A. History and Development of the Company We were incorporated as a limited liability company in the State of Israel on January 2, 2008, and operate under its laws. In November 2017, our corporate name was changed from Invasix Ltd. to InMode Ltd. Our registered office is located at Tavor Building, Sha’ar Yokneam, P.O. Box 533, Yokneam 2069206, Israel. The phone number of our registered office is +972-4-9096313. Our wholly‑owned subsidiary, Invasix Inc., a Delaware corporation, acts as our agent for service of process in the United States and is located at 17 Hughes Irvine, California 92618. The phone number for Invasix Inc. is 949-387-5711. In August 2019, we completed our initial public offering of 10,000,000 of our ordinary shares at an initial public offering price of $7.00 per ordinary share. The effective date of the registration statement on Form F-1 (File No. 333-232615) was August 7, 2019. Also, during August 2019, the underwriters partially exercised their over-allotment option and purchased an additional 1,000,000 ordinary shares at the same price per share. Our ordinary shares commenced trading on Nasdaq on August 8, 2019, under the symbol “INMD.” Our capital expenditures for the years ended December 31, 2025, 2024 and 2023 amounted to approximately $1.0 million, $0.7 million and $0.8 million respectively. Our capital expenditures consist principally of the purchase of molds for manufacturing. We anticipate our capital expenditures in 2026 to be up to $1 million and to be financed from our existing cash and cash equivalents. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, including InMode, that file electronically with the SEC. The address of that site is www.sec.gov. We maintain a corporate website at www.inmodemd.com. Our periodic filings are available, free of charge (other than an investor’s own Internet access charges), on our website soon as reasonably practicable after we electronically file or furnish such material with the SEC. The information contained on our website or available through our website is not incorporated by reference into and should not be considered a part of this Annual Report on Form 20-F, and the reference to our website in this Annual Report on Form 20-F is an inactive textual reference only. B. Business Overview Overview We are a leading global provider of innovative, energy-based, minimally invasive surgical 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 wellness. 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 radio frequency, or RF, energy-based proprietary technologies—(i) Radio Frequency Assisted Lipolysis, or RFAL; (ii) Deep Subdermal Fractional RF; (iii) Simultaneous Fat Destruction and Skin Tightening; and (iv) 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, or GSM. We believe that our products, developed with our 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 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 destruction 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 have historically marketed and sold 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. 29 In addition to the existing group of patients who currently undergo full surgical aesthetic procedures, we believe our minimally invasive solutions satisfy a previously 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 sixteen product platforms: BodyTite, Optimas, Votiva, Contoura, Triton, EmbraceRF, EvolveX, Evoke, Morpheus8, EmpowerRF, Define, Envision, IgniteRF, OptimasMAX, Luxora, ApexRF and Solaria. Each product consists of the following components: a platform that incorporates multiple energy sources, one or more handpieces or hands-free applicators, 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, hands-free applicators 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 that the 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 and consumer needs. 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 ear nose and throat specialists we are in the initial stage of developing a new platform and handpieces that we believe will provide patients with a medical treatment solution for snoring and rhinitis. The handpiece for treatment of turbinates is based on our Deep Subdermal Fractional RF technology and is expected to contract the turbinate to enable free breathing. This platform and handpiece is in the concept design phase. • For urologists, we brought to the market a device using RF energy to for temporary relief of muscle spasms, and temporary improvement of local blood circulation. called ApexRF. We registered a patent application to protect our technological concept, and we believe that our technological concept work well for this indication but much more research and development is needed. 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. Historically, 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, 105 third-party clinical studies have been completed and 11 third-party clinical studies are in the process of being conducted using our products. We also have a portfolio of over 110 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 in demonstrating the efficacy of our technology. 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. 30 Our revenue decreased to approximately $370.5 million for the year ended December 31, 2025, from approximately $394.8 million for the year ended December 31, 2024 and from approximately $492.0 million for the year ended December 31, 2023. For the years ended December 31, 2025, 2024 and 2023, we recorded a gross margin of approximately 79%, 80% and 84%, respectively, and net income of approximately $93.9 million, $181.3 million and $197.9 million, respectively. Our principal market is in the U.S., where our revenue decreased to approximately $198.7 million for the year ended December 31, 2025, from approximately $244.8 million for the year ended December 31, 2024 and from approximately $307.8 million for the year ended December 31, 2023. Outside of the U.S., our revenue increased to approximately $171.8 million for the year ended December 31, 2025, from approximately $150.0 million for the year ended December 31, 2024 and decreased from approximately $184.2 million for the year ended December 31, 2023. Regarding U.S. revenues for the years ended December 31, 2025, 2024 and 2023, we derived approximately $155.4 million, or 78%, $223.7 million, or 92%, and $264.7 million, or 86%, of our total U.S. revenues from the sale of minimally invasive platforms. We derived approximately $5.2 million, or 3%, $15.2 million, or 6%, and $33.9 million, or 11%, respectively, of our total U.S. revenues from the sale of hands-free platforms, and approximately $38.1 million, or 19%, $5.9 million, or 2% and $9.2 million, or 3%, respectively, of our total U.S. revenues from the sale of non-invasive platforms. We have 37 FDA clearances and, in addition to the United States, where we have sold over 13,120 product platforms, we are permitted to sell our products in most countries. As of December 31, 2025, we sell and market our products in the United States, Canada, the United Kingdom, Ireland, Spain, Portugal, France, Belgium, Luxembourg, Italy, Germany, Austria, Japan, Australia, India, Thailand and Argentina through a direct sales force (including distributor sales managers) of approximately 285 representatives. We also sell and market our products through over 73 distributors in over 101 countries. As of December 31, 2025, we had a global installed base of approximately 30,900 product platforms capable of running various multi-use applicators and utilizing minimally invasive consumables. Our Solution We believes that 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 over 110 peer-reviewed publications. • Differentiated, RF energy-based technology simultaneously destroys 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 because less physician time and training is 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 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. 31 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. 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 of devices that deliver 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 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, EmbraceRF and IgniteRF platforms, and the BodyTite, FaceTite and QuantumRF handpieces rely on our proprietary RFAL technology. To date, there have been more than 340,000 successful RFAL procedures conducted with positive clinical results using our BodyTite, EmbraceRF and IgniteRF platforms, and the BodyTite, FaceTite and QuantumRF 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. 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. Our deep subdermal fractional RF can be applied to both face and body. Our Morpheus8, Morpheus8 Body, Morpheus Burst and Morpheus8 V handpieces rely on our proprietary Deep Subdermal Fractional RF technology and are used in conjunction with our BodyTite, Embrace RF, Optimas, IgniteRF, OptimasMAX, EmpowerRF, Envision and Define 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. 32 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 destroy 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 destroys adipose tissue. Our BodyFX handpiece and MiniFX handpiece 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 for Skin and Human Natural Openings 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 Forma, FormaV, and Morpheus8V handpieces utilize 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 Bipolar RF Continuous bipolar 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 bipolar 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 centimeters). Bipolar RF can be delivered to the tissue in one of two modes: either pulse or continuous. In pulse mode, pulse duration is pre-determined and RF energy automatically stops. In continuous mode, the RF energy is delivered uninterrupted into the tissue for as long as the operator deems appropriate. As part of the design, continuous bipolar RF energy allows real-time measurement of the patient’s skin temperature. This allows our products to provide real-time feedback to the operator throughout the treatment process and enhances overall safety and efficiency. All of our RF platforms (both existing and expected) and RF handpieces (both minimally and non-invasive) have both pulse bipolar RF and continuous bipolar RF capabilities. Our proprietary RFAL-based products (such as our BodyTite and IngiteRF platforms with BodyTite, FaceTite and QuantumRF handpiece) and Deep Heating Collagen Remodeling based products (such as our Forma and Plus handpieces) primarily utilize the continuous bipolar RF feature. Our proprietary Deep Subdermal Fractional RF based products (such as our Morpheus8 and Moprheus8 Burst handpieces) and Simultaneous Fat Destruction and Skin Tightening products (such as our BodyFX and Mini FX handpieces) primarily utilize the pulse feature, depending on the procedure and target result. Figure 3 below shows how RF energy is delivered through the handpiece by an electric charge between two electrodes continuously into the tissue. 33 Figure 3: Pulse/Continuous Bi-polar RF mechanism of action. Non-invasive Medical Aesthetic Technologies In addition to our proprietary minimally invasive solutions, we continue to develop innovative non-invasive medical aesthetic solutions, including: • Simultaneous non-invasive fat destruction and skin tightening. We believe our technology is the first RF-based, noninvasive body contouring technology that permanently destroys adipose tissue while simultaneously contracting the skin. This technology addresses problematic fatty tissue in large body areas such as the abdomen, back and thighs. Customers use this technology with the Contoura platform and the BodyFX and MiniFX handpieces. • Dual wavelength for permanent hair reduction. Our single-pulse, dual wavelength product for permanent hair reduction, Triton, combines two wavelengths in one platform, overcoming certain limitations of standard lasers. This optimal mix of wavelengths allows the highest efficiency and safety. This optimal mix of wavelengths allows the highest efficiency and safety. We believe Triton is the only FDA-cleared, single-pulse, dual wavelength product for permanent hair reduction. Customers use this technology with the Triton Duo Light and Triton Duo Dark handpieces. • High-power Intense Pulsed Light. Our high-power IPL is a breakthrough technology that delivers up to three times more energy than typical IPL devices within the 500 to 600 nanometers, or nm, range to improve efficacy for vascular and pigmented lesions. It is optimized to treat a variety of skin types and conditions in a single session. Customers use this technology with the Optimas and the OptimasMAX platforms and the Lumecca handpiece. • Controlled continuous RF heating. We believe our controlled continuous RF technology is the first auto-adjusting non-invasive thermal skin treating technology for deep and uniform tissue stimulation. This technology uses bipolar RF energy delivery that allows uniformity between the electrodes to provide a comfortable thermal effect with immediate and subsequent contraction. Customers use this technology with the Optimas, OptimasMAX, Votiva, Define, Contoura, Evoke and EvolveX hands-free platforms and EmpowerRF, as well as the Envision. • Energy Muscle Stimulation (EMS). This technology is used on several platforms that we sell, such as the EvolveX and EmpowerRF. The technology can be combined with RF or can be stand-alone. Differentiated and Comprehensive Post-Sales Support To complement our innovative aesthetic solutions, we offer post-sales training and support services. We provide physicians training focused on the most beneficial ways to utilize our products, including a disciplined focus on safety. Our clinical training and support program consists of three key components: i. A visit by a new physician customers to one of our many plastic surgery facilities for instruction followed by a live patient demonstration; ii. A visit to the new physician customer’s office by a trained registered nurse or physician’s assistant to attend the first day of treatments; and iii. Open house workshops organized by us, wherein a new physician customer invites his or her patient base and we assist them in “kick starting” marketing efforts. These events typically secure significant procedural revenues for the physician. 34 In addition, we offer ongoing livestream classes for physician customers where they can observe and interact in real-time with both our training staff and highly qualified physician instructors on a regular basis. Advanced training is also available for physicians who choose to expand their education on highly skilled procedures, including non-excisional breast lifting or brachioplasty. We are continuing to build a library of on-line instructional videos as both a reference tool and to expand physicians’ procedural offerings. We also provide support to help customers educate and engage patients about the new minimally invasive procedures available to them through our In-Practice program. This program provides hands-on, personalized marketing support for customers’ practices including marketing materials such as signage, educational collateral, digital marketing and advertising assets. We believe that we provide one of the most extensive training and ongoing support programs available to physicians throughout the aesthetics industry. Our Competitive Strengths We attribute the growing commercial success of our 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 previously could only be generally achieved with more expensive and invasive surgical procedures. Our RF proprietary energy-based technology simultaneously destroys 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. Unlike many of our competitors, our technology is not exclusively laser-based or limited to superficial treatment of the 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. • Strong brand recognition. Our brand is associated with product leadership, significant technological advances and extensive clinical data, which has led to strong customer loyalty. 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. 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 or applicators. 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 37 FDA clearances and in addition to the United States, are permitted to sell in approx. 90 countries. To date, we also have a portfolio of over 110 peer-reviewed publications and 11 ongoing third-party clinical studies on a number of our products (BodyTite, FaceTite, NeckTite, Optimas, Fractora, Morpheus8, Forma, Lumecca, DiolazeXL, Votiva, Morpheus8V, FormaV, Contoura, BodyFX, MiniFX, Evoke, EvolveX, Morpheus8, AccuTite, QuantumRF, Luxora ApexRF and Solaria). 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 technologies. Moshe Mizrahy and Dr. Michael Kreindel, our co-founders, previously founded Syneron Medical Ltd. Our senior executive team has an average of over 16 years of medical aesthetics industry experience and has served in various leadership positions at Syneron Medical Ltd. and Cynosure, Inc. 35 Our Growth Strategy Our objective is to expand our technological leadership in the surgical solutions market and to leverage our RF proprietary technologies to expand into additional medical solutions markets. 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 continue 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 historic customer base. • United States: We have a direct sales presence in United States and plan to keep expanding our direct sales team. • Canada: We have a direct sales presence in Canada and plan to keep expanding our direct sales team. • Europe: We intend to establish sales and marketing organizations and a network of exclusive European distributors in addition to our subsidiaries network in the United Kingdom, Spain, Italy, France and Germany. • Latin America: We plan to strengthen our network of exclusive distributors in all countries in Latin America. In 2025, we established a direct sales operation in Argentina. • Asia-Pacific: In addition to our direct sales presence in India, Australia, Japan and Thailand, we may also establish direct sales presence in China through our fully-owned subsidiary in China, Guangzhou InMode Medical Technology Ltd., as well as enhance our network of exclusive distributors in other countries in Asia. • 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 inception, we have sold over 4.4 million 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 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 historic customer base. Our near-term product development portfolio consists of new and second generation solutions for various conditions, including wearable, noninvasive face and body reshaping products, cellulite, large area lipolysis, fractional RF treatment of stress urinary incontinence , ), vaginal laxity pelvic floor muscle restoration, labiaplasty procedures, post-partum treatments and other GSM symptoms, snoring and rhinitis treatments, dry eye and eyelid treatments, Temporomandibular Joint Disorders and Erectile Dysfunction. • 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 new customer base, which includes OB/GYNs, 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 of technologies 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 properly and patent portfolio. We intend to expand our existing intellectual property and patent portfolio as we develop additional applications and continue to aggressively defend our existing patent portfolio against potential infringement by our competitors. 36 Our Products We offer a broad portfolio of aesthetic and medical treatment solutions that consist of a variety of platforms providing minimally and non-invasive applications. The following tables provide information concerning our product platforms and their applications. Minimally Invasive and Ablative Platforms Product Platform Energy Source(s) Year Introduced Handpiece(s) Primary (not Exclusive) Applications* BodyTite Bipolar RF 2010 BodyTite Body Contouring (MI) FaceTite Face Contouring (MI) NeckTite Neck Contouring (MI) AccuTite Face/Body Contouring (MI) Optimas Optimas MAX Laser Bipolar RF IPL 2016 2024 Morpheus8 Forma Lumecca DiolazeXL Vasculaze Skin Rejuvenation (MI) Skin Rejuvenation (NI) Skin Rejuvenation & Pigmentation (NI) Hair Removal (NI) Vascular Lesion (NI) Facial Wrinkles and Texture (MI) EmbraceRF Bipolar RF 2018 FaceTite Face Remodeling (MI) Morpheus8 Facial Wrinkles and Texture (MI) AccuTite Face/Body Contouring (MI) Votiva Bipolar RF 2017 FormaV Women’s Wellness (MI) Women’s Wellness (NI) Morpheus8 Bipolar RF 2021 Morpheus8 Face and body fractional RF treatment (MI) Morpheus8 Body Envision Bipolar RF and IPL 2023 Forma i Lumecca I Morpheus8 Treatment of dry eyes Facial Rejuvenation Morpheus8 Burst Bipolar RF 2024 Morpheus8 Burst Morpheus8 Burst Deep Face and body fractional RF treatment (MI) EmpowerRF Bipolar RF and EMS 2021 FormaV, Morpheus8V, VTone, Aviva Women’s Wellness (MI) IgniteRF/ Luxora Bipolar RF 2024 QuantumRF Body and face contouring (MI) 37 Non-Invasive Platforms Product Platform Energy Source(s) Year Introduced Handpiece(s) Primary (not Exclusive) Applications* Contoura Bipolar RF 2017 BodyFX Body Contouring MiniFX Face/Neck Contouring Plus Skin Tightening Triton Laser 2018 Triton Duo Light Hair Removal Triton Duo Dark Hair Removal ApexRF BipolarRF 2025 Curved and Straight ED handpieces Improved Blood Circulation Solaria Laser 2025 CO2,HP Facial Rejuvenation Hand-Free Platforms Product Platform Energy Source(s) Year Introduced Handpiece(s) Primary (not Exclusive) Applications* EvolveX Bipolar RF EMS 2021 Tite (HF) Skin Tightening Transform (HF) Body Contouring Tone (HF) EMS Evoke Bipolar RF 2020 Cheek (HF) Skin Rejuvenation Chin (HF) Skin Rejuvenation Define Bipolar RF 2023 Cheek (HF) Chin (HF) Skin Rejuvenation Skin Rejuvenation * “MI” = Minimally Invasive, “NI” = Non-Invasive, “HF” = Hands-free application In addition to the products described above, prior versions of our products continue to be used by customers. Outside of the United States, we also offer some alternative versions of our 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 Our Products Each of our products consists of the following components: • platform; • one or more handpieces or hands-free applicators; • one-time disposable handpiece or tip; and • our proprietary software. Platforms Our 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 our 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 Our 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 our handpieces and hands-free applicators have a contained thermal field that ensures a controlled and safe treatment through our Acquire, Control and Extend, or ACE, technology. Our 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 our handpieces and hands-free applicators are, or contain, one-time use applicators, or consumables, which must be replaced following each treatment. 38 Minimally Invasive BodyTite – The minimally invasive, consumable Bodyrite handpiece, introduced in 2010, 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, introduced in 2012, 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, introduced in 2019, 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, we 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. QuantumRF 10 and QuantumRF25 – The minimally invasive disposable handpieces for minimally invasive treatment of face and body for simultaneous treatment of destroying fat and skin tightening. The QuantumRF handpieces are operated on the IgniteRF platform. Fractora – The minimally invasive Fractora handpiece, introduced in 2011, 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/Morpheus8 Burst/Moprheus8 Deep/Morpheus8V – The minimally invasive Morpheus8 and Morpheus8 Body handpieces use RF energy for subdermal adipose tissue remodeling, and are 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, introduced in 2013, combine vacuum and bipolar RF energy with high and low amplitudes to both permanently destroy 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, introduced in 2017, 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. 39 Triton Duo Light (755nm & 810nm) – The non-invasive Triton Duo Light handpiece, introduced in 2017, 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 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, introduced in 2017, 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 handpiece covers a spot size of 12mm x 26mm and provides two pulse durations and high repetition rates. Forma – The non-invasive Forma handpiece, introduced in 2013, uses our 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. We believe 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. Forma I – The non-invasive handpiece was introduced in 2022 for treatment of peri-orbital and meibomian glands, and for dry eye indication by Health Canada. The energy level is similar to Forma (above), and the handpiece covers a spot size of 10 sq. millimeters. FormaV – The non-invasive FormaV handpiece, introduced in 2017, uses our 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, introduced in 2013, uses our ACE technology to deliver auto-adjusting uniform RF generated heat (up to 43°C) for collagen remodeling and skin contraction of the body. We believe 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 Peak – The non-invasive Lumecca and Lumecca Peak handpieces, introduced in 2015 and 2024, are IPL handpieces 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 and Lumecca Peak are intended for 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. 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. Hands-Free Transform – The non-invasive Transform, introduced in 2021, 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, introduced in 2019, 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 treatment of different body parts and areas without the assistance of a physician or technician. Tone – The non-invasive Tone, introduced in 2019, 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, introduced in 2020, is a hands-free device containing eight applicators that is mounted on the face and designed to be used with the Evoke platform or Define 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, introduced in 2020, is a hands-free device containing two applicators that is mounted on the chin and designed to be used with the Evoke platform or Define 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. 40 Proprietary Software Our 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, our software controls and manages proper system performance and automatic temperature control, system self-calibration, system setup and detection of any malfunction of the system. We believe our software’s automotive capabilities allow physicians to dedicate their attention and focus to patient treatment rather than system monitoring. Our users upgrade their products through the purchase of additional treatment applicators and corresponding software plugs. All of our software complies with applicable medical specifications and regulations. Applications and Procedures Our products provide our customers with a broad range of applications among both traditional procedures and emerging applications. Face and Body Contouring Minimally Invasive Generally performed by a physician, RFAL delivers directional RF energy into a patient’s subcutaneous fat to coagulate and liquefy adipose tissue and heat the subcutaneous fibrous septa, resulting in substantial collagen contraction of the subdermal space. RF energy is delivered through 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 passes through the subcutaneous fat, while the external electrode slides over the skin’s surface. The small conductive tip of the cannula concentrates RF energy in the subcutaneous fat, liquefying it and simultaneously contracting the fiber septa. This liquefied fat can then be removed from the body. Our RFAL technology can be administered on all regions of the body and typical treatments are approximately 30 to 90 minutes each under local anesthesia. We received 510(k) FDA clearance for our 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. In 2024, we introduced the IgniteRF platform with the QuantumRF handpiece which is also based on RFAL technology. We received 510 K FDA clearance for the QuantumRF in 2024. Generally performed by a physician, Deep Subdermal Fractional RF delivers RF energy into the subcutaneous adipose tissue to depths of up to 4mm through an array of coated needles producing localized heat and matrix of small lesions in the subcutaneous fat. The heat generated by the pins in the subdermal tissue promotes connective tissue restructuring. As a result, physicians can offer a versatile fractional treatment creating a three-dimensional collagen contraction and subdermal fat coagulation. The deep fractional remodeling is used when fat layer is not thick enough to use RFAL technology or when patient wants only superficial result. Deep Subdermal Fractional RF can be used for wrinkle reduction, skin tightening and treatment of cellulite appearance. In addition to reshaping, Deep Subdermal Fractional RF provides long-term results for inflammatory acne by coagulating enlarged sebaceous glands. The most common areas of treatment are the face and neck. Patients generally receive between one to three treatments for approximately 30 minutes each. Treatments are typically spaced two to three weeks apart. We received two 510(k) FDA clearances for Fractora in 2011 and 2016, and 510(k) FDA clearance for the Morpheus8 in 2019. In addition, we received 510K clearance for the Morpheus8soft tissue coagulation/contraction in 2024. Customers use this technology with the BodyTite, Embrace, IgniteRF, Votiva, Empower, Optimas and OptimasMAX platforms. Solaria: Solaria is a fractional CO2 technology used for ablative skin resurfacing. It delivers precise microbeam treatments that leave surrounding tissue untreated, supporting deep ablation, faster healing, and fewer side effects. The system provides the trusted benefits of traditional resurfacing with the advantages of fractional procedures, offering controlled optical energy up to 120 microns and 45 mJ per micro spot. With multiple scanning modes, adjustable ablation areas, and four tips, it is a versatile platform for customizable treatments. Non-Invasive Handpieces: Administered by physicians and other aesthetic practitioners, our 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 destroy fat and tighten skin. The handpiece is placed over the desired area of the body and vacuum energy shapes the skin into the cavity for safe and effective RF energy delivery allowing greater volumes of fat to be treated (up to 2.5cm in depth). Subsequently, temperature-controlled RF energy is applied to preheat the tissue and fat uniformly to 42°C to 43°C. High amplitude RF energy delivered in ultra-short pulse duration is then administered via electrodes causing apoptosis of adipose tissue and resulting in simultaneous skin contraction. Our technology can be administered on all regions of the body. Patients generally receive six treatments for approximately 10 to 20 minutes each. Treatments are typically spaced one to two weeks apart. We 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. 41 Hands-Free Hands-Free Applicators: Applied by physicians and other aesthetic practitioners, our 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 setup of the parameters is determined by a doctor. Subsequently, temperature-controlled RF energy is applied to preheat the tissue and fat uniformly to 42°C to 43°C. High amplitude RF energy delivered in ultra-short pulse duration is then administered via electrodes causing apoptosis of adipose tissue and resulting in simultaneous skin contraction. Our 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. We received 510(k) FDA clearance for the Evoke and Evolve in 2019. In 2021, we received 510(k) FDA clearance for the EvolveX which replaced the Evolve platform. Users conduct hands-free face and body contouring with the Evoke 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 and Define. Medical Aesthetics Skin Rejuvenation/Vascular & Pigmented Lesion Treatment Generally performed by a physician or other aesthetic professional, different types of energy and treatments are provided, depending on the handpiece. The application of JPL energy enables the improvement of photo damage, as well as other pigmented abnormalities and superficial vascular lesions. A 1064nm laser is used for the treatment of larger and deeper veins. Patients often see results after a single treatment, but typically two to three treatments of approximately 15 minutes each are recommended. Treatments are typically spaced two to four weeks apart. We 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 and OptimasMAX platforms using the Vasculaze, Lumecca and Lumecca Peak handpieces. Sub-Necrotic Thermal Tissue Remodeling Administered by physicians and other aesthetic practitioners, the application is based on uniform and deep heating of the skin and subdermal layer using bipolar RF energy. The handpiece is moved over the desired area of the treatment area, while maintaining the designated temperature for the predetermined time for safe and effective collagen remodeling. Subsequently, temperature-controlled RF energy is applied automatically to heat tissue uniformly to 42°C to 43°C. The Forma handpiece is utilized to target fat and heats the tissue to depths of up to 4.5mm while the Plus handpiece is used for larger body areas and provides effect up to 6mm in depth. Patients generally receive six treatments for approximately 10 to 20 minutes each. Treatments are typically spaced one to two weeks apart. We received three 510(k) FDA clearances for this technology in 2014, 2016 and 2017. Users conduct facial treatment with the Optimas and OptimasMAX platforms 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, our 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. This procedure is continued over the target area and can last from a few minutes to 90 minutes depending on the size of the treatment area. In general, permanent hair reduction requires four to six treatments spaced four to eight weeks apart. More sessions may be required for stubborn hairs. Due to our unique dual wavelength technology, our Triton platform allows practitioners to address all skin types and tones. We received 510(k) FDA clearance for our Optimas and dual wavelength Triton platforms for permanent hair reduction treatments in 2016 and 2018, respectively. Users perform permanent hair reduction procedures with our Optimas and Triton platforms using the DiolazeXL and Triton Duo Light and Triton Duo Dark handpieces, respectively. 42 Women’s Wellness We have two platforms for women’s wellness: 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. We received 510(k) FDA clearance for FormaV for certain indications in 2017. In July 2018, we received a letter from the FDA seeking information as to the regulatory basis for marketing of our FormaV handpiece based on our promotion and labeling of this device for use in certain women’s wellness conditions and procedures. We timely responded to the FDA by immediately altering the wording of our promotional and labeling materials, and we submitted a response letter in August 2018 answering the FDA’s questions and advising the agency that we had modified our promotional and labeling materials to remove certain statements regarding uses of our products for conditions and procedures that were questioned by the FDA in the agency’s informational request letter. 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 continues to expect us to conduct a review of our marketing and promotional materials to make appropriate changes and remove materials containing uncleared claims. We have received no further communications from the agency regarding this matter. Men’s Health In 2025, we launched the ApexRF, which is based on non-invasive bipolar RF technology intended to treat men who suffer from ED. This treatment is carried our using two different handpieces: the ED straight handpiece for treatment of the perineum and a curved handpiece for treatment of the penis. We are currently conducting two clinical studies in the United States, and, during 2026, we currently intend to launch this product in Europe. We do not yet have RF clearance for Erectile Dysfunction indication and are accordingly are limited in how we may market ApexRF. Sales and Marketing Our primary strategy to increase market penetration relies on selling directly to our historic customer base of plastic and facial surgeons, aesthetic surgeons, dermatologists and OB/GYNs. We believe we are the only company commercializing minimally invasive aesthetic solutions specifically targeting the surgical community and believe our products represent a significant opportunity for these practitioners to deliver improved patient treatment results and significantly increase their ability to generate additional revenue. We are also targeting newer market opportunities consisting of OB/GYNs, ENTs, urologists, ophthalmologists, general practitioners and aesthetic clinicians as an incremental growth opportunity. We target potential customers through office visits, trade shows, professional journals and various forms of paid and unpaid media. We also conduct clinical workshops featuring recognized expert panelists and key opinion leaders to promote existing and new treatment techniques using our products. We believe that these workshops enhance customer loyalty and provide us with new sales opportunities. We plan to continue to offer a large number of workshops spanning from single-day workshops to three-day workshops. We also use direct mail programs to target specific segments of the market that we seek to access, such as members of medical societies and attendees at meetings sponsored by medical societies or associations. In addition, we maintain an active public relations program that has resulted in treatments based on our 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 us as our brand ambassador to share her positive experience with our EvolveX and Morpheus8 technologies, replacing our previous brand ambassador, international pop icon, Paula Abdul. We do not currently have a brand Ambassador. We currently sell and market our products in the United States, Canada, the United Kingdom, Ireland, Spain, Portugal, France, Belgium, Luxembourg, Italy, Germany, Austria, Japan, Australia, India, Thailand and Argentina through a direct sales force of approximately 285 representatives. We also sell and market our products through over 73 distributors in over 101 countries. Our U.S. sales efforts are headquartered in Irvine, California. To support the continued roll-out of our products and further penetrate the market, we anticipate that our direct sales force in the United States will continue to increase. 43 In international markets, to complement our direct sales force, we sell our products through a network of distributors. Our Canadian sales efforts are headquartered in Toronto, Canada. As of December 31, 2025, we had an international sales management team of seven employees supporting over 73 independent distributors. The percentage of our revenues from customers located outside of the United States for each of the years ended December 31, 2025 and 2024 was 46% and 38%, respectively. We intend to continue to increase penetration of our customer base in international markets and expand into attractive new international markets by identifying and training qualified distributors. In addition, we may opportunistically hire a direct sales force and expand our marketing campaigns in select international markets. We require our distributors to provide customer training, to invest in service and demonstration equipment and marketing, and to attend certain exhibitions and industry meetings. Service and Support We support our customers with a range of services, including business and practice development consulting and product service and maintenance. We service our products in three service centers: (1) the U.S. market is serviced through our facility in Irvine, California, (2) the Canadian market is serviced through our facility in Toronto, Canada, and (3) the rest of the world is serviced through our distributors and our facility in Yokneam, Israel. In the event of a technical malfunction, our customers first contact us (if in the United States or Canada) or our distributors (if outside of the United States or Canada) telephonically. If a product requires service or repair that cannot be addressed telephonically, we or our distributors ship a temporary “loaner” system to the customer as soon as possible, often overnight. This unique “loaner” system reduces any product downtime and associated lost revenues for the physician. We then arrange for shipment of the out-of-order product to one of our service centers in the United States or Canada. Outside the United States or Canada, the product is sent to our distributors or our facility in Israel. Either we or our distributors quickly repair the product and ship it back to the customer. We have designed our products in a lightweight, modular fashion to enable quick and efficient service and support. Specifically, we build our platforms to be less than 35 kilograms in weight to ensure acceptance by traditional, commercial third-party logistics providers for next-day delivery of replacement products without requiring specialized shipping procedures. We believe our depot service and support model provides for more efficient and less costly operations. Our standard warranty term is 12 months, however, certain products are sold with multi-year warranties. Our standard warranty covers parts, labor, participation in our loaner program and a white glove, door-to-door, shipping service for expedited repair service, and can be extended for an additional charge. We believe that we have a significant opportunity to increase our recurring customer revenue by increasing the number of our customers that enter into service contracts and extended warranties for our systems. All of our distributors have a service department and are required by us to maintain a full inventory of spare parts. All service staff is trained by our service department in Israel. Manufacturing and Supply We rely primarily on outsourced manufacturing to produce our devices while maintaining control over the production process. Outsourcing allows us to carry lower inventory levels and maintain fixed unit costs without incurring significant capital expenditures than would be in place if products were self-manufactured. We outsource almost all of the manufacturing of our products to three subcontractors located in Israel, two of which we are substantially dependent on as part of our business. Through our strategic arrangement with Flextronics (Israel) Ltd., or Flex, and (BY) Medimor Ltd., or Medimor, we maintain dedicated manufacturing lines supervised by us in Flex and Medimor’s medical-grade manufacturing facilities in Migdal Haemek and Poriya, Israel. Within the Flex and Medimor facilities, all proprietary manufacturing, testing and assembly equipment was built and is owned by us. We also use a separate manufacturer, in addition to Flex and Medimor, to produce our handpieces and disposables. We believe our outsourced manufacturers’ processes comply with all applicable U.S. and international quality and safety standards, such as ISO 13485:2016, CE and the FDA quality system regulations. We conduct in-house prototype development and present detailed manufacturing documents to our subcontractors, who then purchase most of the necessary components and manufacture the product. These 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 facilities. 44 The contracts we have with our main manufacturing subcontractors (Flex and Medimor) do not have minimum purchase requirements and allow us to purchase end products on a purchase order basis. Under these contracts, our manufacturing subcontractors provide manufacturing services pursuant to our written specifications. These manufacturing services include labor, materials, testing, packaging and delivery, as well as allocating production and storage space within their facilities for our products. Pricing under these contracts is reviewed between us and the manufacturing subcontractors every three months. These contracts typically have one-year terms that automatically renew for successive one-year terms unless either we or the manufacturing subcontractor provide three months written notice prior to the expiration of the term. To date, we have not experienced any significant manufacturing delays. These contracts can be terminated by either party, without cause, with four to six months prior written notice. We manufacture all laser and IPL handpieces in our facility in Yokneam, Israel and procure other major components of our products on behalf of our third-party manufacturers from a limited number of suppliers. We have flexibility to adjust the number of lasers and other components that we either manufacture or procure as well as the delivery schedules. The forecasts that we use are based on historical demands and expected future plans. Lead times may vary significantly depending on the size of the order, time required to fabricate and test the components, specific supplier requirements and current market demand for the components. We intend to reduce any potential for delays of supply by maintaining relationships with multiple suppliers of major components. To date, we have not experienced significant delays in obtaining our major components. In November 2019, we signed a Share Purchase and Shareholders Agreement, or the SPA, with Medimor, one of our turnkey manufacturing subcontractors. Pursuant to the SPA, we have invested an aggregate of $600,000, in consideration for 1,369,863 ordinary shares of Medimor (which reflected a 10.34% ownership interest in Medimor at the signing date, on a fully diluted basis), at a price per share of $0.438, of which 414,384 ordinary shares were issued upon consummation of the initial closing on December 31, 2019, and the remaining 955,479 ordinary shares were issued in July 2020 following Medimor achieving certain pre-defined milestone events. In November 2023, we signed an additional Share Purchase and Shareholders Agreement (the “Purchase Agreement”) in which we invested an additional $100,000 in consideration of 117,440 ordinary shares of Medimor. As of December 31, 2025, we hold a 11.73% ownership interest on an as-issued basis and an 11.23% ownership interest on a fully diluted basis of Medimor. Research and Development Our research and development activities are conducted internally by a team of 42 research and development staff, based mainly in Israel. Our research and development efforts are focused on the development of new products, as well as on the extension of our existing products to introduce new applications in the minimally and non-invasive and medical aesthetic markets. We have a number of new projects and products under development. We expect to concentrate our research and development efforts in the coming years on developing procedures and platforms based on our proprietary technologies: (i) RFAL, (ii) Deep Subdermal Fractional RF, (iii) Simultaneous Fat Destruction and Skin Tightening, and (iv) Deep Heating Collagen Remodeling, and developing new technologies. Our research and development expenditures for the years ended December 31, 2025, 2024 and 2023 were approximately $13.3 million, $13.1 million and $13.4 million, respectively. 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. Intellectual Property We rely on a combination of patent, trademark and copyright laws to protect our intellectual property rights. Patents and Patent Applications As of February 10, 2026, we own 21 issued U.S. patents and one issued Korean patent. As of February 10, 2026, we have filed 5 patent applications that are pending in the United States Patent and Trademark Office. Our issued U.S. patents and pending applications are projected to expire between 2027 and 2044 (assuming pending U.S. patent applications are approved). These patents and patent applications cover the technologies described herein, and contribute to the protection of our rights to our proprietary technology. Our patents relate to 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 our existing products. Without these patents, we cannot guarantee that we can prevent others from manufacturing similar products that are covered by our patent rights. We also rely on our issued patents to make, use, sell, and distribute our 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. We also rely upon trademarks in various jurisdictions covering the InMode brand and our product lines, as well as upon U.S. copyright law for protection of the software programs associated with our products. 45 Patent Litigation On October 11, 2023, we filed a complaint of patent infringement against BTL Industries Ltd. (“BTL”) in the United States District Court, Central District of California, alleging that BTL is infringing our U.S. Patent No. 8,961,511 (the “’511 patent”). In December 2024, the litigation was transferred to the District of Massachusetts, and BTL filed an answer to our complaint. On April 10, 2024, BTL filed a petition for inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office. On October 1, 2025, the PTAB issued a final written decision finding all claims of the ’511 patent valid. BTL has appealed the decision to the Federal Circuit. The district court had stayed the litigation during the IPR proceeding but lifted the stay shortly after the PTAB decision. We are pressing forward with the district court litigation, leading up to a final pre-trial conference on January 28, 2027. Meanwhile, the parties continue to discuss settlement. Copyrights, Trademarks and Trade Secrets The software programs associated with our products are protected by U.S. copyright law. We also filed for protection available under trademark law. As of December 31, 2025, we own 19 registered trademarks in the United States and at least 46 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. We also have at least nine pending foreign trademark applications. We also have six trademark applications in the United States pending for “Define by InMode,” “Fusion Dark,” Fusion Light,” “QuantumRF” ”IgniteRF,” and “Luxora.” We also rely upon know-how and continuing technological innovation, and may pursue licensing opportunities in the future in order to develop and maintain our competitive position. We seek to protect our proprietary rights through a variety of methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have access to proprietary information, under which they are bound to assign to us inventions made during the term of their employment or term of service. All professional employees and technical consultants are required to execute confidentiality agreements in connection with their employment and consulting relationships with us. We also require them to agree to disclose and assign to us all inventions conceived in connection with their services to us. However, there can be no assurance that these confidentiality and invention assignment agreements will be enforceable or that they will provide us with adequate protection. Competition Our industry is subject to intense competition, subject to rapid change and highly sensitive to the introduction of new products or other market activities of industry participants. We compete against products offered by other public companies, including AbbVie, Cutera, Inc., Apyx Medical Corporation, Venus Concept Inc. Sisram Medical Ltd. and Sofwave Medical Ltd, as well as by private companies, such as Cynosure LLC, Lumenis Ltd., BTL Aesthetics, Inc. and Candela Medical Inc. In the past few years, several large pharmaceutical and medical device companies have also entered the aesthetic device market, including Valeant Pharmaceuticals International Inc. and Merz Pharma Group. Our products compete against conventional medical products, including Botox®, hyaluronic acid injections and collagen injections, and aesthetic procedures, such as face lifts, liposuction, sclerotherapy, electrolysis, chemical peels and microdermabrasion, which are unrelated to laser, light and RF-based technologies. Our products also compete against laser and other light and radio frequency-based products. 46 Competition among providers of laser and other light and radio frequency-based products for the aesthetic medical market is characterized by extensive research efforts and rapid technological progress. While we attempt to protect our products through patents and other intellectual property rights, there are few barriers to entry that would prevent new entrants or existing competitors from developing products that would compete directly with ours. There are many companies, both public and private, that are developing innovative devices that use laser and other energy-based and alternative technologies. Many of these competitors have significantly greater financial and human resources than we do and have established reputations, greater brand name recognition, broader product lines, and larger customer bases, as well as worldwide distribution channels that are more effective than ours. Additional competitors may enter the market, and we are likely to compete with new companies in the future. Any business combinations or mergers among our competitors that result in larger competitors with greater resources or distribution networks, or the acquisition of a competitor by a major medical or technology corporation seeking to enter this business, could further result in increased competition. To compete effectively, we have to demonstrate that our products are attractive alternatives to other devices and treatments by differentiating our products on the basis of performance, brand name, reputation and price. We have encountered and expect to continue to encounter potential customers who, due to existing relationships with our competitors, are committed to, or prefer the products offered by, these competitors. We expect that competitive pressures may over time result in price reductions and reduced margins for our products. Other medical companies, academic and research institutions, or others, may develop new technologies or therapies, including medical devices, surgical procedures or pharmacological treatments and obtain regulatory approval for products utilizing such techniques that are more effective in treating the conditions that we target or are less expensive than our current or future products. Our technologies and products could be rendered obsolete by such developments. Government Regulation Our products and operations are subject to extensive and rigorous regulation by the relevant governmental authorities in the countries where we market and sell 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 FTC regulates the advertising of our products in the United States. Further, we are subject to laws directed at preventing fraud and abuse, which subject our sales and marketing, training and other practices to government scrutiny. In some jurisdictions, such as the United States, Canada and Israel, we must complete an application process with the relevant regulator, which includes submitting the results of clinical trials for their review. In addition, many countries also impose product standards, packaging requirements, environmental requirements, labeling requirements and import and export restrictions on our devices. Each country also has its own tariff regulations, duties and tax requirements. Failure to comply with applicable regulatory requirements may result in fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, criminal prosecution, or other consequences. In the United States, the FDCA and its regulations govern the following activities that we perform and will continue to perform to help ensure that medical products distributed within the United States are safe and effective for their intended uses: • product design and development; • product testing; • product manufacturing; • product safety; • product labeling; • product storage; • record-keeping; • premarket clearance or approval; • advertising and promotion; • manufacturing and production; 47 • product sales and distribution; • import, export and shipping; • establishment registration and device listing; and • recalls, field-safety corrective actions and post-market surveillance. Each of our currently marketed products has received 510(k) clearance for the uses for which they are being marketed. FDA’s Premarket Clearance and Approval Requirements Unless an exemption applies, each medical device we wish to commercially distribute in the United States requires 510(k) clearance or premarket approval. The FDA classifies medical devices into one of three classes – Class I, Class II or Class III – depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents. While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. All of our current products are Class II devices subject to the 510(k) clearance requirements. Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a premarket approval application, or PMA. Some pre-amendment devices are unclassified, but are subject to the FDA’s premarket notification and clearance process in order to be commercially distributed. 510(k) Clearance Pathway When a 510(k) clearance is required, we must submit a premarket notification demonstrating that our 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. After a 510(k) premarket notification is submitted, the FDA determines whether to accept it for substantive review. If it lacks necessary information for substantive review, the FDA will refuse to accept the 510(k) notification. If it is accepted for filing, the FDA begins a substantive review. By statute, the FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification. As a practical matter, if the FDA requires additional information, clearance often takes far longer, and clearance is never assured. Although most 510(k) premarket notifications are cleared without clinical data, the FDA may require further information, including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review process. If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market the device. If the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA approval process, or seek reclassification of the device through the de novo process. A manufacturer can also submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk. 48 After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, could require a PMA application or de novo classification. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many minor modifications are accomplished by a letter-to-file in which the manufacture documents the change in an internal letter-to-file. The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for such change. The FDA can always review these letters to file in an inspection. If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA is obtained. In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite PMA(s). Over the last several years, the FDA has proposed reforms to its 510(k)-clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k)-clearance process for their products. For example, in November 2018, FDA officials announced forthcoming steps that the FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the FFDCA. Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k)-clearance pathway and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public feedback on these proposals. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation. In September 2019, the FDA finalized guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process. The FDA maintains a list of device types appropriate for the “safety and performance based” pathway and will continue to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible. Laser devices used for aesthetic procedures, such as hair removal, have generally qualified for clearance under 510(k) procedures. The table below presents the specific FDA 510(k) clearances, dates and summary of cleared indications for our BodyTite (Inmode RF/IgniteRF), Optimas, OptimasMAX, Votiva, Contoura, Triton, EmbraceRF, Morpheus8, EvolveX, Define, and Evoke platforms: Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications IgniteRF Radiofrequency (RF) Monopolar: HP101396A HP172296A HP060999A HP102206A (FaceTite Turbo ) HP253966A(BodyTite Turbo) Bipolar: QuantumRF 25 minimally invasive handpiece QuantumRF 10 minimally invasive handpiece Fractional RF Applicators: Morpheus8 Burst Morpheus8 Burst Deep K251254(01/14/2026) The IgniteRF System with the monopolar RFAL handpieces is indicated for: use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed. The IgniteRF System with the bipolar QuantumRF handpieces is indicated for: use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed. The IgniteRF System with the Morpheus8 Burst and Moprheus8 Burst Deep applicators are indicated for: use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Burst and Morpheus8 Burst Deep Applicator is limited to Skin Types I-IV. 49 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications OptimasMAX Radiofrequency (RF), Laser, IPL Laser Applicators: • DiolazeXL MAX 810nm • Fusion Light 755/810nm • Fusion Dark 810/1064nm • VasculazeMAX IPL Applicators: • Lumecca 580 PEAK. • Lumecca 515 PEAK; Non-Invasive RF Applicators: • Forma (Plus) • Plus (Plus Plus) Fractional RF Applicators: • Morpheus8™ • Morpheus8™ DEPP K251632 (06/26/2025) The OptimasMAX System with the Diode laser Applicators is indicated for: • Diolaze XL MAX 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. • Fusion Light 755/810nm & Fusion Dark 810/1064nm Applicators are intended for hair removal. • VasculazeMAX Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The OptimasMAX System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-l200nm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The OptimasMAX System with the non-invasive RF Applicators is indicated for: • Plus and Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. The OptimasMAX System with the Morpheus8 RF Applicators indicated for: Morpheus8 Applicators are intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Moprheus8 applicator is limited to Skin Types I-IV. 50 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications Define Radiofrequency (RF) Cheek Chin Forma MiniFX Morpheus8 K242598 (11/24/2024) The Define System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. The Define System with the Forma Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasms, and for the temporary improvement of local blood circulation. The Define System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasms, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite. The Define System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV. InMode RF / IgniteRF Radiofrequency (RF) QuantumRF 25 minimally invasive handpiece QuantumRF 10 minimally invasive handpiece K240780 (07/24/2024) InMode RF/IgniteRF platform with the FaceTite or BodyTite is indicated for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. InMode system with Morpheus8 90 applicators (coagulation/contraction of software tissue) Radiofrequency (RF) • The standard Morpheus 8 90 Applicator is limited to use with the Morpheus8 90 tip head. K240017 (06/13/2024) The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV. InMode RF / IgniteRF Radiofrequency (RF) BodyTite Turbo minimally invasive handpiece FaceTite Turbo minimally invasive handpiece K233642 (03/20/2024) InMode RF/IgniteRF platform with the FaceTite or BodyTite is indicated for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. 51 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications Evolve system with the Transform applicator Sequential RF/EMS Transform K231495 (10/13/2023) The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. The Transform Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis The Transform Applicator in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain Additionally, the Transform Applicator in sequential RF/EMS mode is intended for: • Non-invasive lipolysis (breakdown of fat) of the abdomen. • Reduction in circumference of the abdomen InMode system with Morpheus8 applicators (coagulation/contraction of software tissue) Radiofrequency (RF) • The standard Morpheus 8 Applicator is limited to use with the 12, 24 & T tip heads. • The Morpheus 8 Body Applicator is limited to use with the 40-tip head. K231790 (07/20/2023) The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV. 52 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications InMode Multi System (interface screen was slightly enlarged from 10 inch to 12 inch) Radiofrequency (RF), Laser, IPL Laser Applicators: • Diolaze XL 810nm • Diolaze XL 755/810nm • Diolaze XL 810/1064nm • VLaze (Vasculaze) • IPL Applicator: • SR IPL (Lumecca 580, Lumecca 515) Non-Invasive RF Applicators: • Forma (Plus) • Plus (Plus Plus) • Plus90 • i-Forma • BodyFX™ (WMBody) • MiniFX™ • WMFace Fractional RF Applicators: Fractora • 24 pins tip (FRF) • 60 pins tip • Morpheus8™ • 12 pins tip (Prime Tip) • 24 pins tip (Fractora 3D) • 40 pins tip (Body Tip) • T tip K221571 (05/26/2022) The InMode Multi System with the Diode laser Applicators is indicated for: • Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. • Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. • VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-l200nm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: • BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions: Relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. • Plus/ Plus90/Plus-Plus (Forma) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. • FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: • FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. • FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-IV. InMode RF Multi Platform – Contoura Radiofrequency (RF) Forma(Plus), Plus90, Plus(Plus-Plus) BodyFX, MiniFX, Wmface, Fractora 24 pins tip Fractora 60 pins tip Morpheus8 24 Pin Applicator Morpheus8 40 Pin treatment tip • Morpheus8 12 Pin treatment tip • Morpheus8 T Pin treatment tip K201150 (07/21/2020) The InMode RF Multi-System with the Non-invasive RF Applicators employs RF energy for various applications: • Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm • , and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV. • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV. 53 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications Inmode Powered muscle stimulator Tone K192249 (12/17/2019) The Evolve platform is used in EMS mode for: • prevention or retardation of disuse atrophy; • maintaining or increasing range of motion; • muscle re-education; • relaxation of muscle spasms; • increasing local blood circulation; and • immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. And in TENS mode for: • symptomatic relief and management of chronic, intractable pain; • post-surgical acute pain; and • post-traumatic acute pain. InMode Powered muscle stimulator vTone K200293 (05/05/2020) The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. EmFace (Evoke) Radiofrequency (RF) Cheek Chin K191855 (10/29/2019) The EmFace (Evoke) device with the Cheek and Chin applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. EmBody (Evolve) Radiofrequency (RF) EMBodyPlus – Tite EmBodyFX – Trim K183450 (06/20/2019) The EmBody (Evolve) platform with its designated applicators is intended for the treatment of the following medical conditions: The EmBodyPlus (Tite) hands-fee applicator is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. The EmBodyFX(Tite) hands-free applicator is intended for the treatment of the following medical conditions using RF combined with massage: • relief of minor muscle aches and pain, relief of muscle spasms, and temporary improvement of local blood circulation; and • temporary reduction in the appearance of cellulite. 54 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications InMode RF / Bodite / EmbraceRF Radiofrequency (RF) Bodyrite minimally invasive handpiece for thick body areas (>20mm) K171593 (10/10/2017) The InMode RFIBodyTitel EmbraceRF platform with the minimally invasive Bodyrite handpiece for thick body areas is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. InMode RF / Bodyrite / EmbraceRF Radiofrequency (RF) Bodyrite minimally invasive handpiece for thin body areas (<20mm) or for large specialty areas K163190 (12/12/2016) The InMode RFIBodyTitel EmbraceRF platform with the minimally invasive Bodyrite handpiece for thin body and large specialty areas is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. InMode RF / EmbraceRF Radiofrequency (RF) FaceTite K151793 (02/19/2016) The InMode RF/EmbraceRF platform with the FaceTite handpiece is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. Optimas / InMode RF Radiofrequency (RF) Fractora (60 pin tip) K102461 (06/02/2011) The Optimas/InMode RF platform with the Fractora 60 pin tip handpiece is indicated for use in dermatological procedures requiring ablation and resurfacing of the skin. Optimas / InMode RF / EmbraceRF Radiofrequency (RF) Fractora (24 pin tip) FractoraV K151273 (01/04/2016) The OptimaslInMode RFI EmbraceRF platform with the Fractora 24 pin tip handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Optimas Radiofrequency (RF) Morpheus8 K180189 (06/01/2018) The Optimas platform with the Morpheus8 handpiece is indicated for use in dermatological and general surgical procedures for electrocoagulation and homeostasis. InMode RF Radiofrequency (RF) Morpheus8 24 Pin Applicator Morpheus8 40 Pin treatment tip (New tip) • Morpheus8 12 Pin treatment tip (New tip) • Morpheus8 T Pin treatment tip (New tip) (maximal treatment depth 4.00 mm) K192695 (12/27/2019) The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV. 55 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications InMode Radiofrequency (RF) Morpheus8 24 Pin Applicator Morpheus8 40 Pin treatment tip (New tip) • Morpheus8 12 Pin treatment tip (New tip) • Morpheus8 T Pin treatment tip (New tip) maximal treatment depth 7.00 mm) K200947 (06/12/2020) The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV. EmBody (Evolve) Radiofrequency (RF) Tone K201285 (03/05/2021) The EmBody (Evolve) platform with its designated applicators is intended for the treatment of the following medical conditions: The EmBody (Evolve) System with Tone Applicator is designed to operate in two modes – EMS and TENS. In EMS mode it is used for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain EmBody (Evolve) Radiofrequency (RF) EMBodyPlus – Tite T3-Transform K210877 (07/19/2021) The EvolveX System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis The T3 Applicator in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially. 56 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications InMode RF Pro Platform – Empower Radiofrequency (RF) i-Forma Forma(Plus), Plus90, Plus(Plus-Plus) BodyFX, MiniFX, Wmface, Fractora 24 pins tip Fractora 60 pins tip Morpheus8 24 Pin Applicator Morpheus8 40 Pin treatment tip • Morpheus8 12 Pin treatment tip • Morpheus8 T Pin treatment tip K201150 (07/21/2021) The InMode RF Pro System with the Non-invasive RF Applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasms, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV. • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV. InMode RF / EmbraceRF Radiofrequency (RF) AccuTite K182325 (08/27/2018) The InMode RFI EmbraceRF platform with the AccuTite handpiece is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. Contoura / Optimas Radiofrequency (RF) Plus Plus90 Plus-Plus K172302 (12/08/2017) The Contoura/Optimas platform with the Forma Plus, Plus90, Plus-Plus handpieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. Optimas Intense Pulsed Light (IPL) Lumecca 515 Lumecca 580 K123860 (04/02/2013) The Optimas platform with the Lumecca 515 and Lumecca 580 handpieces is indicated for: • the treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); and • the treatment of benign cutaneous vascular lesions, including port wine stains, facial truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of civatte, superficial leg veins and venous malformations. Triton / Optimas Laser DiolazeXL K170738 (08/07/2017) The Triton/Optimas platform with the DiolazeXL handpiece is indicated for hair removal and permanent hair reduction defined as stable, long-term reduction in hair counts at six, nine or 12 months following a treatment regime. Triton / Optimas Powered Laser Vasculaze K173677 (02/23/2018) The Triton/Optimas platform with the Vasculaze handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. Votiva Radiofrequency (RF) FormaV f (07/12/2016)* The InMode Plus90 (Votiva) platform with the Forma V handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation. 57 Product Platform Energy Source Handpiece FDA 510(k) Clearance and Cleared Indications Contoura / Optimas Radiofrequency (RF) BodyFX K131362 (10/08/2013) The Contoura/Optimas platform with the BodyFX handpiece is indicated for the treatment of: • relief of minor muscle aches and pains, muscle spasms and temporary improvement of blood circulation; and • temporary reduction in the appearance of cellulite. Contoura / Optimas Radiofrequency (RF) MiniFX K160329 (08/19/2016) The Contoura/Optimas platform with the MiniFX handpiece is indicated for the treatment of: • relief of minor muscle aches and pain, muscle spasms, and temporary improvement of local blood circulation; and • temporary reduction in the appearance of cellulite. Triton / Optimas Laser Triton Duo Light/ Triton Duo Dark InMode Diolaze XL 755/810nm InMode Diolaze XL 810/1064nm InMode Diolaze XL 810nm K180719 (06/14/2018) The Triton/Optimas platform with the Triton Duo Light and Triton Duo Dark handpieces is indicated for hair removal and permanent hair reduction. InMode Laser Diolaze K142952 (11/24/2014) The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime InMode Laser Diolaze K123682 (02/27/2013) The InMode Diolaze device is indicated for use for hair removal InMode Radiofrequency (RF) WMface k140926 (12/03/2014) The InMode WMface device is intended for use in dermatologic procedures for noninvasive treatment of mild to moderate facial wrinkles and rhytids. * In addition to the 510(k) clearance, we also market the FormaV for use with the Votiva platform pursuant to a classification regulation for “genital vibrators for therapeutic use” under 21 C.F.R. 884.5960, which permits “electronically operated devices intended and labeled 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)” to be marketed without a 510(k) clearance. Premarket Approval Pathway A PMA must be submitted to the FDA if the device cannot be cleared through the 510(k) process. A PMA must be supported by extensive data, including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling, to demonstrate the safety and effectiveness of the device to the FDA’s satisfaction. 58 No device that we have developed has required premarket approval, nor do we currently expect that any future device or indication will require premarket approval. Pervasive and Continuing Regulation After the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply. These include: • QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process; • clearance or approval of product modifications to 510(k)-cleared or PMA-approved devices that could affect safety or effectiveness; • labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses; • advertising and promotion requirements; • medical device reporting regulations, which require that manufacturers report to the FDA if their devices may have caused or contributed to deaths or serious injuries or malfunctioned in ways that would likely cause or contribute to deaths or serious injuries if the malfunctions were to recur; • medical device correction and removal reporting regulations, which require the manufacturers to report to the FDA corrections and removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and • post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the devices. We may be subject to similar foreign laws that may include applicable post-marketing requirements such as safety surveillance. Our 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. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain compliance with the QSR or other applicable regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products. The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. The FDA has broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA to determine our compliance with the QSR and other regulations, and these inspections may include the facilities of our manufacturing subcontractors. We also are regulated in the United States 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 law also requires laser manufacturers to file new product and annual reports, maintain manufacturing, testing and sales records, and report product defects. Various warning labels must be affixed and certain protective devices installed, depending on the class of the product. Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: • warning or untitled letters, fines, injunctions, consent decrees and civil penalties; • unanticipated expenditures, repair, replacement, refunds, recalls, administrative detention or seizure of products; 59 • operating restrictions, partial suspension or total shutdown of production; • refusing requests for 510(k) clearance or PMAs of new products or new intended uses; • withdrawing 510(k) clearance or PMAs that have already been granted; and • criminal prosecution. The FDA also has the authority to require us to repair, replace or refund the cost of any medical device that we have manufactured or distributed. If any of these events were to occur, they could have a material adverse effect on our business. We are also subject to a wide range of federal, state and local laws and regulations, including those related to the environment, health and safety, land use, and quality assurance. We believe that we are in compliance with these laws and regulations as currently in effect, and our compliance with such laws will not have a material adverse effect on our capital expenditures, earnings, and competitive and financial position. Federal Communications Commission and other U.S. governmental agencies governing the use of radio frequency energy Our products generate and use radio frequency energy and therefore may be subject to technical equipment authorization and other regulatory requirements in the countries and regions where they are marketed or distributed. In the United States, our products are subject to the Federal Communications Commission’s equipment verification procedures, under which the manufacturer is required to determine or verify that the equipment complies with the applicable technical standards and to keep a record of test measurements demonstrating compliance before the equipment can be marketed or sold in the United States. Any modifications to our products may require reverification before we are permitted to market and distribute the modified devices. We obtain regulatory approvals in countries requiring advance clearance of our products before they are marketed or distributed in those countries. Our failure to comply with the technical, equipment authorization or other regulatory requirements of a specific country or region could impair our ability to commercially market and distribute our products in that country or region. Other Healthcare Laws 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 be subject to a number of foreign, federal, and state laws and regulations that may restrict our business practices, including, without limitation, anti-kickback, false claims, physician payment transparency and data privacy and security laws. The government has interpreted these laws broadly as they apply to the marketing and sales activities of manufacturers and distributors. Companies targeted in such prosecutions and in civil litigation have paid substantial fines, penalties, and settlements in the hundreds of millions of dollars or more, have been forced to implement extensive corrective action plans, can be excluded from federal health care programs, and have often become subject to consent decrees, settlement agreements or corporate integrity agreements severely restricting the manner in which they conduct their business. Many U.S. states and countries outside the United States have similar fraud and abuse statutes or regulations that may be broader in scope than the U.S. federal laws, and may apply regardless of payor, in addition to items and services reimbursed under government programs. International Regulations International manufacturing and sales of medical devices are subject to foreign governmental regulations, which vary substantially from country to country. The time required to obtain clearance or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may be different. For example, the European Union has adopted numerous specific directives regulating the design, manufacture, clinical investigations, conformity assessment, labeling and adverse event reporting for medical devices that do not necessarily have an exact equivalent under U.S. law. 60 Devices that comply with the essential requirements of the EU Medical Devices Directive (Directive 93/42/EEC) will be entitled to bear CE conformity marking, indicating that the device conforms with the essential requirements of the EU Medical Devices Directive and, accordingly, can be commercially distributed throughout the member states of the European Union, the member states of the European Economic Area, or EEA (which is comprised of the 27 EU countries, plus Norway, Liechtenstein, and Iceland), and countries that have entered into a Mutual Recognition Agreement. The method of assessing conformity varies depending on the type and (risk) class of the product but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a notified body, an independent organization designed by an EU country to conduct the conformity assessment. This third-party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s device. An assessment by a notified body in one member state of the European Union, the EEA or a country that has entered into a Mutual Recognition Agreement is required in order for a manufacturer to commercially distribute the product throughout these countries. European Standardization Committees and the International Organization for Standardization, or ISO, have promulgated voluntary harmonized standards. Compliance with applicable standards establishes the presumption of conformity with the essential requirements for a CE Marking. As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence. All manufacturers placing medical devices into the market in the EEA must comply with the EU Medical Device Vigilance System. Under this system, incidents must be reported to the relevant authorities of the Member States of the EEA, and manufacturers are required to take Field Safety Corrective Actions, or FSCAs, to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. An incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient or user or of other persons or to a serious deterioration in their state of health. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices. On May 25, 2017, the EU passed the Medical Devices Regulation (Regulation 2017/745), or MDR, entered into force, which repeals and replaces the EU Medical Devices Directive. The MDR allows devices lawfully placed on the market prior to May 26, 2021 pursuant to the EU Medical Devices Directive (discussed above), to generally continue to be made available on the market or put into service until December 31, 2028. Once the MDR phase-in period is complete after December 31, 2028, some of our products that entered the market prior to December 31, 2028 may come out of service. The Medicines and Healthcare Products Regulatory Agency of the United Kingdom, or MHRA, is responsible for monitoring the UK medical device market. The MHRA requires that medical devices sold in the U.K. be required with the MHRA. Manufacturers based outside the UK need to appoint a UK Responsible Person to register devices with the MHRA in line with the grace periods. From July 1, 2023, all medical devices sold in the UK were required to carry a UKCA (UK Conformity Assessed) mark. However, UKCA marking alone will not be recognized in the EU. The rules for placing medical devices on the Northern Ireland market differs from those in the UK. All of our platforms and applicators require UKCA marking. Several member states of the EEA have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices. Other countries, such as Switzerland, have entered into Mutual Recognition Agreements and allow the marketing of medical devices that meet European Union requirements. In Israel, the Medical Equipment Law generally governs the regulatory process and authorizations required for the manufacture, marketing and use of medical and certain aesthetic products in Israel. Under the Medical Equipment Law, we are required to register our products with the Israeli Ministry of Health. The Medical Equipment Law offers a fast-track approval process for devices that received approval from certain non-Israeli regulatory agencies, including FDA clearance or CE marks. The registration process under this fast-track process involves submitting an application to the Israeli Ministry of Health which includes, among other things, documentation confirming receipt of the necessary regulatory approvals, such as 510(k) clearance or CE mark certification. In addition, we must provide details regarding the approval, including the period for which the applicable device was authorized for marketing in the applicable country, registration terms, any limitations, and any instructions given with respect to the labeling and packaging of such device. If approved, the registration of the device in Israel will be valid for the same period that such device was authorized to be marketed in the applicable non-Israeli country (but in any event not more than five years from the date of registration in Israel), and the device will be subject to the terms and conditions imposed by the relevant non-Israeli regulatory agency, if any. We have taken advantage of such fast-track approval in the past. All of our products that we currently sell in Israel are registered with the Israeli Ministry of Health, with registrations that are set to expire on June 10, 2029 up to May 6, 2030. 61 Data Protection Our business involves the use, storage and transmission of information about our employees, our customers and, to a certain extent, clients of our customers. In the course of our operations, we may gain 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. With the increase in publicity regarding data breaches resulting in improper dissemination of consumer information, many states have passed laws regulating the actions that a business must take if it experiences a data breach, such as prompt disclosure to affected customers, governmental entities, and the media. In addition to data breach notification laws, some states have enacted statutes and rules requiring businesses to protect certain types of personal information they hold or to otherwise comply with certain specified data security requirements for personal information. We intend to protect all personal information and to comply with all applicable laws regarding the protection of such information. As an Israeli headquartered company, we are 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 our operations or the operations of our 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 pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection with the processing of the personal data. The GDPR provides that EU and EEA member states may make their own further laws and regulations limiting the processing of genetic, biometric or health data, which could limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial condition. Failure to comply with the requirements of GDPR and the applicable national data protection laws of the EU and EEA member states may result in fines of up to €20 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. To comply with the new data protection rules imposed by GDPR, we may be required to put in place additional mechanisms ensuring compliance. Further, since January 1, 2021, we are subject to the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR, e.g., fines up to the greater of €20 million or 4% of global turnover. The relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, and it is unclear how UK data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. It is not clear whether (and when) an adequate decision may be granted by the European Commission enabling data transfers from European Union member states to the United Kingdom long-term without additional measures. These changes will lead to additional costs and increase our overall risk exposure. Corporate and Social Responsibility Our management continues to participate in Corporate Social Responsibility, or CSR, Reporting on our website to respond to increased awareness of the importance of environmental and sustainability topics and non-material company activities towards the long-term success of the company. As a manufacturer of medical devices, we already adhere to strict quality and safety requirements dictated by regulatory bodies such as the FDA, CE, Health Canada, TGA (Australia), Brazil, Japan, China’s National Medical Products Administration, ISO, as well as international GMP standards. We successfully completed all audits conducted by the regulatory bodies in 2025, including a physical audit of our facilities and the facilities of our Tier 1 subcontractors – Medimor and Flex. Our mission is to develop and produce innovative, life-changing technologies to enable patients to become their ‘best possible self’, in the safest and most effective manner. Our commitment to CSR topics complements InMode’s core values to provide the ultimate in customer care and support. 62 Community Involvement in the Periphery Robotics Mentoring in Dimona Since 2017, Moshe Mizrahy and InMode engineers have been involved with the FIRST Robotics Group at Amit Zinman High School in Dimona. Dimona is located in southern Israel and is an area in the lower rungs of the socioeconomic scale. InMode supports the robotics team of Amit Zinman High School with more than just financial resources. Our engineers provide ongoing mentoring and opportunities to design electromechanical devices. One of the program’s goals is to introduce STEM subjects into the community through projects and our outreach programs and activities for kindergartens and elementary schools. We continue to support the high school’s robotics team with mentoring, resources, and funds and plan to continue to do so in 2026. Technology Project at ORT Maale Tiberias High School InMode, together with Medimor, our Tier 1 supplier, has established a partnership with ORT Maale Tiberias school to create a sustainable technology project. We have earmarked one hundred thousand dollars to this educational project. Tiberias is in an economically depressed area of Israel and we are proud to sponsor such an exciting and impactful project. C. Organizational Structure Our subsidiaries, the countries of their incorporation/residence and proportion of ownership interest are as follows: Name Jurisdiction of Incorporation Percentage Ownership Invasix Inc. Delaware, USA 100% Invasix Corp. Canada 100% Invasix UK Ltd. United Kingdom 100% InMode Japan KK Japan 100% Invasix Iberia S.L. Spain 100% Guangzhou InMode Medical Technology Ltd. China 100% InMode India Private Limited India 100% InMode Australia Pty Ltd Australia 100% IMD France EURL France 100% InMode Innovations Ltd. Israel 100% InMode Italy S.r.l Italy 100% InMode Germany GmbH Germany 100% InMode (Thailand) Ltd. Thailand 100%* Invasix SAS Argentina 100% InMode Manufacturing Ltd Israel 100% * Due to local requirements, InMode Innovations Ltd. and Rafael Lickerman each own less than 0.1% of shares of InMode (Thailand) Ltd. D. Property, Plants and Equipment We lease our main office, manufacturing and research and development facilities, located in the Industrial Zone in Yokneam, Israel, pursuant to a lease that expires in December 2027. The original agreement was signed in May 2018. In January 2019, February 2020, March 2021, May 2023, June 2024 and July 2024, we signed supplemental lease agreements, further expanding our headquarters in Israel. We currently lease approximately 44.1 thousand square feet in the Israeli facility. Our current monthly rent payment is approximately $92.8 thousand. In addition, we currently lease a warehouse in Zarzir, Israel with approximately 12.4 square feet; our current monthly rent payment for such warehouse is approximately $12.9 thousand. In August of 2020, our U.S. subsidiary, Invasix Inc., signed a leasing agreement for an approximately 24-thousand-square-foot facility located in Orange County, California, to support our operations in the U.S. The lease agreement is for seven years and four months and occupation of the facility commenced in the middle of April of 2021. The current monthly rent payment is approximately $29.1 thousand. 63 Our Canadian subsidiary signed a lease agreement in April 2022 for an approximately 12-thousand-square-foot facility in Richmond Hill, Ontario. The lease agreement is for three years which began in July 2022. In April 2025 our Canadian subsidiary signed a new lease agreement, extending the lease for additional 5 years from July 2025. The current monthly rent payment is approximately $18 thousand. Our subsidiaries in France and Spain signed new lease agreement in January and February 2025 respectively, for an approximately 2-thousand-square-foot facility in France and approximately 3-thousand-square-foot facility in Spain. The lease agreement is for approximately six years for each lease agreement, and the current monthly rent payment is approximately $5 thousand for each lease agreement. From time to time, we also lease small properties, mainly for offices for our subsidiaries around the world, for periods that generally last up to three years. We believe our current office space is sufficient to meet our anticipated needs for the foreseeable future and is suitable for the conduct of our business.