The Latest Cardiac and Vascular News
inancing to Provide Approximately $19 Million in Upfront Proceeds LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or the “Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that it has entered into a securities purchase agreement with certain accredited investors […]
MINNEAPOLIS and BRISBANE, Australia, Oct. 15, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the “PARADIGM Trial”). Patient recruitment at Danish centers is expected to begin in 4Q 2025. PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices With the first regulatory clearance secured, Anteris is positioned to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement. “Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial. This groundbreaking study has been designed with world-leading experts and is attracting significant interest from clinicians globally, reflecting the potential for DurAVR® to transform care for patients with aortic stenosis,” said Anteris Chief Medical Officer, Chris Meduri, M.D. “The PARADIGM Trial enables us to bring promising new technology to patients across all surgical risk groups, building on the growing body of evidence supporting the DurAVR® THV’s favorable hemodynamic performance. We look forward to contributing meaningful data which could support both PMA* and CE Mark approvals,” said Dr. Michael Reardon and Professor Stephan Windecker, Study Co-Chairs of the global PARADIGM Trial. “The PARADIGM trial is a multi center global study which, if successful, will result in multiple approvals and labels for the DurAVR® THV. This is a watershed moment in the company’s life cycle and marks the beginning of the commercialization planning phase as we march towards global approvals. Anteris is excited to be able to allow access to an increasing pool of patients globally who will benefit from this life saving technology. The commencement of this trial reflects the commitment and tireless work of our talented Anteris team, as well as our Physician and Scientific Advisors. The company would like to express its gratitude to the physicians, patients and shareholders who have been fundamental in developing this important new therapy,” said Vice Chairman and CEO, Wayne Paterson. In parallel, an Investigational Device Exemption (IDE) application remains under review by the U.S. Food and Drug Administation (FDA). Anteris continues to expect FDA approval in the near term, which will allow initiation of study sites in the PARADIGM Trial in the United States, pending Institutional Review Board (IRB) approval. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aoric valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies includes additional cohorts. *A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including statements regarding the planned expansion of the PARADIGM Trial, the results of the PARADIGM Trial, the contours of the PARADIGM Trial, and the timing of the IDE approval. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Investor Relations Investor Relations (US)investor@anteristech.com mchatterjee@bplifescience.comDebbie Ormsby Malini Chatterjee, Ph.D.Anteris Technologies Global Corp. Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269 Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech
Initial target markets for commercialization include Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia Expands distributor channel coverage to ~35% of European Union population with ~300,000 annual endovascular procedures BERKELEY, Calif, Oct. 15, 2025 (GLOBE NEWSWIRE) — Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces it has expanded its commercial footprint for its Lumee Oxygen platform in Europe with the signing of a letter of intent to establish logistics and commercialization footprint with Angiopro GmbH (“Angiopro”). Initial markets targeted for launch and commercialization of the Lumee platform include Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia. The arrangement with AngioPro builds upon Profusa’s distributor sales coverage in Europe. Combined with the Company’s previously announced distributor partner in Spain, Profusa now has approximately 35% of European Union population covered through its distribution channels. “As industry specialists on clinical needs in vascular and peripheral diseases, we recognize the innovation and need for Profusa’s Lumee platform technology. We are also enthusiastic about collaborating with Profusa on additional pipeline clinical indications, such as diabetes and other chronic conditions where continuous tissue monitoring could provide significant patient benefits,” said Benjamin J. Rieck, CEO and General Manager of Angiopro. “Leveraging our marketing and sales infrastructure, established networks, regulatory expertise, and strong presence in European regions, we are excited to build a strong foundation for long term partnership and growth with Profusa.” Angiopro is a specialized MedTech distributor and importer dedicated to bringing cutting-edge cardiovascular technologies that enhance patient care to market, driving commercial success. Angiopro’s industry expertise spans high quality technologies in interventional cardiology, vascular surgery and healthcare IT, with regulatory proficiency and an experienced clinical sales infrastructure calling on an extensive network across Europe. “With growth capital in hand, we are focused on building our robust distribution infrastructure in Europe and are excited to partner with Angiopro as we execute on our strategy to bring our pioneering real-time personal healthcare technologies to the clinical community, driving growth in our business,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “With an estimated $10.5B+ global addressable market for our tissue oxygen technology across three indications, including peripheral artery disease, chronic wounds, and critical limb ischemia, including approximately 300,000 annual endovascular procedures in Europe, Profusa is well-positioned to address this large market need with our differentiated Lumee platform technology.” About Profusa Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on. “LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.For more information, visit https://profusa.com. Special Note Regarding Forward-Looking Statements Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa or the combined company. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including risks regarding the highly volatile nature of the price of Bitcoin and other cryptocurrencies, as well as the risk that the Company’s stock price may be highly correlated to the price of the digital assets that it holds. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and described in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate. Contacts Investor and Media Contacts email: info@coreir.comphone: 1 (212) 655-0924
DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 15, 2025 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular care, today announced that it will report third quarter 2025 financial results and conduct a conference call on Wednesday, October 29, 2025. The Company will issue a press release detailing its third quarter 2025 financial results in the pre-market hours, followed by a conference call with senior management at 8:00 a.m. ET. Information on how to participate is as follows. Access to the live call: Via telephone: Dial in within the United States: 877-545-0523 International dial in: 973-528-0016 Access Code: 459510 Via online: A webcast of the call will be available on the Investor Relations section of the Company’s website at www.amarincorp.com. Access to the replay: Via telephone: Dial in within the United States: 877-481-4010 International dial in: 919-882-2331 Access Code: 53008 Via online: A replay of the webcast will be accessible through the Investor Relations section of the Company’s website at www.amarincorp.com, beginning shortly after the call and available until 3/29/26. About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally through a syndicate of reputable and well-established partners with significant geographic expertise, covering over 90 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. Availability of Other Information About Amarin Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (http://www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Bob Burrows Western Avenue Advisers LLC Bob.burrows.ext@amarincorp.comInvestor.relations@amarincorp.com
ST. LOUIS, Oct. 15, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the US for the Synchrony™ system. Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim and stunning 55” 4K ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and less than a single frame latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available with SynX™, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. “In my role managing the technology across our electrophysiology labs and advising labs across the country, I have significant experience with the various interventional lab display offerings,” said Matthew Dare, CEPS, Research and Technology Coordinator, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The underlying hardware and software architecture of Synchrony and SynX is far beyond what anyone else has developed. It promises a better intraoperative experience for physicians and nurses, improved equipment reliability and maintenance, and attractive tools for managing a cardiovascular program with remote monitoring, collaboration and recordings.” “We have long recognized the importance of remote connectivity and collaboration for our EP labs,” said Dr. Jim Cheung, Professor of Medicine and Director of Cardiac Electrophysiology Fellowship and Research at Weill Cornell Medicine in New York City. “Technologies to date though have not made reliable high-quality connectivity easy. SynX provides a much-needed solution that can permit seamless collaboration across labs and enhance our ability to ensure the best patient care and to train the next generation of physicians.” Synchrony and SynX have been engineered to be foundational platforms for future innovations. The advanced architecture enables future applications and the leveraging of artificial intelligence for enhanced clinical insights, automation, and safety. “Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities,” said David Fischel, Stereotaxis Chairman and CEO. “The technology improves the robotic cockpit, and will be critical in supporting future robotic efforts for remote long-distance procedures and automated catheter navigation. The opportunity is much broader than robotic labs as we believe all cath labs stand to benefit from improved workflow, connectivity, and collaboration.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, including statements regarding the completion of the Company’s offering and the anticipated use of proceeds therefrom, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. There can be no assurance that the Company will recognize revenue related to customer purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com
Expanded partnerships with leading European centers create a strategic pathway to accelerate market adoption and drive future commercialization opportunities NASHUA, N.H., Oct. 14, 2025 /PRNewswire/ — Conformal Medical, Inc., a medical device company developing next-generation technology for left atrial appendage occlusion (LAAO), today announced the initiation of patient enrollment in the European Union for […]
inancing supports ongoing clinical operations, development, and commercialization preparation HALIFAX, NS, Oct. 14, 2025 /PRNewswire/ – ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, today announced an oversubscribed US$35 million Series D financing. The round was led by new investor, J.P. Morgan Life […]
With this labeling approval, Medtronic continues to lead the way in advancing aortic care with clinical evidence for the treatment of ruptured abdominal aortic aneurysms (rAAA). Medtronic plc, a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) labeling approval1 for the Medtronic Endurant™ […]
SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the pioneer of deep clinical AI and the global leader in image-based decision support and workflow efficiencies, today announced that its Lumina 3D™ built on the Rapid Enterprise™ Platform has been named to TIME’s List of the Best Inventions of 2025, honoring 300 extraordinary innovations changing the […]
97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tachycardia LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced preliminary acute (within 7 days) safety and efficacy results […]
