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As filed with the Securities and Exchange Commission on July 29, 2019
Registration No. 333-232615​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Amendment No. 1 to
FORM F-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
INMODE LTD.
(Exact name of registrant as specified in its charter)
Not Applicable
(Translation of Registrant’s name into English)
State of Israel
3845
Not Applicable
(State or other jurisdiction of
incorporation or organization)
(Primary Standard Industrial
Classification Code Number
(I.R.S. Employer
Identification No.)
Moshe Mizrahy
InMode Ltd.
Tavor Building, Sha’ar Yokneam
P.O. Box 533
Yokneam 2069206, Israel
Tel. +972-4-9096313
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Invasix Inc.
20996 Bake Parkway, Suite 106
Lake Forest, California 96230
Tel. +1-949-387-5711
(Name, address, including zip code and telephone number, including area code, of agent for service)
Copies to:
Anna T. Pinedo
Brian D. Hirshberg
Mayer Brown LLP
1221 Avenue of the Americas
New York, New York 10020-1001
Tel. (212) 506-2275
Fax (212) 849-5767
Galia Amir Cheyne
Sagi Omer
Primes, Shiloh, Givon, Meir
Law Firm
16 Derech Hayam
Haifa 34741, Israel
Tel. (972-4) 838-8332
Fax (972-4) 838-1401
Joshua G. Kiernan
Nathan Ajiashvili
Latham & Watkins LLP
885 Third Avenue
New York, New York 10022-4834
Tel. (212) 906-1200
Fax (212) 751-4864
Chaim Friedland
Ari Fried
Gornitzky & Co.
Zion House
45 Rothschild Blvd.
Tel Aviv 6578403, Israel
Tel. (972-3) 710-9191
Fax (972-3) 560-6555
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, 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 of 1933, as amended, check the following box and list the 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 of 1933, as amended, check the following box and list the 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 of 1933, as amended, check the following box and list the registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933, as amended. ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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 of 1933, as amended. ☒
CALCULATION OF REGISTRATION FEE
Title of each class of securities to be registered
Amount to be
Registered(1)
Proposed
Maximum Offering
Price Per Share
Proposed Maximum
Aggregate Offering
Price(2)
Amount of
Registration Fee(3)
Ordinary shares, par value NIS 0.01 per ordinary share
5,750,000 $ 16.00 $ 92,000,000 $ 11,150.40
(1)
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(a) under the Securities Act of 1933, as amended. Includes 750,000 ordinary shares that the underwriters have the option to purchase.
(2)
Includes the aggregate offering price of additional ordinary shares that the underwriters have an option to purchase.
(3)
$9,090.00 of this registration fee was previously paid by the Registrant in connection with the filing of its Registration Statement on Form F-1 on July 11, 2019.
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, as amended, or until the 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 contained in this preliminary prospectus is not complete and may be changed. This preliminary prospectus is not an offer to sell these securities, and we are not soliciting an offer to buy these securities in any jurisdiction where an offer or sale is not permitted.
Subject to Completion, dated July 29, 2019
PROSPECTUS
5,000,000 Shares
[MISSING IMAGE: lg_inmode.jpg]
InMode Ltd.
Ordinary Shares
This is our initial public offering of our ordinary shares. We are offering 5,000,000 of our ordinary shares. No public market currently exists for our ordinary shares. We currently expect the initial public offering price to be between $14.00 and $16.00 per ordinary share.
We have been approved to list our ordinary shares on The Nasdaq Global Select Market under the symbol ‘‘INMD,’’ subject to official notice of issuance.
We are an ‘‘emerging growth company’’ as defined under federal securities laws and, as such, may elect to comply with certain reduced public company reporting requirements.
Investing in our ordinary shares involves risks that are described in the “Risk Factors” section beginning on page14 of this prospectus.
Per Ordinary
Share
Total
Price to public
$ $
Underwriting discounts and commissions(1)
$ $
Proceeds to us (before expenses)
$ $
(1)
See ‘‘Underwriting’’ for a description of the compensation payable to the underwriters.
The underwriters may also exercise their option to purchase up to an additional 750,000 ordinary shares from us at the initial public offering price, less underwriting discounts and commissions, for 30 days after the date of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of the securities being offered by this prospectus, or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The underwriters expect to deliver the ordinary shares to purchasers on or about            , 2019.
Joint Book-Running Managers
Barclays
UBS Investment Bank​
Lead Manager
Canaccord Genuity
Co-Manager
Baird
Prospectus dated            , 2019

TABLE OF CONTENTS
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F-1
You should rely only on the information contained in this prospectus any amendment or supplement to this prospectus or in any free writing prospectus prepared by us or on our behalf. Neither we nor any of the underwriters have authorized anyone to provide you with different information. We are offering to sell, and seeking offers to buy, ordinary shares only in jurisdictions where offers and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our ordinary shares.
We own or have rights to trademarks, service marks or trade names that we use in connection with the operation of our business. In addition, our names, logos and website names and addresses are our service marks or trademarks. Other trademarks, service marks and trade names appearing in this prospectus are the property of their respective owners. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus are listed without the ©, ® and TM symbols, but we will assert, to the fullest extent under applicable law, our rights to these trademarks, service marks and trade names.
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PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. You should read the following summary together with the entire prospectus including our unaudited interim consolidated financial statements and audited consolidated financial statements and related notes appearing elsewhere in this prospectus. You should also consider carefully, among other matters, the matters we discuss in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” Unless otherwise indicated, all references in this prospectus to “InMode” or the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to InMode Ltd., together with its consolidated subsidiaries, and “dollar” or “$” refer to U.S. dollars. The terms “shekels” and “NIS” refer to New Israeli Shekels, the lawful currency of the State of Israel. Except as otherwise indicated, all share amounts, per share amounts and related information in this prospectus have been adjusted retroactively for a 1-for-1.789 stock split of our ordinary shares by way of an issuance of bonus shares, which we refer to as the “Stock Split,” that occurred pursuant to a resolution of our board of directors dated July 24, 2019. Unless otherwise indicated, the information in this prospectus assumes no exercise of the underwriters’ overallotment option.
Overview
We are a leading global provider of innovative, energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. Within the global aesthetics market, our products and solutions are primarily designed to address three energy-based treatment categories comprised of: (i) face and body contouring; (ii) medical aesthetics; and (iii) women’s health. We have developed and commercialized products utilizing medically-accepted radio frequency energy, or RF energy, technology, which can penetrate deep into the subdermal fat, allowing adipose tissue remodeling. We believe our RF energy-based proprietary technologies — (i) Radio Frequency Assisted Lipolysis, or RFAL, (ii) Deep Subdermal Fractional Radio Frequency, or Deep Subdermal Fractional RF, (iii) Simultaneous Fat Destruction and Skin Tightening and (iv) Deep Heating Collagen Remodeling — represent a paradigm shift in the minimally-invasive aesthetic solutions market. These technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including liposuction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Our products, developed with our proprietary RF energy-based technologies, overcome many of the shortcomings of other aesthetic options by delivering surgical-grade results while significantly minimizing risks of scarring, downtime, pain and other complications typically accompanying surgical procedures. In addition to our minimally-invasive solutions, we design, develop, manufacture and market differentiated, non-invasive medical aesthetic products that target a wide array of procedures. These include simultaneous fat killing and skin tightening, permanent hair reduction through the use of our innovative dual wavelength technology and other treatments targeting skin appearance and texture through the use of our high power intense pulsed light, or IPL, technology. Our products, which we market and sell traditionally to plastic and facial surgeons, aesthetic surgeons, dermatologists and aesthetic obstetricians/gynecologists, or OB/GYNs, or collectively, our traditional customer base, may be used on a variety of body parts including the face, neck, abdomen, upper arms, thighs and intimate feminine regions.
In addition to the existing group of patients who currently undergo full surgical aesthetic procedures, we believe our minimally-invasive solutions satisfy an unmet market demand in two incremental groups of patients: (i) those whose skin laxity or other physical attributes have previously prevented them from undergoing surgical aesthetic procedures and (ii) those who would entertain the idea of surgical or minimally-invasive aesthetic procedures, but are averse to the associated costs, downtime and potential safety risks. We believe these patient populations will continue to represent a significant opportunity for our differentiated minimally-invasive aesthetic solutions.
We believe our products have consistently been at the forefront of technological development in the aesthetic solutions market. Since 2010, we have launched six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. Each product consists of the following components: a platform that incorporates multiple energy sources, one or more handpieces, our proprietary software and a simple, user interface with touch screen. Our platforms have a small footprint and are lightweight compared to our
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competitors’ systems, which are typically larger and heavier. Our products can be upgraded easily by the user in order to perform additional treatments by adding handpieces to and/or installing software on the existing platforms. The ease of upgrades enables our customers to meet demand for aesthetic solutions through additional service offerings.
Our focus on innovation has resulted in a strong track record of sustained new and next-generation product development. We believe our ability to bring new products to market and continuously innovate is a distinct competitive advantage. We expect to launch three new product platforms by the end of 2019, all of which will be based on our existing RF energy-based proprietary technology, with the goal of further penetrating the market for surgical aesthetic and medical treatment solutions. Our three new product platforms are intended to address the treatment of cellulite appearance (CelluTite), body skin tightening (Evolve), and face and neck skin tightening (Evoke). Our CelluTite platform is comprised of three handpieces, each of which has been cleared by the U.S. Food and Drug Administration, or FDA, intended to address the treatment of cellulite appearance. Two of the handpieces are cleared for use in dermatological and general surgical procedures for electrocoagulation and hemostasis of tissues including fat, and the third handpiece has been cleared for use in treatments for the temporary reduction in the appearance of cellulite. We expect to introduce the CelluTite product platform to the market during the fourth quarter of 2019. The Evolve platform received FDA clearance in June 2019 and is expected to be introduced to the market during the second half of 2019. We submitted a premarket notification to the FDA pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act for our Evoke product platform in July 2019. Subject to receipt of FDA clearance, we intend to introduce Evoke to the market during the second half of 2019. The CelluTite, Evolve and Evoke product platforms are subject to the same FDA 510(k) clearance process as our current products.
In response to customers’ desires to enhance and expand their offering of our aesthetic and wellness office-based procedures, we are developing additional RF energy-based platforms, handpieces and applicators targeted towards several medical specialties.

For OB/GYNs, we currently sell the Votiva platform, which includes two handpieces, FormaV and Morpheus8. We are currently developing additional handpieces and applicators as part of this platform to assist with the following procedures:

non-incisional labiaplasty (a procedure to reshape the labia minora) using our AccuTite RFAL handpiece (Aviva); and

post-partum restoration of abdominal muscles and pelvic floor restoration using our external and internal electro-muscle stimulation, or EMS, handpieces.

For ophthalmologists, we are developing a new platform that, in addition to our existing aesthetic handpieces, we expect will assist with the following procedures:

lower and upper eyelid contraction and fat reduction using the AccuTite and Morpheus8 handpieces; and

treatment of periorbital wrinkles and dry eye with a new continuous bi-polar RF energy handpiece.
Our new handpiece to treat dry eye and periorbital wrinkles is currently in an in-office ex vivo preclinical evaluation. We expect to introduce our new product platform for ophthalmologists comprising of three handpieces (AccuTite, Morpheus8 and our new handpiece to treat dry eye and periorbital wrinkles) to the market during the second quarter of 2020.

For ear, nose and throat physicians, or ENTs, we are in the initial stage of developing a new platform and handpiece that we believe will provide patients with a medical treatment solution for snoring. The handpiece is based on our Deep Subdermal Fractional RF technology and is expected to contract and stiffen the soft palate (located on the back of the roof of the mouth), which blocks the airway, causing tissues to vibrate during sleep. This platform and handpiece are in the concept design phase.
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We are focused on establishing and using clinical evidence to support and broaden our marketing claims and drive customer awareness and acceptance of our products. Traditionally, the aesthetic solutions market has relied heavily on marketing efforts and “before-and-after” pictures in an attempt to distinguish products. We believe our focus on establishing clinical evidence for the efficacy of our products has been important for adoption by our surgically-trained customers, who are accustomed to seeing extensive clinical data in their non-aesthetic practices. To date, we have a portfolio of 44 peer-reviewed publications and a number of our products have been used in 36 completed third-party clinical studies and 18 ongoing third-party clinical studies. While we did not have any involvement in the clinical studies mentioned above, such studies provide qualitative results that we believe are meaningful. However, because these were third-party studies, we do not have access to any raw data to conduct any quantitative analyses.
To complement our surgical aesthetic and medical treatment solutions, we offer post-sales training and support services. We provide physicians with training focused on the most beneficial ways to utilize our products, including safety and instructional videos to expand procedural offerings and hands-on, personalized marketing support. We believe that we provide one of the most extensive training and ongoing support programs available to physicians throughout the aesthetic solutions market.
Our revenue increased to approximately $30.6 million for the three months ended March 31, 2019, from approximately $20.9 million for the three months ended March 31, 2018. Our revenue increased to approximately $100.2 million for the year ended December 31, 2018 from approximately $53.5 million for the year ended December 31, 2017. For the three months ended March 31, 2019 and 2018, we recorded a gross margin of approximately 86% and 83%, respectively, and net income of approximately $10.2 million and $6.4 million, respectively. For the years ended December 31, 2018 and 2017, we recorded a gross margin of approximately 85% and 83%, respectively, and net income of approximately $22.4 million and $8.8 million, respectively. We have 18 FDA clearances and, in addition to the United States, where we have over 2,400 customers, we are permitted to sell our products in Europe, Argentina, Australia, Brazil, Canada, China, Colombia, the Commonwealth of Independent States, Israel, Mexico, Panama, Philippines, Russia, South Korea, Taiwan and Thailand. As of June 30, 2019, we sell and market our products in the United States, the United Kingdom, Spain and India, through a direct sales force of approximately 96 representatives. We also sell and market our products through 37 distributors in 44 countries. As of June 30, 2019, we had a global installed base of over 3,900 product platforms capable of running various multi-use applicators and utilizing minimally-invasive consumables.
Industry
Overview
The global market for aesthetic solutions is significant and growing. The American Society for Aesthetic Plastic Surgery, or ASAPS, estimates that U.S. consumers spent more than $8.5 billion on a total of 7.8 million aesthetic procedures in 2017, of which $6.6 billion was spent on surgical aesthetic procedures. According to ASAPS, in 2017, total aesthetic procedures in the United States grew 6%, with surgical aesthetic procedure growth of 11% and non-surgical aesthetic procedure growth of 4%.
According to the 2017 International Society of Aesthetic Plastic Surgery, or ISAPS, Global Aesthetic Survey, which includes survey results from 35,000 plastic surgeons in the top 30 countries for aesthetic procedures, approximately 23.4 million total aesthetic procedures, including 10.8 million surgical procedures and 12.6 million non-surgical procedures, were performed globally in 2017. Of these total procedures, approximately 18%, or 4.3 million, were performed in the United States.
According to ISAPS, the top five surgical and minimally-invasive procedure categories globally in 2017, by number of procedures, that we provide innovative aesthetic solutions for were liposuction (1.6 million), eyelid surgery (1.3 million), abdominoplasty (0.8 million), face/neck lift (0.7 million) and women’s health (0.2 million). The top five non-invasive procedure categories globally in 2017 that we provide innovative aesthetic solutions for were facial rejuvenation (2.1 million), hair removal (1.0 million), non-invasive fat reduction (0.5 million), cellulite treatment (0.3 million) and vascular lesions/sclerotherapy (0.1 million).
No one treatment procedure is offered by all physicians, and treatments vary in terms of the treatment goal and desired effect. As a result, the total aesthetic market, as reported by ASAPS and ISAPS, does not necessarily represent the total market potential for us or any other single product or treatment, but
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illustrates that each year patients elect to have millions of procedures performed to enhance their appearance. We believe our total addressable market potential also includes aesthetic procedures performed by non-plastic surgeons, which are not tracked by ASAPS and ISAPS data.
We believe the following factors are contributing to the growth in aesthetic procedures:

the aging of the population in the western world;

the growing global obesity epidemic;

the increasing desire of many individuals to improve their appearance;

the reduction in procedure costs, which has attracted a broader consumer base; and

the impact of managed care and reimbursement on physician economics, which has motivated physicians to establish or expand the menu of elective, private-pay aesthetic procedures that they offer.
Within each of our treatment categories, face and body contouring, medical aesthetics and women’s health, we believe our products provide a differentiated solution that overcomes many of the limitations of other existing treatment options.
Our Solution
Key benefits of our minimally-invasive surgical aesthetic and medical treatment solutions include:

Small to no incisions, which reduces the drawbacks and risks typically associated with surgical procedures, such as significant pain, local or widespread scarring, infection, perforation and hemorrhage.

Outpatient procedures that typically do not require general anesthesia, which decreases patient downtime, discomfort and other potential complications.

Minimally-invasive procedures with similar efficacy to surgical procedures that have the ability to expand the addressable patient population for aesthetic procedures.

Effective and long-lasting aesthetic solutions, many of which are supported by compelling clinical data, including 44 peer-reviewed publications.

Differentiated, RF energy-based technology simultaneously kills fat and tightens skin, overcoming the many shortcomings of traditional surgical, minimally and non-invasive aesthetic procedures.

Innovative dual wavelength laser technology that allows for permanent hair reduction on a wider range of skin types and hair textures than other aesthetic solutions currently on the market, reducing the number of treatments required.

Typically less expensive than other aesthetic solutions on the market while providing comparable results as a result of less required physician time and training.
Our Competitive Strengths
We attribute the growing commercial success of our various platforms and products to the following:

Pioneer of the minimally-invasive aesthetic solutions market. We believe our proprietary technologies represent a paradigm shift in the minimally-invasive and surgical aesthetic solutions market. We believe our technologies and products demonstrate numerous performance advantages over other aesthetic options and enable physicians and patients to obtain results that can typically only be achieved with more expensive and invasive surgical procedures. Our RF proprietary energy-based technology simultaneously kills fat and tightens skin, overcoming many of the limitations of other surgical, minimally and non-invasive procedures, positioning us to address unmet patient needs and expand the addressable patient population for aesthetic solutions.
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Although each of our product platforms has a primary handpiece or applicator that is either minimally or non-invasive, our platforms are designed to be modular, which enables the user to provide complementary treatments using a single platform by attaching different handpieces and applicators.

Strong brand recognition. Our brand is associated with product leadership, significant technological advances and extensive clinical data, which has led to strong customer loyalty. Unlike many of our competitors, our technology is not exclusively laser-based or limited to superficial treatment of skin. Instead, we have developed and commercialized products utilizing medically-accepted RF energy technology, which can penetrate deep into the subdermal fat, allowing adipose tissue remodeling. We believe our brand is synonymous throughout the physician and patient communities with having the broadest RF energy-based portfolio in the minimally-invasive aesthetics market for fat destruction and remodeling, face and body contouring and skin tightening.

Provide comprehensive solutions for physicians and patients. We have an extensive product portfolio that includes solutions for a wide range of both minimally and non-invasive procedures across the aesthetic solutions market. For each of our products, we offer post-sales support services including training, installation, practice growth consulting and repair support that minimizes product downtime and associated lost revenues to physicians.

Broad regulatory approvals supported by extensive clinical data. We have 18 FDA clearances and, in addition to the United States, are permitted to sell our products in Europe, Argentina, Australia, Brazil, Canada, China, Colombia, the Commonwealth of Independent States, Israel, Mexico, Panama, Philippines, Russia, South Korea, Taiwan and Thailand. To date, we also have a portfolio of 44 peer-reviewed publications, and there are 36 completed and 18 ongoing third-party clinical studies on a number of our products (BodyTite, FaceTite, NeckTite, Optimas, Fractora, Forma, Lumecca, DiolazeXL, Votiva, FractoraV, FormaV, Contoura, BodyFX, MiniFX, Evolve, Morpheus8 and AccuTite). While we did not have any involvement in the clinical studies mentioned above, such studies provide qualitative results that we believe are significant. However, because these were third-party studies we do not have access to any raw data to conduct any quantitative analyses. We believe our focus on demonstrated clinical data and effectiveness differentiates us from our competition and helps to validate our technology with surgically-trained physicians, who we believe are typically the most difficult segment of the market to penetrate.

Strong management team with proven track record. Our management team has significant expertise in the medical aesthetics industry with a proven track record of successfully developing and commercializing innovative technology. Moshe Mizrahy and Dr. Michael Kreindel, our co-founders, previously founded Syneron Medical Ltd. Our senior executive team has an average of over 15 years of medical aesthetics industry experience and has served in various leadership roles at Syneron Medical Ltd. and Cynosure, Inc.
Our Growth Strategy
Our objective is to expand our technological leadership in the aesthetic solutions market and to leverage our RF proprietary technologies to expand into the medical solutions market. We intend to achieve this goal by implementing the following strategies:

Increase our sales presence to target and expand our addressable market globally. We plan to expand our direct sales organization and our distribution network and seek to recruit and train exceptionally talented sales representatives in existing and new markets to help us broaden the adoption of our products, drive further market penetration and expand beyond our traditional customer base.

North America: We plan to expand our direct sales team in the United States and Canada by approximately 15 representatives by the end of 2019.
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Europe: We intend to establish sales and marketing organizations and a network of exclusive European distributors (in addition to our existing network in the United Kingdom and Spain).

Latin America: We plan to expand our network of exclusive distributors in Argentina, Brazil, Colombia, Mexico and Panama.

Asia-Pacific: In addition to our direct sales presence in India, we intend to establish a direct sales presence in China through our joint venture in Guangzhou, as well as expand our network of exclusive distributors in Australia, Japan, Philippines, South Korea, Taiwan and Thailand.

Continue to further penetrate our existing customer base and drive recurring revenues. We believe that there are opportunities for us to generate additional revenue from existing customers who are already familiar with our products. Since our inception, approximately 30% of our North America customers have purchased a second platform to expand their treatment offerings. Additionally, we have experienced growth in the sales of consumables (handpieces that are, or contain, one-time use applicators that must be replaced following each treatment) over the past three years. Since inception, we have sold over 257,000 consumables. We expect that as our customer base grows, the percentage of our revenues attributable to consumables will increase. We also expect that certain customers will be candidates for technology upgrades to enhance the capabilities of their existing InMode products. In addition, as we continue to grow our support services program, we expect to seek to increase the number of customers that enter into service contracts and extended warranties, which would provide us with additional recurring revenues.

Leverage our existing technology to expand into new minimally and non-invasive applications. We have an active research and development pipeline focused on additional solutions targeted to our traditional customer base. Our near-term product development portfolio consists of new and second generation solutions for various conditions, including wearable, non-invasive face and body reshaping, cellulite, large area lipolysis, severe vaginal laxity, labiaplasty, pelvic floor muscle restoration, post-partum treatments, snoring, dry eye and eyelid contraction and fat reduction. We expect to launch three new product platforms by the end of 2019, which we believe will allow us to continue to grow our revenues over the long term and further penetrate the market for aesthetic solutions. Each such product is or will be subject to the FDA regulatory framework, and specifically, the FDA’s 510(k) clearance requirements described in this prospectus.

Expand our customer base beyond traditional customers. We intend to develop products that leverage our minimally and non-invasive technologies to address the unmet market needs of a non-traditional customer base, which includes ENTs, ophthalmologists, general practitioners and aesthetic clinicians. We intend to adapt our products to the expertise and skill level of these providers, further expanding our addressable market.

Actively pursue business development opportunities. We may seek to engage in targeted business development activities, including acquisitions and strategic partnerships, in order to augment our product and technology portfolio in our existing and potentially adjacent markets. We believe we can leverage our global infrastructure and existing relationships to implement a disciplined tuck-in acquisition strategy.

Expand our intellectual property and patent portfolio. We intend to expand our existing intellectual property and patent portfolio as we develop additional applications and continue to aggressively defend against potential infringement by our competitors.
Preliminary Financial Results
We are currently finalizing our financial results for the three months ended June 30, 2019. While complete financial information and operating data are not yet available, set forth below are certain preliminary estimates of our financial results for such period. Our actual results may differ materially from these estimates due to the completion of our financial closing procedures, final adjustments and other developments that may arise between now and the time such financial results are finalized.
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The following are our preliminary estimates for the three months ended June 30, 2019:

Revenue is expected to be between $38.6 million and $38.8 million, an estimated 55% increase compared to revenue of  $25.0 million for the three months ended June 30, 2018. Consistent with our prior period results, this estimated increase is primarily attributable to higher revenues in North America, as a result of an expansion of our direct sales organization, an increase in the number of clinical workshops for customers and prospects in the region and an increased average sale price of our platforms in the region.

Gross margin is expected to be between 86% and 87%, an estimated 3% increase compared to a gross margin of 84% for the three months ended June 30, 2018. This estimated increase is primarily attributable to an increase in average sale price of our platforms in North America.

Operating income is expected to be between $15.5 million and $15.7 million, an estimated 97% increase compared to operating income of  $7.9 million for the three months ended June 30, 2018. This estimated increase is primarily attributable to an estimated increase in our gross profit exceeding the increase in our operating expenses. The increase in our operating expenses is primarily attributable to the expansion of our direct sales organization, an increase in compensation as a result of our increased North American revenue and an increase in costs related to our marketing activities.

Net income is expected to be between $15.6 million and $15.8 million, an estimated 107% increase compared to net income of  $7.6 million for the three months ended June 30, 2018. The estimated increase in net income is attributable to the same factors that resulted in the increase to our operating income.
As of June 30, 2019, our total cash and cash equivalents, marketable securities and short-term bank deposits are expected to be approximately $82.8 million compared to $64.1 million as of March 31, 2019. This estimated increase is attributable to the same factors that resulted in the increase to our operating income.
The estimates above represent the most current information available to management and do not present all necessary information for an understanding of our financial condition as of and the results of operations for the three months ended June 30, 2019. We have provided a range for the preliminary results described above primarily because our financial closing procedures are not yet complete for the three months ended June 30, 2019. As a result, there is a possibility that our final results will vary from these preliminary estimates. The estimates are not necessarily indicative of any future period and should be read together with “Risk Factors,” “Special Note Regarding Forward-Looking Statements,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Selected Consolidated Financial Data” and our financial statements and related notes included elsewhere in this prospectus.
The preliminary financial data included in this prospectus has been prepared by, and is the responsibility of, our management. Our independent registered public accounting firm has not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, our independent registered public accounting firm does not express an opinion or any other form of assurance with respect thereto.
Risks Associated with Our Business
Our business is subject to a number of risks of which you should be aware of before making an investment decision. These risks are discussed more fully in the “Risk Factors” section of this prospectus. These risks include, but are not limited to, the following:

our success depends upon market acceptance of our products;

if there is not sufficient demand for the procedures performed with our products, practitioner demand for our products could decline, resulting in unfavorable operating results;

the success and continued development of our products depends, in part, upon maintaining strong relationships with physicians and other healthcare professionals;
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we rely heavily on our sales professionals to market and sell our products worldwide. If we are unable to hire, effectively train, manage, improve the productivity of, and retain our sales professionals, our business will be harmed, which would impair our future revenue and profitability;

due to our limited history of operations, we may not be able to continue our revenue growth and profitability;

the failure to attract and retain key personnel could adversely affect our business;

if we do not continue to develop and commercialize new products and identify new markets for our products and technologies, we may not remain competitive or expand beyond our traditional customer base, and our revenues and operating results could suffer;

product liability suits could be brought against us due to defective material or design, or due to misuse of our products, and could result in expensive and time-consuming litigation, payment of substantial damages and an increase in our insurance rates;

our products and operations are subject to extensive and continuing regulatory compliance obligations in the United States and other countries, and failure to meet those obligations could adversely harm our business;

we outsource almost all of the manufacturing of our products to a small number of manufacturing subcontractors. If our subcontractors’ operations are interrupted or if our orders exceed our subcontractors’ manufacturing capacity, we may not be able to deliver our products on time;

if we are unable to protect our intellectual property rights, our competitive position could be harmed. Our success and ability to compete depends in large part upon our ability to protect our proprietary technology;

third parties have and may in the future commence litigation against us claiming that our products infringe upon their patents or other intellectual property rights;

if we fail to obtain and maintain necessary FDA clearances for our products, if clearances for future products and proposed indications are delayed or not issued, if we or any of our third-party suppliers or manufacturers fail to comply with applicable regulatory requirements, or if there are regulatory changes, our commercial operations could be harmed;

as a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and Nasdaq corporate governance rules and are permitted to file less information with the Securities and Exchange Commission, or the SEC, than U.S. domestic public companies, which may limit the information available to holders of our ordinary shares; and

we may become subject to the requirements of the Investment Company Act of 1940, or the 1940 Act, which would limit our business operations and require us to spend significant resources to comply with such act.
Implications of Being an Emerging Growth Company
As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include, among others:

a requirement to have only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in this prospectus;

an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act; and
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an exemption from compliance with any requirement that the Public Company Accounting Oversight Board, or 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.
We may take advantage of these provisions for up to five years 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 to occur of  (1) the last day of the fiscal year in which we have total annual gross revenues of  $1.07 billion or more, (2) the last day of the year after the five-year anniversary of this offering, (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years, or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. We may choose to take advantage of some but not all of these reduced burdens, and therefore the information that we provide holders of our ordinary shares may be different than the information you might receive from other public companies in which you hold equity. In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies. We have irrevocably elected to opt out of such extended transition period.
Implications of Being a Foreign Private Issuer
Upon consummation of this offering, we will report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;

the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K relating to the occurrence of specified significant events.
We intend to take advantage of these exemptions for as long as we qualify as a foreign private issuer.
Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.
Corporate Information
We were incorporated in the State of Israel on January 2, 2008. In November 2017, our corporate name was changed from Invasix Ltd. to InMode Ltd. Our headquarters are located at Tavor Building, Sha’ar Yokneam, P.O. Box 533, Yokneam 2069206, Israel. Our phone number is +972-4-9096313. Our website address is www.inmodemd.com. The information contained on or that can be accessed through our website is not incorporated by reference into this prospectus, and you should not consider information on our website to be part of this prospectus or in deciding to purchase our ordinary shares.
9

The Offering
Ordinary shares offered by us
5,000,000 ordinary shares
Ordinary shares to be outstanding after this offering
31,973,572 ordinary shares (32,723,572 ordinary shares if the underwriters exercise their option to purchase additional ordinary shares in full).
Option to purchase additional ordinary shares
We have granted the underwriters an option, exercisable within 30 days from the date of this prospectus, to purchase up to 750,000 additional ordinary shares.
Use of proceeds
We estimate that the net proceeds to us from this offering will be approximately $67.9 million, assuming an initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering to expand our sales and marketing operations, to fund our research and development activities, and the remainder for general corporate purposes. See “Use of Proceeds.”
Risk factors
See “Risk Factors” and other information included in this prospectus for a discussion of factors that you should consider carefully before deciding to invest in our ordinary shares.
Proposed Nasdaq Global Select Market symbol
We have been approved to have our ordinary shares listed on The Nasdaq Global Select Market, or Nasdaq, under the symbol “INMD,” subject to offical notice of issuance.
Directed share program
At our request, the underwriters have reserved up to 5% of the ordinary shares being offered by this prospectus for sale at the initial public offering price to our directors, officers, employees and other individuals associated with us and members of their families. The sales will be made by UBS Financial Services Inc., a selected dealer affiliated with UBS Securities LLC, an underwriter of this offering, through a directed share program. We do not know if these persons will choose to purchase all or any portion of these reserved shares, but any purchases they do make will reduce the number of shares available to the general public. Any reserved shares not so purchased will be offered by the underwriters to the general public on the same terms as the other ordinary shares. See “Underwriting” and “Certain Relationships and Related Party Transactions — Directed Share Program.”
The number of ordinary shares that will be outstanding after this offering is based on 26,973,572 ordinary shares outstanding as of June 30, 2019. The number of ordinary shares referred to above to be outstanding after this offering and, unless otherwise indicated, the other information in this prospectus excludes:

9,542,045 ordinary shares issuable upon the exercise of options outstanding as of June 30, 2019 at a weighted-average exercise price of  $1.18 per ordinary share; and
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890,741 ordinary shares reserved for future issuance under our 2018 Incentive Plan, as well as ordinary shares that may be issued pursuant to provisions in our 2018 Incentive Plan that automatically increase the ordinary share reserve under our 2018 Incentive Plan.
Unless otherwise indicated, all information contained in this prospectus assumes or gives effect to:

the adoption and effectiveness of our amended and restated articles of association upon the effectiveness of the registration statement of which this prospectus forms a part;

no exercise of the outstanding options described above;

no exercise by the underwriters of their option to purchase up to 750,000 additional ordinary shares; and

a 1-for-1.789 stock split of our ordinary shares by way of an issuance of bonus shares effected on July 24, 2019.
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Summary CONSOLIDATED Financial Data
The following tables present our summary consolidated financial data and should be read in conjunction with “Selected Consolidated Financial Data” and “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. The historical results are not necessarily indicative of the results to be expected for any future periods. We derived the summary statements of income data below for the three months ended March 31, 2019 and 2018 and the summary balance sheet data as of March 31, 2019 from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. We have prepared the unaudited condensed consolidated financial statements on the same basis as the audited consolidated financial statements and have included, in our opinion, all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair statement of the financial information set forth in those statements. We have derived the summary statements of income data below for the years ended December 31, 2018 and 2017 from our audited consolidated financial statements included elsewhere in this prospectus. Our unaudited condensed consolidated financial statements and audited consolidated financial statements are presented in U.S. dollars and prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP.
Three months ended March 31,
Year ended December 31,
2019
2018
2018
2017
(in thousands, except share and per share data)
Consolidated Statements of Income Data:
Revenues
$ 30,552 $ 20,911 $ 100,162 $ 53,456
Cost of revenues
4,271 3,532 15,057 9,053
Gross profit
26,281 17,379 85,105 44,403
Operating expenses:
Research and development
1,199 880 4,180 2,575
Sales and marketing
14,097 9,665 44,622 28,514
General and administrative
1,053 895 4,814 4,364
Legal settlements and loss contingencies
8,000
Total operating expenses
16,349 11,440 61,616 35,453
Operating income
$ 9,932 $ 5,939 $ 23,489 $ 8,950
Financial income, net
403 278 136 849
Income before taxes
$ 10,335 $ 6,217 $ 23,625 $ 9,799
Income tax
177 (149) 1,260 980
Net income
$ 10,158 $ 6,366 $ 22,365 $ 8,819
Net loss (income) attributable to non-controlling
interests
(34) 6
Net income attributable to controlling interest
$ 10,124 $ 6,366 $ 22,371 $ 8,819
Net income per ordinary share:
Basic
$ 0.38 $ 0.22 $ 0.82 $ 0.29
Diluted
$ 0.28 $ 0.17 $ 0.62 $ 0.26
Weighted average number of ordinary shares:
Basic
26,818,179 26,497,050 26,613,942 26,283,548
Diluted
35,457,601 34,711,741 35,006,644 29,669,922
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As of March 31, 2019
Actual
Pro Forma(1)(2)
(in thousands)
Consolidated Balance Sheet Data:
Cash and cash equivalents, short-term bank deposits and marketable securities
$ 64,083 $ 132,108
Working capital(3)
58,057 126,082
Total assets
85,067 153,092
Total liabilities
27,491 27,491
Redeemable non-controlling interest
2,252
Retained earnings
43,030 43,030
Non-controlling interests
1,441 3,693
Total shareholders’ equity
55,324 125,601
(1)
The pro forma consolidated balance sheet data gives effect to the issuance and sale of 5,000,000 ordinary shares by us in this offering at the assumed initial public offering price of $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
(2)
Each $1.00 increase (decrease) in the assumed initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover of this prospectus, would increase (decrease) our pro forma cash and cash equivalents, working capital total assets and total shareholders’ equity by $4.7 million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. An increase (decrease) of 1.0 million ordinary shares offered by us at the assumed initial public offering price would increase (decrease) our pro forma cash and cash equivalents, working capital, total assets and total shareholders’ equity by $14.0 million, assuming no change in the assumed public offering price per ordinary share.
(3)
We define working capital as current assets less current liabilities. See our consolidated financial statements included elsewhere in this prospectus for further details regarding our current assets and current liabilities.
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RISK FACTORS
Investing in our ordinary shares involves a high degree of risk. You should consider carefully the following risk factors, as well as the other information in this prospectus, before deciding to invest in our ordinary shares. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occurs and, as a result, the market price of our ordinary shares could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may have similar adverse effects on us.
Risks Related to Our Business and Industry
Our success depends upon market acceptance of our products.
We design, develop, manufacture and commercialize innovative minimally and non-invasive aesthetic medical products. We have developed products that apply our technology to rejuvenate the skin’s appearance through body and face reshaping and tightening, the treatment of superficial benign vascular and pigmented lesions, hair removal, wrinkle reduction and the treatment of acne, cellulite and leg veins. We were established in 2008 and have expanded our product offerings to include six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. We expect to introduce three additional product platforms by the end of 2019. If we fail to significantly penetrate current or new markets with our products or fail to properly manage the manufacturing and distribution of multiple products, our business, financial condition and results of operations could be negatively impacted. The success of our products depends on adoption and acceptance of our technology. The rate of adoption and acceptance may be affected adversely by perceived issues relating to quality and safety, customers’ reluctance to invest in new technologies, the cost of competitive treatments and widespread acceptance of other technologies. Our business strategy is based, in part, on our expectation that we will continue to make novel product introductions and upgrades that we can sell to new and existing users of our products, and that we will be able to identify new markets for our existing technologies.
To increase our revenues, we must:

continue to further penetrate our existing, traditional customer base, including plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/GYNs, and drive recurring revenues by demonstrating to our customers that our products or product upgrades would be an attractive revenue-generating addition to their practices;

expand our customer base to include non-traditional customers, such as ENTs, opthalmologists, general practitioners and aesthetic clinicians;

leverage our existing technology to expand into new minimally and non-invasive applications that either add to or significantly improve our current products;

increase our sales presence to target and expand our market globally;

actively pursue business development opportunities including potential acquisitions and strategic partnerships to augment our product and technology portfolio; and

expand and maintain our intellectual property and patent portfolio.
In addition, the aesthetic solutions market is highly competitive and dynamic and marked by rapid and substantial technological development and product innovations. Demand for our products could be diminished by equivalent or superior products and technologies offered by competitors.
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If there is not sufficient demand for the procedures performed with our products, practitioner demand for our products could decline, resulting in unfavorable operating results.
Continued expansion of the global market for energy-based aesthetic procedures is a material assumption of our business strategy. Most procedures performed using our products are not reimbursable through government or private health insurance and are therefore elective procedures, the cost of which must be borne by the patient. The decision to utilize our products may therefore be influenced by a number of factors, including:

consumer disposable income and access to consumer credit;

the cost of procedures performed using our products;

the cost, safety and effectiveness of alternative treatments, including treatments which are not based upon laser or other energy-based technologies and treatments which use pharmaceutical products;

the success of our sales and marketing efforts;

the education of our customers and patients on the benefits and uses of our products compared to competitors’ products and technologies; and

consumer confidence, which may be impacted by economic and political conditions.
If, as a result of these factors, there is not sufficient demand for the procedures performed with our products, practitioner demand for our products could decline, which could have a material adverse effect on our results of operations.
The success and continued development of our products depends, in part, upon maintaining strong relationships with physicians and other healthcare professionals.
If we fail to maintain our working relationships with physicians and other ancillary healthcare professionals, our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support our products. If we are unable to maintain these strong relationships, or form new relationships with physicians and other healthcare professionals beyond our traditional customer base, the development and marketing of our products could suffer, which could have a material adverse effect on our business, financial condition and results of operations.
We rely heavily on our sales professionals to market and sell our products worldwide. If we are unable to hire, effectively train, manage, improve the productivity of, and retain our sales professionals, our business will be harmed, which would impair our future revenue and profitability.
Our success largely depends on our ability to hire, train, manage and improve the productivity levels of our sales professionals worldwide. We train our existing and recently recruited sales professionals to better understand our existing and new product technologies and how they can be positioned against our competitors’ products and increase the revenue of our customers. It may take time for the sales professionals to become productive and there can be no assurance that recently recruited sales professionals will be adequately trained in a timely manner, or that our direct sales productivity will improve, or that we will not experience significant levels of attrition in the future.
Due to the complex nature of some of our products, we could be subject to product liability claims, including adverse outcomes resulting from treatments.
Our systems are inherently complex in design and require ongoing scheduled maintenance. Our products may malfunction when used by our customers. Furthermore, our products are sold in jurisdictions that vary as to the specific qualifications or training required for purchasers or operators of the products. There is a risk that our products may be purchased or operated by physicians with varying levels of training, and in some cases, by practitioners such as nurses, chiropractors and technicians who may not be adequately trained. The purchase and use of our products by non-physicians, or persons who lack adequate training, may result in the misuse of our products, which could give rise to adverse treatment outcomes. If we are unable to prevent product malfunctions or misuse, or if we fail to do so in a timely manner, we could
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also experience, among other things, delays in the recognition of revenues or loss of revenues, particularly in the case of new products; legal actions by customers, patients and other third parties, which could result in substantial judgments against us or settlement costs; action by regulatory bodies; and diversion of development, engineering and management resources.
Such potential adverse effects may cause a significant increase in the premiums under our insurance policies. Further, the coverage limits of our product liability insurance policies may not be adequate to cover future claims. A successful claim brought against us in excess of, or outside of, our insurance coverage could have a material adverse effect on our business, financial condition and results of operations. Even if unsuccessful, such a claim could nevertheless have an adverse impact on us, due to damage to our reputation and diversion of management resources.
Due to our limited history of operations, we may not be able to continue our revenue growth and profitability.
We were incorporated in 2008 and launched our first product in 2010. Consequently, we have a somewhat limited history of operations. The future success of our business will depend, among other things, on our ability to increase product sales, successfully introduce new products, expand our sales force and distribution network and control costs, which we may be unable to do. As a result, we may not be able to continue to experience revenue growth and profitability.
We may have difficulty managing our growth which could limit our ability to increase sales and cash flow.
We have experienced significant growth in our operations and the number of our employees has significantly increased since inception. This growth has placed significant demands on our management, as well as our financial and operational resources. In order to achieve our business objectives, we will need to continue to grow our business. Continued growth would increase the challenges involved in:

implementing appropriate operational and financial systems;

expanding our sales and marketing infrastructure and capabilities;

ensuring compliance with applicable FDA and other regulatory requirements;

providing adequate training and supervision to maintain high quality standards; and

preserving our culture and values.
If our growth continues, it will require that we continue to develop and improve our operational, financial and other internal controls. If we cannot scale and manage our business appropriately, we will not realize our projected growth and our financial results will suffer.
The failure to attract and retain key personnel could adversely affect our business.
Our success also will depend in large part on our ability to continue to attract, retain and motivate qualified and highly skilled personnel. Competition for highly skilled employees is intense. We may be unable to continue to attract and retain sufficient numbers of highly skilled employees. Our inability to attract and retain additional key employees or the loss of one or more of our current key employees could adversely affect our business, financial condition and results of operations.
Our financial results may fluctuate from quarter to quarter.
We base our production, inventory and operating expenditure levels on anticipated orders. If orders are not received when expected in any given quarter, expenditure levels could be disproportionately high in relation to sales for that quarter. A number of additional factors, over which we have limited control, may contribute to fluctuations in our financial results, including:

customer adoption of our products;

the willingness of individuals to pay directly for aesthetic medical procedures, in light of the lack of reimbursement by third-party payors;
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continued availability of attractive equipment leasing terms for our customers, which may be negatively influenced by interest rate increases;

changes in our ability to obtain and maintain regulatory approvals and maintain compliance with applicable regulatory requirements;

positive or negative coverage in the media or clinical publications of our products or products of our competitors or industry;

increases in the length of our sales cycle;

performance of our independent distributors; and

delays in, or failure of, product and component deliveries by our subcontractors and suppliers.
Competition among providers of energy-based devices for the medical aesthetics market is characterized by rapid innovation. If we do not continue to develop and commercialize new products and identify new markets for our products and technologies and expand beyond our traditional customer base, we may not remain competitive, and our revenues and operating results could suffer.
The industry in which we operate is subject to continuous technological development and product innovation. If we do not continue to be innovative in the development of new products and applications, our competitive position will likely deteriorate as other companies successfully design and commercialize new products and applications. While we attempt to protect our products through patents and other intellectual property, there are few barriers to entry that would prevent new entrants or existing competitors from developing products that compete directly with ours. We expect that any competitive advantage we may enjoy from our current and future innovations may diminish over time, as companies successfully respond to our, or create their own, innovations. Accordingly, our success depends in part on developing new and innovative applications of laser and other energy-based technology and identifying new markets for and applications of existing products to new customers and technology. Our future growth also depends, in part, on our ability to expand beyond our traditional customer base to ENTs, ophthalmologists, general practitioners and aesthetic clinicians. If we are unable to develop and commercialize new products and identify and penetrate new markets for our products and technology, our products and technology could become obsolete and our revenues and operating results could be adversely affected.
Our long-term growth depends on our ability to enhance our products, expand our indications and develop and commercialize additional products.
It is important to our business that we continue to enhance our products and develop and introduce new products. Developing products is expensive and time-consuming and could divert management’s attention away from our core business. The success of any new product offering or product enhancement to our current products will depend on several factors, including our ability to:

properly identify and anticipate physician and patient needs;

develop and introduce new products and product enhancements in a timely manner;

avoid infringing upon the intellectual property rights of third parties;

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

obtain the necessary regulatory clearances or approvals for expanded indications, new products or product modifications; and

be fully FDA-compliant with marketing of new devices or modified products.
If we are not successful in expanding our indications and developing and commercializing new products and product enhancements, our ability to increase our revenue may be impaired, which could have a material adverse effect on our business, financial condition and results of operations.
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Our inability to compete effectively with our competitors may prevent us from achieving significant market penetration or improving our operating results.
Our products compete against products offered by public companies, including Allergan plc, Cutera, Inc., Hologic Inc. and Viveve Medical, Inc., as well as by private companies such as Lumenis Ltd., Sisram Medical Ltd. and Syneron Medical Ltd. Competition with these companies could result in reduced prices and profit margins and loss of market share, any of which could harm our business, financial condition and results of operations. We also face competition from medical products, including Botox, hyaluronic acid injections and collagen injections, and aesthetic procedures, such as face lifts, liposuction, sclerotherapy, electrolysis and chemical peels. Furthermore, we currently sell our products only to trained physicians and face competition from the medical spa market, which may offer a broader range of medical and non-medical products and technologies that are more readily available to customers at a lower cost. Our ability to compete effectively depends upon our ability to distinguish our company and our products from our competitors and their products, and includes the following factors:

product performance;

product pricing;

product safety;

intellectual property protection;

quality of customer support;

success and timing of new product development and introductions; and

development of successful distribution channels.
Furthermore, potential customers also may need to recoup the cost of expensive products that they already have purchased from our competitors and may decide not to purchase our products, or to delay such purchases. If we are unable to achieve continued market penetration, we will be unable to compete effectively and our business will be harmed.
Consolidation in our industry may make it more difficult for us to compete.
The trend towards consolidation in our industry has increased, and may continue to increase, the intensity of the competition in our industry and could result in increased downward pressure on our product prices. Recently, many of our competitors in the aesthetics market have acquired other companies that operate within the same market. If this trend continues, we will be forced to compete primarily with and against larger competitors with greater resources and distribution networks. Our competitors could use their greater financial resources to acquire other companies to gain enhanced name recognition and market share, as well as to develop new technologies or products that could effectively compete with our product lines. If we are unable to effect strategic mergers or acquisitions of our own and are unable to obtain capital and other resources that would allow us to compete effectively, our business will be harmed.
The introduction of disruptive technological breakthroughs, whether pharmaceutical or other newer therapeutic solutions, may present an additional threat to our success in our target markets.
The medical technology industry is intensely competitive. Pharmaceutical alternative treatments compete vigorously with traditional laser and other energy-based procedures, such as those carried out with our products. Some pharmaceutical companies, academic and research institutions or others may develop new, non-invasive or minimally invasive therapies that are more effective, more convenient or less expensive than our current or future products. The introduction of new technologies, along with these potential new therapies, could result in increased competition or make our products obsolete. Moreover, we could expand our business to include new, non-invasive or minimally invasive therapies which may compete with our current product offerings. We may not be able to respond effectively to technological changes and emerging industry standards, or to successfully identify, develop or support new technologies or enhancements to existing products in a timely and cost-effective manner. Any such developments could have a material adverse effect on our business, financial condition and results of operations.
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Our markets are characterized by evolving technological standards and changes in customer requirements, and we may not be able to react to such changes and introduce new products in a timely manner.
The aesthetics market is characterized by extensive research and development, technological change, frequent modifications and enhancements, innovations, new applications, evolving industry standards and changes in customer requirements. Our future growth depends in part on our ability to introduce new products on a timely basis, as well as to introduce other product enhancements that address the evolving customer needs. This requires us to design, develop, manufacture, assemble, test, market and support these new products or product enhancements on a timely and cost-effective basis. It also requires continued substantial investment in research and development.
During each stage of the research and development process we may encounter obstacles that could delay development and consequently increase our expenses. This may ultimately force us to abandon a potential product in which we have already invested substantial time and resources. Technologies in development could prove to be more complex than initially understood or not scientifically or commercially viable. Even if we develop new products and technologies ahead of our competitors, we will still need to obtain the requisite regulatory approvals for such products, including from public agencies, such as the FDA, before we can commercially distribute them. We cannot assure you that we will successfully identify new technological opportunities, develop and bring new or enhanced products to market, obtain sufficient or any patent or other intellectual property protection for such new or enhanced products or obtain the necessary regulatory approvals in a timely and cost-effective manner, or, if such products are introduced, that those products will achieve market acceptance. Our failure to do so, or to address the technological changes and challenges in our markets, could have a material adverse effect on our business, financial condition and results of operations.
We rely on our own direct sales force to sell our products in certain territories, which may result in higher fixed costs than our competitors and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.
We rely on our own direct sales force to market and sell our products in certain territories. Some of our competitors rely predominantly on independent sales agents and third-party distributors. A direct sales force may subject us to higher fixed costs than those of companies that market competing products through independent third parties, due to the costs that we will bear associated with employee benefits, and training and managing sales personnel. As a result, we could be at a competitive disadvantage. Additionally, these fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our products, which could have a material adverse effect on our business, financial condition and results of operations.
To successfully market and sell our products internationally, we must address many issues with which we have little or no experience.
International (non-U.S. and Canada) sales accounted for approximately 12% and 11% of our total revenue for the three months ended March 31, 2019 and year ended December 31, 2018, respectively. We believe that an increasing percentage of our future revenue will come from international sales as we expand our operations and develop opportunities in additional international territories. We currently depend on third-party distributors and a direct sales team in certain regions to sell our products internationally, including in connection with our joint venture in China. If these distributors or direct sales personnel underperform, we may be unable to increase or maintain our level of international revenue. We will need to attract additional distributors to grow our business and expand the territories in which we sell our products. Distributors may not commit the necessary resources to market and sell our products to the level of our expectations. If current or future distributors do not perform adequately, or we are unable to locate distributors in particular geographic areas, we may not realize expected international revenue growth. Additionally, we expect to expand our direct sales force in the United States, Canada, Europe and Latin America. If we are unable to do so successfully, our revenue from international operations will be adversely affected.
International sales are subject to a number of risks, including:

difficulties in staffing and managing our foreign operations;
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difficulties in penetrating markets in which our competitors’ products are more established;

reduced protection for intellectual property rights in some countries;

export restrictions, trade regulations and foreign tax laws;

fluctuating foreign currency exchange rates;

obtaining and maintaining foreign certification and compliance with other regulatory requirements;

customs clearance and shipping delays; and

political and economic instability.
If one or more of these risks were realized, it could require us to dedicate significant resources to remedy the situation, and if we are unsuccessful at finding a solution, our revenue may decline.
We outsource almost all of the manufacturing of our products to a small number of manufacturing subcontractors. If our subcontractors’ operations are interrupted or if our orders exceed our subcontractors’ manufacturing capacity, we may not be able to deliver our products on time.
We outsource almost all of the manufacturing of our products to four subcontractors located in Israel, two of which we are substantially dependent on, while we manufacture our laser and intense pulsed light, or IPL, handpieces in-house in Israel. These subcontractors have limited manufacturing capacity that may be inadequate if our customers place orders for unexpectedly large quantities of our products. In addition, because our subcontractors are located in Israel, they on occasion may feel the impact of potential economic or political instability in the region. If the operations of one or more of our subcontractors were halted or limited, even temporarily, or if they were unable or unwilling to fulfill large orders, we could experience business interruption, increased costs, damage to our reputation and loss of our customers. In addition, finding new subcontractors that meet our manufacturing requirements, comply with regulatory requirements, and are ISO certified could take several months.
Components used in our products are complex in design, and defects may not be discovered prior to shipment to customers, which could result in warranty obligations, reducing our revenue and increasing our costs.
In manufacturing our products, we and our subcontractors depend upon third-party suppliers for various components. Many of these components require a significant degree of technical expertise to produce. If our suppliers fail to produce components to specification, or if the suppliers, our subcontractors, or we, use defective materials or workmanship in the manufacturing process, the reliability and performance of our products will be compromised.
If our products contain defects that cannot be repaired easily and inexpensively, we may experience:

loss of customer orders and delay in order fulfillment;

damage to our brand reputation;

increased cost of our warranty program due to product repair or replacement;

inability to attract new customers;

diversion of resources from our manufacturing and research and development departments into our service department;

product recalls; and

legal action.
The occurrence of any one or more of the foregoing could materially harm our business, financial condition and results of operations.
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We and our manufacturing subcontractors depend upon third-party suppliers, making us vulnerable to supply shortages, price fluctuations or other degradations in performance of these suppliers, which could harm our business and financial condition.
Many of the components that comprise our products are currently manufactured by a limited number of suppliers. Although each of our components can be obtained from more than one supplier, we do not have the ability to manufacture the components we outsource. Additionally, our subcontractors rely on a limited number of suppliers, or in some cases, one supplier, for some of the materials and components used in our products. If our subcontractors were to lose such suppliers, there can be no assurance that they will be able to identify or enter into agreements with alternative suppliers on a timely basis on acceptable terms, if at all, which could cause interruptions in their operations. If any of these third-party suppliers fails to adequately perform, our revenue and profitability could be adversely affected. A supply interruption or an increase in demand beyond current suppliers’ capabilities could harm our ability to manufacture our products until we identify and qualify a new source of supply, which could take several months.
There is a risk that our suppliers will not always act consistent with our best interests, and may not always supply goods that meet our requirements. Any interruption in the supply of components or materials, or our inability to obtain substitute components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers, which would have an adverse effect on our business, financial condition and results of operations.
Transitioning to a new supplier could be time-consuming and expensive, may result in interruptions in our operations and product delivery, could affect the performance specifications of our products or could require that we modify the design of certain product systems. If a change in manufacturer results in a significant change to any product, a new 510(k) clearance from the FDA or similar international regulatory authorization may be necessary before we implement the change, which could cause substantial delays.
There exists potential for misuse of our products, over which we have very little to no control, which could harm our reputation and our business.
In the United States, federal regulations allow us to sell our products to or on the order of  “licensed practitioners.” The definition of  “licensed practitioners” varies from state to state. As a result, depending on state law, our products may be purchased or operated by physicians or other licensed practitioners, including nurse practitioners, chiropractors and technicians. Outside the United States, many jurisdictions do not require specific qualifications or training for purchasers or operators of our products. Although we offer training on the use of our products, we do not supervise the treatments performed. Purchase and use of our products by non-physicians may result in product misuse. The potential misuse of our products by physicians and non-physicians may result in adverse treatment outcomes, which could harm our reputation and expose us to costly product liability litigation.
Our products include a limited time warranty which could result in substantial additional costs to us should we fail to monitor product quality effectively.
We generally provide a 12-month warranty on our products. After the warranty period, maintenance and support is provided on a service contract basis. If our products malfunction, warranty claims may become significant, which could cause a significant drain on our resources and materially adversely affect our results of operations.
Product liability suits could be brought against us due to defective material or design, or due to misuse of our products, and could result in expensive and time-consuming litigation, payment of substantial damages and an increase in our insurance rates.
If our products are alleged to be defectively designed, manufactured or labeled, contain defective components or are misused, we may become subject to substantial and costly litigation by our customers or their patients. Misusing our products or failing to adhere to operating guidelines could cause burns, scarring and tissue irregularities. In addition, if our operating guidelines are found to be inadequate, we may be subject to liability. We may in the future be involved, in claims related to the use of our products. Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us. While we believe we are covered by insurance from
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recognized insurers in such amounts and covering such risks as is sufficient for the conduct of our business and as is customary for companies engaged in similar businesses, our insurance coverage may be inadequate in amount or scope sufficient to provide us with adequate coverage against all potential liabilities, or we may be unable to maintain such insurance or obtain new insurance in the future. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and reduce product sales. Product liability claims in excess of our insurance coverage would be paid out of cash reserves harming our financial condition and reducing our operating results. In addition, if our cash reserves are not sufficient to cover such contingency, our financial results could be harmed.
We forecast sales to determine requirements for our products and if our forecasts are incorrect, we may experience either shipment delays or increased costs.
Our subcontractors keep limited materials and components on hand. To help them manage their manufacturing operations and minimize inventory costs, we forecast anticipated product orders to predict our inventory needs up to six months in advance and enter into purchase orders on the basis of these forecasts. Our limited historical experience may not provide us with enough data to accurately predict future demand. If our business expands, our demand would increase and our suppliers may be unable to meet our demand. If we overestimate our requirements, our subcontractors will have excess inventory, and may transfer to us any increase in costs. If we underestimate our requirements, our subcontractors may have inadequate components and materials inventory, which could interrupt, delay or prevent delivery of our products to our customers. Any of these occurrences would negatively affect our financial performance and the level of satisfaction our customers have with our business.
Under applicable employment laws, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
We have entered into non-competition agreements with many of our professional employees. These agreements prohibit our employees, if they cease working for us, from competing directly with us or working for our competitors for a limited period. Under applicable employment laws, we may be unable to enforce these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise our former employees gained while working for us. For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the employer which have been recognized by the courts, such as the secrecy of a company’s confidential commercial information or its intellectual property. If we cannot demonstrate that harm would be caused to us, we may be unable to prevent our competitors from benefiting from the expertise of our former employees.
We may become subject to the requirements of the 1940 Act, which would limit our business operations and require us to spend significant resources to comply with such act.
Section 3(a)(1)(C) of the 1940 Act defines an investment company as any issuer that “is engaged or proposes to engage in the business of investing, reinvesting, owning, holding or trading in securities, and owns or proposes to acquire investment securities having a value exceeding 40% of the value of such issuer’s total assets (exclusive of U.S. government securities and cash items).” As of March 31, 2019, we held approximately 16% of our total assets (excluding U.S. government securities and cash items) in investment securities. However, we exceeded the 40% asset threshold in June 2018, marking the beginning of a one-year safe harbor period under Rule 3a-2 under the 1940 Act. Rule 3a-2 provides temporary relief from the registration requirements of the 1940 Act to an issuer that, on a transient basis, is deemed to be an investment company. The transient investment company exemption is available to a company no more than once every three years. Assuming no other exclusion from the definition of investment company is available to us, we will have to comply with the 40% asset threshold for at least three years following December 31, 2018, the date we ceased being an inadvertent investment company. This may limit our ability to make certain investments or enter into joint ventures that could otherwise have a positive impact on our earnings. We do not intend to engage primarily in the business of investing, reinvesting, owning, holding or trading in
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investment securities but rather intend to engage primarily in the business of producing and distributing medical aesthetics products and solutions, and intend to continue to maintain our holdings of investment securities to less than 40% of our total assets (excluding U.S. government securities and cash items).
If we are deemed to be an investment company, the consequences of failing to register under the 1940 Act would be significant. For example, investment companies that fail to register under the 1940 Act are prohibited from conducting business in interstate commerce. The ramifications of registering as an investment company, both in terms of the restrictions imposed on us and the cost of compliance, would be significant. For example, in addition to expenses related to initially registering as an investment company, the 1940 Act also would impose various restrictions with regard to our ability to enter into affiliated transactions, the diversification of our assets, and our ability to borrow money. If we became subject to the 1940 Act at some point in the future, our ability to continue pursuing our business plan would be severely limited.
The expense and potential unavailability of insurance coverage for our customers and our company could adversely affect our ability to sell our products and our financial condition.
Some of our customers and prospective customers are required to maintain liability insurance to cover their operations and use of our products. Medical malpractice carriers are withdrawing coverage in certain states or substantially increasing premiums. If this trend continues or worsens, our customers may discontinue using our products and, industry-wide, potential customers may opt against purchasing light, laser or radio frequency-based products due to the cost or inability to procure insurance coverage.
Global economic and social conditions may adversely affect our business, financial condition and results of operations.
Any negative conditions in the national and global economic environments may adversely affect our business, financial condition and results of operations. During uncertain economic times and in tight credit markets, many of our customers may experience financial difficulties or be unable or unwilling to borrow money to fund their operations, including obtaining credit lines for purchasing our products, and may delay or reduce purchases or reduce the extent of their operations. The market for aesthetic procedures and the market for our premium products can be particularly vulnerable to economic uncertainty, since the end-users of our products may decrease the demand for our products when they have less discretionary income or feel uneasy about spending their discretionary income. In addition, in many instances, the ability of our customers to purchase our products depends in part upon the availability of obtaining financing at acceptable interest rates.
These factors could result in reductions in revenues from sales of our products, longer sales cycles, difficulties in collection of accounts receivable, slower adoption of new technologies and increased price competition. Payment by our customers of our receivables is dependent upon the financial stability of the economies of certain countries. In light of the current economic state of many countries outside of the United States, we continue to monitor the creditworthiness of our customers because weakness in the end-user market could negatively affect the cash flows of our customers who could, in turn, delay paying their obligations to us. This would increase our credit risk exposure and cause delays in our recognition of revenues on current and future sales to these customers. Any of these events would likely harm our business, and could have a material adverse effect on our business, financial condition and results of operations.
Any acquisitions that we make could disrupt our business and harm our financial condition.
We expect to evaluate potential strategic acquisitions of complementary businesses, products or technologies. We may also consider joint ventures and other collaborative projects. We may not be able to identify appropriate acquisition candidates or strategic partners, or successfully negotiate, finance or integrate any businesses, products or technologies that we acquire. Furthermore, the integration of any acquisition and management of any collaborative project may divert management’s time and resources from our core business and disrupt our operations. We do not have any experience with acquiring companies or products. If we decide to expand our product offerings, we may spend time and money on projects that do not increase our revenue. Any cash acquisition we pursue would diminish the proceeds from this offering available to us for other uses, and any stock acquisition would be dilutive to our shareholders. While we
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from time to time evaluate potential collaborative projects and acquisitions of businesses, products and technologies, and anticipate continuing to make these evaluations, we have no present understandings, commitments or agreements with respect to any acquisitions or collaborative projects.
We may need to raise additional capital in the future, which may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.
In the future, we may finance our cash needs through a combination of equity offerings, debt financings, grants, and license and development agreements in connection with any collaborations. We do not have any committed external source of funds. In the event we seek additional funds, we may raise additional capital through the sale of equity or convertible debt securities. In such an event, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our ordinary shares. Debt financing, if available, could result in increased fixed payment obligations and may involve agreements that include restrictive covenants, such as limitations on our ability to incur additional debt, make capital expenditures, acquire, sell or license intellectual property rights or declare dividends, and other operating restrictions that could hurt our ability to conduct our business.
Investing in marketable securities is subject to risks.
As of March 31, 2019, we had $19.0 million in cash and cash equivalents, $29.0 million in marketable securities (including U.S. government securities), and $16.1 million in bank deposits. We historically have invested excess cash in marketable securities, which may consist of equity securities, corporate or government bonds and mutual fund securities. These investments are subject to general credit, liquidity, and market risks, including from changes in interest rates and downturns similar to the U.S. sub-prime mortgage defaults that affected various sectors of the financial markets and caused credit and liquidity issues during the 2008 global financial crisis. Although we have not realized any significant losses from our investments in marketable securities, we may realize losses in the fair value of these investments, an inability to access cash in these investments for a potentially meaningful period, or a complete loss of these investments, which would have a negative effect on our operations, liquidity and financial condition.
In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would decline. The market risks associated with our marketable securities may have an adverse effect on our results of operations, liquidity and financial condition.
We have broad discretion in the use of our existing cash, cash equivalents and marketable securities and may not use them effectively,
Our management will have broad discretion in the application of our cash, cash equivalents and marketable securities. Because of the number and variability of factors that will determine our use of our cash, cash equivalents and marketable securities, their ultimate use may vary substantially from their currently intended use. Our management might not apply our cash, cash equivalents and marketable securities in ways that ultimately increase the value of your investment. The failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest our cash in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to us. If we do not use our resources in ways that enhance shareholder value, we may fail to achieve expected financial results, which could cause our share price to decline.
Exchange rate fluctuations may decrease our earnings if we are not able to hedge our currency exchange risks successfully.
A majority of our revenues and a substantial portion of our expenses are denominated in U.S. dollars. However, a portion of our revenues and a portion of our costs, including personnel and some marketing and facilities expenses, are incurred in New Israeli Shekels, Canadian dollars and Euros. Inflation in Israel or Europe may have the effect of increasing the U.S. dollar cost of our operations in that country. If the U.S. dollar declines in value in relation to one or more of these currencies, it will become more expensive for
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us to fund our operations in the countries that use those other currencies. To date, we have not found it necessary to hedge the risks associated with fluctuations in currency exchange rates. In the future, if we do not successfully engage in hedging transactions, our results of operations may be subject to losses from fluctuations in foreign currency exchange rates.
Cyber-attacks as well as improper disclosure or control of personal information could result in liability and harm our reputation, which could adversely affect our business and results of operations. We may face liability if we breach our obligations related to the protection, security, nondisclosure of confidential customer information or disclosure of sensitive data or failure to comply with data protection laws and regulations.
Our business is heavily dependent on the security of our IT networks and those of our customers. Internal or external attacks on any of those could disrupt the normal operations of our engagements and impede our ability to provide critical services to our customers, thereby subjecting us to liability under our contracts. Additionally, our business involves the use, storage and transmission of information about our employees, our customers and clients of our customers. While we take measures to protect the security of, and unauthorized access to, our systems, as well as the privacy of personal and proprietary information, it is possible that our security controls over our systems, as well as other security practices we follow or those systems of our customers into which we operate and rely upon, may not prevent the improper access to or disclosure of personally identifiable or proprietary information. Such disclosure could harm our reputation and subject us to liability under our contracts and laws that protect personal data, resulting in increased costs or loss of revenue.
Further, data privacy is subject to frequently changing rules and regulations, which sometimes conflict among the various jurisdictions and countries in which we provide services and continue to develop in ways which we cannot predict. We are subject to U.S. federal and state laws regarding data privacy and security including Section 5 of the Federal Trade Commission Act, or FTC Act. We are also subject to foreign data privacy and security laws, including the Global Data Protection Regulation, or GDPR, the European Union-wide legal framework to govern data collection, use and sharing and related consumer privacy rights. The GDPR includes significant penalties for non-compliance. Our failure to adhere to or successfully implement processes in response to changing regulatory requirements in this area could result in legal liability or impairment to our reputation in the marketplace, which could have a material adverse effect on our business, financial condition and results of operations.
In the course of providing services to our customers, we may have access to confidential customer information, including nonpublic personal data. We are bound by certain agreements to use and disclose this information in a manner consistent with the privacy standards under regulations applicable to our customers and are subject to numerous U.S. and foreign jurisdiction laws and regulations designed to protect this information, such as the European Union Directive on Data Protection and various U.S. federal and state laws governing the protection of health or other individually identifiable information. If any person, including a team member of ours, misappropriates customer confidential information, or if customer confidential information is inappropriately disclosed due to a security breach of our computer systems, system failures or otherwise, we may have substantial liabilities to our customers or our customers’ clients and may incur substantial liability and penalties in connection with any violation of applicable privacy laws and/or criminal prosecution. In addition, in the event of any breach or alleged breach of our confidentiality agreements with our customers, these customers may terminate their engagements with us or sue us for breach of contract, resulting in the associated loss of revenue and increased costs and damaged reputation. We may also be subject to civil or criminal liability if we are deemed to have violated applicable regulations. We cannot assure you that we will adequately address the risks created by the regulations to which we may be contractually obligated to abide.
We may become subject to numerous foreign, federal, and state healthcare statutes and regulations and our failure to comply could result in a material adverse effect to our business and operations.
Although none of our products or procedures using our products are currently covered by any state or federal government healthcare programs, or any private commercial payor, we may become subject to foreign, federal, and state laws intended to prevent healthcare fraud and abuse, including those that apply to all payors. These laws could include state anti-kickback and false claims laws, which may extend to services
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reimbursable by any payor, as well as state consumer protection laws. Although we currently are not subject to transparency laws, we may become subject to such laws in the future. Such laws could include requirements to disclose payments to certain healthcare professionals and healthcare entities or disclosures related to sales and marketing, or that could require healthcare professionals to provide notice to their patients of ownership or financial arrangements with manufacturers.
Efforts to ensure that our internal operations and business arrangements with third parties comply with future applicable healthcare laws and regulations may involve substantial costs. These laws and regulations, among other things, could constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements, including financing programs, we may have with physicians or other potential purchasers of our products. It is possible that governmental authorities may conclude that our business practices, including our arrangements with physicians, some of whom received stock options as compensation for services provided, as well as fees for marketing to other physicians, are subject to and do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our current or future operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties which could adversely affect our ability to operate our business and pursue our strategy.
We are subject to anti-bribery, anti-corruption and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.
As we grow our international presence and global operations, we will be increasingly exposed to trade and economic sanctions and other restrictions imposed by the United States, the European Union, the State of Israel and other governments and organizations. The U.S. Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the U.S. Foreign Corrupt Practices Act, or the FCPA, and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC. In addition, the U.K. Bribery Act of 2010, or the Bribery Act, prohibits both domestic and international bribery, as well as bribery across both private and public sectors. An organization that “fails to prevent bribery” by anyone associated with the organization can be charged under the Bribery Act unless the organization can establish the defense of having implemented “adequate procedures” to prevent bribery. Under these laws and regulations, as well as other anti-corruption laws, anti-money laundering laws, export control laws, customs laws, sanctions laws and other laws governing our operations, various government agencies may require export licenses, may seek to impose modifications to business practices, including cessation of business activities in sanctioned countries or with sanctioned persons or entities and modifications to compliance programs, which may increase compliance costs, and may subject us to fines, penalties and other sanctions. A violation of these laws or regulations would negatively affect our business, financial condition and results of operations.
We are in the process of implementing policies and procedures designed to ensure compliance by us and our directors, officers, employees, representatives, consultants and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations. We cannot assure you, however, that our policies and procedures are or will be sufficient or that directors, officers, employees, representatives, consultants and agents have not engaged and will not engage in conduct for which we may be held responsible, nor can we assure you that our business partners have not engaged and will not engage in conduct that could materially affect their ability to perform their contractual obligations to us or even result in our being held liable for such conduct. Violations of the FCPA, OFAC restrictions, the Bribery Act or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could have a material adverse effect on our business, financial condition and results of operations.
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Risks Related to Our Intellectual Property
If we are unable to protect our intellectual property rights, our competitive position could be harmed. Our success and ability to compete depends in large part upon our ability to protect our proprietary technology.
Our success and ability to compete depends in large part upon our ability to protect our proprietary technology. We rely primarily upon a combination of patents and trademarks, as well as nondisclosure, confidentiality and other contractual agreements to protect the intellectual property related to our brands, products and other proprietary technologies.
We generally apply for patents only in those countries where we intend to make, have made, use, offer for sale, or sell products. To date, we have only pursued patents in the United States, which we consider to be our main target market, and South Korea. Substantially all of our revenues for the three months ended March 31, 2019 and the years ended December 31, 2018 and 2017 were derived from the United States where we have patent protection. We do not seek protection in all countries where we sell products and we may not accurately predict all the countries where patent protection would ultimately be desirable. At this time, the countries in which we have not sought patent protection, but intend to offer our products for sale, are not our main target markets. We acknowledge that 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 in which we do not have patent protection. Such activity may prevent us from protecting our proprietary technology, and thus, may harm our competitive position.
Our patent portfolio consists of four issued patents and nine pending patent applications in the United States relating to our technology and products. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will be advantageous to us. Any issued patents may be challenged, invalidated or legally circumvented by third parties. We cannot be certain that our patents will be upheld as valid, proven enforceable or prevent the development of competitive products. Other companies may also design around technologies we have patented. Third parties may have blocking patents that could prevent us from marketing our products or practicing our own patented technology. In addition, competitors could purchase one of our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts, design around our protected technology, or develop their own competitive technologies that fall outside of our intellectual property rights. If our intellectual property is not adequately protected against competitors’ products and methods, our competitive position could be adversely affected, as could our business and financial results.
The U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by U.S. and foreign legislative bodies.
We rely on a combination of patent and other intellectual property laws and confidentiality, non-disclosure and assignment of inventions agreements, as appropriate, with our employees and consultants, to protect and otherwise seek to control access to, and distribution of, our proprietary information. These measures may not be adequate to protect our technology from unauthorized disclosure, third-party infringement or misappropriation. Parties may breach these agreements, and we may not have adequate remedies for any breach. Also, the laws of certain countries in which we develop, manufacture or sell our products may not protect our intellectual property rights to the same extent as the laws of the United States or Israel.
The aesthetics industry is highly competitive and marked by frequent litigation. New patent applications may be pending or may be filed in the future by third parties covering technology that we currently use or may ultimately use. Third parties may from time to time claim that our current or future products infringe their patent or other intellectual property rights and may seek to prevent, limit or interfere with our ability to make, use, sell or import our products. Moreover, if such a claim were to be decided adversely to us or if we settled such a claim on adverse terms, we could be forced to pay substantial damages, to license the technology in question at high rates or to redesign or modify our products so as to avoid any infringement. Any of those results could adversely affect our sales, margins and results of operations.
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If it appears necessary or desirable, we may try to obtain licenses for those patents or intellectual property rights that we are allegedly infringing, may infringe, or desire to use. Although holders of these types of intellectual property rights commonly offer these licenses, we cannot assure you that licenses will be offered or that the terms of any offered licenses will be acceptable to us. Our failure to obtain a license for key intellectual property rights from a third party for technology used by us could cause us to incur substantial liabilities and to suspend the manufacturing and selling of products utilizing the technology.
Alternatively, we could be required to expend significant resources to develop non-infringing technology. We cannot assure you that we would be successful in developing non-infringing technology.
Third parties have and may in the future commence litigation against us claiming that our products infringe upon their patents or other intellectual property rights.
From time to time, we may be party to, or threatened with, litigation or other proceedings with third parties, including non-practicing entities, who allege that our products, components of our products, services, and/or proprietary technologies infringe, misappropriate or otherwise violate their intellectual property rights. The types of situations in which we may become a party to such litigation or proceedings include:

we or our collaborators may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our products or processes do not infringe those third parties’ patents;

we or our collaborators may participate at substantial cost in International Trade Commission proceedings to abate importation of products that would compete unfairly with our products

if our competitors file patent applications that claim technology also claimed by us, we may be required to participate in interference, derivation or opposition proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position;

if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend against such proceedings;

if third parties initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product, service, or technology does not infringe our patents or patents licensed to us, we will need to defend against such proceedings;

we may be subject to ownership disputes relating to intellectual property, including disputes arising from conflicting obligations of consultants or others who are involved in developing our products; and,

if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate its patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our collaborators would need to defend against such proceedings.
These lawsuits and proceedings, regardless of merit, are time-consuming and expensive to initiate, maintain, defend or settle, and could divert the time and attention of managerial and technical personnel, which could materially adversely affect our business. Any such claim could also force use to do one or more of the following:

incur substantial monetary liability for infringement or other violations of intellectual property rights, which we may have to pay if a court decides that the product, service, or technology at issue infringes or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the third party’s attorneys’ fees;

pay substantial damages to our customers or end users to discontinue use or replace infringing technology with non-infringing technology;
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stop manufacturing, offering for sale, selling, using, importing, exporting or licensing the product or technology incorporating the allegedly infringing technology or stop incorporating the allegedly infringing technology into such product, service, or technology;

obtain from the owner of the infringed intellectual property right a license, which may require us to pay substantial upfront fees or royalties to sell or use the relevant technology and which may not be available on commercially reasonable terms, or at all;

redesign our products, services, and technology so they do not infringe or violate the third party’s intellectual property rights, which may not be possible or may require substantial monetary expenditures and time;

enter into cross-licenses with our competitors, which could weaken our overall intellectual property position;

lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property against others;

find alternative suppliers for non-infringing products and technologies, which could be costly and create significant delay; or

relinquish rights associated with one or more of our patent claims, if our claims are held invalid or otherwise unenforceable.
In April 2018, Syneron Medical Ltd., or Syneron, and Candela Corporation, together with Syneron, Syneron-Candela, filed claims with the International Trade Commission and with Massachusetts General Hospital, or MGH, in the United States District Court for the District of Massachusetts against our U.S. and Israeli subsidiaries, alleging that our fractional RF products infringed two U.S. patents owned by Syneron-Candela and MGH that purport to cover systems and methods for treating skin and arranging electrodes on skin therapy devices. In January 2019, we reached a settlement with Syneron-Candela and MGH that resolved all patent claims previously in dispute in exchange for a one-time cash payment that we made to Syneron-Candela and MGH in February 2019. As part of such settlement agreement, we entered into a sublicense agreement with Syneron-Candela and MGH that granted us and our affiliates a fully paid non-exclusive, royalty-free worldwide sublicense to practice the patents and applications previously in dispute in the licensed field. The sublicense shall continue until the expiration of the last surviving patent or application granted pursuant to the sublicense agreement. Although we may try to resolve any potential future claims or actions, we may not be able to do so on reasonable terms, if at all. Infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate, and could divert management’s attention from our core business. If we lose this kind of litigation, a court could require us to pay substantial damages and could prohibit us from using technologies essential to our products, either of which would have a material adverse effect on our business, results of operations and financial condition.
We may become involved in litigation to protect the trademark rights associated with our company name or the names of our products. If we have to change the name of our company or products, we may experience a loss in goodwill associated with our brand name, customer confusion and a reduction in sales.
Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays, or prohibit us from manufacturing, marketing or otherwise commercializing our products, services and technology. Any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operation, financial condition or cash flows.
In addition, we may indemnify our customers and distributors against claims relating to the infringement of intellectual property rights of third parties related to our products. Third parties may assert infringement claims against our customers or distributors. These claims may require us to initiate or defend protracted and costly litigation on behalf of our customers or distributors, regardless of the merits of these
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claims. If any of these claims succeed, we may be forced to pay damages on behalf of our customers, suppliers or distributors, or may be required to obtain licenses for the products or services they use. If we cannot obtain all necessary licenses on commercially reasonable terms, our customers may be forced to stop using our products or services.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a material adverse effect on the price of our ordinary shares. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our ordinary shares.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to protect our rights in these trademarks and trade names, which we need in order to build name recognition with potential partners or customers in our markets of interest. If we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
We do and may employ individuals who were previously employed at universities or other pharmaceutical or medical device companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject to such claims. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. 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.
For example, in April 2017, Syneron-Candela filed a lawsuit in the United States District Court for the Western District of Tennessee against us and our wholly-owned subsidiaries in Israel and the United States, asserting claims for inducement to breach contract, interference with employment relationships, tortious interference with business and violation of the Tennessee Uniform Trade Secrets Act with respect to four former employees of Syneron-Candela who subsequently accepted employment with us. In January 2018, we reached a settlement and the case was dismissed with prejudice. Additionally, in May 2017, Cynosure, Inc., or Cynosure, filed a claim with the United States District Court for the Southern District of Texas (Houston) against us and our U.S. subsidiary, claiming that we unlawfully solicited certain former Cynosure employees, misappropriated Cynosure’s trade secrets, and aided and abetted the employees’ breach of their fiduciary duties to Cynosure. We reached a settlement in February 2018 and the case was dismissed with prejudice.
Intellectual property rights do not necessarily address all potential threats to our business.
The degree of future protection afforded by our intellectual property rights is uncertain because even granted intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors or permit us to maintain our competitive advantage. Moreover, if a third party has intellectual property rights that cover the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights. The following examples are illustrative:

others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology, but that are not covered by the claims of the patents that we own or control, assuming such patents have issued or do issue;
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we or any future strategic partners might not have been the first to conceive or reduce to practice the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed;

we or any future strategic partners might not have been the first to file patent applications covering certain of our inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

it is possible that our pending patent applications will not lead to issued patents;

issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license;

parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property;

we may not develop or in-license additional proprietary technologies that are patentable;

we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and

the patents of others may have an adverse effect on our business.
Should any of these events occur, they could significantly harm our business and results of operations.
Risks Related to Government Regulation
Our business is subject to extensive and continuing regulatory compliance obligations. If we fail to obtain and maintain necessary market clearances from the FDA and other marketing authorizations from counterpart foreign regulatory authorities for our products and indications, if clearances or other marketing authorizations for future products and indications are delayed or not issued, if we or any of our third-party suppliers or manufacturers fail to comply with applicable regulatory requirements, or if there are U.S. federal or state level or counterparty foreign regulatory changes, our commercial operations could be harmed.
Our products are medical devices subject to extensive regulation by the applicable regulatory authorities where our products are or will be sold prior to their marketing for commercial use. In the United States, our products are subject to extensive regulation by the FDA for developing, testing, manufacturing, labeling, sale, marketing, advertising, promotion, distribution, import, export, shipping, establishment registration and device listing, inspections and audits, record keeping, recalls and field safety corrective actions and post-market surveillance, including reporting of certain events.
Before a new medical device, or a new use of, or claim for, an existing product can be marketed in the United States, it must first receive marketing authorization from the FDA unless it is exempt. The FDA marketing authorizations include a 510(k) clearance or premarket approval. A relatively small number of devices may be exempt from 510(k) clearance or may receive marketing authorization through the de novo classification pathway. These processes can be expensive and lengthy. The FDA’s 510(k) clearance process usually takes from three to 12 months, but it can last longer. The process of obtaining premarket approval is much more costly and uncertain than the 510(k) clearance process and it generally takes from one to three years, or even longer, from the time the application is filed with the FDA. Our future products and enhancements or changes to products may require new 510(k) clearance or premarket approval from the FDA. All products that we currently market in the United States that require an FDA marketing authorization have received 510(k) clearance for the uses for which they are marketed.
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Medical devices may be marketed only for the indications for which they are approved or cleared. We have obtained 510(k) clearance for the current treatments for which we offer our products. However, our clearances can be revoked under certain circumstances. If the FDA disagrees with us concerning the scope or applicability of a clearance or exemption with respect to a device, we may be required to change our promotional and/or labeling materials and/or stop marketing that device. Changes or modifications to an FDA-cleared device that could significantly affect its safety or effectiveness or that constitute a major change or modification in its intended use would require a new 510(k) clearance or possibly premarket approval. We may not be able to obtain additional 510(k) clearances or premarket approvals for new products or for modifications to, or additional indications for, our existing products in a timely fashion, or at all. Delays in obtaining future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our revenue and future profitability. We have made modifications to our devices in the past and may make additional modifications in the future that we believe do not or will not require additional clearances or approvals. If the FDA disagrees, and requires new clearances or approvals for the modifications, we may be required to recall and to stop marketing the modified devices. We also are subject to the FDA’s Medical Device Reporting regulations, which require us to report to the FDA if our products cause or contribute to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury.
The FDA or the applicable foreign regulatory bodies can delay, limit or deny clearance or approval of a device for many reasons, including:

our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory bodies that our products are safe or effective for their intended uses;

the disagreement of the FDA or the applicable foreign regulatory bodies with the design or implementation of our clinical trials or the interpretation of data from pre-clinical studies or clinical trials;

serious and unexpected adverse device effects experienced by participants in our clinical trials;

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

our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;

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

the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.
In addition, the FDA or applicable foreign regulatory bodies may change their clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new clearances, increase the costs of compliance or restrict our ability to maintain our current clearances. For example, as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012, Congress reauthorized the Medical Device User Fee Amendments with various FDA performance goal commitments and enacted several “Medical Device Regulatory Improvements” and miscellaneous reforms, which are further intended to clarify and improve medical device regulation both pre- and post-clearance and approval. Some of these proposals and reforms could impose additional regulatory requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance or restrict our ability to maintain our current clearances.
Additionally regulatory clearances or approvals to market a product can contain limitations on the indicated uses for such product. Product clearances and approvals can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial clearance or approval. FDA regulations depend heavily on administrative interpretation, and there can be no assurance that future interpretations made by the FDA or other regulatory bodies will not adversely affect our operations. We and our manufacturers may be inspected by the FDA from time to time to determine
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whether we or our manufacturers are in compliance with applicable laws, including the cGMP regulations set forth in the QSR, including those relating to specifications, development, documentation, validation, testing, quality control and product labeling. A determination that we are in violation of FDA or other applicable foreign regulations or any of our product clearances or approvals could lead to imposition of civil penalties, including fines, product recalls or product seizures and, in certain cases, criminal sanctions.
The use, misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
The use, misuse or off-label use of our products may harm our reputation or the image of our products in the marketplace, result in injuries that lead to product liability suits, which could be costly to our business, or result in legal sanctions if we are deemed or alleged to have engaged in off-label promotion.
A medical device may be authorized by the FDA for marketing through several regulatory mechanisms. The FDA classifies medical devices as Class I, Class II, or Class III, in increasing order of risk. Most of our products are Class I or Class II medical devices. As such, they are either exempt from premarketing authorization requirements or are subject to the 510(k) clearance process, and all are listed with the FDA pursuant to FDA’s medical device listing requirements.
Under FDA regulations, for each of our products we must only use labeling, including advertising and promotional materials, that is consistent with the specific indication(s) for use included in the FDA exemption regulation, clearance, or approval, that is applicable to the specific product. If the FDA or other authorities determine that our promotional or training materials constitute the unlawful promotion of an off-label use, they could request that we modify our training or promotional materials and/or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, civil money penalties, seizure, injunction or criminal fines and penalties. For example, on July 30, 2018, we received a letter, dated July 24, 2018, from the FDA seeking information as to the regulatory bases for marketing of our FormaV and FractoraV handpieces based on our promotion and labeling of these devices for use in certain women’s health conditions and procedures. For the three months ended March 31, 2019 and 2018, we derived approximately 15% and 28%, respectively, of our total U.S. revenues from our FormaV and FractoraV handpieces and related products. For the years ended December 31, 2018 and 2017, we derived approximately 23% and 21%, respectively, of our total U.S. revenues from our FormaV and FractoraV handpieces and related products. We timely responded to the FDA in August 2018 answering the FDA’s questions. We informed the FDA that the Forma V had received 510(k) clearance for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation and that we had determined that the device also fell within a Class II premarketing exemption enabling marketing of the device for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel’s exercise (tightening of the muscles of the pelvic floor to increase muscle tone) without the need to obtain a 510(k) clearance. We also informed the FDA that the FractoraV has received 510(k) clearance for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. In addition, we advised the FDA that we have modified our promotional and labeling materials to remove statements using the terms “sexual dysfunction,” “vaginal rejuvenation” or “urinary stress incontinence,” which were the subject of the agency’s letter to us. The FDA responded in September 2018 by stating that the agency had reviewed our response letter and verified the changes in terminology made to our website. Moreover, the FDA further responded in November 2018 and confirmed we addressed all items raised by the agency in its letter, and that the FDA continued to expect us to conduct a review of our marketing and promotional materials to make appropriate changes and remove materials containing uncleared claims regarding this matter. We have received no further communications from the agency regarding this matter. We cannot be certain whether any further information may be requested by the FDA in the future and/or any further action may be required on our part, and we cannot guarantee that the FDA will continue to deem our response and actions to have addressed all items raised by the agency in this matter. If the FDA issues a further communication finding that some or all of our modifications to our marketing and labeling materials are insufficient, or otherwise takes the position that our products are being marketed for off-label uses, we could be subject to further discussions with and/or action by the agency, including the possibility of a warning letter or other enforcement activity. Other federal, state or foreign governmental authorities might also take action if they consider our promotion or training materials to constitute promotion of an
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uncleared or unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement, or exclusion from participation in federal health programs. In each event, our reputation could be damaged and the use of our products in the marketplace could be impaired, or our business could face significant hardship. While no third-party claims have been brought against us to date, it is possible that the FDA letter may lead to private litigation by third parties, potentially including purchasers of FormaV and FractoraV handpieces or patients who were treated using those handpieces.
In addition, there may be increased risk of injury if physicians or others attempt to use our products off-label. The FDA does not restrict or regulate a physician’s use of a medical product within the practice of medicine, and we cannot prevent a physician from using our products for an off-label use. The use of our products for indications other than those for which our products have been approved or cleared by the FDA may not effectively treat the conditions not referenced in product indications, which could harm our reputation in the marketplace among physicians and patients. Physicians may also misuse our products or use improper techniques if they are not adequately trained in the particular use, potentially leading to injury and an increased risk of product liability. Product liability claims are expensive to defend and could divert management’s attention from our primary business and result in substantial damage awards against us. Any of these events could harm our business, results of operations and financial condition.
We are subject to ongoing regulatory obligations and a failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
Even after we have obtained the proper regulatory clearance or approval to market a product, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations. The FDA, state and foreign regulatory authorities have broad enforcement powers. The regulations to which we are subject are complex and have become more stringent over time. Regulatory changes could result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales.
Our products and/or their use are also subject to state regulations and additional regulations in other foreign jurisdictions outside of the United States, which may change at any time. We cannot predict the impact or effect of future legislation or regulations and any changes in regulations may impede sales.
Furthermore, the FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions:

warning letters or untitled letters, fines, injunctions, consent decrees and civil penalties;

repair, replacement, refunds, recalls, termination of distribution, administrative detention or seizure of our products;

operating restrictions or partial suspension or total shutdown of production;

refusing our requests for 510(k) clearance or premarket approval of new products, new intended uses, or modifications to existing products;

withdrawing 510(k) clearances or premarket approvals or foreign regulatory approvals that have already been granted, resulting in prohibitions on sales of our products; and

criminal prosecution.
The occurrence of any of these events could harm our business, financial condition and results of operations.
If we or our subcontractors fail to comply with federal and state regulation, including the FDA’s Quality System Regulation/Medical Device Good Manufacturing Practices and performance standards, our or our subcontractors’ manufacturing operations could be halted, and our business would suffer.
We and our subcontractors currently are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation/Medical Device Current Good Manufacturing Practices, or QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing,
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control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products. Because our products use optical energy, including lasers, our products also are covered by a performance standard for lasers set forth in FDA regulations. The laser performance standard imposes specific record-keeping, reporting, product testing and product labeling requirements. These requirements include affixing warning labels to laser products, as well as incorporating certain safety features in the design of laser products. The FDA enforces the QSR and laser performance standards through periodic announced or unannounced inspections. We and our subcontractors are subject to such inspections. Although we place our own quality control employee at each of our subcontractor’s facilities, we do not have complete control over our subcontractor’s compliance with these standards.
Any failure by us or our subcontractors to take satisfactory corrective action in response to an adverse QSR inspection or to comply with applicable laser performance standards could result in enforcement actions against us or our subcontractors, including warning letters or untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals or clearances; seizures or recalls of our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for our products; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us or our employees. Any of these actions could significantly and negatively impact the supply of our products, and could cause our sales and business to suffer. In addition, we are subject to standards imposed on our activities outside of the United States, such as obtaining DEKRA certification (CE certification in Europe) and the Standards Institution of Israel (imposed on our activities in Israel), and failure to comply with such standards could adversely impact our business.
Our products may cause or contribute to adverse medical events or other undesirable side effects that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
We are subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting obligations, the FDA could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance, seizure of our products or delay in clearance of future products.
The FDA and foreign regulatory bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. We may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future. Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals or clearances for the product before we may market or distribute the corrected product. Seeking such approvals or clearances may delay our ability to replace the recalled products in a timely manner. Moreover, if we do not adequately address problems associated with our products, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.
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Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations, it could require us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales.
We may be unable to obtain or maintain international regulatory qualifications or approvals for our current or future products and indications, which could harm our business. Additionally, obtaining and maintaining regulatory approval in one jurisdiction does not mean we will be successful in obtaining regulatory approval for our products in other jurisdictions.
Sales of our products outside the United States are subject to foreign regulatory requirements that vary widely from country to country, including some regulatory requirements that we may not be fully aware, or that may change in ways that affect our ability to sell our products in those jurisdictions. Complying with international regulatory requirements can be an expensive and time-consuming process and approval is not certain. The regulatory process in foreign jurisdictions includes all the risks associated with obtaining FDA clearance, as well as additional risks not present in the FDA process. For example, the time required to obtain foreign clearance or approvals may be longer than that required for FDA clearance or approvals, and requirements for such clearances or approvals may significantly differ from FDA requirements, adding costs and variability. Foreign regulatory authorities may not approve our product for the same uses cleared by the FDA. Although we have obtained regulatory approvals to sell our products in the European Union and other countries outside the United States, we may be unable to maintain regulatory qualifications, clearances or approvals in these countries or to obtain approvals in other countries. We also may incur significant costs in attempting to obtain and in maintaining foreign regulatory approvals or qualifications. If we experience delays in receiving necessary qualifications, clearances or approvals to market our products outside the United States, or if we fail to receive those qualifications, clearances or approvals, we may be unable to market some of our products or enhancements in certain international markets effectively, or at all. Since the enactment of the Israeli Medical Equipment Law, 2012, or the Medical Equipment Law, in 2012, the manufacturing and marketing of medical and certain aesthetic devices, including our products, in Israel requires registration with the Israeli Ministry of Health. The Medical Equipment Law offers a fast-track registration process for devices that received approval from certain non-Israeli regulatory agencies, including FDA clearance or CE marks. We have taken advantage of such fast-track registration process in the past. If we are unable to obtain and maintain the necessary registration for any of our products in Israel, we may have to move the manufacturing of such unregistered products to a location outside of Israel and stop selling these products in Israel until the products are registered. We may also suffer harm to our reputation as a result.
New regulations may limit our ability to sell to non-physicians in the future.
Currently, we sell our products solely to physicians. However, where permitted under applicable laws, we intend to introduce certain of our products in the developing medical spa market, where aesthetic procedures are being performed at dedicated facilities by non-physicians under physician supervision. U.S., state and international regulations could change at any time, disallowing sales of our products to aestheticians, and/or limiting the ability of aestheticians and non-physicians to operate our products. We cannot predict the impact or effect of changes in U.S., state or international laws or regulations.
Risks Related to this Offering
Our ordinary shares have not been publicly traded, and we expect that the price of our ordinary shares will fluctuate substantially.
Before this offering, there has been no public market for our ordinary shares. An active public trading market may not develop after completion of this offering or, if developed, may not be sustained. The lack of a trading market may result in the loss of research coverage by securities analysts. Moreover, we cannot
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assure you that any securities analysts will initiate or maintain research coverage of our company and our ordinary shares. The price of the ordinary shares sold in this offering will not necessarily reflect the market price of our ordinary shares after this offering. The market price for our ordinary shares after this offering will be affected by a number of factors, including:

fluctuations in our operating results or the operating results of our competitors;

changes in the estimates of the future size and growth rate of our market opportunities;

changes in the general economic, industry and market conditions;

success of competitive technologies and procedures;

recruitment or departure of key personnel;

the announcement of new products or enhancements by us or our competitors;

the commencement or outcome of litigation against us, or involving our general industry or both;

changes in earnings estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ earning estimates;

developments in our industry, including the announcement of significant new technologies, procedures or acquisitions by us or our competitors;

actual or expected sales of our ordinary shares by the holders of our ordinary shares; and

the trading volume of our ordinary shares.
In addition, the stock prices of many companies in the medical device industry have experienced wide fluctuations that often have been unrelated to the operating performance of those companies. These factors and price fluctuations may materially and adversely affect the market price of our ordinary shares.
An active trading market for our ordinary shares may not develop, and you may not be able to resell your ordinary shares at or above the public offering price.
Prior to this offering, there has been no public market for our ordinary shares. The initial public offering price has been determined by negotiation between the representatives of the underwriters and us. This price may not reflect the market price of our ordinary shares following this offering. In addition, an active trading market may not develop following completion of this offering or, if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses, applications or technologies using our shares as consideration.
Purchasers in this offering will experience immediate and substantial dilution in net tangible book value.
The assumed initial public offering price will be substantially higher than the pro forma net tangible book value per share of our outstanding ordinary shares. As a result, investors purchasing ordinary shares in this offering will incur immediate dilution of  $11.07 per ordinary share, based on an assumed initial public offering price of  $15.00 per ordinary share, the midpoint of the range set forth on the cover page of this prospectus. Investors purchasing ordinary shares in this offering will pay a price per ordinary share that substantially exceeds the net tangible book value per ordinary share.
In addition, the exercise of outstanding options will, and future equity issuances may, result in further dilution to investors. As of March 31, 2019, there were outstanding options to purchase 9,599,293 ordinary shares under our share option plans at a weighted average exercise price of  $1.08 per ordinary share.
A significant share ownership position in our company is held by a small number of existing shareholders, who may make decisions with which you may disagree.
Our directors and officers, along with our two largest shareholders, in the aggregate, currently beneficially own or control approximately 77% of our outstanding ordinary shares and will beneficially own or control approximately 65% of our outstanding ordinary shares following the completion of this offering,
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or 64% if the underwriters exercise their over-allotment option in full. The interests of these shareholders may differ from your interests. These shareholders are not prohibited from selling a controlling interest in us to a third party. While these shareholders will not have the right to appoint board members directly after the closing of this offering, these shareholders, acting together, could exercise significant influence over our operations and business strategy and will have sufficient voting power to influence all matters requiring approval by our shareholders, including the ability to elect or remove directors, to approve or reject mergers or other business combination transactions, the raising of future capital and the amendment of our articles of association, which govern the rights attached to our ordinary shares. In addition, this concentration of ownership may delay, prevent or deter a change in control, or deprive you of a possible premium for your ordinary shares as part of a sale of our company. Furthermore, this concentration of ordinary share ownership may adversely affect the trading price for our ordinary shares because investors may perceive disadvantages in owning shares in companies where persons have a significant interest.
We will have broad discretion in how we use the proceeds of this offering and we may not apply the proceeds to uses that will benefit shareholders.
We intend to use the net proceeds of this offering to expand our sales and marketing operations, to fund our research and development activities, and the remainder for general corporate purposes, including potential acquisitions of complementary products, technologies or businesses and research and development. We have no current agreements or commitments with respect to any investment or acquisition, and we are not engaged in negotiations with respect to any investment or acquisition. Our management will have broad discretion over the use and investment of the net proceeds from this offering, and accordingly investors in this offering will need to rely upon the judgment of our management with respect to the use of proceeds. Our management could spend the proceeds in ways that you do not agree with or that do not improve our results of operations or enhance the value of our ordinary shares. Our failure to apply these proceeds effectively could have a material adverse effect on our business and cause the price of our ordinary shares to decline.
The requirements of being a public company may strain our resources and divert management’s attention.
The requirements of being a public company may strain our resources and divert management’s attention. As a public company, whose ordinary shares are listed in the United States, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq as applicable to foreign private issuers, and other applicable federal and state securities rules and regulations. We expect that compliance with these rules and regulations will increase our legal, accounting and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our business systems and resources. The Exchange Act requires, among other things, that we file annual and current reports with respect to our business and financial condition. Our management will be required to devote substantial time and attention to our public company reporting obligations and other compliance matters.
If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our ordinary shares, the price of our ordinary shares could decline.
The trading market for our ordinary shares will rely in part on the research and reports that equity research analysts publish about us and our business, our market or our competitors, if at all. We do not have control over these analysts and we do not have commitments from them to write research reports about us. The price of our ordinary shares could decline if no research reports are published about us or our business, if one or more equity research analysts downgrade our ordinary shares or if those analysts issue other unfavorable commentary or cease publishing reports about us or our business, or if any of those analysts issues a comparatively more favorable recommendation about our competitors.
Future sales of our ordinary shares could reduce the price of our ordinary shares.
Sales by shareholders of substantial amounts of our ordinary shares, or the perception that these sales may occur in the future, could materially and adversely affect the market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities and our ability to
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acquire other companies by using our ordinary shares as consideration. The ordinary shares we are offering for sale in this offering will be freely tradable immediately following this offering (except for ordinary shares purchased in the directed share program, which are subject to a 180-day lock-up period). In addition, a substantial number of ordinary shares held by our current shareholders or issuable upon exercise of options will be eligible for sale in the public market after this offering, and could be sold pursuant to registration under the Securities Act of 1933, as amended, or the Securities Act, or an exemption from registration. Our executive officers, directors, and certain of our shareholders have agreed not to sell their ordinary shares for a period of 180 days after the date of this prospectus. As these restrictions on resale end, the market price of our ordinary shares could drop significantly if the holders of these restricted ordinary shares sell them or are perceived by the market as intending to sell them.
We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our ordinary shares.
We have never paid cash dividends on our ordinary shares and do not anticipate distributing cash or other dividends on our ordinary shares in the foreseeable future. The distribution of dividends on our ordinary shares will depend on our earnings, financial condition and other business and economic factors affecting us at such time as our board of directors may consider relevant. We may only distribute dividends out of  “profits,” as defined by the Israeli Companies Law, 1999, as amended, or the Companies Law, and provided that the distribution is not reasonably expected to impair our ability to fulfill our outstanding and anticipated obligations as they become due. See “Description of Share Capital — Dividend and Liquidation Rights” for additional information. If we do not distribute dividends, our ordinary shares may be less valuable because a return on your investment will only occur if the price of our ordinary shares appreciates.
We will incur significant increased costs as a result of operating as a public company in the United States, and our management will be required to devote substantial time to new compliance initiatives.
As a public company whose ordinary shares are listed in the United States, we will be subject to an extensive regulatory regime, requiring us, among other things, to maintain various internal controls and facilities and to prepare and file periodic and current reports and statements. Complying with these requirements will be costly and time consuming. We will need to retain additional employees to supplement our current finance staff, and we may not be able to do so in a timely manner, or at all. In the event that we are unable to demonstrate compliance with our obligations as a public company in a timely manner, or are unable to produce timely or accurate financial statements, we may be subject to sanctions or investigations by regulatory authorities and investors may lose confidence in our operating results and the price of our ordinary shares could decline.
We may be subject to securities litigation, which is expensive to defend and could divert management’s attention.
In the past, following periods of market volatility in the price of a company’s securities or the reporting of unfavorable news, security holders have often instituted class action litigation. If the market value of our securities experience adverse fluctuations and we become involved in this type of litigation, regardless of the outcome, we could incur substantial legal costs and our management’s attention could be diverted from the operation of our business, causing our business to suffer. Any adverse determination in litigation could also subject us to significant liabilities.
U.S. investors in the Company could suffer adverse tax consequences if we are characterized as a passive foreign investment company.
We believe that we were not a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for our taxable year ended December 31, 2018, and we do not expect to be classified as a PFIC for the current year ending December 31, 2019 or the foreseeable future. However, the relevant rules for determining whether or not we are a PFIC as applied to our business are not entirely clear and certain aspects of such determination will be outside our control. Therefore, no assurance can be given that we will not be classified as a PFIC for any taxable year.
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If we are determined to be a PFIC at any time during which a U.S. Holder (as defined in “Taxation — Material U.S. Federal Income Tax Considerations to U.S. Holders”) holds our shares, such U.S. Holder may be subject to materially adverse consequences, including additional U.S. federal income tax liability and tax filing obligations. See “Taxation — Material U.S. Federal Income Tax Considerations to U.S. Holders — Passive Foreign Investment Company Considerations.” U.S. Holders are strongly urged to consult their tax advisors as to whether or not we will be a PFIC.
We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth companies may make our ordinary shares less attractive to investors.
We are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions from various requirements that are applicable to other public companies that are not emerging growth companies.
For as long as we remain an emerging growth company we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not “emerging growth companies.” These exemptions include, among others:

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

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

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements.
We will remain an emerging growth company until the earliest of: (i) the last day of our fiscal year during which we have total annual gross revenues of at least $1.07 billion; (ii) the last day of our fiscal year following the fifth anniversary of the closing of this offering; (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (iv) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act. We have irrevocably opted out of the extended transition period made available to emerging growth companies to comply with newly adopted public company accounting requirements.
When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We cannot predict if investors will find our ordinary shares less attractive as a result of our reliance on exemptions under the JOBS Act. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares and our ordinary share price may be more volatile.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ordinary shares.
Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404 of the Sarbanes-Oxley Act, or Section 404, or any subsequent testing by our independent registered public accounting firm, as and when required, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our ordinary shares.
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We are a “foreign private issuer” and have disclosure obligations that are different from those of U.S. domestic reporting companies.
We are a foreign private issuer and are not subject to the same requirements that are imposed upon U.S. domestic issuers by the SEC. Under the Exchange Act, we will be subject to reporting obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting companies. For example, we will not be required to issue quarterly reports or proxy statements that comply with the requirements applicable to U.S. domestic reporting companies. Furthermore, although under regulations promulgated under the Companies Law, as an Israeli public company listed on the Nasdaq, we will be required to disclose the compensation of our five most highly compensated officers on an individual basis, this disclosure will not be as extensive as that required of U.S. domestic reporting companies. We will also have four months after the end of each fiscal year to file our annual report with the SEC and will not be required to file current reports as frequently or promptly as U.S. domestic reporting companies. Furthermore, our officers, directors and principal shareholders will be exempt from the requirements to report transactions and short-swing profit recovery required by Section 16 of the Exchange Act. Also, as a “foreign private issuer,” we are not subject to the requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. These exemptions and leniencies will reduce the frequency and scope of information and protections available to you in comparison to those applicable to a U.S. domestic reporting companies.
As a “foreign private issuer,” we are permitted, and intend, to follow certain home country corporate governance practices instead of otherwise applicable SEC and Nasdaq requirements, which may result in less protection than is accorded to investors under rules applicable to domestic U.S. issuers.
As a “foreign private issuer,” we will be permitted, and intend, to follow certain home country corporate governance practices instead of those otherwise required under the listing rules of Nasdaq for domestic U.S. issuers. For instance, we intend to follow our home country law instead of the listing rules of Nasdaq that require that we obtain shareholder approval for certain dilutive events, such as the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of us, certain transactions other than a public offering involving issuances of a 20% or greater interest in the Company, and certain acquisitions of the stock or assets of another company. Under the Companies Law as currently applicable to us, there is no requirement to receive shareholder approval for the issuance of securities for such dilutive events, and under our amended and restated articles of association our board of directors is authorized to issue securities, including ordinary shares, warrants and convertible notes. Additionally, under the Companies Law, unless the articles of association otherwise provide, the quorum required for an ordinary meeting of shareholders must consist of at least two shareholders who hold at least 25% of the voting rights (instead of the 3313% required under Nasdaq rules), and we are not required to have a nominating committee consisting solely of independent directors for the nomination of directors. See “Management — Corporate Governance Practices” for details on the differences between Israeli corporate governance practices and comparable U.S. requirements and other home country practices we intend to follow instead of the listing rules of Nasdaq. We may in the future elect to follow home country corporate governance practices in Israel with regard to other matters. Following our home country corporate governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on Nasdaq may provide less protection to you than what is accorded to investors under the listing rules of Nasdaq applicable to domestic U.S. issuers.
Risks Related to Our Operations in Israel
Political, economic and military instability in Israel may impede our ability to operate and harm our financial results.
Our principal executive offices and research and development facilities as well as our third-party manufacturers are located in Israel. In addition, all of our subcontractors are located in Israel. Accordingly, political, economic and military conditions in Israel and the surrounding region could directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors, Hamas (an Islamist militia and political group in the Gaza Strip) and Hezbollah (an Islamist militia and political group in Lebanon). Any hostilities involving Israel or the
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interruption or curtailment of trade between Israel and its present trading partners could affect adversely our operations. Ongoing and revived hostilities or other Israeli political or economic factors, could prevent or delay shipments of our products, harm our operations and product development and cause our sales to decrease. In the event that hostilities disrupt the ongoing operation of our facilities or the airports and seaports on which we depend to import and export our supplies and products, our operations may be materially adversely affected. Furthermore, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries, principally those in the Middle East, still restrict business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or increases. These restrictive laws and policies may seriously limit our ability to sell our products in these countries and may have an adverse impact on our operating results, financial conditions or the expansion of our business.
In addition, political uprisings and conflicts in various countries in the Middle East are affecting the political stability of those countries. This instability has raised concerns regarding security in the region and the potential for armed conflict. In Syria, a country bordering Israel, a civil war is taking place. In addition, there are concerns that Iran, which has previously threatened to attack Israel, may step up its efforts to achieve nuclear capability. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon. Additionally, the Islamic State of Iraq and Levant, or ISIL, a violent jihadist group whose stated purpose is to take control of the Middle East, has been growing in influence. The tension between Israel and Iran and/or these groups may escalate in the future and turn violent, which could affect the Israeli economy in general and us in particular. Any potential future conflict could also include missile strikes against parts of Israel, including our offices and facilities. Such instability may lead to deterioration in the political and trade relationships that exist between the State of Israel and certain other countries. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our results of operations and could make it more difficult for us to raise capital. Parties with whom we do business may be disinclined to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in order to meet our business partners face to face. In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.
Our insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle East or for any resulting disruption in our operations. Although the Israeli government has in the past covered the reinstatement value of direct damages that were caused by terrorist attacks or acts of war, we cannot be assured that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred and the government may cease providing such coverage or the coverage might not suffice to cover potential damages. Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions generally and could harm our results of operations.
Our operations may be disrupted by the obligations of our personnel to perform military service.
Many of our employees in Israel, including members of our senior management, are obligated to perform up to 36 days, and in some cases longer periods, of military reserve duty annually until they reach the age of 40 (or older, for citizens who hold certain positions in the Israeli armed forces reserves) and, in the event of a military conflict or emergency situations, could be called to immediate active duty for extended periods of time. In response to increases in terrorist activity, there have been periods of significant call-ups of military reservists. It is possible that there will be similar large-scale military reserve duty call-ups in the future. Our operations could be disrupted by the absence due to military service of a significant number of our employees or of one or more of our key employees for extended periods of time, and such disruption could materially adversely affect our business. Additionally, the absence of a significant number of the employees of our Israeli suppliers and subcontractors related to military service or the absence for extended periods of one or more of their key employees for military service may disrupt their operations which may subsequently disrupt our operations.
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We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
We have entered into assignment of invention agreements with our employees pursuant to which such individuals agree to assign to us all rights to any inventions created during their employment or engagement with us. A significant portion of our intellectual property has been developed by our employees in the course of their employment with us. Under the Israeli Patent Law, 1967, or the Patent Law, inventions conceived by an employee during the scope of his or her employment with a company and as a result thereof are regarded as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that if there is no agreement between an employer and an employee with respect to the employee’s right to receive compensation for such “service inventions,” the Israeli Compensation and Royalties Committee, a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his or her service inventions and the scope and conditions for such remuneration. Although our employees have agreed to assign to us service invention rights, as a result of uncertainty under Israeli law with respect to the efficacy of waivers of service invention rights, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current and/or former employees, or be forced to litigate such claims, which could negatively affect our business.
Our operations may be affected by negative economic conditions or labor unrest in Israel.
General strikes or work stoppages, including at Israeli ports, have occurred periodically or have been threatened in the past by Israeli trade unions due to labor disputes. These general strikes or work stoppages may have an adverse effect on the Israeli economy and on our business, including our ability to deliver products to our customers and to receive raw materials from our suppliers in a timely manner and could have a material adverse effect on our results of operations.
You may have difficulties enforcing a U.S. judgment against us, our executive officers and directors and Israeli experts named in this prospectus in Israel or the United States, asserting U.S. securities laws claims in Israel or serving process on our officers and directors and these experts in Israel.
We are incorporated in Israel and our corporate headquarters are located in Israel. A significant portion of our assets and the assets of certain of our directors and executive officers are located outside the United States. Therefore, a judgment obtained against us or any of them in the United States, including one based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be enforced by an Israeli court. Further, if a foreign judgment is enforced by an Israeli court, it will be payable in Israeli currency. It also may be difficult for you to assert U.S. securities law claims in original actions instituted in Israel. Additionally, it may be difficult for an investor, or any other person or entity, to initiate an action with respect to U.S. securities laws in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws reasoning that Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proven as a fact by expert witnesses, which can be a time consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters described above. As a result of the difficulty associated with enforcing a judgment in Israel, you may not be able to collect any damages awarded by either a United States or foreign court. For more information regarding the enforceability of civil liabilities against us, our directors and our executive officers, please see “Enforceability of Civil Liabilities.”
The tax benefits available to us require us to meet several conditions and may be terminated or reduced in the future, which would increase our costs and taxes.
We have generated income and are able to take advantage of tax exemptions and reductions resulting from the “Benefited Enterprise” status of our facilities in Israel. Our “Benefited Enterprise” status provides us with a ten-year tax exemption for undistributed income. The first year in which we were exempted from tax as stated above was 2012 and such ten-year eligibility period of tax exemption will terminate in 2021. Our entitlement to these tax benefits as a “Benefited Enterprise” is subject to the conditions stipulated by
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Israeli law. Specifically, we must produce all of our products, directly or through subcontractors, in Israel. Additionally, for any given year, we must meet one of the following conditions: (i) our revenues from any one country cannot exceed 75% of our total revenues, or (ii) 25% or more of our total revenues are derived from sales in a country with a population of at least 14 million. If we fail to meet these conditions in the future, the tax benefits could be canceled and we could be required to refund any tax benefits we might already have enjoyed. These tax benefits may not be continued in the future at their current levels or at any level. The termination or reduction of these tax benefits will increase our expenses in the future, which would reduce our expected profits or increase our losses. Additionally, if we increase our activities outside of Israel, for example, by future acquisitions, our increased activities generally will not be eligible for inclusion in Israeli tax benefit programs.
Provisions of our amended and restated articles of association and Israeli law may delay, prevent or make difficult an acquisition of our company which could prevent a change of control even when the terms of such transaction are favorable to us and our shareholders and, therefore, could depress the price of our ordinary shares.
As a company incorporated under the laws of the State of Israel, we are subject to Israeli corporate law. Israeli corporate law regulates mergers, requires tender offers for acquisitions of ordinary shares above specified thresholds, requires special approvals for transactions involving directors, officers or certain significant shareholders and regulates other matters that may be relevant to these types of transactions. In addition, our amended and restated articles of association, which will be effective upon the effectiveness of the registration statement of which this prospectus forms a part, contain provisions that may make it more difficult to acquire us, such as classified board provisions. Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to some of our shareholders. These provisions of our amended and restated articles of association and Israeli law may delay, prevent or make difficult an acquisition of us, which could prevent a change of control and therefore depress the price of our ordinary shares. See “Description of Share Capital — Anti-Takeover Provisions; Mergers and Acquisitions” for additional information.
Your rights and responsibilities as a holder of our ordinary shares will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.
The rights and responsibilities of the holders of our ordinary shares are governed by our articles of association and by Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders in typical U.S. corporations. In particular, a shareholder of an Israeli company has certain duties, including to act in good faith and fairness and in a customary manner in exercising its rights and performing its obligations towards the company and other shareholders and to refrain from abusing its power in the company including, among other things, in voting at the general meeting of shareholders on certain matters, such as an amendment to the company’s articles of association, an increase of the company’s authorized share capital, a merger of the company, and approval of related party transactions that require shareholder approval. A shareholder also has a general duty to refrain from discriminating against other shareholders. In addition, a controlling shareholder or a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of an officer of the company has a duty to act in fairness towards the company with regard to such vote or appointment. See “Management — Approval of Related Party Transactions under Israeli Law — Shareholders” for additional information. There is limited case law available to assist in understanding the nature of these duties or the implications of these provisions. These provisions may be interpreted to impose additional obligations on holders of our ordinary shares that are not typically imposed on shareholders of U.S. corporations.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

our ability to identify and penetrate new markets for our products and technology;

our ability to innovate, develop and commercialize our existing and new products and expand beyond our traditional customer base;

our ability to obtain and maintain regulatory clearances;

our expectation regarding the safety and efficacy of our products;

commercial experience of our management team;

our commercialization, marketing and manufacturing capabilities and strategy;

our estimates regarding the potential market opportunity for our products;

developments and projections relating to our competitors or our industry;

our ability to differentiate and distinguish our products from those of our competitors;

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

our sales and marketing capabilities and strategy in the United States and internationally;

the implementation of our business model, strategic plans for our business, products and technology;

our ability to attract or retain key personnel;

our intellectual property portfolio and position and our ability to protect our intellectual property rights;

our assessment of the impact to us of any third-party litigation claiming patent infringement;

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make.
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You should read this prospectus and the documents that we have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this prospectus are made as of the date of this prospectus, and we do not assume any obligation to update any forward-looking statements except as required by applicable law.
MARKET, INDUSTRY AND OTHER DATA
In this prospectus, we have used industry and market data obtained from our own internal estimates and research as well as from industry publications and research, surveys and studies conducted by third parties. We have compiled, extracted and reproduced industry and market data from external sources that we believe to be reliable. We caution prospective investors not to place undue reliance on the above mentioned data. Unless otherwise indicated in the prospectus, the basis for any statements regarding our competitive position is based on our own assessment and knowledge of the market in which we operate. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
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USE OF PROCEEDS
We estimate that the net proceeds to us from our issuance and sale of 5,000,000 ordinary shares in this offering will be approximately $67.9 million (or $78.3 million if the underwriters exercise their option to purchase additional shares in full), based on the assumed initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
Each $1.00 increase (decrease) in the assumed initial public offering price of  $15.00 per ordinary share, the midpoint of the price range set forth on the cover of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, would increase (decrease) net proceeds to us from this offering by approximately $4.7 million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of ordinary shares we are offering. Each increase (decrease) of 1.0 million ordinary shares offered by us at the assumed initial public offering price would increase (decrease) the net proceeds to us from this offering by approximately $14.0 million, assuming no change in the assumed public offering price per ordinary share.
The principal purposes of this offering are to obtain additional capital to support our operations, to create a public market for our ordinary shares, to facilitate our future access to the public equity markets and to increase awareness of our Company among potential customers. We intend to use the net proceeds from this offering to hire additional sales and marketing personnel, to expand our global sales and marketing programs, to fund research and development activities, and the remainder for working capital and general corporate purposes.
We may also use a portion of the net proceeds from this offering to acquire or invest in products, technologies or businesses that are complementary to our business. However, we currently have no agreements or commitments to complete any such transaction.
Our expected use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend. The amounts and timing of our actual use of net proceeds will vary depending on numerous factors. As a result, our management will have broad discretion in the application of the net proceeds of this offering, and investors will be relying on our judgment regarding the application of the net proceeds.
Pending their use, we may plan to invest certain of the net proceeds of this offering in short- and intermediate-term interest-bearing investments.
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DIVIDEND POLICY
We have never declared or paid cash dividends to our shareholders and currently we do not intend to pay cash dividends in the foreseeable future. We intend to reinvest any future earnings in developing and expanding our business.
Our ability to pay cash dividends may be limited by Israeli law, which permits the distribution of dividends only out of profits. See “Description of Share Capital — Dividend and Liquidation Rights.” In addition, the payment of cash dividends may be subject to Israeli withholding taxes. See “Taxation —  Material Israeli Tax Considerations.”
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CAPITALIZATION
The following table sets forth our cash and cash equivalents, short-term bank deposits and marketable securities and capitalization as of March 31, 2019:

on an actual basis; and

on a pro forma basis to give effect to our issuance and sale of 5,000,000 ordinary shares in this offering, based on the assumed initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
You should read this table in conjunction with our consolidated financial statements and related notes appearing elsewhere in this prospectus, as well as the sections of this prospectus titled “Selected Consolidated Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
As of March 31, 2019
Actual
Pro Forma(1)
Unaudited
(dollars in thousands, except share data)
Cash and cash equivalents, short-term bank deposits and marketable securities
$ 64,083 $ 132,108
Shareholders’ equity:
Ordinary shares, NIS 0.01 par value: 100,000,000 ordinary shares authorized, 26,946,737 shares issued and outstanding, actual;      100,000,000 ordinary shares authorized, 31,946,737 ordinary shares issued and outstanding, pro forma
$ 75 $ 89
Additional paid-in capital
10,675 78,686
Accumulated other comprehensive income
103 103
Retained earnings
43,030 43,030
Non-controlling interests
1,441 3,693
Total shareholders’ equity
$ 55,324 $ 125,601
Total capitalization
$ 55,324 $ 125,601
(1)
Each $1.00 increase (decrease) in the assumed initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover of this prospectus, would increase (decrease) our pro forma cash and cash equivalents, additional paid-in capital, total shareholders’ equity and total capitalization by approximately $4.7 million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of ordinary shares we are offering. Each increase (decrease) of 1.0 million ordinary shares offered by us at the assumed initial public offering price would increase (decrease) our pro forma cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $14.0 million, assuming no change in the assumed public offering price per ordinary share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
The outstanding share information in the table above excludes:

9,599,293 ordinary shares issuable upon the exercise of options outstanding as of March 31, 2019 at a weighted-average exercise price of  $1.08 per ordinary share; and

976,613 ordinary shares reserved for future issuance under our 2018 Incentive Plan as of March 31, 2019, as well as ordinary shares that may be issued pursuant to provisions in our 2018 Incentive Plan that automatically increase the ordinary share reserve under our 2018 Incentive Plan.
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DILUTION
Our net tangible book value as of March 31, 2019 was $56.6 million, or $2.10 per ordinary share. Net tangible book value per ordinary share represents the amount of our total consolidated tangible assets less our total consolidated liabilities, divided by the number of ordinary shares outstanding.
Pro forma net tangible book value dilution per ordinary share represents the difference between the amount per ordinary share paid by purchasers of ordinary shares in this offering and net tangible book value per ordinary share immediately after the completion of this offering on a pro forma basis. After giving effect to the sale of 5,000,000 ordinary shares by us in this offering at the assumed initial public offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma net tangible book value would have been approximately $125.6 million, or approximately $3.93 per ordinary share based on 31,946,737, ordinary shares outstanding upon completion of this offering. This represents an immediate increase in pro forma net tangible book value of  $1.83 per ordinary share to existing shareholders and an immediate dilution of  $11.07 per ordinary share to purchasers of ordinary shares in this offering. The following table illustrates this per ordinary share dilution:
Assumed initial public offering price per ordinary share
       ​
$ 15.00
Net tangible book value per ordinary share as of March 31, 2019
$ 2.10
Increase in net tangible book value per ordinary share attributable to this offering
$ 1.83
Pro forma net tangible book value per ordinary share after this offering
$ 3.93
Dilution per ordinary share to investors in this offering
$ 11.07
Each $1.00 increase (decrease) in the assumed initial public offering price of  $15.00 per ordinary share, the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma net tangible book value by $0.15 per ordinary share and would increase (decrease) dilution to investors in this offering by $0.85 per ordinary share, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of ordinary shares we are offering. Each increase (decrease) of 1.0 million ordinary shares in the number of ordinary shares offered by us at the assumed initial public offering price would increase (decrease) our pro forma net tangible book value by $0.30 or $(0.32), respectively per ordinary share and would (decrease) increase dilution to investors in this offering by $(0.30) or $0.32, respectively per ordinary share, assuming no change in the assumed public offering price per ordinary share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
If the underwriters exercise their option to purchase additional ordinary shares in full, our pro forma net tangible book value after giving effect to this offering would be $4.16 per ordinary share, which amount represents an immediate increase in pro forma net tangible book value of  $0.23 per ordinary share to existing shareholders and an immediate dilution in net tangible book value of  $10.84 per ordinary share to new investors.
If all of our outstanding stock options had been exercised as of March 31, 2019, our pro forma net tangible book value as of March 31, 2019, before giving effect to the issuance and sale of ordinary shares in this offering, would have been $10.4 million, or $1.81 per ordinary share, and our pro forma net tangible book value as of March 31, 2019 after this offering would have been $136.0 million, or $3.27 per share, causing dilution to new investors of  $11.73 per ordinary share.
The following table presents, on a pro forma basis, as of March 31, 2019, the differences between the number of ordinary shares purchased from us, the total consideration paid to us, and the average price per ordinary share paid by existing shareholders and by new investors purchasing ordinary shares at the assumed initial offering price of  $15.00 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting estimated underwriting discounts and
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commissions and estimated offering expenses payable by us. The total number of ordinary shares does not include ordinary shares issuable upon the exercise of the over-allotment option granted to the underwriters.
Ordinary Shares Purchased
Total Consideration
Average Price Per
Ordinary Share
Number
Percent
Amount(1)
Percent
Existing shareholders
26,946,737 84.4% $ 4,643 5.8% $ 0.17
New investors
5,000,000 15.7% 75,000 94.2% $ 15.00
Total
31,946,737 100.00% $ 79,643 100.00% $ 2.49
(1)
Amount in thousands.
If the underwriters exercise their option to purchase additional ordinary shares in full, the total consideration paid by new investors and the average price per ordinary share paid by new investors would be approximately $86.3 million and $15.00 per ordinary share, respectively.
The above tables and discussions are based on our ordinary shares outstanding as of March 31, 2019, which gives effect to the pro forma transactions described above and excludes:

9,599,293 ordinary shares issuable upon the exercise of options outstanding as of March 31, 2019 at a weighted-average exercise price of  $1.08 per ordinary share; and

976,613 ordinary shares reserved for future issuance under our 2018 Incentive Plan, as well as ordinary shares that may be issued pursuant to provisions in our 2018 Incentive Plan that automatically increase the ordinary share reserve under our 2018 Incentive Plan.
The pro forma information discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our ordinary shares and other terms of this offering determined at pricing.
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SELECTED CONSOLIDATED FINANCIAL DATA
The following tables present our selected consolidated financial data and should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes appearing elsewhere in this prospectus. The historical results are not necessarily indicative of the results to be expected for any future. We derived the selected consolidated statements of income data below for the three months ended March 31, 2019 and 2018 and the selected balance sheet data as of March 31, 2019 and 2018 from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. We have prepared the unaudited condensed consolidated financial statements on the same basis as the audited consolidated financial statements and have included, in our opinion, all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair statement of the financial information set forth in those statements. We derived the selected consolidated statements of income data below for the years ended December 31, 2018 and 2017 and the selected balance sheet data as of December 31, 2018 and 2017 from our audited consolidated financial statements included elsewhere in this prospectus. Our unaudited condensed consolidated financial statements and audited consolidated financial statements are presented in U.S. dollars and prepared in accordance with U.S. GAAP.
Three months ended March 31,
Year ended December 31,
2019
2018
2018
2017
(in thousands, except share and per share data)
Consolidated Statements of Income Data:
Revenues
$ 30,552 $ 20,911 $ 100,162 $ 53,456
Cost of revenues
4,271 3,532 15,057 9,053
Gross profit
26,281 17,379 85,105 44,403
Operating expenses:
Research and development
1,199 880 4,180 2,575
Sales and marketing
14,097 9,665 44,622 28,514
General and administrative
1,053 895 4,814 4,364
Legal settlements and loss contingencies
8,000
Total operating expenses
16,349 11,440 61,616 35,453
Operating income
$ 9,932 $ 5,939 $ 23,489 $ 8,950
Financial income, net
403 278 136 849
Income before taxes
$ 10,335 $ 6,217 $ 23,625 $ 9,799
Income tax
177 (149) 1,260 980
Net income
$ 10,158 $ 6,366 $ 22,365 $ 8,819
Net loss (income) attributable to non-controlling interests
(34) 6
Net income attributable to controlling interest
$ 10,124 $ 6,366 $ 22,371 $ 8,819
Net income per ordinary share:
Basic
$ 0.38 $ 0.22 $ 0.82 $ 0.29
Diluted
$ 0.28 $ 0.17 $ 0.62 $ 0.26
Weighted average number of ordinary shares:
Basic
26,818,179 26,497,050 26,613,942 26,283,548
Diluted
35,457,601 34,711,741 35,006,644 29,669,922
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As of March 31,
As of December 31,
2019
2018
2017
(in thousands)
Consolidated Balance Sheet Data:
Cash and cash equivalents
$ 18,951 $    24,721 $    17,593
Working capital(1)
58,057 48,335 23,694
Total assets
85,067 81,056 39,442
Total liabilities
27,491 34,193 16,923
Redeemable non-controlling interests
2,252 2,187 3,066
Retained earnings
43,030 32,971 10,819
Non-controlling interests
1,441 1,413
Total shareholders’ equity
55,324 44,676 19,453
(1)
We define working capital as current assets less current liabilities. See our consolidated financial statements included elsewhere in this prospectus for further details regarding our current assets and current liabilities.
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MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction with “Selected Consolidated Financial Data” and our consolidated financial statements and the related notes to those statements included elsewhere in this prospectus. In addition to historical consolidated financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” and elsewhere in this prospectus. On July 24, 2019, the Stock Split of our ordinary shares by way of an issuance of bonus shares was effected and all information in this prospectus reflects the Stock Split unless otherwise indicated.
Overview
We design, develop, manufacture and commercialize innovative, energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. Our proprietary minimally-invasive RFAL, Deep Subdermal Fractional RF, Simultaneous Fat Destruction and Skin Tightening and Deep Heating Collagen Remodeling technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including fat reduction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Our non-invasive medical aesthetic products target a wide array of procedures including simultaneous fat killing and skin tightening, permanent hair reduction through the use of our innovative dual wavelength technology, and other treatments targeting skin appearance and texture through the use of our high power IPL technology. Our products may be used on a variety of body parts, including the face, neck, abdomen, upper arms, thighs and intimate feminine regions. Since 2010, we have launched six product platforms (BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF) that we market and sell traditionally to plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/​GYNs.
Our revenues increased to approximately $30.6 million for the three months ended March 31, 2019, from approximately $20.9 million for the three months ended March 31, 2018. Our revenues increased to approximately $100.2 million for the year ended December 31, 2018 from approximately $53.5 million for the year ended December 31, 2017. For the three months ended March 31, 2019 and 2018, we recorded a gross profit margin of approximately 86% and 83%, respectively, and net income of approximately $10.2 million and $6.4 million, respectively. For the years ended December 31, 2018 and 2017, we recorded a gross profit margin of approximately 85% and 83%, respectively, and net income of approximately $22.4 million and $8.8 million, respectively.
We were incorporated in January 2008 and have a limited history of operations, having commenced sales in 2010. In February 2016, we received FDA clearance enabling us to market our RFAL-based BodyTite products for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. We sell our products directly in the United States, Canada, United Kingdom, Spain and India, and indirectly through third-party distributors in other countries. As of June 30, 2019, we had a global installed base of over 3,900 product platforms capable of running various multi-use applicators and minimally-invasive consumables.
As a result of continued innovation, recently received FDA clearances and product launches, we increased our sales and marketing efforts in connection with product introductions and other marketing activities, as well as expanded the number of our direct salespersons in North America from 55 representatives as of December 31, 2017, to 86 representatives as of June 30, 2019.
We outsource a majority of the manufacturing of our products to four subcontractors in Israel, while we manufacture our laser and IPL handpieces in-house in Israel. Outsourcing allows us to carry low inventory levels and maintain fixed unit costs without incurring significant capital expenditures. Our manufacturing subcontractors provide us fully assembled, or “turn-key,” services. We control and monitor the quality of our products by having one of our quality control employees at each of our subcontractor’s
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facilities. All assembled products are sent to our warehouse in Israel where they are inspected and tested. We ship the finished products to our distributors upon receipt of a purchase order or to our subsidiaries to replenish inventory levels. Usually, products are tested again locally by our distributors or subsidiaries prior to being shipped and sold to the customer.
We anticipate that our quarterly results of operations may fluctuate from quarter to quarter due to several factors, including seasonality, unexpected delays in the introduction and market acceptance of our products, unexpected delays in our manufacturing operations, introduction of new and improved products by our competitors and the performance of our direct sales organization.
Components of Our Results of Operations
Revenues
We generate our revenues primarily from the sale of energy-based medical aesthetic products, which consist of platforms and non-consumable handpieces. To a lesser extent, we generate revenue from the sale of consumables and from the sale of extended warranties. For the three months ended March 31, 2019 and 2018, we derived approximately 91% and 93%, respectively, of our revenues from the sale of medical aesthetic products and approximately 9% and 7%, respectively, of our revenues from the sale of consumables and extended warranties. For the years ended December 31, 2018, 2017 and 2016, we derived approximately 93% of our revenues from the sale of medical aesthetic products and approximately 7% of our revenues from the sale of consumables and extended warranties. We expect our revenues from the sale of consumables and extended warranties to increase over time as our installed base continues to grow. We have experienced growth in sales of consumables in the past three years. Recent revenue growth has been driven by, and we expect continued growth as a result of, increased patient and physician awareness of our medical aesthetic products and additional sales representatives. We have expanded our sales and marketing organization to help us drive and support revenue growth and intend to continue this expansion.
For the three months ended March 31, 2019 and 2018, we derived approximately 23% and 35%, respectively, of our total revenues from the sale of products and solutions relating to our BodyTite and EmbraceRF platforms in the United States, approximately 22% and 17%, respectively, of our total revenues from the sale of products and solutions relating to our Optimas platform in the United States, approximately 15% and 28%, respectively, of our total revenues from the sale of products and solutions in the United States primarily designed to address women’s health and approximately 13% and 8%, respectively, of our total revenues from the sale of products and solutions relating to our Contoura platform in the United States. For the years ended December 31, 2018, 2017 and 2016, we derived approximately 27%, 26% and 17%, respectively, of our total revenues from the sale of products and solutions relating to our BodyTite and EmbraceRF platforms in the United States, approximately 19%, 10% and 0%, respectively, of our total revenues from the sale of products and solutions relating to our Optimas platform in the United States and approximately 23%, 21% and 0%, respectively, of our total revenues from the sale of products and solutions in the United States primarily designed to address women’s health. For the years ended December 31, 2018, 2017 and 2016, we derived less than 10% of our total revenues from the sale of products and solutions related to our Contoura platform in the United States. In the future, we expect that the contributions to revenues from the sale of products and solutions relating to our BodyTite, EmbraceRF and Optimas platforms and women’s health related treatments in the United States will continue to be similar to the contributions to revenues for year ended December 31, 2018 (excluding the impact of new products from which we generate revenues). We do not anticipate that the platforms that are currently under development will contribute meaningfully to our revenues in 2019.
We sell our products directly in the United States, Canada, United Kingdom, Spain and India, and indirectly through third-party distributors in other countries. For the three months ended March 31, 2019, we derived approximately 88% of our revenues in North America compared to approximately 89% of our revenues for the three months ended March 31, 2018. For the year ended December 31, 2018, we derived approximately 89% of our revenues in North America compared to approximately 83% of our revenues for the year ended December 31, 2017.
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The following table provides information regarding the breakdown of our revenue by geographic region for the three months ended March 31, 2019 and 2018 and for the years ended December 31, 2018 and 2017:
Percent of Revenue
Three months ended
March 31,
Years ended
December 31,
Geographic region
2019
(%)
2018
(%)
2018
(%)
2017
(%)
North America (excluding Mexico)(1)
88 89 89 83
Europe 7 8 6 9
Asia-Pacific 3 1 3 6
Other 2 2 2 2
Total
100 100 100 100
(1)
For the three months ended March 31, 2019 and 2018, we derived approximately 79% and 83%, respectively, of our total revenues from the United States. For the years ended December 31, 2018 and 2017, we derived approximately 81% and 80%, respectively, of our total revenues from the United States.
We believe that there are opportunities for us to generate additional revenue from existing customers who are already familiar with our products. For example, one-third of our customers purchase a second platform to expand their treatment offerings within 18 months of their first transaction. We intend to continue to make significant investments in research and development activities, increase the number of sales representatives in our sales and marketing organization and introduce innovative next-generation pipeline products to our customers. As a result, we expect that certain existing customers will be candidates for technology upgrades to enhance the capabilities of their existing InMode products. In addition, as we continue to grow our support services program, we expect to increase the number of customers that enter into service contracts and extended warranties with us, which would result in additional recurring revenues. We also plan to expand our current product line in order to reach non-traditional customers, such as ENTs, ophthalmologists, general practitioners and aesthetic clinicians, and generate additional revenue.
Cost of Revenues
Our cost of revenues consists primarily of the expenses we incur to have our products manufactured and assembled by third parties and the direct costs we incur in order to obtain the materials, labor and overhead that are needed to manufacture and assemble our products.
Our cost of revenues also includes shipping, handling, service and warranty expenses, as well as salaries and personnel-related expenses for our operations management team, which is comprised of subcontractor supervisors and purchasing and quality control employees. We expect our cost of revenues to increase in absolute dollars primarily as, and to the extent, our revenue grows.
Our cost of revenues as a percentage of revenues has been, and we expect it to continue to be, affected by a variety of factors, including manufacturing costs, the average selling price of our products, the maturity of our existing products, promotional prices being offered to existing customers for our new products, and to a lesser extent the sales mix between the United States and the rest of the world as our average selling price in the United States tends to be higher than in the rest of the world. We expect our gross margin to be positively affected over time to the extent we are successful in reducing manufacturing costs as our sales volume increases and our average selling prices are maintained. However, our gross margin may fluctuate from period to period.
Research and Development Expenses
Our research and development expenses consist of salaries and personnel-related expenses, including share-based compensation expenses, for our employees that are primarily engaged in research, development and engineering activities. Our research and development expenses also include regulatory-related costs and
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expenses, external engineering fees, materials used and other overhead expenses that are incurred in connection with the design and development of our products. We expense all of our research and development costs as incurred. While we do not track our research and development spending by technology, product or application, we do expect that our overall research and development costs will increase in absolute dollars in the future as we develop more products and technologies. We expect research and development expenses as a percentage of our total revenue to vary over time depending on the level and timing of initiating new product development efforts.
Sales and Marketing Expenses
Our sales and marketing expenses consist primarily of salaries, commissions and personnel-related expenses, including share-based compensation expenses, for our employees that are engaged in sales and marketing activities, which include marketing and public support of our products, participation in trade shows and industry events, promotional and public relations activities, and administrative functions in support of sales and marketing. We expect sales and marketing expenses to continue to increase in absolute dollars as we continue to expand our marketing organization to both drive and support our planned growth in revenue. However, we expect sales and marketing expenses to decrease as a percentage of our total revenue primarily as, and to the extent, our revenue grows.
General and Administrative Expenses
Our general and administrative expenses consist primarily of salaries and personnel-related expenses, including share-based compensation expenses, for executive, accounting and administrative personnel, professional fees and other general corporate expenses. We expect our general and administrative expenses will increase in the future as we increase our headcount and expand our administrative infrastructure to support our growth and operations as a public company. We also expect to see an increase in our share-based compensation expense with the establishment of our new equity plan in connection with this offering and related grants either in the form of restricted stock or options. During the three months ended March 31, 2019 and the year ended December 31, 2018, the majority of our general and administrative expenses were attributable to legal costs and expenses related to our patent litigations. We expect general and administrative expenses to remain flat as a percentage of our total revenue due to the dismissal of all patent litigation following the entry into a settlement agreement in January 2019.
Financial Income (Expenses), Net
Our financial income, net, consists primarily of the interest we earn on our cash, cash equivalents, deposits, marketable securities and long-term installment sales contracts with end-users, taking into consideration appropriate exchange rate adjustments.
Income Tax
We are subject to income taxes in Israel, the United States and numerous foreign jurisdictions.
Our facilities in Israel were granted the status of  “Benefited Enterprise” that provides us with a ten-year corporate tax exemption for undistributed income, provided that we meet certain conditions, including that the production of all of our products, directly or through subcontractors, is performed in Israel. The first year in which we were exempted from Israeli corporate tax was 2012 with the ten-year eligibility period of tax exemption expected to terminate in 2021.
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Three Months Ended March 31, 2019 Compared to Three Months Ended March 31, 2018
Three months ended March 31,
2019
2018
($)
(%)
($)
(%)
(in thousands)
Revenues 30,552 100 20,911 100
Cost of revenues
4,271 14 3,532 17
Gross profit
26,281 86 17,379 83
Operating expenses:
Research and development
1,199 4 880 4
Sales and marketing
14,097 46 9,665 46
General and administrative
1,053 3 895 5
Total operating expenses
16,349 53 11,440 55
Income from operations
9,932 33 5,939 28
Financial income, net
403 1 278 1
Income before taxes
10,335 34 6,217 29
Income tax (tax benefit)
177 1 (149) (1)
Net income
10,158 33 6,366 30
Net income attributable to non-controlling interests
34 0
Net income attributable to controlling interest
10,124 33 6,366 30
Revenue.   Our revenues increased by approximately $9.6 million, or 46%, to approximately $30.6 million for the three months ended March 31, 2019, compared to approximately $20.9 million for the three months ended March 31, 2018. This increase was primarily attributable to increased sales resulting from our increased participation in global marketing, tradeshows and clinical workshops, which we believe has resulted in increased patient and physician awareness of our technologies and product offerings through personal experience and referrals. Additionally, this increase in revenue is also attributable to the expansion of our direct sales organization, which continued to expand worldwide.
Our revenues in North America increased by approximately $8.3 million, or 45%, to approximately $26.9 million for the three months ended March 31, 2019, compared to approximately $18.6 million for the three months ended March 31, 2018. This increase was primarily attributable to the expansion of our direct sales organization and an increase in clinical workshops for customers and prospects.
Our revenues in Europe increased by approximately $0.5 million, or 27%, to approximately $2.1 million for the three months ended March 31, 2019, compared to approximately $1.6 million for the three months ended March 31, 2018. This increase was primarily driven by the expansion of the direct sales team in the United Kingdom and Spain and their subsequent training, experience and familiarity with our products.
Our revenues from the sale of consumables and extended warranties for the three months ended March 31, 2019 increased by approximately 70% compared to the three months ended March 31, 2018. This increase was primarily attributable to the growth in our installed platform base, as well as increased patient and physician awareness of our technologies and product offerings through personal experience and referrals.
Cost of Revenues.   Our cost of revenues increased by approximately $0.7 million, or 21%, to approximately $4.3 million for the three months ended March 31, 2019, compared to approximately $3.5 million for the three months ended March 31, 2018. This increase was primarily due to increased costs to purchase manufactured products to support the higher sales volume. Our gross margin increased to approximately 86% for the three months ended March 31, 2019, compared to approximately 83% for the three months ended March 31, 2018, primarily due to a reduction in fixed expenses and service costs related to legacy products.
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Research and Development Expenses.   Our research and development expenses increased by approximately $0.3 million, or 36%, to approximately $1.2 million for the three months ended March 31, 2019, compared to approximately $0.9 million for the three months ended March 31, 2018. This increase was primarily attributable to an increase in salaries and related expenses resulting from our increased headcount.
Sales and Marketing Expenses.   Our sales and marketing expenses increased by approximately $4.4 million, or 46%, to approximately $14.1 million for the three months ended March 31, 2019, compared to approximately $9.7 million for the three months ended March 31, 2018. This increase was primarily attributable to the expansion of our direct sales organization and an increase in compensation related to revenue increases in North America.
General and Administrative Expenses.   Our general and administrative expenses increased by approximately $0.2 million, or 18%, to approximately $1.1 million for the three months ended March 31, 2019, compared to approximately $0.9 million for the three months ended March 31, 2018. This increase was primarily attributable to an increase in salaries and related expenses resulting from our increased headcount and increased premiums and related expenses under our product liability insurance policy as a result of our increase in sales compared to the prior period.
Financial Income, Net.   Our financial income, net, was approximately $0.4 million for the three months ended March 31, 2019, compared to approximately $0.3 million for the three months ended March 31, 2018. This increase was primarily attributable to an increase in income from interest derived from our increased investments in government and corporate debt securities and bank deposits.
Income Tax.   Our income tax was approximately $0.2 million for the three months ended March 31, 2019, compared to a tax benefit of approximately $0.2 million for the three months ended March 31, 2018.
Year Ended December 31, 2018 Compared to Year Ended December 31, 2017
Years ended December 31,
2018
2017
($)
(%)
($)
(%)
(in thousands)
Revenues 100,162 100 53,456 100
Cost of revenues
15,057 15 9,053 17
Gross profit
85,105 85 44,403 83
Operating expenses:
Research and development
4,180 4 2,575 5
Sales and marketing
44,622 45 28,514 53
General and administrative
4,814 5 4,364 8
Legal settlements and loss contingencies
8,000 8
Total operating expenses
61,616 62 35,453 66
Income from operations
23,489 23 8,950 17
Financial income, net
136 1 849 2
Income before taxes
23,625 24 9,799 18
Income tax
1,260 (2) 980 (2)
Net income
22,365 22 8,819 16
Net loss attributable to non-controlling interests
6 0
Net income attributable to controlling interest
22,371 22 8,819 16
Revenue.   Our revenues increased by approximately $46.7 million, or 87%, to approximately $100.2 million for the year ended December 31, 2018, compared to approximately $53.5 million for the year ended December 31, 2017. This increase was primarily attributable to an increased patient and physician awareness of our technologies and product offerings and the expansion of our direct sales organization. In
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addition, approximately $11.8 million, or 25%, of this increase was attributable to the introduction of new products, including our Votiva platform that launched in the third quarter of 2017. Approximately $4.3 million, or 9%, of the increase was attributable to an increase in our average selling prices in North America.
Our revenues in North America increased by approximately $44.8 million, or 100%, to approximately $89.4 million for the year ended December 31, 2018, compared to approximately $44.6 million for the year ended December 31, 2017. This increase was primarily attributable to the expansion of our direct sales organization, which increased sales in North America, the commercial launch of our Votiva platform, during the third quarter of 2017, and an increase in our average selling prices in North America.
Our revenues in Europe increased by approximately $1.1 million, or 24%, to approximately $5.7 million for the year ended December 31, 2018, compared to approximately $4.6 million for the year ended December 31, 2017. This increase was primarily driven by the establishment of a direct sales team in the United Kingdom and Spain, which increased sales in those regions and an increase in the number of distributors in Europe.
Our revenues from the sale of consumables and extended warranties for the year ended December 31, 2018 increased by approximately 107% compared to the year ended December 31, 2017. This increase was primarily attributable to the growth in our installed platform base, as well as patients and physicians becoming more familiar with our products.
Cost of Revenues.   Our cost of revenues increased by approximately $6.0 million, or 66%, to approximately $15.1 million for the year ended December 31, 2018, compared to approximately $9.1 million for the year ended December 31, 2017. This increase was primarily due to increased costs to purchase manufactured products to support the higher sales volume. Our gross margin increased to approximately 85% for the year ended December 31, 2018, compared to approximately 83% for the year ended December 31, 2017, primarily due to the increase in our average selling prices in North America, as well as a higher percentage of revenue derived from North America as compared to other regions, because our average selling price in the United States tends to be higher than in rest of the world.
Research and Development Expenses.   Our research and development expenses increased by approximately $1.6 million, or 62%, to approximately $4.2 million for the year ended December 31, 2018, compared to approximately $2.6 million for the year ended December 31, 2017. This increase was primarily attributable to the increased costs of materials used in research and development activities.
Sales and Marketing Expenses.   Our sales and marketing expenses increased by approximately $16.1 million, or 56%, to approximately $44.6 million for the year ended December 31, 2018, compared to approximately $28.5 million for the year ended December 31, 2017. This increase was primarily attributable to the expansion of our direct sales organization and an increase in compensation related to revenue increases in North America.
General and Administrative Expenses.   Our general and administrative expenses increased by approximately $0.4 million, or 10%, to approximately $4.8 million for the year ended December 31, 2018, compared to approximately $4.4 million for the year ended December 31, 2017. This increase was primarily attributable to an increase in salaries and related expenses resulting from our increased headcount and increased premiums and related expenses under our product liability insurance policy offset by a decrease in legal costs and expenses related to our patent litigations.
Legal Settlements and Loss Contingencies.   Our legal settlements and loss contingencies were approximately $8.0 million for the year ended December 31, 2018, compared to approximately $0 million for the year ended December 31, 2017. This increase was primarily attributable to a settlement agreement entered into in January 2019.
Financial Income, Net.   Our financial income, net was approximately $0.1 million for the year ended December 31, 2018, compared to approximately $0.8 million for the year ended December 31, 2017. This decrease in financial income, net was primarily attributable to loss from foreign currency translation and
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loss from marketable equity securities revaluation. This decrease was partially offset by an increase in income from dividend and interest derived from our investments in government and corporate debt securities, in the year ended December 31, 2018, as compared to a gain on foreign currency translation in the year ended December 31, 2017.
Income Tax.   Our income taxes increased by approximately $0.3 million, or 29%, to approximately $1.3 million for the year ended December 31, 2018, compared to approximately $1.0 million for the year ended December 31, 2017. In 2018, the tax benefit derived from our “Benefited Enterprise” status was approximately $5.1 million, which represents approximately 22% of our income before taxes.
Selected Quarterly Results of Operations
The following table sets forth our unaudited consolidated quarterly results of operation for the periods indicated. You should read the following table in conjunction with our audited consolidated financial statements. We have prepared the unaudited consolidated quarterly financial information on the same basis as our consolidated financial statements. The unaudited consolidated quarterly financial information includes all adjustments, consisting only of normal and recurring adjustments, that we consider necessary for a fair representation of our operating results for the quarters presented.
For the three months ended,
2019
2018
2017
Mar. 31
Dec. 31
Sep. 30
Jun. 30
Mar. 31
Dec. 31
Sep. 30
Jun. 30
(unaudited)
(in thousands)
Revenues $ 30,552 $  28,783 $  25,418 $  25,050 $  20,911 $  19,807 $  14,293 $  13,877
Cost of revenues
4,271 3,939 3,669 3,917 3,532 3,556 2,075 2,327
Gross profit
26,281 24,844 21,749 21,133 17,379 16,251 12,218 11,550
Operating expenses:
Research and development
1,199 1,354 1,005 941 880 774 674 510
Sales and marketing
14,097 12,521 11,106 11,330 9,665 10,434 7,491 6,734
General and administrative
1,053 1,656 1,244 1,019 895 1,322 1,223 1,118
Legal settlements and loss contingencies
8,000
Total operating expenses
16,349 23,531 13,355 13,290 11,440 12,530 9,388 8,362
Income (loss) from operations
9,932 1,313 8,394 7,843 5,939 3,721 2,830 3,188
Financial income (expenses), net
403 (487) 415 (70) 278 218 221 247
Income (loss) before
taxes
10,335 826 8,809 7,773 6,217 3,939 3,051 3,435
Income tax (tax benefit)
177 1,045 171 193 (149) 620 144 123
Net income (loss)
$ 10,158 $ (219) $ 8,638 $ 7,580 $ 6,366 $ 3,319 $ 2,907 $ 3,312
Seasonality
Our business is not significantly impacted by seasonality; however, our fourth quarter has historically generated slightly stronger operating results. We have historically experienced stronger sales in the fourth quarter in correlation with our customers’ spending patterns and budget cycles. Most physicians operate on an annual budget cycle with a fiscal year that begins on January 1. It is not uncommon to experience a higher level of purchasing activity from physicians in the final months and weeks of their fiscal year. Consequently, our fourth quarter revenues may be greater than other quarters. Our business is also impacted by general economic conditions, which may impact future seasonal variations.
Liquidity and Capital Resources
Historically, we have funded our operations primarily from cash flows from operations and from private placements of our ordinary shares. Since our inception in January 2008, we have not received any debt financing from banks or issued any preferred or debt securities. We have received aggregate net proceeds of approximately $4.6 million from issuances of our ordinary shares.
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As of March 31, 2019, we had working capital of approximately $58.1 million, and our primary source of liquidity was approximately $64.1 million in cash and cash equivalents, marketable securities and bank deposits.
We anticipate that the proceeds of this offering and cash flows from operations will be adequate to fund our expected capital expenditures and other cash requirements and commitments through at least the next 12 months. If existing cash and cash generated from operations are insufficient to satisfy our liquidity requirements, we may seek to sell additional equity or debt securities or obtain a credit facility. If we raise additional funds by issuing equity securities, our shareholders would experience dilution. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our shareholders. Additional financing may not be available at all, or in amounts or on terms unacceptable to us. If we are unable to obtain additional financing, we may be required to delay the development, commercialization and marketing of our aesthetic medical products.
Cash Flows
The following table represents a summary of our cash flow for the periods indicated:
Three months ended
March 31,
Years ended
December 31,
2019
2018
2018
2017
(in thousands)
Net cash provided by (used in):
Operating activities
$ 2,771 $ 7,397 $ 36,886 $ 14,609
Investing activities
(8,693) (1,993) (29,739) (5,684)
Financing activities
122 150 186 1,785
Effects of exchange rate changes on cash
30 (11) (205) 187
Net increase (decrease) in cash and cash equivalents
$ (5,770) $ 5,543 $ 7,128 $ 10,897
Net Cash Provided by Operating Activities
Net cash provided by operating activities decreased by approximately $4.6 million, or 63%, to approximately $2.8 million for the three months ended March 31, 2019, compared to approximately $7.4 million for the three months ended March 31, 2018. This decrease was primarily attributable to the payment of a settlement agreement entered into in January 2019. Net cash provided by operating activities increased by approximately $22.3 million, or 152%, to approximately $36.9 million for the year ended December 31, 2018, compared to approximately $14.6 million for the year ended December 31, 2017. This increase was primarily attributable to an increase in our net income. As we expect our revenues to continue to grow, we anticipate our accounts receivables and inventory will similarly continue to grow, including our available working capital.
Net Cash Used in Investing Activities
Net cash used in investing activities increased by approximately $6.7 million, or 336%, to approximately $8.7 million for the three months ended March 31, 2019, compared to approximately $2.0 million for the three months ended March 31, 2018. This increase was primarily attributable to investment in short-term deposits and purchases of marketable securities, which increased from approximately $0 million and $9.4 million, respectively, as of March 31, 2018, to approximately $16.1 million and $29.1 million, respectively, as of March 31, 2019. Net cash used in investing activities increased by approximately $24.0 million, or 423%, to approximately $29.7 million for the year ended December 31, 2018, compared to approximately $5.7 million for the year ended December 31, 2017. This increase was primarily attributable to purchases of marketable securities, which increased from approximately $7.4 million as of December 31, 2017, to approximately $26.5 million as of December 31, 2018.
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Net Cash Provided by Financing Activities
Net cash provided by financing activities was approximately $0.1 million for the three months ended March 31, 2019, and approximately $0.2 million for the three months ended March 31, 2018. This decrease was primarily attributable to proceeds from exercise of options. Net cash provided by financing activities was approximately $0.2 million for the year ended December 31, 2018, and approximately $1.8 million for the year ended December 31, 2017. This decrease was primarily attributable to funding from a non-controlling partner in our Chinese joint venture in 2017.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations and commitments as of March 31, 2019:
Payments Due by Period
Total
Less than
1 year
1 – 3 years
3 – 5 years
More than
5 years
($) (in thousands)
Operating lease (including imputed
interest)
1,800 508 1,221 71
Subcontracting agreement
2,400 2,400
Quantitative and Qualitative Disclosure of Market Risks
Foreign Currency Risk
Our consolidated revenues are generated primarily in U.S. dollars. In addition, a substantial portion of our consolidated costs are incurred in dollars. We believe that the U.S. dollar is the primary currency of the economic environment we operate in. Thus, the U.S. dollar is our primary functional and reporting currency.
Our transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into U.S. dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-U.S. dollar transactions and other items in the consolidated statements of income (indicated below), the following exchange rates are used: (i) for transactions, exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization), historical exchange rates. Currency translation gains and losses are presented in financial income or expenses, as appropriate.
A significant portion of our operations is conducted through operations in countries other than the United States and Israel. Revenues from our global operations that were recorded in U.S. dollars represented approximately 83% for the three months ended March 31, 2019, and 84% for the year ended December 31, 2018.
The functional currencies of our subsidiaries are their respective local currencies or the U.S. dollar. For purposes of consolidation, the financial statements of the Foreign Subsidiaries are translated into U.S. dollars in accordance with Accounting Standards Codification, or ASC, No. 830, “Foreign Currency Matters” (“ASC 830”). Assets and liabilities are translated at period-end exchange rates, while revenues and expenses are translated at exchange rates for each transaction. All gains and losses resulting from translation are presented in other comprehensive income within the consolidated statements of comprehensive income.
Interest Rate Risk
The primary objective of our investment activities is to preserve principal while maximizing the interest income we receive from our investments, without increasing risk. Currently, we do not have any outstanding borrowings. We intend to invest our cash balances primarily in bank deposits and fixed-income securities issued by corporations, the United States and non-U.S. governments. We are exposed to market risks resulting from changes in interest rates relating primarily to our financial investments in cash, cash
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equivalents, deposits and marketable securities. We do not use derivative financial instruments to limit exposure to interest rate risk. Our interest gains may decline in the future as a result of changes in the financial markets; however, we believe any such potential loss would be immaterial to us.
Off Balance Sheet Arrangements
As of June 30, 2019, we have not engaged in any off balance sheet arrangements.
Related Parties
For a description of our related party transactions, see “Certain Relationships and Related Party Transactions.”
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of our operations is based upon our audited consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of our consolidated financial statements requires us to make estimates and judgments that affect the reported amount of assets, liabilities, sales and expenses and related disclosure of contingent assets and liabilities. On a periodic basis, we evaluate our estimates, including those related to revenue recognition, warranty provision, income taxes and share-based compensation. We base our estimates on historical experience, authoritative pronouncements and various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.
The following are our critical accounting policies and the significant judgments and estimates affecting the application of those policies in our consolidated financial statements.
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Update No. 2014-09 (“ASC 606”) “Revenue from Contracts with Customers,” when our customers obtain control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, we perform the following five steps:
i.
identify the contract(s) with a customer;
ii.
identify the performance obligations in the contract — we determined that our arrangements are generally comprised of the following elements that are recognized as separate performance obligations: products, consumables and extended warranties. Installation and training services are not essential to the functionality of our products;
iii.
determine the transaction price;
iv.
allocate the transaction price to the performance obligations in the contract — we estimated the standalone selling prices of the services to be provided based on expected pricing of service contract purchased on a standalone basis and used the residual approach to estimate the selling price of the products; and
v.
recognize revenue when (or as) the performance obligation is satisfied.
We apply the five-step model to contracts only when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to our customer, after considering any price concession expected to be provided to the customer, when applicable. At contract inception, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
We early adopted ASC 606 using the full retrospective transition method.
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From time to time, we may decide to enter into installment sales contracts with certain end users that provide them with long-term (generally up to 60 months) financing of the purchase of our product. The interest rate used in these contracts reflects the credit characteristics of the party receiving financing in the contract, as well as any collateral or security provided by the customer. Interest income on these receivables is recognized as financing income and earned over the term of the contract.
We recognize any variable consideration at the time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration mainly includes price concessions related to installment sales contracts.
We also generate revenues from long-term maintenance contracts, or Extended Warranties. Revenue from Extended Warranties is recognized ratably, on a straight-line basis, over the period of the applicable service contract. Contract liabilities include deferred revenues derived from these maintenance agreements.
Revenue from repairs performed in the absence of Extended Warranties is recognized when the related services are performed and it is probable that we will collect the consideration we are entitled to. We classify the portion of contract liabilities not expected to be earned in the subsequent 12 months as long-term.
We do not grant any right of return, refund, cancelation or termination.
Income Taxes
We account for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”), using the liability method whereby deferred tax assets and liability account balances are determined based on the differences between financial reporting and the tax basis for assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We provide a valuation allowance, if necessary, to reduce deferred tax assets to the amounts that are more likely-than-not to be realized.
ASC 740 also contains a two-step approach to recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes.
The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. We accrue interest and penalties related to unrecognized tax benefits in our income taxes.
Share-Based Compensation
We account for share-based compensation in accordance with ASC 718 which requires that all share-based payments to employees and non-employees be recognized in our consolidated statements of income based on their fair values. The grant date fair value of share-based compensation is recognized as an expense over the requisite service period, net of estimated forfeitures. We recognize compensation expense for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach, and classify these amounts in our consolidated statements of income based on the department to which the related employee and non-employee reports.
Option Valuations
We selected the binomial option-pricing model to determine the fair value of each option grant to our employees and non-employees.
The binomial model includes assumptions regarding dividend yields, expected volatility, and risk-free interest rates, early exercise multiple and expected lives. These assumptions reflect our best estimates, but these items involve inherent uncertainties based on market conditions that are generally outside of our
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control. As a result, if other assumptions had been used in the current period, share-based compensation expense could have been materially impacted. Furthermore, if management uses different assumptions in future periods, share-based compensation expense could be materially impacted in future years.
Expected dividend yield:    We have never declared or paid any cash dividends and we do not plan to pay cash dividends in the foreseeable future.
Volatility:   The expected volatility is based on the historical volatility of comparable companies.
Risk-free interest rate:   The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted in dollar terms.
Early exercise multiple:   Since our ordinary shares are not publicly traded, the early exercise multiple was based on academic empirical findings. The early exercise multiple of grantees in private companies is expected to be higher due to the lack of marketability that leads to a longer exercise period for options.
The underlying data used for computing the fair value of the options are as follows:
For the three months ended
March 31,
For the year ended
December 31,
2019
2018
Dividend yield
0%
0%
Expected volatility
51.91%
51.20%
Risk-free interest rate
2.56 – 2.60%
2.96%
Early exercise multiple
150% – 250%
150% – 250%
Contractual term
7 years
7 years
These assumptions represent our best estimates and involve inherent uncertainties and the application of our judgment. As a result, if we use significantly different assumptions or estimates, our share-based compensation expense could be materially different.
The following table shows information concerning options granted to employees and non-employees during the period from March 31, 2017 through June 30, 2019:
Grant Date
Number of
Options
Granted
Exercise
Price
Fair Value
per Share
Fair Value
per Option  
June 1, 2017
2,598,619 $ 0.56 $ 0.58 $ 0.26
November 1, 2017
21,468 $ 0.56 $ 3.12 $ 2.56
December 31, 2017
35,780 $ 0.56 $ 4.11 $ 3.57
February 15, 2018
3,578 $ 0.56 $ 4.86 $ 4.33
September 17, 2018
354,402 $ 6.32 $ 6.32 $ 2.54
January 6, 2019
169,956 $ 7.49 $ 7.49 $ 2.09
January 7, 2019
305,919 $ 7.49 $ 7.49 $ 2.09
April 1, 2019
30,413 $ 10.23 $ 10.23 $ 2.82
April 5, 2019
67,982 $ 10.23 $ 10.23 $ 2.82
April 6, 2019
14,313 $ 10.23 $ 10.23 $ 2.82
Ordinary Share Valuation
In preparation for our initial public offering, in January 2019 and February 2019, with the assistance of a third-party valuation firm, we performed prospective valuations of our ordinary shares as of December 31, 2018 and February 28, 2019 which determined that their fair value was $7.49 and $10.23 per ordinary share, respectively. In July 2018, with the assistance of a third-party valuation firm, we performed retrospective valuations of our ordinary shares as of December 31, 2016, May 31, 2017, March 31, 2018 and July 31, 2018, which determined that their fair values were $0.44, $0.58, $5.53 and $6.32 per ordinary share, respectively. For the purpose of determining our equity value, we used the discounted cash flow, or
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DCF, method. Under the DCF method, our projected after-tax cash flows available to return to holders of invested capital were discounted back to present value, using an appropriate discount rate. Since it is not possible to project our after-tax cash flows beyond a limited number of years, the DCF method relies on determining a “terminal value” representing the aggregate value of the future after-tax cash flows after the end of the period for which annual projections are possible. The discount rate, known as the weighted average cost of capital, or WACC, accounts for the time value of money and the appropriate degree of risk inherent in a business. The DCF method requires significant assumptions, in particular, regarding our projected cash flows and the discount rate applicable to our business. For the purpose of the abovementioned valuations we applied discount rates in the range of 13.0%-16.5%, and projected after-tax cash flows based on the possible scenarios in regards to our prospective as a result of the realization of the legal proceedings against us at each valuation date.
Having determined our equity value, we allocated it among the different elements of our share capital using the option pricing method, or OPM. Under the OPM, each security — ordinary shares and options — is treated as a call option having an exercise price based on the amount and optimal conversion price. The value of the call option is determined using the Black-Scholes option pricing model. The Black-Scholes model requires significant assumptions and in particular the assumptions regarding the volatility of our ordinary shares.
Accounts Receivable and Allowance for Doubtful Accounts
Our accounts receivable balance, net of allowance for doubtful accounts, was approximately $7.4 million as of March 31, 2019, compared to approximately $7.5 million as of March 31, 2018. The allowance for doubtful accounts as of March 31, 2019 was approximately $0.4 million compared to approximately $0.3 million as of March 31, 2018. Our accounts receivable balance, net of allowance for doubtful accounts, was approximately $7.6 million as of December 31, 2018, compared to approximately $6.9 million as of December 31, 2017. The allowance for doubtful accounts for the years ended December 31, 2018 and 2017 was approximately $0.4 million. This increase is primarily attributable to increasing sales.
We maintain an allowance, or reserve, for doubtful accounts based upon known collectability issues. While our credit losses have historically been within our expectations and the allowances established, we may not continue to experience the same credit losses that we have in the past, which could cause our provisions for doubtful accounts to increase. We work to mitigate bad debt exposure through our credit evaluation policies and geographical dispersion of sales.
Inventories Valuation
We state all inventories at the lower of cost or net realizable value. We determine our finished products using a “moving average” method and we determine our raw materials using a “first in, first out” method. Our inventory balance was approximately $7.1 million as of March 31, 2019, compared to approximately $5.9 million as of March 31, 2018. Our inventory balance was approximately $7.0 million as of December 31, 2018, compared to approximately $5.0 million as of December 31, 2017. We review the need for inventory allowances when conditions indicate that the selling price could be less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand and reductions in selling prices. We balance the need to maintain strategic inventory levels with the risk of obsolescence due to changing technology and customer demand levels. Unfavorable changes in market conditions may result in a need for inventory reserves that could adversely impact our gross margins. Conversely, favorable changes in demand could result in higher gross margins when we sell products.
Product Warranty and Service Costs
We generally provide, as a standard, a one-year parts delivery and labor warranty on end-user sales of our aesthetic treatment systems. Distributors generally provide a one-year manufacturing warranty on parts only. We estimate and provide for future costs for initial product warranties at the time revenue is recognized. We base product warranty costs on related material costs, delivery cost, technical support labor costs and overhead.
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We provide for the estimated cost of product warranties by considering historical material, delivery, labor and overhead expenses and applying the experience rates to the outstanding warranty period for products sold. As we sell new products to our customers, we exercise considerable judgment in estimating the expected failure rates and warranty costs. If actual product failure rates, material usage, service delivery costs or overhead costs differ from our estimates, we would be required to revise our estimated warranty liability.
Recent Accounting Pronouncements
For accounting pronouncements adopted prior to January 1, 2019, see note 2(w1) in our consolidated financial statements.
For accounting pronouncements adopted from January 1, 2019, see note 2(b) in our condensed consolidated financial statements.
JOBS Act
On April 5, 2012, the JOBS Act was signed into law. Section 107 of the JOBS Act 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.
This means that an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected to opt out of such extended transition period.
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BUSINESS
Overview
We are a leading global provider of innovative, energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. Within the global aesthetics market, our products and solutions are primarily designed to address three energy-based treatment categories comprised of: (i) face and body contouring; (ii) medical aesthetics; and (iii) women’s health. We have developed and commercialized products utilizing medically-accepted RF energy technology, which can penetrate deep into the subdermal fat, allowing adipose tissue remodeling. We believe our RF energy-based proprietary technologies — (i) RFAL, (ii) Deep Subdermal Fractional RF, (iii) Simultaneous Fat Destruction and Skin Tightening and (iv) Deep Heating Collagen Remodeling — represent a paradigm shift in the minimally-invasive aesthetic solutions market. These technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including liposuction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Our products, developed with our proprietary RF energy-based technologies, overcome many of the shortcomings of other aesthetic options by delivering surgical-grade results while significantly minimizing risks of scarring, downtime, pain and other complications typically accompanying surgical procedures. In addition to our minimally-invasive solutions, we design, develop, manufacture and market differentiated, non-invasive medical aesthetic products that target a wide array of procedures. These include simultaneous fat killing and skin tightening, permanent hair reduction through the use of our innovative dual wavelength technology and other treatments targeting skin appearance and texture through the use of our high power IPL technology. Our products, which we market and sell traditionally to plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/GYNs may be used on a variety of body parts including the face, neck, abdomen, upper arms, thighs and intimate feminine regions.
In addition to the existing group of patients who currently undergo full surgical aesthetic procedures, we believe our minimally-invasive solutions satisfy an unmet market demand in two incremental groups of patients: (i) those whose skin laxity or other physical attributes have previously precluded them from undergoing surgical aesthetic procedures and (ii) those who would entertain the idea of surgical or minimally-invasive aesthetic procedures, but are averse to the associated costs, downtime and potential safety risks. We believe these patient populations will continue to represent a significant opportunity for our differentiated minimally-invasive aesthetic solutions.
We believe our products have consistently been at the forefront of technological development in the aesthetic solutions market. Since 2010, we have launched six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. Each product consists of the following components: a platform that incorporates multiple energy sources, one or more handpieces, our proprietary software and a simple user interface with touch screen. Our platforms have a small footprint and are lightweight compared to our competitors’ systems, which are typically larger and heavier. Our products can be upgraded easily by the user in order to perform additional treatments by adding handpieces and/or installing software in the existing platform. The ease of upgrades enables our customers to meet demand for aesthetic solutions through additional service offerings.
Our focus on innovation has resulted in a strong track record of sustained new and next-generation product development. We believe our ability to bring new products to market and continuously innovate is a distinct competitive advantage. We expect to launch three new product platforms by the end of 2019, all of which will be based on our existing RF energy-based proprietary technology, with the goal of further penetrating the market for surgical aesthetic and medical treatment solutions. Our three new product platforms are intended to address the treatment of cellulite appearance (CelluTite), body skin tightening (Evolve), and face and neck skin tightening (Evoke). Our CelluTite platform is comprised of three handpieces, each of which has been cleared by the FDA, intended to address the treatment of cellulite appearance. Two of the handpieces are cleared for use in dermatological and general surgical procedures for electrocoagulation and hemostasis of tissues including fat, and the third handpiece has been cleared for use in treatments for the temporary reduction in the appearance of cellulite. We expect to introduce the CelluTite platform to the market during the fourth quarter of 2019. The Evolve platform received FDA clearance in June 2019 and is expected to be introduced to the market during the second half of 2019. We submitted a premarket notification to the FDA pursuant to Section 510(k) of the Federal Food, Drug and
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Cosmetic Act for our Evoke product platform in July 2019. Subject to receipt of FDA clearance, we intend to introduce Evoke to the market during the second half of 2019. The CelluTite, Evolve and Evoke product platforms are subject to the same FDA 510(k) clearance process as our current products.
We expect that these new product platforms will complement our existing portfolio of products, allowing us to increase our offerings to existing customers and attract new customers. We believe that introducing new product platforms is important in order to satisfy consumer demand and respond to evolving technological developments.
In response to customers’ desires to enhance and expand their offering of our aesthetic and wellness office-based procedures, we are developing additional RF energy-based platforms, handpieces and applicators targeted towards several medical specialties.

For OB/GYNs, we currently sell the Votiva platform, which includes two handpieces, FormaV and Morpheus8. We are currently developing additional handpieces and applicators as part of this platform to assist with the following procedures:

non-incisional labiaplasty (a procedure to reshape the labia minora) using our AccuTite RFAL handpiece (Aviva); and

post-partum restoration of abdominal muscles and pelvic floor restoration using our external and internal EMS handpieces.

For ophthalmologists, we are developing a new platform that, in addition to our existing aesthetic handpieces, we expect will assist with the following procedures:

lower and upper eyelid contraction and fat reduction using the AccuTite and Morpheus8 handpieces; and

treatment of periorbital wrinkles and dry eye with a new continuous bi-polar RF energy handpiece.
Our new handpiece to treat dry eye and periorbital wrinkles is currently in an in-office ex vivo preclinical evaluation. We expect to introduce our new product platform for ophthalmologists comprising of three handpieces (AccuTite, Morpheus8 and our new dry eye and periorbital wrinkles treatment handpiece) to the market during the second quarter of 2020.

For ENTs, we are in the initial stage of developing a new platform and handpiece that we believe will provide patients with a medical treatment solution for snoring. The handpiece is based on our Deep Subdermal Fractional RF technology and is expected to contract and stiffen the soft palate (located on the back of the roof of the mouth), which blocks the airway, causing tissues to vibrate during sleep. This platform and handpiece are in the concept design phase.
We are focused on establishing and using clinical evidence to support and broaden our marketing claims and drive customer awareness and acceptance of our products. Traditionally, the aesthetic solutions market has relied heavily on marketing efforts and “before-and-after” pictures in an to attempt to distinguish products. We believe our focus on establishing clinical evidence for the efficacy of our products has been important for adoption by our surgically-trained customers, who are accustomed to seeing extensive clinical data in their non-aesthetic practices. To date, 36 third-party clinical studies have been completed and 18 third-party clinical studies are in the process of being conducted using our products. We also have a portfolio of 44 peer-reviewed publications. While we did not have any involvement in the clinical studies mentioned above, such studies provide qualitative results that we believe are meaningful. However, because these were third-party studies, we do not have access to any raw data to conduct any quantitative analyses.
To complement our surgical aesthetic and medical treatment solutions, we offer post-sales training and support services. We provide physicians with training focused on the most beneficial ways to utilize our products, including safety and instructional videos to expand procedural offerings and hands-on, personalized marketing support. We believe that we provide one of the most extensive training and ongoing support programs available to physicians throughout the aesthetic solutions market.
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Our revenue increased to approximately $30.6 million for the three months ended March 31, 2019, from approximately $20.9 million for the three months ended March 31, 2018. Our revenue increased to approximately $100.2 million for the year ended December 31, 2018 from approximately $53.5 million for the year ended December 31, 2017. For the three months ended March 31, 2019 and 2018, we recorded a gross margin of approximately 86% and 83%, respectively, and net income of approximately $10.2 million and $6.4 million, respectively. For the years ended December 31, 2018 and 2017, we recorded a gross margin of approximately 85% and 83%, respectively, and net income of approximately $22.4 million and $8.8 million, respectively. We have 18 FDA clearances and in addition to the United States, where we have over 2,400 customers, are permitted to sell our products in Europe, Argentina, Australia, Brazil, Canada, China, Colombia, the Commonwealth of Independent States, Israel, Mexico, Panama, Philippines, Russia, South Korea, Taiwan and Thailand. As of June 30, 2019, we sell and market our products in the United States, Canada, United Kingdom, Spain and India, through a direct sales force of approximately 96 representatives. We also sell and market our products through 37 distributors in 44 countries. As of June 30, 2019, we had a global installed base of over 3,900 product platforms capable of running various multi-use applicators and utilizing minimally-invasive consumables.
Industry
Overview
The global market for aesthetic solutions is significant and growing. ASAPS estimates that U.S. consumers spent more than $8.5 billion on a total of 7.8 million aesthetic procedures in 2017, of which $6.6 billion was spent on surgical aesthetic procedures. According to ASAPS, in 2017 total aesthetic procedures in the United States grew 6%, with surgical aesthetic procedure growth of 11% and non-surgical aesthetic procedure growth of 4%.
According to the 2017 ISAPS Global Aesthetic Survey, which includes survey results from 35,000 plastic surgeons in the top 30 countries for aesthetic procedures, approximately 23.4 million total aesthetic procedures, including 10.8 million surgical procedures and 12.6 million non-surgical procedures, were performed in 2017. Of these total procedures, approximately 18%, or 4.3 million, were performed in the United States. According to ISAPS, the top five surgical and minimally-invasive procedure categories in 2017, by number of procedures, that we provide innovative aesthetic solutions for were liposuction (1.6 million), eyelid surgery (1.3 million), abdominoplasty (0.8 million), face and neck lifts (0.7 million) and women’s health (0.2 million). The top five non-invasive procedure categories in 2017 that we provide innovative aesthetic solutions for were facial rejuvenation (2.1 million), hair removal (1.0 million), non-invasive fat reduction (0.5 million), cellulite treatment (0.3 million) and vascular lesions/sclerotherapy (0.1 million).
No one treatment procedure is offered by all physicians and treatments vary in terms of the treatment goal and desired effect. As a result, the total aesthetic market, as reported by ASAPS and ISAPS, does not necessarily represent the market potential for us or any other single product or treatment, but illustrates that each year patients elect to have millions of procedures performed to enhance their appearance. We believe our total addressable market also includes aesthetic procedures performed by non-plastic surgeons, which are not tracked by ASAPS and ISAPS data.
We believe the following factors are contributing to the growth in aesthetic procedures:

the aging of the population in the western world;

the growing global obesity epidemic;

the increasing desire of many individuals to improve their appearance;

the reduction in procedure costs, which has attracted a broader consumer base; and

the impact of managed care and reimbursement on physician economics, which has motivated physicians to establish or expand the menu of elective, private-pay aesthetic procedures that they offer.
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Within each of our treatment categories, face and body contouring, medical aesthetics and women’s health, we believe our products provide a differentiated solution that overcomes many of the limitations of other existing treatment options.
Face and Body Contouring Market
The most common face and body contouring treatments typically involve excess fat removal, or liposuction and the correction and reduction of skin laxity, or skin tightening. Within those treatment types, various surgical, minimally-invasive or non-invasive energy-based techniques exist, including:

Liposuction. The existing surgical and minimally-invasive techniques for fat reduction include surgical liposuction and laser lipolysis, while non-invasive techniques include cryolipolysis, ultrasound lipolysis and other energy-based systems. To date, surgical liposuction remains the most commonly performed plastic surgery procedure in the United States. According to ASAPS, 304,850 liposuction procedures were performed in the United States in 2017, compared to 180,833 non-surgical fat reduction procedures during the same period.

Skin Tightening. The existing surgical techniques for the correction and reduction of skin laxity include facelifts, breast lifts, lower body lifts, arm lifts and tummy tucks, while minimally and non-invasive techniques include radio frequency, ultrasound and other energy-based systems. According to ASAPS, surgical techniques including breast lifts and tummy tucks were among the top five surgical procedures performed in the United States in 2017.
According to Medical Insight, Inc., the global market for all body shaping and skin tightening device platforms and consumables is expected to expand by 14% per year, reaching $2.3 billion in 2022.
Medical Aesthetic Market
Common medical aesthetic treatments include hair reduction, skin rejuvenation and resurfacing, and vascular and pigmented lesion removal. These treatments are predominantly performed in a minimally and non-invasive fashion, using intense pulses of a highly-focused laser or other optical energy to selectively target hair follicles, veins or collagen in the dermis, as well as cells responsible for pigmentation in the epidermis. The most common medical aesthetic treatments, in addition to face and body contouring, include:

Permanent Hair Reduction. Non-invasive hair reduction procedures utilizing laser, IPL or other optical energy.

Skin Rejuvenation. A range of non-invasive and ablative procedures that stimulate production of new collagen in the skin to repair wrinkles and other surface imperfections. Surgical treatments using ablative techniques have largely been supplanted by non-invasive and, particularly, fractional techniques.

Acne Reduction. Minimally and non-invasive procedures that target bacteria and cessation of oil production, primarily using light energy-based devices and fractional techniques.

Vascular and Pigmented Lesion Removal. Non-invasive procedures typically performed using laser and IPL energy-based devices to penetrate below the surface of the skin in order to remove vascular and pigmented lesions. Energy-based treatments have displaced alternative surgical techniques, such as sclerotherapy, as they achieve comparable results in a non-invasive manner.
According to Medical Insight, Inc., the global market for platforms and consumables in the non-invasive medical aesthetic market is expected to expand by 6% per year, reaching $2.3 billion in 2022.
Women’s Health Market
As average life expectancy continues to increase and awareness of women’s wellness continues to grow, women are more frequently looking for solutions to address conditions such as vaginal atrophy and vaginal relaxation syndrome. With over 800 million women between the ages of 50 and 80 worldwide, women’s health represents a large and growing market. Several popular surgical, minimally-invasive or non-invasive energy-based techniques exist, including:
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Vaginoplasty. A surgical procedure that involves the removal of excess lining within the vagina, and the suturing of the underlying muscles together to reduce the size of the vagina.

Vagina/Labial Remodeling. A minimally-invasive procedure that involves heating targeted connective tissue with thermal energy, while cooling the mucosal epithelial surface over the targeted tissue.

CO2 Laser Therapy. A non-invasive procedure that generates microscopic laser “spots” where thermal energy is absorbed by the sub-epithelial layers.

Mono and Bipolar Radio Frequency. A precise, non-invasive procedure that provides full depth heating in the subdermal tissue layers.

Ultrasound Therapy. A non-invasive procedure that involves sending thermal energy waves into the tissue.
According to Medical Insight, Inc., the global market for women’s health platforms and consumables is expected to expand by 16% per year, reaching $413 million in 2022.
Physician and Patient Market Opportunity
Aesthetic treatment procedures have traditionally been performed by plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/GYNs. These physicians represent our traditional customer base. More recently, a broader group of physicians in the United States, including ENTs, ophthalmologists, general practitioners and aesthetic clinicians, have incorporated aesthetic treatment procedures into their practices. These non-traditional customers are motivated to offer aesthetic procedures in order to generate a reliable revenue stream that is unaffected by managed care and government payor reimbursement economics. We believe that there are approximately 300,000 potential non-traditional physician customers in the United States and Canada, representing a significant market opportunity that is only beginning to be addressed by suppliers of energy-based aesthetic equipment.
In addition to the existing group of patients who undergo full surgical aesthetic procedures, we have identified an unmet market demand for two new additional groups of patients, referred to as the “Treatment Gap” group and the “Sideline” group. We believe these potential patient populations represent a significant opportunity for our innovative and differentiated minimally-invasive aesthetic solutions.
The Treatment Gap group consists of patients, typically ranging from 35 to 55 years of age, who have sufficient financial resources to afford aesthetic solutions but are limited in the types of existing procedural options available to them prior to the introduction of our proprietary (i) RFAL, (ii) Deep Subdermal Fractional RF, (iii) Simultaneous Fat Destruction and Skin Tightening and (iv) Deep Heating Collagen Remodeling technologies. For example, for patients whose skin is not amenable to liposuction, such as those patients whose skin lacks an adequate degree of elastin, thereby preventing the skin from retracting, the only available alternatives to reduce skin looseness were high-cost surgeries requiring full anesthesia, such as an abdominoplasty, facelift, blepharoplasty or brachioplasty. In these procedures, the excess skin is gathered, cut and removed, typically leaving the patient with significant scars. In addition, there is a large population of patients whose skin is not of the quality needed for a liposuction procedure but also not damaged enough to be a candidate for a surgical procedure. We believe this Treatment Gap group represents a significant market opportunity for us.
In addition to the Treatment Gap group, we believe there is also a large group of potential patients that would entertain having surgery-like results if the procedure was delivered in a painless, safe and fast manner. We believe this Sideline group has the ability to expand our current market significantly.
Current Treatment Landscape
Many existing surgical, minimally and non-invasive procedures are available to treat the aforementioned conditions; however, each has certain limitations.
Surgical and Minimally-Invasive Procedures
Although each of these treatments has varying degrees of effectiveness, we believe they present the following limitations:
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Surgical risks. Surgical and minimally-invasive procedures carry risks of infection, local or widespread scarring, perforation, and hemorrhage. These procedures generally require a general or local anesthesia, which has additional risks.

Pain and downtime. Surgical procedures may involve pain and require weeks of post-surgical recovery. As a result, patients may need to spend significant time away from work and take prescribed pain medications for extended periods of time post-surgery. In addition, body lifts may severely limit muscle movement in the treated area during recovery, which can limit a patient’s mobility for a significant period of time. Existing minimally-invasive procedures typically require a relatively large surgical incision, which can also cause pain and discomfort. Patients generally require at least two days of recovery time after a minimally-invasive procedure, which may require the patient to miss work and necessitate prescribed pain medications post-surgery.

Potentially undesired results. Surgical procedures may cause non-uniform fat reduction, dimpling, lumpiness, numbness, scarring, discoloration or sagging skin in the treated area. Follow-up surgeries may be required to correct these problems. Existing minimally-invasive procedures can cause skin or tissue damage if, among other things, the physician does not carefully control the intensity of energy delivered to the treatment area.

High cost. Surgical and existing minimally-invasive procedures are significantly more expensive for patients than non-invasive aesthetic procedures. In addition, there is an opportunity cost for physicians as these procedures require direct physician involvement and supervision.

Limited repeatability. The process of removing or destroying fat cells with surgical or existing minimally-invasive procedures triggers the body’s wound healing response, which leads to the formation of scar tissue in the treated area. If a patient desires further fat reduction or is not satisfied with the aesthetic results from a procedure, the scar tissue in the treated area may prevent the patient from undergoing follow-up procedures to enhance or correct the original treatment results.

Physician skill and technique dependent. The aesthetic results achieved through surgical and existing minimally-invasive procedures often depend upon a particular physician’s skill and training. In addition, these procedures require significant physician time.
Non-Invasive Procedure Limitations
Although current non-invasive procedures are generally safer and less expensive than surgical and minimally-invasive procedures, we believe these procedures have the following limitations:

Limited, inconsistent and unpredictable results. Existing non-invasive procedures have limited efficacy and produce inconsistent fat reduction and skin rejuvenation results. In addition, the technology used to perform these procedures is not capable of selectively targeting fat cells, blood cells, hair follicles and deeper-lying pigments, which can lead to unpredictable results, including damage to the surrounding tissue.

Multiple treatments required. Existing non-invasive procedures based on radio frequency or laser energy often require multiple treatments over several weeks before the patient obtains noticeable aesthetic results, requiring the patient to schedule multiple, time-consuming office visits.

Maintenance or diet and exercise required. Certain existing non-invasive procedures have only a temporary treatment effect, and thus require periodic maintenance treatments to sustain the desired aesthetic results. Additionally, some of these procedures require the patient to change his or her diet habits and exercise routines during the several-week treatment period.

Technique dependent. Existing non-invasive procedures often require highly trained personnel to conduct the treatment. Poor technique may lead to reduced efficacy and inconsistent aesthetic results.
Prior to the introduction of our products, we believed that the market was poised to accept new sophisticated technology that can address the shortcomings of the then-available solutions. We also believe that in selecting solutions, physicians are increasingly focusing on the economics of owning aesthetic
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treatment equipment, including the likelihood of increased revenues, as well as the predictability of ownership costs and are placing greater emphasis on product reliability, the quality of service provided by the manufacturer, minimization of downtime required for maintenance, the length of warranty coverage and the ongoing cost of purchasing consumables and handpieces following the initial platform purchase.
Our Solution
Key benefits of our minimally-invasive surgical aesthetic and medical treatment solutions include:

Small to no incisions, which reduces the drawbacks and risks typically associated with surgical procedures such as significant pain, local or widespread scarring, infection, perforation and hemorrhage.

Outpatient procedures that typically do not require general anesthesia, which can decrease patient downtime, discomfort and other potential complications and typically reduces cost.

Minimally-invasive procedures with similar efficacy to surgical procedures that have the ability to expand the addressable patient population for aesthetics procedures.

Effective and long-lasting aesthetic solutions, many of which are supported by compelling clinical data, including 44 peer-reviewed publications.

Differentiated, RF energy-based technology simultaneously kills fat and tightens skin, overcoming the many shortcomings of traditional surgical, minimally and non-invasive aesthetic procedures.

Innovative dual wavelength laser technology that allows for permanent hair reduction on a wider range of skin types and hair textures than other aesthetic solutions currently on the market, reducing the number of treatments required.

Typically less expensive than other aesthetic solutions on the market that provide comparable results as a result of less required physician time and training required.
Leader in RF Energy
We believe we are the leader in using RF energy for both minimally-invasive and subdermal ablative aesthetic purposes. RF energy is different from optical energy because it is not absorbed by the epidermis and is able to be targeted to penetrate deep into the tissue. The application of RF energy in medicine is a well established practice. For example, RF energy is the basis of magnetic resonance imaging, or MRI, and surgical diathermy, used to cauterize blood vessels to prevent excessive bleeding, both commonplace applications administered regularly in medical practice. RF energy is also used in cardiology for ablative interventions and in oncology surgery for tumor/metastasis ablation.
RF energy can be delivered to the skin in a variety of ways, the most common being monopolar delivery, whereby RF energy is delivered through a single probe placed on the skin with a grounding pad distant to the probe site. Alternatively, in bipolar delivery, RF energy is delivered from a probe with two electrodes placed over the treatment area. Bipolar delivery has an important advantage over monopolar delivery: depth of penetration of the RF energy is not dependent on the tissue impedance, or electrical resistance, which varies from person to person, or the cross-sectional area of the probe. That is not the case with monopolar delivery. Instead, in bipolar delivery, depth of penetration of the RF energy depends on the distance between the two electrodes on the probe, with increasing distance resulting in increased depth of penetration. We believe we are the leader in the development, design and commercialization of bipolar RF energy devices for minimally-invasive and subdermal ablative aesthetic purposes.
Radio-Frequency Assisted Lipolysis
Using our expertise in bipolar RF energy delivery, we developed what we believe is the next generation of lipolysis and adipose tissue remodeling technology, a new category that delivers a thermal response to the adipose tissue, skin and subdermal matrix. Our RFAL products deliver directional RF energy into the subcutaneous fat to coagulate, liquefy and remodel adipose tissue and heat the subcutaneous fibrous septa, or partitions, resulting in substantial collagen contraction of subdermal space. We believe we are the first company to utilize bipolar radio frequency in a minimally-invasive manner. Our RFAL products generate a
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higher power and more efficient energy transfer than laser energy systems and allow the treatment of larger volumes of the subcutaneous tissue with optimal thermal profiles, facilitating the significant tightening of the tissue. The shrinkage of tissue is significant and can reach double-digit percentages of the heated tissue volume. The thermal energy is delivered by an innovative handpiece comprised of two electrodes: the internal electrode is inserted into the fat layer while the other larger electrode is applied externally to the skin surface above the cannula tip. The internal cannula is passed through the subcutaneous fat while the external electrode is moved above and over the skin’s surface. The small, conductive tip of the cannula delivers RF energy into the subcutaneous fat, liquefying it and simultaneously contracting fibrous septa. The liquefied fat can then be removed from the body through a suction cannula. Our RFAL products also apply gentle uniform heating of the dermis, thereby promoting skin tightening. Figure 1 below shows how the RF energy is delivered through the handpiece to simultaneously liquefy fat and tighten the skin.
Our BodyTite platform and the BodyTite and FaceTite handpieces rely on our proprietary RFAL technology. To date, there have been more than 55,000 successful RFAL procedures conducted with positive clinical results using our BodyTite platform and the BodyTite and FaceTite handpieces. We have demonstrated that RFAL has the potential to elicit three-dimensional soft tissue contraction reliably and predictably to both serve otherwise non-traditional liposuction candidates, as well as to improve outcomes in patients for whom liposuction is an option.
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Figure 1: RFAL mechanism of action.
Deep Subdermal Fractional RF
Our Deep Subdermal Fractional RF delivers RF energy into the subdermal fat tissue to depths of up to four millimeters, or mm. Deep Subdermal Fractional RF provides skin tightening and adipose tissue remodeling directly under the dermal layer. Our Deep Subdermal Fractional RF products deliver RF energy under the dermis through an array of pins producing localized heat and small micro-lesion dots in the treatment area. The heat generated by the pins in the subdermal tissue promotes collagen restructuring and tissue reshaping. Physicians can offer a versatile fractional treatment creating a three-dimensional matrix of coagulation volumes inside the tissue. Deep Subdermal Fractional RF is used for wrinkle reduction, skin tightening and treatment of cellulite appearance. The most common areas of treatment are the face and neck. Our Fractora and FractoraV handpieces rely on our proprietary Deep Subdermal Fractional RF technology and are used in conjunction with our BodyTite, Optimas and Votiva platforms. Figure 2 below shows how the RF energy is delivered through the coated pins on the handpiece to reshape tissue under the dermal layer.
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Figure 2: Deep Subdermal Fractional RF mechanism of action.
Simultaneous Fat Destruction and Skin Tightening
Our Simultaneous Fat Destruction and Skin Tightening proprietary technology combines vacuum and bipolar RF energy with high and low amplitudes to both permanently kill adipose tissue and contract the skin. We believe our Simultaneous Fat Destruction and Skin Tightening technology is the first and only RF-based, non-invasive body contouring technology that permanently kills adipose tissue. Our BodyFX product platform and MiniFX handpieces utilize our Simultaneous Fat Destruction and Skin Tightening technology to address problematic fatty tissue in larger body areas such as the abdomen, back and thighs.
Deep Heating Collagen Remodeling
Our Deep Heating Collagen Remodeling propriety technology delivers heat in a uniform and volumetric form targeting deep into tissue while providing collagen remodeling with real-time control of the device’s temperature. The versatility of this technology allows the operator to provide a customized solution to address a variety of women’s wellness concerns that occur due to aging, hormonal stress or physical damage. Our FormaV handpiece on our Votiva product platform utilizes Deep Heating Collagen Remodeling technology while harnessing continuous bipolar RF energy with real-time temperature measurement. RF energy generated heat is delivered uniformly to vaginal tissue through a consumable applicator to provide vaginal and labia contraction with patients often seeing effects of the procedure immediately.
Pulse/Continuous Bi-polar RF
Continuous Bi-polar RF is electrical energy in the RF spectrum (1 MHz) that results from the flow of an electric charge between two electrodes. This conducted energy increases ion movement in the tissue and generates kinetic energy that is transformed to thermal energy (heating). In turn, this thermal energy causes controlled damage to the tissue and triggers a natural healing mechanism and tissue-renewal resulting in tissue tightening and remodeling. The distance between the electrodes allows for control of the depth of penetration of the bi-polar RF energy into the tissue. The distance between the electrodes is chosen based on the particular treatment and according to the tissue to be treated (generally varies between a few millimeters to 3–4