Company Overview - InMode Ltd. is a leading global provider of innovative medical technologies, focusing on developing, manufacturing, and marketing devices that utilize novel radiofrequency (RF) technology [3] - The company aims to enable new surgical procedures and enhance existing treatments across various medical fields, including plastic surgery, gynecology, dermatology, otolaryngology, and ophthalmology [3] Upcoming Event - InMode's CEO Moshe Mizrahy and CFO Yair Malca will present at the 25th Annual Needham Virtual Healthcare Conference on April 13, 2026 [1] - The presentation will be moderated by Michael Matson, a Senior Equity Analyst, and will include a live webcast [2] - InMode will also conduct virtual one-on-one investor meetings on the same day [2]

Core Insights - Stryker has launched the Synchfix EVT, a next-generation flexible syndesmotic fixation device aimed at simplifying surgical procedures and enhancing ankle stabilization for patients with syndesmotic disruptions [1] Product Features - Synchfix EVT is designed to reduce procedural complexity compared to previous devices, featuring an all-in-one system that integrates suture tensioning handles within the implant instrumentation [1] - The device allows for one-handed surgical implant deployment and includes an ergonomic handle and a low-profile titanium medial implant [1] - It is intended for soft tissue and bone fixation for ankle syndesmosis disruptions, applicable for both adult and adolescent patients, marking it as the first flexible fixation device for adolescents [1] Recognition and Impact - The Synchfix EVT has received the prestigious Red Dot Design Award for its innovative design aimed at simplifying syndesmotic fixation and improving surgical efficiency [1] - Stryker emphasizes its commitment to enhancing patient care and surgical efficiency through continuous innovation based on customer feedback [1] Market Engagement - The device will be showcased at the 2026 American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting, featuring demonstrations to highlight its capabilities [1] - Stryker's broader impact includes improving healthcare outcomes for over 150 million patients annually through its innovative medical technologies [1]

Core Viewpoint - InMode Ltd. has concluded its independent transaction committee review and determined that none of the final proposals for a potential transaction are adequate for the company and its shareholders, leading to the discontinuation of the process [1] Group 1: Transaction Review - The independent transaction committee of InMode's Board of Directors has completed its review of proposals related to a potential transaction [1] - The committee conducted a comprehensive evaluation with the assistance of external financial and legal advisors [1] - Following the review, the committee concluded that the proposals received were not in the best interests of the company and its shareholders [1] Group 2: Future Strategy - InMode will continue to assess its business and growth strategy, as well as its cash allocation strategy, focusing on enhancing long-term shareholder value [1] - The company does not plan to provide further updates on this matter unless additional disclosure is deemed appropriate or required [1] Group 3: Company Overview - InMode is a leading global provider of innovative medical technologies, developing, manufacturing, and marketing devices that utilize novel radio frequency technology [1] - The company aims to enable new surgical procedures and improve existing treatments across various medical fields, including plastic surgery, gynecology, dermatology, otolaryngology, and ophthalmology [1]

As filed with the U.S. Securities and Exchange Commission on February 19, 2026. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ––––––––––––––––––––––– MEDICAL 21, INC. (Exact name of registrant as specified in its charter) ––––––––––––––––––––––– | Minnesota | 3842 | 81-1497154 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | inc ...

Financial Data and Key Metrics Changes - Fiscal year 2025 marked the most successful year in the history of the company, with record product sales growth of 163% to $9.1 million [3] - Fourth quarter product revenue increased 907% to $2.7 million compared to $0.3 million in the same quarter of fiscal 2024 [15] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024, with a full-year gross margin of 56.5% compared to 31.3% in fiscal 2024 [15][16] - Net loss in Q4 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in Q4 2024 [17] - Cash and cash equivalents increased to $6.6 million as of September 30, 2025, from $1.5 million a year earlier [17] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with potential partnerships for gene therapy and glioblastoma drug delivery [5][6] - The company reported its first preclinical drug delivery device sales to a large pharmaceutical company [6] Market Data and Key Metrics Changes - The OneRF brain ablation system, marketed by Zimmer Biomet, continues to gain traction, with positive clinical outcomes reported [12] - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5][8] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a final forecast from its distribution partner, Zimmer Biomet [4] - The strategy includes leveraging existing technologies for new applications, such as the basivertebral nerve ablation system for lower back pain [9][38] - The company aims to strengthen its patent portfolio, with 17 issued and pending patents [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [14] - The company anticipates significant growth opportunities in drug delivery and pain management platforms, with a focus on FDA clearance for new products [8][18] Other Important Information - The company has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price rule [4] - Total operating expenses decreased by 2% in Q4 2025 compared to the same quarter in the previous year [16] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that three other centers have planned cases, pending some ancillary equipment [22] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling of future cases [23] Question: What is the status of the drug delivery program with the large pharma player? - Additional orders are expected mid-year for preclinical testing, with ongoing efforts to validate manufacturing processes [25] Question: What is the timing for establishing the epilepsy registry? - The registry is expected to be established by Q2 2026, pending internal approvals from participating sites [28] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, and the cost advantages of its technology have not hindered adoption [44]

Core Insights - LivaNova PLC presented its strategic roadmap and long-range financial plan during its 2025 Investor Day, outlining targets for revenue and earnings per share (EPS) growth by 2030 [1][2] Financial Targets - The company aims for a high-single-digit-plus revenue compound annual growth rate (CAGR) [4] - Adjusted annual operating margin is projected to exceed 20% over the next three years, targeting high twenties by 2030 [4] - Earnings-per-share CAGR is expected to be in the low double digits to mid-teens [4] - Adjusted free cash flow conversion is anticipated to be above 80% [4] Business Segments - Cardiopulmonary business operates in a $2 billion global market, with expected mid-to-high single-digit revenue CAGR and adjusted operating margin expansion of over 300 basis points by 2030 [4] - In the Epilepsy segment, the company expects mid-single-digit revenue CAGR and adjusted operating income margin expansion of approximately 200 basis points by 2030, supported by real-world evidence and new product launches [4] - The Obstructive Sleep Apnea (OSA) market is targeted with differentiated technology, projected to generate $200 million to $400 million in revenue by 2030 and adjusted operating income margin of greater than 25% [5] Strategic Initiatives - LivaNova is focused on maximizing core businesses, scaling OSA, and preserving upside in Difficult-to-Treat Depression (DTD) [3][4] - The company plans to commercialize its OSA product independently in 2027, retaining full control over pricing and customer relationships [5] - DTD remains a strategic extension of its Neuromodulation platform, with potential value creation pending coverage reconsideration by the U.S. Centers for Medicare & Medicaid Services [5]

Core Insights - AngioDynamics reported a strong first quarter for fiscal year 2026, with net sales reaching $75.7 million, reflecting a year-over-year growth of 12.2% [2][7] - The Med Tech segment experienced significant growth, with net sales of $35.3 million, marking a 26.1% increase compared to the previous year [2][8] - The company continues to focus on operational excellence and innovative technologies to drive profitable growth and enhance patient care [4][5] Financial Performance - Net sales for the first quarter of fiscal year 2026 were $75.7 million, an increase of 12.2% from the prior year [2][7] - Med Tech net sales were $35.3 million, a 26.1% increase from $28.0 million in the prior-year period [2][8] - Med Device net sales were $40.4 million, a 2.3% increase compared to $39.5 million in the prior-year period [9] Profitability Metrics - The company reported a GAAP gross margin of 55.3%, which is 90 basis points higher than the first quarter of fiscal 2025 [10] - Adjusted EBITDA for the first quarter was $2.2 million, compared to a loss of $0.2 million in the prior year [12] - The company recorded a GAAP net loss of $10.9 million, or a loss per share of $0.26, while the adjusted net loss was $4.2 million, or a loss per share of $0.10 [11][12] Cash Flow and Guidance - The company ended the first quarter with $38.8 million in cash and cash equivalents, down from $55.9 million at the end of the previous quarter [14] - AngioDynamics expects to be cash flow positive for the full fiscal year 2026 [5][13] - The company raised its full-year guidance for net sales, Med Tech net sales growth, Adjusted EBITDA, and Adjusted EPS [5][19] Clinical Developments - The first patients were enrolled in the AMBITION BTK and RECOVER-AV clinical trials, demonstrating the company's commitment to advancing clinical evidence [15][16] - Results from the NanoKnife PRESERVE study were published, showing promising outcomes for prostate cancer treatment [18]

Core Insights - Biorad Medisys has launched its US subsidiary, Medtimo Inc, following the acquisition of business assets from ReShape Lifesciences, marking its entry into the US market [1][2] - The expansion aligns with Biorad Medisys' strategy to grow in regulated markets and enhance its product portfolio [2][4] - Medtimo will focus on two primary products: the Lap-Band® for weight loss and Stimel-03 for neurological rehabilitation, addressing the increasing demand in these areas [3][7] Company Overview - Biorad Medisys is an Indian medical technology company with a presence in over 50 countries and a workforce of more than 1,700 [6] - The company operates two manufacturing facilities in Pune and Bengaluru and is committed to global needs and innovation [6] - Biorad Medisys has received investments from True North and Kotak Alternate Asset Managers Limited [6] Medtimo Inc. Details - Medtimo Inc. offers a portfolio that includes the FDA-approved Lap-Band® System and a proprietary vagal neuromodulation system for treating type 2 diabetes [7] - The Obalon® balloon technology is also part of Medtimo's offerings, providing a non-surgical option for weight loss [7] - The leadership of Medtimo expresses confidence in the partnership with Biorad Medisys to accelerate growth and innovation [5]

Company Overview - Ventripoint Diagnostics Ltd. has developed software that transforms standard heart ultrasound machines into diagnostic tools that compete with expensive MRI scanners, significantly reducing costs and appointment complexities [4]. Business Model Shift - Following FDA approval, Ventripoint is transitioning from a traditional equipment sales model to a subscription-based service, facilitating easier adoption of their technology by healthcare providers [4]. Cost Comparison - Heart scans using Ventripoint's technology are priced at 5.5 times less than traditional MRI scans in the U.S., and the equipment costs are under 10% of conventional MRI systems [4]. Revenue Expectations - The company anticipates generating real revenue before the end of the year as it moves from product development to actual sales [4].

Core Viewpoint - InspireMD, Inc. has appointed Raymond W. Cohen to its Board of Directors, bringing over 40 years of experience in medical technology to enhance the company's strategic vision and operational execution [1][2]. Company Overview - InspireMD is focused on developing the CGuard® Prime carotid stent system aimed at preventing strokes, utilizing proprietary MicroNet™ mesh technology to achieve superior acute results and long-term outcomes [6]. Leadership Experience - Raymond W. Cohen has a notable track record, having co-founded Axonics, Inc., which went public in 2018 and was acquired by Boston Scientific for $3.7 billion in November 2024 [2]. - Cohen previously served as Chairman of SoniVie Ltd., which was acquired by Boston Scientific for $600 million, and has held leadership roles in various medical technology companies [3][4]. Strategic Goals - The company is shifting its focus towards the commercial launch of the CGuard Prime stent system following its recent PMA approval, with expectations of capturing market share and delivering long-term value [2][5]. - Cohen expressed confidence in InspireMD's potential to lead the U.S. carotid stent market due to its innovative approach and commitment to clinical excellence [5].