InMode Stock

InMode Ltd. is a leading global provider of innovative, energy-based, minimally invasive surgical medical treatment solutions. Within the global aesthetics market, the company’s products and solutions are primarily designed to address three energy-based treatment categories consists of face and body contouring; medical aesthetics; and women’s health. The company has developed and commercialized products utilizing medically-accepted RF energy technology, which can penetrate deep into the subdermal fat, allowing adipose tissue remodeling.

The company’s RF energy-based proprietary technologies—Radio Frequency Assisted Lipolysis, or RFAL; Deep Subdermal Fractional RF; Simultaneous Fat Destruction and Skin Tightening; and Deep Heating Collagen Remodeling for skin and human natural openings -- 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, ablative skin rejuvenation treatments and treatment of Genitourinary Syndrome of Menopause (GSM). The company’s products, developed with its proprietary RF energy-based technologies, overcome many of the shortcomings of other surgical options by delivering surgical-grade results under local anesthetics while significantly minimizing risks of scarring, downtime, pain and other complications typically accompanying surgical procedures. In addition to its minimally invasive solutions, the company designs, develops, manufactures and markets 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 its innovative dual wavelength technology and other treatments targeting skin appearance and texture through the use of its high power IPL technology. The company’s products, which it markets and sells 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 undergo full surgical aesthetic procedures, the company’s minimally invasive solutions satisfy an unmet market demand in two incremental groups of patients: those whose skin laxity or other physical attributes have previously precluded them from undergoing surgical aesthetic procedures and those who would entertain the idea of surgical or minimally invasive aesthetic procedures.

The company has launched 12 product platforms: BodyTite, Optimas, Votiva, Contoura, Triton, EmbraceRF, EvolveX, Evoke, Morpheus8, EmpowerRF, Define and Envision. In 2023, the company launched two products: the Define and the Envision. Each product consists of the following components: a platform that incorporates multiple energy sources, one or more handpieces or hands-free applicators, its proprietary software and a simple user interface with touch screen. The company’s products can be upgraded easily by the user in order to perform additional treatments by adding handpieces, hands-free applicators and/or installing software in the existing platform. The ease of upgrades enables the company’s customers to meet demand for aesthetic solutions through additional service offerings.

The company launched two new product platforms in 2021, which are based on its existing RF energy-based proprietary technology, with the goal of further penetrating the market for surgical and medical treatment solutions. The two platforms that were introduced in 2021 are the EmpowerRF which is for women’s health indications and EvolveX which replaced the company’s Evolve platform.

The company is developing additional RF energy-based platforms, handpieces and applicators targeted towards several medical specialties.

For ENTs, the company is in the initial stage of developing a new platform and handpieces that will provide patients with a medical treatment solution for snoring and rhinitis. The handpiece for the treatment of snoring is based on the company’s 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 both handpieces are in the concept design phase.

For urologists, the company is in the early-stages of developing a device using RF energy to treat ED (Erectile Dysfunction). The company registered a patent application to protect its technological concept, and that its technological concept will work well for this indication but much more research and development is needed.

The company focuses on establishing and using clinical evidence to support and broaden its marketing claims and drive customer awareness and acceptance of its products. Traditionally, the aesthetic solutions market has relied heavily on marketing efforts and before-and-after pictures in an attempt to distinguish products. As of December 31, 2023, 85 third-party clinical studies have been completed and seven third-party clinical studies are in the process of being conducted using the company’s products. The company also has a portfolio of 90 peer-reviewed publications.

To complement its surgical aesthetic and medical treatment solutions, the company offers post-sales training and support services. The company provides physicians with training focused on the most beneficial ways to utilize its products, including safety and instructional videos to expand procedural offerings and hands-on, personalized marketing support. The company provides one of the most extensive training and ongoing support programs available to physicians throughout the aesthetic solutions market.

The company has 31 FDA clearances and, in addition to the United States, where it has an installed base of approximately 10,250 product platforms, it is permitted to sell its products in most countries. As of December 31, 2023, the company sold and marketed its products in the United States, Canada, United Kingdom, Irland, Spain, Portugal, France, Belgium, Luxembourg, Italy, Germany, Austria, Japan, Australia and India through a direct sales force (include distributer sales managers) of approximately 263 representatives. The company also sells and markets its products through 59 distributors in 82 countries. As of December 31, 2023, the company had a global installed base of approximately 22,900 product platforms capable of running various multi-use applicators and utilizing minimally invasive consumables.

Growth Strategy

The key elements of the company’s strategy are to increase its sales presence to target and expand its addressable market globally; continue to further penetrate its existing customer base and drive recurring revenues; leverage its existing technology to expand into new minimally and non-invasive applications; expand its customer base beyond traditional customers; actively pursue business development opportunities; and expand its intellectual properly and patent portfolio.

Products

The company offers a broad portfolio of aesthetic and medical treatment solutions that consist of a variety of platforms providing minimally and non-invasive applications. Outside of the United States, the company also offers some alternative versions of its aesthetic treatment solutions, in some cases under different trademarks, which are tailored to the specific preferences and needs of certain countries and regions.

Components of Products

Each of the company’s products consists of the following components platform; one or more handpieces or hands-free applicators; and proprietary software.

Platforms

The company’s platforms are mostly electronic boxes, comprised of RF energy generators and modules supporting lasers and IPL, as applicable, a 110/220VAC input power supply, controller and a user interface with touch screen. The user interface allows the physician to select the handpiece and set treatment parameters to meet the requirements of a particular application and patient. Using the touch screen, the physician can independently adjust the energy level, pulse width and other parameters depending on application to optimize the treatment’s safety and effectiveness. The user interface on the company’s multiple energy workstations also allows the user to change energy sources with the press of a button. The control system communicates the operator’s settings from the user interface to the system’s modules and manages system operation and performance.

Handpieces and Hands-Free Applicators

The company’s handpieces and hands-free applicators are used to apply the energy to the patient treatment area. The handpieces and hands-free applicators are designed for specific targeted body areas, type of energy to maximize treatment safety and efficacy for specific treatment. Certain of the company’s handpieces and hands-free applicators have a contained thermal field that ensures a controlled and safe treatment through its Acquire, Control and Extend, or ACE, technology. The company’s ACE technology ensures that no areas are under- or over-treated using therapeutic temperatures safely and efficiently. Built-in safeguards, including real time measurements of skin temperature, impedance monitoring, power cut-off and audible feedback, help ensure patient safety throughout the procedure. A number of the company’s handpieces and hands-free applicators are, or contain, one-time use applicators, or consumables, that must be replaced following each treatment.

Minimally Invasive

BodyTite – The minimally invasive, consumable BodyTite handpiece utilizes directional RF energy for RFAL treatments using needle-size cannula and external electrodes to apply RF energy to the subcutaneous adipose tissue. The tissue is heated to 50°C to 70°C to destroy fat and contract connective tissue, simultaneously remodeling the dermis at external temperatures of up to 42°C. This handpiece allows tissue treatment using a 17cm cannula that provides treatment depth up to 50mm.

Facerite/NeckTite – The minimally invasive, consumable FaceTite and NeckTite handpieces utilize directional RF energy for RFAL treatments using cannula with diameters of 1.8mm and 2.2mm and external electrodes to apply RF energy to the subcutaneous adipose tissue. The tissue is heated to 50°C to 70°C to destroy fat and contract connective tissue, simultaneously remodeling the dermis at external temperatures up to 42°C. This handpiece allows tissue treatment using a 10cm cannula that provides treatment depth up to 25mm.

AccuTite – The minimally invasive AccuTite handpiece utilizes directional RF energy for RFAL treatments using sub-millimeter cannula with diameters of 0.9mm and external electrodes to apply RF energy to subcutaneous adipose tissue. The tissue is heated to 50°C to 70°C to destroy fat and contract connective tissue, simultaneously remodeling the dermis at external temperatures of up to 42°C. This handpiece allows tissue treatment using a 60mm cannula that provides treatment depth up to 25mm. Additionally, in 2019, the company began marketing AccuTite for Aviva, a minimally invasive procedure that restores the function and appearance of the vulva by offering a non-excisional alternative to a labiaplasty. Aviva is powered by AccuTite to deliver safe and uniform heat to the entire soft tissue matrix of the labia minora, labia majora, clitoral hood, vaginal introitus and perineal body.

Fractora – The minimally invasive Fractora handpiece uses customizable fractional energy and superficial fractional resurfacing for subdermal adipose tissue remodeling. The handpiece offers two treatment depths (skin surface and subdermal) and is safe on all skin types including type IV. The consumable applicator tip contains 24-coated pins with a length of up to 4mm.

Morpheus8/Morpehus8 Body/Morpheus8V – The minimally invasive Morpheus8 and Morpheus8 Body handpieces use RF energy for subdermal adipose tissue remodeling, which is programmable by the user according to treatment area. The handpieces offer treatment depth up to 7mm. The upper part of the needle and external electrodes are coated with a polymer to prevent skin surface thermal damage while delivering RF energy into the subdermal space.

Non-Invasive

BodyFX/MiniFX – The non-invasive BodyFX and MiniFX handpieces combine vacuum and bipolar RF energy with high and low amplitudes to both permanently kill adipose tissue and contract the skin. The BodyFX handpiece, intended for use on various parts of the body, comprises a vacuum cavity with a size of 1.36in x 1.2in. The MiniFX handpiece, better suited to address problematic fatty tissue in smaller areas, comprises a vacuum cavity with a size of 1.24in x 0.87in.

DiolazeXL (810nm) – The non-invasive DiolazeXL (810nm) handpiece is a high-speed, gold standard 810nm (diode) laser indicated for permanent hair reduction. DiolazeXL’s differentiated triple contact cooling technology (pre, parallel and post), or 3PC technology, provides for a safe and comfortable patient experience. The handpiece covers a spot size of 12mm x 26mm to allow for the removal of a variety of hair colors and thickness. This handpiece offers short and long pulse durations and repetition rates that enable treatment times up to 6cm2/second.

Triton Duo Light (755nm & 810nm) – The non-invasive Triton Duo Light handpiece combines two wavelengths for optimal treatment of light skin patients. The handpiece utilizes a blend of 755nm (Alexandrite) and 810nm (diode) laser wavelengths that have been optimized for hair removal on patients with skin types I to IV. The Triton platform is the only FDA-cleared device capable of firing two wavelengths in one pulse. The handpiece covers a spot size of 12mm x 26mm and provides two pulse durations and high repetition rates.

Triton Duo Dark (810nm & 1064nm) – The non-invasive Triton Duo Dark handpiece combines two wavelengths for optimal treatment of dark skin patients. The handpiece utilizes a blend of 810nm (diode) and 1064nm (Nd:YAG) laser wavelengths that have been optimized for hair removal on patients with skin types Ito IV. The Triton platform is the only FDA-cleared device capable of firing two wavelengths in one pulse. The handpiece covers a spot size of 12mm x 26mm and provides two pulse durations and high repetition rates.

Forma – The non-invasive Forma handpiece uses the company’s ACE technology to deliver auto-adjusting uniform RF energy-generated heat (up to 43°C) for collagen remodeling and skin contraction of the face and neck. Forma is the first thermal face and neck skin tightening device to have both temperature monitoring and automatic, user programmable, RF on/off control. This handpiece has an RF energy output power of up to 65 watts and covers a spot size of 22mm x 20mm.

FormaV – The non-invasive FormaV handpiece uses the company’s ACE technology to deliver auto-adjusting uniform RF energy generated heat (up to 43°C) to vaginal tissue through a consumable applicator.

VTone – Intervaginal EMS device to treat SUI and pelvic floor muscle restorations.

Plus – The non-invasive Plus handpiece uses the company’s ACE technology to deliver auto-adjusting uniform RF generated heat (up to 43°C) for collagen remodeling and skin contraction of the body. Plus is the first thermal body skin tightening device to have both temperature monitoring and automatic, user programmable, RF on/off control. This handpiece has an RF energy output of up to 65 watts and covers a spot size of 45mm x 45mm.

Lumecca – The non-invasive Lumecca handpiece is an IPL handpiece optimized for both light and dark skin that uses a xenon flash lamp to deliver filtered optical energy in the 515nm to 1200nm range for light skin treatment and 580nm to 1200nm range for darker skin. Lumecca is intended for the treatment of superficial vascular and pigmented lesions. The handpiece covers a spot size of 30mm x 10mm with a peak optical power of 10,000 watts.

Lumecca I – a version of Lumecca for the treatment of dry eye.

Vasculaze – The non-invasive Vasculaze handpiece, introduced in 2018, is a 1064nm wavelength diode laser intended for use in the coagulation and hemostasis of benign vascular legions, such as but not limited to, reticular leg veins, spider veins, hemangiomas, port wine stains and venous lakes. Vasculaze is optimized with high peak power, strong contact cooling and an ergonomic head intended to maximize treatment efficiency. The handpiece covers a spot size of 3mm x 4mm and has pulse duration of 20 to 100 milliseconds, or msec.

Forma I – a non-invasive handpiece that is based on Bipolar RF for the treatment of lower and upper lids in order to improve dry eye.

Hands-Free

Transform – The non-invasive Transform is a set of six hands-free applicators for the EvolveX platform. The mechanism of action is a combination of Bipolar RF and EMS. The Transform is mounted on a belt and works automatically without the assistance of a physician or technician.

Tite – The non-invasive Tite is a set of eight hands-free applicators for the EvolveX platform. The mechanism of action is similar to the Plus handpiece. The Tite is mounted on a belt for the treatment of different body parts and areas without the assistance of a physician or technician.

Tone – The non-invasive Tone is a set of four hands-free electro-muscle stimulation applicators. The Tone is designed to be used on the EvolveX platform for muscle stimulation and improving skin tone.

Cheek – The non-invasive Cheek is a hands-free device containing eight applicators that is mounted on the face and designed to be used with the Evoke platform. The mechanism of action is similar to the Forma handpiece, but works automatically on both sides of the face without the assistance of a physician or technician.

Chin – The non-invasive Chin is a hands-free device containing two applicators that is mounted on the chin and designed to be used with the Evoke platform. The mechanism of action is similar to the Forma handpiece, but works automatically on the chin without the assistance of a physician or technician.

Proprietary Software

The company’s software permits the user to define treatment parameters to be communicated to the electronic modules in the platform and deliver RF or optical energy through the handpiece or hands-free applicator to the patient. In addition, the company’s software controls and manages proper system performance and automatic temperature control, system self-calibration, system setup and detection of any malfunction of the system. The company’s software’s automotive capabilities allow physicians to dedicate their attention and focus to patient treatment rather than system monitoring. The company’s users upgrade their products through the purchase of additional treatment applicators and corresponding software plugs. All of the company’s software complies with applicable medical specifications and regulations.

Applications and Procedures

The company’s products provide its customers with a broad range of applications among both traditional procedures and emerging applications.

Face and Body Contouring

Minimally Invasive

The company’s RFAL technology can be administered on all regions of the body and typical treatments are approximately 30 to 90 minutes each under local anesthesia. The company received 510(k) FDA clearance for its RFAL technology in 2016. Users conduct minimally invasive face and body contouring using RFAL technology with the BodyTite and Embrace platforms and BodyTite, FaceTite and AccuTite handpieces. The company received two 510(k) FDA clearances for Fractora in 2011 and 2016, and 510(k) FDA clearance for the Morpheus8 in 2019. Customers use this technology with the BodyTite, Embrace, Votiva and Optimas platforms.

Non-Invasive

Handpieces: Administered by physicians and other aesthetic practitioners, the company’s differentiated fat reduction solution is based on skin shaping using a vacuum and delivering both low amplitude bipolar RF energy for gentle deep tissue heating and high amplitude RF energy to simultaneously kill fat and tighten skin. The company received 510(k) FDA clearance for this technology in 2013. Users conduct non-invasive face and body contouring with the Contoura platform using the BodyFX or MiniFX handpieces.

Hands-Free

Hands-Free Applicators: Applied by physicians and other aesthetic practitioners, the company’s differentiated skin tightening, fat reduction and muscle stimulation solution is based on bipolar RF and EMS technologies, delivered through a set of hands-free applicators mounted or placed over the body or face. The company’s technology can be administered on all regions of the body and face. Patients generally receive three to six treatments for approximately 30 minutes each. Treatments are typically spaced one to two weeks apart. The company received 510(k) FDA clearance for the Evoke and Evolve in 2019. In 2021, the company received 510(k) FDA clearance for the EvolveX which replace the Evolve platform. Users conduct hands-free face and body contouring with the Evoke/Define and EvolveX platforms using the Transform, Tite and Tone hands-free applicators for the EvolveX, and Cheek and Chin hands-free applicators for the Evoke.

Medical Aesthetics

Skin Rejuvenation/Vascular & Pigmented Lesion Treatment

The company received 510(k) FDA clearance for superficial vascular and pigmented lesion treatments in 2013 and for hair removal and permanent hair reduction in 2017 and 2018, respectively. Users rejuvenate the skin with the Optimas platform using the Vasculaze and Lumecca handpieces.

Sub-Necrotic Thermal Tissue Remodeling

The company received three 510(k) FDA clearances for this technology in 2014, 2016 and 2017. Users conduct facial treatment with the Optimas platform using the Forma handpiece and body contouring with the Contoura platform using the Plus handpiece.

Permanent Hair Reduction

Administered by a user, who is not necessarily a physician, the company’s differentiated dual wavelength technology incorporated in the Triton platform fires two wavelengths in a single pulse destroying the hair follicles located in the dermis and subdermal layers. Due to the company’s unique dual wavelength technology, its Triton platform allows practitioners to address all skin types and tones. The company received 510(k) FDA clearance for its Optimas and dual wavelength Triton platforms for permanent hair reduction treatments in 2016 and 2018, respectively. Users perform permanent hair reduction procedures with the company’s Optimas and Triton platforms using the DiolazeXL and Triton Duo Light and Triton Duo Dark handpieces, respectively.

Women’s Health

The company has two platforms for women’s health: the Votiva and the EmpowerRF. Procedures with these platforms are performed by a physician. Depending on the handpiece, the administration of bipolar RF energy or subdermal heating is applied to gently warm and massage the internal vaginal tissue (FormaV), the external vaginal tissue (Morpheus8V), or to deliver uniform heat to the entire soft tissue matrix of the labia minora, labia majora, clitoral hood, vaginal introitus and perineal body (Aviva procedure administered by the AccuTite handpiece), and pelvic floor muscle restoration (with VTone). Depending on the treatment type, patients typically receive between two to three treatments of approximately 15 minutes each. Treatments are typically spaced two to three weeks apart. The company received 510(k) FDA clearance for FormaV for certain indications in 2017. In July 2018, the company received a letter from the FDA seeking information as to the regulatory basis for marketing of its FormaV handpiece based on its promotion and labeling of this device for use in certain women’s health conditions and procedures.

Ophthalmology

In 2023, the company introduced a new platform called Envision, which includes the Forma I handpiece and the Lumecca I handpiece for the treatment of upper and lower lids and dry eye. This platform also includes the Moprheus8 handpiece for the treatment of peri-orbital wrinkles.

Sales and Marketing

The company’s primary strategy to increase market penetration relies on selling directly to its traditional customer base of plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/GYNs. The company is also targeting newer market opportunities consisting of OB/GYNs, ENTs, ophthalmologists, general practitioners and aesthetic clinicians as an incremental growth opportunity.

The company targets potential customers through office visits, trade shows, professional journals and various forms of paid and unpaid media. The company also conducts clinical workshops featuring recognized expert panelists and key opinion leaders to promote existing and new treatment techniques using its products. The company uses direct mail programs to target specific segments of the market that it seeks to access, such as members of medical societies and attendees at meetings sponsored by medical societies or associations. In addition, the company maintains an active public relations program that has resulted in treatments based on its products being featured in various televised and printed media outlets, including InStyle, Shape, The Doctors and Harper’s Bazaar. In September 2022, international actress and producer, Eva Longoria, agreed to join the company as its brand ambassador to share her positive experience with its EvolveX and Morpheus8 technologies, replacing its previous brand ambassador, international pop icon, Paula Abdul.

The company sells and markets its products in the United States, Canada, the United Kingdom, Ireland, Spain, Portugal, France, Belgium, Luxemburg, Italy, Germany, Austria, Japan, Australia and India, through a direct sales force of approximately 256 representatives. The company also sells and markets its products through 59 distributors in 82 countries.

In international markets, to complement its direct sales force in Canada, the United Kingdom, Spain, Portugal, France, Belgium, Luxemburg, Italy, Australia and India the company sells its products through a network of distributors. The company’s Canadian sales efforts are headquartered in Toronto, Canada. As of December 31, 2023, the company had an international sales management team of seven employees supporting 59 independent distributors. The percentage of the company’s revenues from customers located outside of the United States for each of the years ended December 31, 2023. The company intends to continue to increase penetration of its customer base in international markets and expand into attractive new international markets, including within Canada, the United Kingdom, Ireland, Spain, Portugal, France, Belgium, Luxemburg, Italy, Germany, Austria, Japan, Australia and India, by identifying and training qualified distributors. The company requires its distributors to provide customer training, to invest in equipment and marketing, and to attend certain exhibitions and industry meetings.

Service and Support

The company supports its customers with a range of services, including business and practice development consulting and product service and maintenance.

The company services its products in three service centers:the U.S. market is serviced through its facility in Irvine, California, the Canadian market is serviced through its facility in Toronto, Canada, and the rest of the world is serviced through its distributors and its facility in Yokneam, Israel. In the event of a technical malfunction, the company’s customers first contact it (if in the United States or Canada) or its distributors (if outside of the United States or Canada) telephonically. The company then arranges for shipment of the defective product to one of its service centers in the United States or Canada. Outside the United States or Canada, the product is sent to the company’s distributors or its facility in Israel.

Manufacturing and Supply

Through its strategic arrangement with Flextronics (Israel) Ltd., or Flex, and (BY) Medimor Ltd., or Medimor, the company maintains dedicated manufacturing lines supervised by it in Flex and Medimor’s medical-grade manufacturing facilities in Migdal Haemek and Poriya, Israel. The contracts the company has with its main manufacturing subcontractors (Flex and Medimor) do not have minimum purchase requirements and allow it to purchase end products entered into on a purchase order basis.

Research and Development

The company’s research and development expenditures for the year ended December 31, 2023, were approximately $13.4 million.

Seasonality

The company’s fourth quarter has historically generated slightly stronger operating results. The company has historically experienced stronger sales in the fourth quarter in correlation with its 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, the company’s fourth quarter revenues may be greater than other quarters (year ended December 31, 2023). The company’s business is also impacted by general economic conditions.

Intellectual Property

Patents and Patent Applications

As of February 13, 2024, the company owned ten issued U.S. patents and one issued Korean patent. As of February 13, 2024, the company had filed seven patent applications that are pending in the United States Patent and Trademark Office. Out of those applications, one was filed also under The Patent Cooperation Treaty and one in Europe. The company’s issued U.S. patents are projected to expire between 2027 and 2038 (assuming pending U.S. patent applications are approved). These patents and patent applications cover the technologies described herein, and contribute to the protection of its rights to its proprietary technology. The company’s patents relate to radio frequency (RF) based technology that may be used for minimally invasive aesthetic solutions, such as fat destruction, and fractional skin ablation relating to skin tightening and fat destruction, among others, and cover its existing products. The company also relies on its issued patents to make, use, sell, and distribute its products. The term of the patents depends on the legal term for patents in the countries in which they are granted. In most countries, including the United States, the patent term is generally 20 years from the earliest claimed filing date of a non-provisional patent application in the applicable country. The company also relies upon trademarks in various jurisdictions covering the InMode brand and its product lines, as well as upon U.S. copyright law for protection of the software programs associated with its products.

Patent Litigation

On March 16, 2021, the company filed a complaint with the United States International Trade Commission (ITC) alleging ILOODA’s fractional radio frequency (RF) microneedling system, distributed in the United States by Cutera, Inc., infringes on its U.S. Patent No. 10,799,285. Additionally, the company requested that the ITC investigate ILOODA’s infringing imports and issue an exclusion order to bar importation of ILOODA’s microneedling system. On November 22, 2021, the company reached a settlement agreement with ILOODA and, accordingly, filed an agreed motion to terminate the investigation.

On October 11, 2023, the company filed a complaint of patent infringement against BTL Industries Ltd. (BTL) in the United States District Court, Central District of California, alleging that BTL infringed its U.S. patent no. 8961511. This litigation process is in the early stage and BTL has not yet submitted its response to this complaint. The company expects the first BTL response to be submitted to the Court no later than February 2024.

Copyrights, Trademarks and Trade Secrets

The software programs associated with the company’s products are protected by U.S. copyright law.

The company also filed for protection available under trademark law. As of December 31, 2023, the company owned 14 registered trademarks in the United States and it owned at least 38 registered trademarks in various jurisdictions outside the United States, including for the marks InMode and RFAL and certain key product names, in particular, BodyTite, Contoura by InMode, FaceTite, InMode, Optimas by InMode, Triton by InMode, Votiva by InMode, Triton by InMode, AccuTite, Morpheus, BodyFX, Diolaze, Fractora and Lumecca. The company also has at least nine pending foreign trademark applications. The company also has six pending trademark applications in the United States.

Competition

The company’s products compete against products offered by public companies, including Allergan plc, Cutera, Inc., Apyx Medical Corporation, Venus Concept Inc., Sisram Medical Ltd and Viveve Medical, Inc., as well as by private companies, such as Cynosure LLC, Lumenis Ltd., BTL Aesthetics, Inc. and Candela Medical Inc.

The company competes against products offered by public companies, including Allergan plc, Cutera, Inc., Apyx Medical Corporation, Venus Concept Inc., and Sisram Medical Ltd.., as well as by private companies, such as Cynosure LLC, Lumenis Ltd., BTL Aesthetics, Inc. and Candela Medical Inc.

Government Regulation

The company’s products and operations are subject to extensive and rigorous regulation by the relevant governmental authorities in the countries where it markets and sells or products. These governmental authorities include the FDA, which enforces, the FDCA, as well as other similar laws, and regulatory bodies worldwide. In addition, the Federal Trade Commission, or FTC, regulates the advertising of the company’s products in the United States. Further, the company is subject to laws directed at preventing fraud and abuse, which subject its sales and marketing, training and other practices to government scrutiny.

In the United States, the FDCA and its implementing regulations govern the following activities that the company performs and will continue to perform to help ensure that medical products distributed within the United States are safe and effective for their intended uses:

Each of the company’s marketed products has received 510(k) clearance for the uses for which they are being marketed.

The company’s manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. As a manufacturer, the company’s facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. The company is subject to unannounced inspections by the FDA to determine its compliance with the QSR and other regulations, and these inspections may include the facilities of its manufacturing subcontractors.

The company is also are regulated under the Radiation Control for Health and Safety Act, which requires laser products to comply with performance standards, including design and operation requirements, and manufacturers to certify in product labeling and in reports to the FDA that their products comply with all such standards.

The FDA also has the authority to require the company to repair, replace or refund the cost of any medical device that it has manufactured or distributed. When a 510(k) clearance is required, the company must submit a premarket notification demonstrating that its proposed device is substantially equivalent, as defined in the statute, to a previously cleared 510(k) device or a device that was in commercial distribution in the United States before May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, for which the FDA has not yet called for the submission of premarket approval applications.

The company is regulated under the Radiation Control for Health and Safety Act, which requires laser products to comply with performance standards, including design and operation requirements, and manufacturers to certify in product labeling and in reports to the FDA that their products comply with all such standards.

As an Israeli headquartered company, the company is subject to the Israeli Protection of Privacy Law of 1981 and the Privacy Protection Regulations (Data Security) 5777-2017. Further, in the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy laws and consumer protection and advertising laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to its operations or the operations of its collaborators and third-party providers.

In the European Union and the EEA, the GDPR imposes several stringent requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining to health data and pseudonymised (i.e., key-coded) data and additional obligations when it contracts third-party processors in connection with the processing of the personal data.

Further, since January 1, 2021, the company is subject to the GDPR and also the U.K. GDPR, which, together with the amended the U.K. Data Protection Act 2018, retains the GDPR in the U.K. national law.

History

InMode Ltd. was founded in 2008. The company was incorporated in 2008.