq, we cannot assure you that our securities will continue to be listed on Nasdaq.

 

In addition, following this offering, in order to maintain our listing on Nasdaq, we will be required to comply with certain rules of Nasdaq, including those regarding minimum stockholders’ equity, minimum share price, minimum market value of publicly held shares, and various additional requirements. Even if we initially meet the listing requirements and other applicable rules of Nasdaq, we may not be able to continue to satisfy these requirements and applicable rules. If we are unable to satisfy Nasdaq criteria for maintaining our listing, our securities could be subject to delisting.

 

If Nasdaq does not list our securities, or subsequently delists our securities from trading, we could face significant consequences, including:

 

  a limited availability for market quotations for our securities;
     
  reduced liquidity with respect to our securities;

 

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  a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our common stock;
     
  limited amount of news and analyst coverage; and
     
  a decreased ability to issue additional securities or obtain additional financing in the future.

 

We have agreed to indemnify our officers and directors against lawsuits to the fullest extent of the law.

 

Delaware law permits the indemnification of officers and directors against expenses incurred in successfully defending against a claim. Delaware law also authorizes Delaware corporations to indemnify their officers and directors against expenses and liabilities incurred because of their being or having been an officer or director. Our organizational documents provide for this indemnification to the fullest extent permitted by Delaware law.

 

Prior to, and in no event not later than, the closing of the offering, we will obtain director and officer liability insurance to cover liabilities our directors and officers may incur in connection with their services to us. There is no guarantee that such insurance coverage will protect us from any damages or loss claims filed against it.

 

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the Company pursuant to provisions of the laws of the State of Delaware, the Company has been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

 

Some provisions of Delaware law and our amended and restated certificate of incorporation (“Certificate of Incorporation”) and amended and restated bylaws (“Bylaws”) that will be in effect immediately prior to the completion of this offering may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.

 

Our Certificate of Incorporation and our Bylaws contain provisions that could delay or prevent a change of control of our Company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:

 

  a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors, by our President, by the Chairman of our board of directors, or by stockholders holding at least a majority of the outstanding shares of our common stock;
     
  the Court of Chancery of the State of Delaware (or, if the Court of Chancery lacks jurisdiction, the federal district court for the District of Delaware unless said court lacks subject matter jurisdiction in which case the Superior Court of the State of Delaware) is designated as the exclusive forum for the resolution of claims involving the Company; and
     
  the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock.

 

In addition, Section 203 of the Delaware General Corporate Law, or DGCL, may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These antitakeover provisions and other provisions in our Certificate of Incorporation and Bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our Company. These provisions could discourage, delay or prevent a transaction involving a change in control of our Company. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and cause us to take corporate actions other than those you desire. See “Description of Capital Stock.”

 

Taking advantage of the reduced disclosure requirements applicable to “emerging growth companies” may make our common stock less attractive to investors.

 

The JOBS Act provides that, so long as a company qualifies as an “emerging growth company,” it will, among other things:

 

  be required to present only two years of audited financial statements and related management’s discussion and analysis of financial condition and results of operations in a registration statement for its initial public offering;
     
  be exempt from compliance with the requirement that its independent registered public accounting firm provide an attestation report on the effectiveness of its internal control over financial reporting;

 

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  be exempt from compliance with any requirement that the PCAOB may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
     
  be exempt from the “say on pay,” “say when on pay,” and “say on golden parachute” non-binding advisory vote requirements; and
     
  be exempt from certain disclosure requirements of the Dodd-Frank Wall Street Reform and Consumer Protection Act relating to compensation of its executive officers and be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act.

 

We currently intend to take advantage of each of the exemptions described above. We could be an emerging growth company for up to five years after this offering. We cannot predict if investors will find our common stock less attractive if we elect to rely on these exemptions, or if taking advantage of these exemptions would result in less active trading or more volatility in the price of our common stock.

 

Further, because we have elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act, we may delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates.

 

Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.

 

Because of the exemptions from various reporting requirements provided to us as an “emerging growth company” and because we will have an extended transition period for complying with new or revised financial accounting standards, we may be less attractive to investors, and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry. If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

 

Failure to establish and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price.

 

We are not currently required to comply with the rules of the SEC implementing Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) and are, therefore, not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. Upon becoming a public company, we will be required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which will require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting. Although we will be required to disclose changes made in our internal controls and procedures on a quarterly basis, we will not be required to make our first annual assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act (“Section 404”) until the year following our first annual report required to be filed with the SEC. As an emerging growth company, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until the later of (i) the year following our first annual report required to be filed with the SEC or (ii) the date we are no longer an emerging growth company. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed or operating.

 

As a private company, we do not currently have any internal audit function. To comply with the requirements of being a public company, we have undertaken various actions, and will need to take additional actions, such as implementing numerous internal controls and procedures and hiring additional accounting or internal audit staff or consultants. Testing and maintaining internal control can divert our management’s attention from other matters that are important to the operation of our business. Additionally, when evaluating our internal control over financial reporting, we may identify material weaknesses that we may not be able to remediate in time to meet the applicable deadline imposed upon us for compliance with the requirements of Section 404. If we identify any material weaknesses in our internal control over financial reporting or are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting once we are no longer an emerging growth company, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be negatively affected. We could also become subject to investigations by the SEC, the stock exchange on which our securities are listed or other regulatory authorities, which could require additional financial and management resources. In addition, if we fail to remedy any material weakness, our financial statements could be inaccurate and we could face restricted access to capital markets.

 

The requirements of being a public company, including compliance with the reporting requirements of the Exchange Act, the requirements of the Sarbanes-Oxley Act and the continuing listing standards of Nasdaq, may strain our resources, increase our costs, and divert management’s attention, and we may be unable to comply with these requirements in a timely or cost-effective manner. In addition, certain members of our management team have limited experience managing a public company.

 

As a public company, we will be subject to the reporting requirements of the Exchange Act, the requirements of the Sarbanes-Oxley Act, and the listing standards of the Nasdaq Capital Market. These requirements will place a strain on our management, systems and resources and we will incur significant legal, accounting, insurance and other expenses that we have not incurred as a private company. The Exchange Act will require us to file annual, quarterly and current reports with respect to our business and financial condition within specified time periods and to prepare a proxy statement with respect to our annual meeting of stockholders. The Sarbanes-Oxley Act will require that we maintain effective disclosure controls and procedures, and internal controls over financial reporting. The Nasdaq Capital Market will require that we comply with various corporate governance requirements. To maintain and improve the effectiveness of our disclosure controls and procedures and internal controls over financial reporting, and comply with the Exchange Act and Nasdaq Capital Market requirements, significant resources and management oversight will be required. This may divert management’s attention from other business concerns and lead to significant costs associated with compliance, which could have a material adverse effect on us and the price of our common stock.

 

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We expect these reporting and corporate governance rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. These laws and regulations could also make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors or its committees or as our executive officers. Advocacy efforts by stockholders and third parties may also prompt even more changes in governance and reporting requirements. We cannot predict or estimate the amount of additional costs we may incur or the timing of these costs. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions and other regulatory action, and potentially civil litigation.

 

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

 

If securities or industry analysts cease publishing research or reports about us, our business or our markets, or if they adversely change their recommendations or publish negative reports regarding our business or our stock, our stock price and trading volume could materially decline.

 

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our markets, or our competitors. We cannot provide any assurance that analysts will continue to cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our stock, or provide more favorable relative recommendations about our competitors, our stock price could materially decline. If any analyst who may cover us were to cease coverage of our Company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to materially decline.

 

Existing stockholders may sell significant quantities of common stock.

 

The existing stockholders will beneficially own approximately % of our common stock following the successful completion of this offering. Notwithstanding that certain officers and directors and 5% or more stockholders will be locked up for a period of 180 days following the completion of this offering, they may have acquired their shares at a lower price than that of this offering. Accordingly, they may be incentivized to sell all or part of their holdings as soon as any applicable transfer restrictions have ended and such sales could have a negative impact on the market price of our securities.

 

We currently do not intend to declare dividends on our common stock in the foreseeable future and, as a result, your returns on your investment may depend solely on the appreciation of our common stock.

 

We currently do not expect to declare any dividends on our common stock in the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future will be used to provide working capital, to support our operations and to finance the growth and development of our business. Any determination to declare or pay dividends in the future will be at the discretion of our board of directors, subject to applicable laws and dependent upon a number of factors, including our earnings, capital requirements and overall financial conditions. In addition, terms of any future debt or preferred securities may further restrict our ability to pay dividends on our common stock. Accordingly, your only opportunity to achieve a return on your investment in our common stock may be if the market price of our common stock appreciates and you sell your shares at a profit. The market price for our common stock may never exceed, and may fall below, the price that you pay for such common stock. See “Dividend Policy.”

 

IN ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT THE COMPANY’S BUSINESS OPERATIONS AND THE VALUE OF THE COMPANY’S SECURITIES.

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains 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. In particular, statements about the markets in which we operate, including growth of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this prospectus under the headings “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” are forward-looking statements.

 

We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this prospectus under the headings “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” may cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:

 

  our use of the net proceeds of this offering;
     
  our ability to obtain and maintain regulatory approval or clearance of our products;
     
  our ability to successfully commercialize and market our products, if and when approved;
     
  our ability to contract with third-party suppliers, manufacturers, and other service providers and their ability to perform adequately;
     
  the potential market size, opportunity, and growth potential for our products, if and when approved;
     
  our ability to obtain additional funding for our operations and development activities;
     
  the accuracy of our estimates regarding expenses, capital requirements, and needs for additional financing;
     
  the initiation, timing, progress, and results of our preclinical studies and clinical trials, and our research and development programs;
     
  the timing of anticipated regulatory filings;
     
  the timing of availability of data from our clinical trials;
     
  our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements;
     
  our ability to retain the continued service of our key professionals and to identify, hire, and retain additional qualified professionals;
     
  our ability to advance product candidates into, and successfully complete, clinical trials;
     
  our ability to recruit and enroll suitable patients in our clinical trials;
     
  the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;
     
  the pricing and reimbursement of our product candidates, if and when approved;
     
  the rate and degree of market acceptance of our product candidates, if and when approved;
     
  the implementation of our business model and strategic plans for our business, product candidates, and technology;
     
  the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
     
  developments relating to our competitors and our industry;
     
  the development of major public health concerns, including the ongoing COVID-19 pandemic or other pandemics arising globally, and the future impact of COVID-19 or other pandemics on our clinical trials, business operations, and funding requirements; and
     
  other risks and factors listed under “Risk Factors” and elsewhere in this prospectus.

 

Given the risks and uncertainties set forth in this prospectus, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this prospectus are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this prospectus. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this prospectus, they may not be predictive of results or developments in future periods.

 

Any forward-looking statement that we make in this prospectus speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this prospectus.

 

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USE OF PROCEEDS

 

The net proceeds to us from the sale of shares of common stock by us in this offering will be approximately $          , assuming an initial public offering price of $           per share (the midpoint of the range set forth on the cover of this prospectus), and after deducting underwriting discounts and commissions and estimated offering expenses.

 

The principal purposes of this offering are to fund our product development and marketing activities, increase our capitalization and financial flexibility, to create a public market for our common stock and to facilitate our future access to the capital markets, and for general corporate and working capital purposes. We intend to use the net proceeds from this offering as follows:

 

  approximately $      to $     to fund our development and marketing activities, including:

 

  approximately $       to $        to fund general research and development activities at our Synkotech laboratory which will allow us to obtain regulatory approval and clearance of each of our BondEase and TearRepair products and, upon such approval and clearance, initiate the commercial launch of such products;
     
  approximately $       to $        to fund several animal studies, including proof of concept studies, for our surgical adhesive for the treatment of chronic wounds, as well as the filing of an Investigational Device Exemption with the FDA to request approval to conduct human clinical trials; and
     
  approximately $       to $        to fund research and development activities to optimize the formulation of our surgical adhesive for internal clinical indications, perform biocompatibility testing to evaluate the product’s safety, and conduct animal studies to pursue development towards regulatory approval;

 

  approximately $       to $      to fund the expansion of our research and development and manufacturing facility to increase our manufacturing capacity from 40,000 tissue adhesive devices per month to more than 200,000 tissue adhesive devices per month;
     
  approximately $4.7 million to fund the repayment of the Senior Secured Loans;
     
  approximately $2.1 million to fund the repayment of other indebtedness; and
     
  the remaining amounts to fund working capital and general corporate purposes.

 

Based on our current operating plan, we believe that the net proceeds of this offering, together with our existing cash and cash equivalents, will be sufficient to fund our development and marketing activities and the planned expansion of our research and development facility through at least the         quarter of 2023.

 

The Senior Secured Loans to be paid with the proceeds of this offering had an original maturity date of July 1, 2018, but the Senior Lenders have agreed to forbear from exercising any default-related rights and remedies against us until the earliest of: (i) September 30, 2022 and (ii) the date on which we complete this offering. If we do not expect to this offering by September 30, 2022, we will need to seek a further forbearance through the date on which we actually complete this offering, and there is no assurance that we will successfully obtain such forbearance. The interest rate of the Senior Secured Loans is 12% per annum.

 

The remaining indebtedness to be satisfied using a portion of the proceeds from this offering have already matured but have not been repaid. Such remaining portion includes approximately $313 thousand to be repaid to Sterm Group, an entity formed by certain of our officers and directors, in satisfaction of a credit line extended by them, and approximately $1.7 million to satisfy other indebtedness under certain promissory notes. The interest rates of the remaining indebtedness range from 5% to 15%. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources — Sources of Liquidity” for a complete discussion of the Senior Secured Loans and remaining indebtedness that we plan to satisfy with a portion of the use of proceeds from this offering.

 

Pending the use of proceeds from this offering as described above, we plan to invest the net proceeds that we receive in this offering in short-term and intermediate-term interest-bearing obligations, investment-grade investments, certificates of deposit or direct or guaranteed obligations of the U.S. government. Our management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of our management regarding the application of the proceeds.

 

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 underwriting discounts and commissions and estimated offering expenses payable by us. Each increase (decrease) of 500,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by $        million, assuming the assumed initial public offering price stays the same.

 

As of the date of this prospectus, we cannot specify with certainty the particular uses of the net proceeds that we will receive from this offering or the amounts we actually spend on the uses set forth above. The use of proceeds represents management’s estimates based upon current business and economic conditions. We reserve the right to use the net proceeds we receive in the offering in any manner we consider to be appropriate. Although we do not contemplate changes in the proposed use of proceeds, to the extent we find that adjustment is required for other uses by reason of existing business conditions, the use of proceeds may be adjusted. The actual use of proceeds of this offering could differ materially from those outlined above as a result of several factors including those set forth under “Risk Factors” and elsewhere in this prospectus.

 

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DIVIDEND POLICY

 

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, for use in the operation of our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future. The payment of dividends is within the discretion of our board of directors and will depend on our earnings, capital requirements, financial condition, prospects, applicable Delaware law, which provides that dividends are only payable out of surplus or current net profits, and other factors our board of directors might deem relevant. Investors should not purchase our common stock with the expectation of receiving cash dividends.

 

CAPITALIZATION

 

The following table sets forth our cash and cash equivalents, as well as our total capitalization, as of March 31, 2022:

 

  on an actual basis;
     
  on a pro forma basis, giving effect to the automatic conversion of all outstanding shares of preferred stock and convertible notes into an aggregate of           shares of common stock, which will occur immediately prior to the completion of this offering; and
     
  on a pro forma as adjusted basis, giving effect to the pro forma adjustments set forth above and the receipt of the estimated net proceeds from the sale and issuance by us of           shares of our common stock in this offering (assuming no exercise of the underwriters’ option to purchase additional shares of common stock from us) at an assumed initial public offering price of $            per share (the midpoint of the range set forth on the cover of this prospectus), and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

 

You should read this table together with our consolidated financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included elsewhere in this prospectus.

 

   As of March 31, 2022 
   Actual   Pro Forma   Pro Forma As Adjusted(1) 
(in thousands)   (unaudited)    (unaudited)    (unaudited) 
Cash and cash equivalents  $168,199   $   $ 
                
Stockholders’ deficit:               
Common stock, $0.0001 par value per share: 100,000,000 shares authorized; 42,276,340 and 42,276,340 issued and outstanding at March 31, 2022
   4,228           
Preferred stock Series A, $0.0001 par value per share; 6,000,000 shares authorized; 4,670,779 issued and outstanding at March 31, 2022 (no liquidation preference)
   467           
Preferred stock Series B, $0.0001 par value per share; 4,000,000 shares authorized; no shares issued and outstanding at March 31, 2022
   -           
Preferred stock Series BB-1, $0.0001 par value per share: 4,000,000 shares authorized; 3,841,512 issued and outstanding at March 31, 2022 (liquidation preference of $3,199,979)   384           
Preferred stock Series BB-2, $0.0001 par value per share 4,446,174 shares authorized; 4,446,174 issued and outstanding at March 31, 2022 (liquidation preference of $2,000,003)
   445           
Additional paid-in capital   30,933,590           
Accumulated deficit    (43,567,751)            
                
Total stockholders’ deficit   (12,628,637)          
                
Total capitalization  $        $ 

 

 

(1) A $1.00 increase or decrease in the assumed initial public offering price per share of our common stock would increase or decrease each of cash, additional paid-in-capital and total capitalization on a pro forma as adjusted basis by approximately $          , assuming the number of shares of our common stock offered by us remains the same and after deducting the estimated underwriting discounts and commissions and offering expenses payable by us.

 

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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 public offering price per share of our common stock and the pro forma net tangible book value per share of our common stock immediately after this offering. Dilution in pro forma net tangible book value per share to new investors represents the difference between the amount per share paid by purchasers of shares of our common stock in this offering and the pro forma net tangible book value per share of our common stock immediately after completion of this offering.

 

Net tangible book value per share is determined by dividing our total tangible assets less our total liabilities and common stock in stockholders’ equity (deficit) by the number of shares of our common stock outstanding. Our historical net tangible book value (deficit) as of March 31, 2022, was approximately $       , or $        per share. After giving effect to the sale by us of shares of our common stock in this offering at the assumed public offering price of $         per share, the midpoint of the price range per share, and after deducting underwriting discounts and commissions, and estimated offering expenses payable by us, our pro forma net tangible book value as of March 31, 2022, would have been $        million, or $        per share. This 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 investors purchasing shares of our common stock in this offering. The following table illustrates this dilution:

 

Public offering price per share of common stock       $ 
Historical net tangible book value (deficit) per share as of March 31, 2022  $       
Increase per share attributable to new investors purchasing shares of common stock in this offering          
Pro forma net tangible book value per share immediately after this offering          
Dilution in pro forma net tangible book value per share to new common stock investors in this offering       $  

 

The following table presents, on a pro forma basis as of March 31, 2022, after giving effect to the sale by us of shares of our common stock in this offering at the assumed offering price of $           per share, the difference between the directors, officers and their affiliates and the new investors purchasing shares of our common stock in this offering with respect to the number of shares of our common stock purchased from us, the total consideration paid or to be paid to us, and the average price per share paid or to be paid to us by such persons during the last five years and new investors, before deducting underwriting discounts and commissions and estimated offering expenses payable by us:

 

   Shares Purchased   Total Consideration   Average Price 
   Number   Percent   Amount   Percent   Per Share 
   ($ in millions) 
Directors, officers and their affiliates                             %  $                           %  $          
New investors        %         %    
Total        %  $     %    

 

If the underwriters exercise in full their option to purchase             additional shares of our common stock from us in this offering, the pro forma net tangible book value (deficit) per share after this offering would be $          per share and the dilution to new investors in this offering would be $         per share. If the underwriters exercise such option in full, the number of shares held by new investors will increase to approximately          shares of our common stock, or approximately          % of the total number of shares of our common stock outstanding after this offering.

 

A $1.00 increase (decrease) in the assumed public offering price of $         per share would increase (decrease) the as-adjusted net tangible book value per share by $        , and the dilution per share to new investors i