Stryker launches Synchfixâ"¢ EVT, expanding options for flexible syndesmotic fixation [Accessibility Statement] Skip NavigationElevating care with Stryker's next generation device, [Synchfix EVT], which will be featured at the 2026 American College of Foot and Ankle Surgeons (ACFAS) Annual MeetingPORTAGE, Mich., Feb. 24, 2026 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, announced the launch of Synchfixâ"¢ EVT, its next-generation flexible syndesmotic fixation device designed ...

InMode Announces Conclusion of Independent Transaction Committee Review [Accessibility Statement] Skip NavigationYOKNEAM, Israel, Feb. 23, 2026 /PRNewswire/ -- InMode Ltd. (Nasdaq: INMD) a leading global provider of innovative medical technologies ("InMode" or the "Company"), today announced that the independent transaction committee of its Board of Directors (the "Committee") has completed its review of proposals received in connection with a potential transaction.Since its formation, the Committee has con ...

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].

Core Insights - Edwards Lifesciences is experiencing strong growth in its premium surgical technologies, particularly in the TAVR platform, which is expected to maintain global leadership and sustainable growth [1][9] - The company is also benefiting from a strategic portfolio in Transcatheter Mitral and Tricuspid Therapies, although macroeconomic challenges and currency fluctuations pose risks to its operations [1][9] Financial Performance - Over the past year, Edwards Lifesciences' stock has declined by 11.2%, compared to a 12.9% decline in the industry and a 13.1% growth in the S&P 500 [2] - The company has a market capitalization of $44.66 billion and an earnings yield of 3.2%, which is favorable compared to the industry's -3.6% [2] - In the last four quarters, Edwards surpassed earnings estimates twice and matched on two occasions, with an average surprise of 3.5% [2] Business Segments - The Surgical Structural Heart segment grew by 1% year-over-year in Q1 2025, driven by the adoption of premium surgical technologies like INSPIRIS, MITRIS, and KONECT [4] - TAVR sales exceeded $1 billion for the second consecutive quarter, with strong performance from SAPIEN 3 Ultra RESILIA in the U.S. and Europe [6][9] - The TMTT segment saw a 58% increase in sales in Q1, driven by the adoption of the PASCAL and EVOQUE systems [9][11] Innovations and Developments - Edwards launched the MITRIS system in China, receiving positive feedback from surgeons [5] - The acquisition of Endotronix in 2024 marks the company's entry into implantable heart failure management [5] - The SAPIEN M3 mitral valve replacement system received CE Mark for treating symptomatic mitral regurgitation patients unsuitable for surgery [12] Challenges - The company faces macroeconomic pressures, including inflation, credit market conditions, and geopolitical complications, which are impacting operating results [13] - Foreign exchange fluctuations are a significant headwind, with a 170 basis point decrease in reported sales growth attributed to unfavorable currency impacts [14]