Series C financing supports continued clinical development of the Acolyte™ Image-Guided coronary chronic total occlusion (CTO) platform, an FDA Breakthrough Device Company rebrands as Elumn8 Medical™ to better reflect expanded vision for image-enabled coronary interventions Progress continues in the Acolyte™ pre-market clinical trial CAMPBELL, Calif.–(BUSINESS WIRE)–Elumn8 Medical, Inc., formerly known […]
Author: Ken Dropiewski
JLL Partners Raises $1.4 Billion for its Fund IX
NEW YORK–(BUSINESS WIRE)–JLL Partners (“JLL” or the “Firm”), a New York-based middle market private equity firm focused on investing in the healthcare, industrials and business services sectors, announced today the final close of JLL Partners Fund IX, L.P. (“Fund IX” or the “Fund”) with approximately $1.4 billion in equity commitments. […]
Elsevier expands ClinicalKey AI with unrivaled full-text knowledge base and technology upgrades to help clinicians make decisions with confidence
ClinicalKey AI now includes full-text content from premium journals and medical organizations such as The Lancet, the New England Journal of Medicine (NEJM), the European Society For Medical Oncology and the American College of Cardiology, offering the broadest collection of trusted…
NewAmsterdam Pharma Reports Full Year 2025 Financial Results and Provides Corporate Update
— Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 — — Phase 3 PREVAIL CVOT blinded event rate tracking in line with observed event rate in BROADWAY– — Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 — — $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 — NAARDEN, the Netherlands and MIAMI, Feb. 18, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the full year ended December 31, 2025 and provided a corporate update. “2025 marked a year of meaningful clinical and regulatory progress for NewAmsterdam, as we advanced our mission to bring a potentially transformative therapy with obicetrapib to cardiometabolic disease patients who continue to struggle to reach their LDL-C goals,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency (“EMA”), Switzerland, and United Kingdom regulators, and we anticipate a decision from each in the second half of 2026. In parallel, together with our partner Menarini, we are actively preparing for a potential commercial launch in Europe. In the United States, we continue to expand our commercial capabilities with the notable hiring of Steve Albers, former senior vice president of market access and public affairs at Novo Nordisk, who will now lead our market access and public affairs efforts, further strengthening our established team.” “At the same time, we remain focused and well positioned to execute our clinical development strategy, including the advancement of obicetrapib in our three ongoing Phase 3 trials: PREVAIL, REMBRANT and RUBENS. In December 2025, we initiated the RUBENS trial, which will evaluate obicetrapib alone and in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy, with topline data expected by year-end 2026. Our PREVAIL cardiovascular outcomes trial continues to progress well, where the overall blinded MACE event rate in PREVAIL through the initial 12-months was in line with what we observed in BROADWAY. NewAmsterdam continues to operate from a position of financial strength, with cash runway expected to be sufficient to fund operations through the PREVAIL readout and, if approved, support the subsequent U.S. commercial launch. Additionally, following positive biomarker results from the Alzheimer’s disease analysis in the BROADWAY trial, we plan to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients this year.” Clinical Development and Regulatory Updates NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated. In August 2025, NewAmsterdam announced acceptance of MAAs for review by the EMA for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe FDC for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in UK and Switzerland and accepted for review. The MAAs were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A. (“Menarini”), who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive License Agreement (the “Menarini License”). NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the European countries covered by the Menarini License and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.In August 2025, NewAmsterdam presented pooled data from its pivotal Phase 3 BROADWAY and BROOKLYN trials on the impact of obicetrapib on major adverse cardiovascular events at the European Society of Cardiology Congress (“ESC”) 2025, along with the simultaneous publication in the Journal of the American College of Cardiology, highlighting obicetrapib’s performance across diverse lipid-lowering backgrounds observed in these trials. The presentation and publication underscore the Company’s continued momentum in advancing obicetrapib as a differentiated oral therapy for patients with elevated LDL-C.In June and July 2025, NewAmsterdam announced positive data from the prespecified AD biomarker analysis in the BROADWAY clinical trial and presented at the 2025 Alzheimer’s Association International Conference (“AAIC”). The pre-specified analysis was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full analysis set and in patients carrying the apolipoprotein E4 (“ApoE4”) gene, based on phenotypic analysis. NewAmsterdam observed statistically significant reductions in p-tau217, a key biomarker of AD pathology, in both the full analysis set (p
Retia Medical Receives FDA 510(k) Clearance for Argos Infinity™, Expanding Cardiovascular Intelligence Across High-Risk Surgical and Critical Care Environments
WHITE PLAINS, N.Y., Feb. 17, 2026 /PRNewswire/ — Retia Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Argos Infinity™, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care…
Nanox to Showcase Nanox.ARC Live in Europe for First Time and Present New AI Capabilities at ECR 2026
Live demonstrations of the Nanox.ARC will feature at the ECR booth #425 in Hall X4Oral presentation by Dr. Nogah Shabshin to present data on potential role of digital tomosynthesis in lung cancer screeningOral presentation by Dr. Orit Wimpfheimer to explore how Nanox AI transforms routine CT scans into tools for early detection of cardiovascular disease, osteoporosis and fatty liver diseasePoster presentations to highlight new clinical data from ADOPT study featuring AI bone solution PETACH TIKVA, Israel, Feb. 17, 2026 – NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will showcase its Nanox.ARC digital tomosynthesis system live in Europe for the first time and present new AI solutions in development at the European Congress of Radiology (ECR), taking place March 4-8, 2026 in Vienna, Austria. The Nanox.ARC is a CE-marked and FDA-cleared, multi-source digital tomosynthesis system that makes 3D imaging possible in more places, at a lower cost and significantly reduced radiation dose than traditional CT. Nanox.ARC’s smaller footprint and simplified installation requirements make it well-suited to a range of European healthcare settings, from major medical centers to community clinics. Software upgrades and new capabilities can be added remotely following regulatory clearances. Live demonstrations of the Nanox.ARC will be featured at booth #425 (Hall X4) every 30 minutes. The Company will present new clinical data on the potential role of digital tomosynthesis in lung cancer screening and demonstrate the Nanox.ARC’s TAP2D cloud-enabled image enhancement, recently FDA-cleared. Nanox will also showcase Nanox.AI’s FDA-cleared solutions that analyze routine CT scans for indicators of chronic diseases – AI Cardiac solution (HealthCCSng) and AI Bone solution (HealthOST), both of which have also received CE Mark certification, as well as AI Liver solution (HealthFLD). Additionally, Nanox will present two new AI solutions under development for aortic valve calcification and body composition measurement. Poster presentations will feature new data from the ADOPT study conducted at National Health Service hospitals in the United Kingdom, demonstrating the impact of AI-enabled vertebral fracture identification on clinical workflows and treatment recommendations. “Presenting the Nanox.ARC live in Europe for the first time, a year after receiving CE Mark certification, represents a significant milestone in our European market expansion,” said Erez Meltzer, CEO and Acting Chairman of Nanox. “European healthcare systems need advanced imaging solutions that can operate beyond major medical centers, and that is exactly what the Nanox.ARC was designed to do. At ECR 2026, we will highlight new AI capabilities and clinical evidence demonstrating the performance of the capabilities of the Nanox.ARC in lung cancer screening, as shown in clinical studies. We remain focused on making high-quality imaging more affordable, more accessible and available at scale with our end-to-end imaging solutions.” Nanox representatives will be available throughout ECR 2026 for product demonstrations and discussions of clinical data and collaboration opportunities. Schedule a meeting at booth #425 More details about Nanox’s ECR 2026 presentations and events are as follows: Oral Presentation: The potential role of Digital Tomosynthesis in improving the efficiency of Lung Cancer Screening at reduced radiation doses, costs and radiologists burden Presenter: Nogah Shabshin, MD (Medical Director, ARC Division of Nanox)Location: Research Stage 6Session Title: RPS 304 – Hot Topic: AI-driven lung cancer screeningSession Day/Time: Wednesday, March 4, 2026 at 11:30 am – 12:30 pm CET Oral Presentation: Activating Latent Data to Promote Early Detection: The Role of AI in CT Imaging Presenter: Orit Wimpfheimer, MD (Chief Medical Officer of Nanox)Location: AI Theatre (Level -2, Room D1)Session Title: AI-IND 2 – AI Lightning Talks 2Session Day/Time: Wednesday, March 4, 2026, at 11:00 am – 12:00 pm CET Poster Presentation: Tomosynthesis Augmented Projection (TAP2D) vs Conventional Chest Radiography as a Supplement to Digital Tomosynthesis: A Pilot Study Presenter: Nogah Shabshin, MD (Medical Director, ARC Division of Nanox)Location: EPOS Area, Level -2 Poster Presentation: Tomosynthesis Augmented Projection (TAP2D) vs Conventional [Musculoskeletal] Radiography as a Supplement to Digital Tomosynthesis: A Pilot Study Presenter: Nogah Shabshin, MD (Medical Director, ARC Division of Nanox)Location: EPOS Area, Level -2 Poster Presentation: Comparison of radiology augmented vs asynchronous implementation of AI enabled Vertebral Fracture reporting Presenter: Orit Wimpfheimer, MD (Chief Medical Officer of Nanox)Location: EPOS Area, Level -2 Poster Presentation: Impact of AI-enabled vertebral fracture (VF) identification on Fracture Liaison Service (FLS) Key Performance Indicators (KPIS) and treatment recommendations Presenter: Orit Wimpfheimer, MD (Chief Medical Officer of Nanox)Location: EPOS Area, Level -2 Cocktail Event Location: Altia Skybar (57 Lounge, 58th Floor)Day/Time: Thursday, March 5, 2026, at 5:30-7:30 pm CETPresentation to be given by Emilio Quaia, MD (Professor of Radiology, University of Padova)Registration Link About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT, which combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit www.nanox.vision Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Jessica Hodgson ICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
Cytokinetics Announces European Commission Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
European Commission Approval Based on Results of SEQUOIA-HCM First European Launch Expected in Germany in Q2 2026 SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Commission (EC) has approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. “The approval of MYQORZO in the European Union is an important milestone towards bringing this medicine to more patients living with obstructive HCM around the world,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased that the European label allows providers flexibility to determine whether a patient starts treatment at either 5 mg or 10 mg, based on the severity of their baseline LVOT obstruction. We look forward to making MYQORZO available in Europe, beginning with our first launch in Germany in the second quarter of this year.” “Myosin inhibition is establishing itself as an important therapy that may improve the lives of patients with hypertrophic obstructive cardiomyopathy. The approval of aficamten by the European Commission brings another treatment option into our clinical practice, allowing for more treatment flexibility to reach more patients,” said Prof. Benjamin Meder, FESC, Chair of Precision Digital Health, Head of the Institute for Cardiomyopathies Heidelberg and Deputy Medical Director, Department of Cardiology, Angiology and Pneumology, University Hospital Heidelberg. “Obstructive HCM can dramatically impact patients’ lives and often requires them to make difficult life choices based on their symptoms and how they feel,” said Emil Tsenov, Founding and Managing Director, HCM Patient Foundation. “The approval of MYQORZO in the European Union brings hope for patients and reflects meaningful progress for the HCM community.” The EC approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization in the European Union (EU) for MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients. MYQORZO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, and by the China National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms. The Summary of Product Characteristics for MYQORZO is available on the EMA website at www.ema.europa.eu. About SEQUOIA-HCM The EC approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints. The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.76 mL/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002).1 The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. During the 24-week treatment period, 3.5% of patients in the treatment group experienced a reversible dose related reduction in left ventricular ejection fraction (LVEF) to
Medtronic reports strong third quarter fiscal 2026 results with highest enterprise revenue growth in 10 quarters
Cardiovascular portfolio up 11% year-over-year; Cardiac Ablation Solutions grew 80% on strength of pulsed field ablation portfolio GALWAY, Ireland, Feb. 17, 2026 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its…
AMT Medical Appoints Geert van Gansewinkel as CEO to Lead Company into Next Growth Phase Revolutionizing Coronary Artery Bypass Surgery
Geert van Gansewinkel appointed as new CEO of AMT Medical
AMT Medical is a pioneering medical technology company developing a next-generation minimally invasive coronary bypass platform. Its ELANA® Heart Bypass System delivers a minimally invasive solution designed to replace traditional open-heart bypass surgery, ultimately leading to robot-assisted keyhole surgery compatible with surgical robots from industry leaders.
www.amt-medical.nlhttps://vimeo.com/636954313 Anticipated Clinical Results on Graft Durability and Minimally Invasive Applications to Shape Company’s Future EDE/UTRECHT, The Netherlands – February 17, 2026 – AMT Medical, a pioneering medical technology company developing a next-generation minimally invasive coronary bypass platform, today announced the appointment of Geert van Gansewinkel as Chief Executive Officer, effective immediately. The leadership transition positions the company for its next phase of development of its ELANA® Heart Bypass System, as AMT anticipates sharing significant clinical program updates in the near term that are expected to define its regulatory pathway and commercial trajectory. ELANA® delivers a minimally invasive solution designed to replace traditional open-heart bypass surgery, ultimately leading to robot-assisted keyhole surgery compatible with surgical robots from industry leaders. Founder and former CEO Rutger Tulleken will transition to the role of Founder & Strategic Advisor, where he will continue to support platform innovation, intellectual property development, grant funding initiatives, and collaboration with surgeons and research institutions, while ensuring a smooth leadership transition. Strategic timingThe appointment reflects strategic timing as the company approaches key inflection points. AMT expects to provide important updates on its clinical programs, including patency performance data (data showing the bypasses remain open) and progress in minimally invasive MIDCAB (keyhole bypass surgery) applications, that will inform the company’s transition from technology validation to structured regulatory advancement, clinical expansion, and operational scale-up. These anticipated milestones underscore the strategic rationale for bringing in experienced leadership at this juncture. Geert van Gansewinkel most recently served as Chief Executive Officer of GATT Technologies BV, a Dutch medical technology company focused on developing innovative polymer-based surgical sealant and adhesive solutions for tissue repair and hemostasis. He led the company through the complete development pathway, including preclinical validation, multiple clinical trials in Europe and the United States, and full regulatory approval processes. Under his leadership, GATT obtained CE marking in 2023 and FDA PMA approval in 2025, culminating in a successful acquisition by Johnson & Johnson in 2025. He managed the strategic transaction and subsequent integration into the acquiring organization. Earlier in his career, Geert held senior leadership roles at IQVIA and Polaris, where he co-led the exit to IQVIA. He also worked at The Boston Consulting Group, leading strategy, transformation, and post-merger integration initiatives across life sciences and healthcare. He holds a Master of Science degree in International Business Administration from Maastricht University and an MBA from IESE Business School in Barcelona. “Under Rutger’s leadership, AMT has transformed from a bold technological concept into a clinically advancing platform with strong strategic potential,” said Idgar van Kippersluis, Chairman of the Supervisory Board. “As we approach a critical inflection point and anticipate significant clinical milestones that will transition the company from technology validation to regulatory and commercial preparation, this is the optimal moment to bring in a leader with Geert’s proven track record. He has successfully navigated the complete journey from preclinical development through regulatory approval to strategic exit, and we are confident he brings the expertise required to guide AMT through this next phase.” “I am honored to join AMT at a pivotal moment as the company prepares to enter its next phase of development,” said Geert van Gansewinkel. “AMT’s technology platform has significant potential to address fundamental challenges in coronary surgery. My immediate priorities will be preparing the organization for expected clinical milestones, establishing a clear regulatory pathway, scaling our clinical operations and operational infrastructure, and ensuring we build sustainable long-term value.” Rutger Tulleken added: “The technology foundation we have built over the past years positions AMT to make meaningful contributions to coronary surgery. As we approach important clinical updates that will define our path forward, this is the natural time to transition day-to-day leadership to someone with Geert’s specific expertise in taking medical technology companies from clinical validation through regulatory approval and commercial success. I look forward to continuing to contribute to AMT’s innovation roadmap, IP strategy, and strategic partnerships in my advisory capacity.” The company expects to provide detailed updates on its clinical programs and regulatory pathway in the coming months as key milestones are achieved. About AMT MedicalAMT Medical is a medical technology company developing a next-generation coronary bypass platform designed to simplify and standardize coronary artery bypass grafting (CABG) procedures. While coronary bypass surgery remains one of the most durable and clinically proven treatments for coronary artery disease, conventional approaches typically require invasive sternotomy and technically demanding hand-sewn anastomoses. This can limit reproducibility and broader adoption of minimally invasive techniques. AMT’s ELANA® Heart Bypass System is a technology designed to enable a simpler, standardized anastomosis technique, supporting reproducible outcomes in both open beating-heart and minimally invasive MIDCAB (minimally invasive direct coronary artery bypass) procedures. By facilitating standardized minimally invasive workflows, the platform aims to support a broader transition from conventional sternotomy-based CABG toward reproducible, less-invasive coronary revascularization, including its potential role in the evolution toward minimally invasive, hybrid, and robotic coronary surgery workflows. Headquartered in Ede, with laboratories in Utrecht, The Netherlands, AMT Medical collaborates with leading cardiac surgeons in The Netherlands, Charité – Universitätsmedizin Berlin in Germany, and in the United States with UChicago Medicine and Mayo Clinic, with the shared goal of initiating first-in-human clinical applications. AMT Medical has raised over $40 million to date, including a $25 million Series B round in 2025 led by Bender Analytical Holding B.V. and supported by Invest-NL, the European Innovation Council, and Oost NL, along with multi-million-euro grants from RVO and the EIC Accelerator, to advance regulatory approvals and clinical development. For more information, visit AMT-Medical’s website, or find us on Linkedin. For further background info, please contact: AMT-Medical, Ede/Utrecht, the NetherlandsGeert van Gansewinkel, CEOEmail: info@amt-medical.nl LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensPhone: +31 6 538 16 427Email: lmelens@lifespring.bio
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Geert van Gansewinkel appointed as new CEO of AMT Medical
Heartflow to Report Fourth Quarter and Full Year 2025 Financial Results on March 18, 2026
MOUNTAIN VIEW, Calif., Feb. 13, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it will release financial results for the fourth quarter and full year of 2025 after market close on Wednesday, March 18, 2026. Management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on March 18, 2026. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide.1 Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Investor ContactNick Laudiconlaudico@heartflow.com Media ContactElliot Levyelevy@heartflow.com ____________________1Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol.



