The Latest Cardiac and Vascular News
Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these…
NEWTOWN, Pa.–(BUSINESS WIRE)–Micro Interventional Devices (MID), a pioneering company in Transcatheter Tricuspid Valve Repair (TTVr) developing MIA-T (Minimally Invasive Annuloplasty – Tricuspid), a novel technology for the treatment of tricuspid annular disease, today announced that the U.S. Food & Drug Administration (FDA) has approved the company’s technology for Investigational Device […]
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
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 […]
Phase 1c Clinical Trial to Begin Immediately ENCINITAS, Calif. and WROCLAW, Poland, Oct. 13, 2025 /PRNewswire/ — Vasa Therapeutics, (“Vasa”), a private, clinical stage biotechnology company developing novel therapies for cardiovascular and metabolic aging, today announced that the U.S….
Completed Enrollment in First-In-Human Phase I study of Less Invasive Approach Expected to Present 6-Month data in 2026 at a major Cardiology Congress Via Less Invasive Approach, more Cardiologists could implant out-patient Additional studies expanding indications and level of evidence…
With over 120 issued and pending patent applications, Autonomix is building a comprehensive, global IP portfolio in nerve-sensing and modulation Newly issued patent strengthens the Company’s strategic position in a multi-billion-dollar market opportunity and unlocking potential across cardiovascular, renal, and other high-burden diseases THE WOODLANDS, TX, Oct. 09, 2025 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,369,852 (the ‘852 patent), titled, “Controlled and Precise Treatment of Cardiac Tissues.” The newly issued ‘852 patent covers systems, devices, and methods that sense autonomic/cardiac signals, map targets, and then deliver therapy with closed-loop feedback to precisely treat cardiac tissues by performing feedback-driven neuromodulation, denervation, and/or ablation of tissues. “We are pleased to further reinforce our intellectual property around our technology. The autonomic nervous system plays a major role in regulating and maintaining normal cardiac activity. Cardiac disease is often treated by sympathetic beta-receptor blockade, which affects all cells and organs of the body and often leads to unwanted and intolerable side effects. Our breakthrough technology has the potential to provide precision nerve-targeted therapies that could transform treatment in high-growth areas of cardiology, including renal denervation for hypertension, arrhythmia management, heart failure, and refractory angina, offering new solutions with fewer complications,” commented Brad Hauser, CEO of Autonomix. In particular, the ‘852 patent relates to systems, devices, and methods for performing precise treatment, mapping, and/or testing of tissues and for identifying, localizing, monitoring, and mapping neural traffic near targeted regions. Further, the patent highlights applications across arrhythmias (atrial & ventricular), ischemia/angina (including refractory angina pain), coronary spasm, myocardial infarction risk modulation, heart failure, hypertension (including interplay with renal-cardiac nerves), and plaque/inflammation modulation, where local, feedback-guided denervation or modulation may reduce dependence on systemic beta blockade and its side effects. Autonomix’s first-in-class technology constitutes a platform with the potential to address dozens of indications in multiple high-need therapeutic areas, including cardiology and resistant hypertension or high blood pressure, interventional pain management, pulmonary and gastrointestinal disorders, and more. For more information about the Company’s technology, please visit autonomix.com. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 29, 2025, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLCJenene Thomas908.824.0775autonomix@jtcir.com
Presentation to provide comprehensive overview of AVIM Therapy clinical evidence demonstrating the potential to halt the progression of hypertensive heart diseaseOrchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration to develop and commercialize AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, an estimated global population of over 750,000 patients annuallyAVIM Therapy has received FDA Breakthrough Device Designation for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk, an estimated U.S. population of over 7.7 million patients NEW HOPE, Pa., Oct. 09, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced a data summary supporting the transformative potential of Atrioventricular Interval Modulation (“AVIM”) Therapy in the management of hypertensive heart disease will be presented in a keynote talk at the Georgia Innovation Summit in Tbilisi, Georgia on October 10, 2025. The presentation, to be delivered by Avi Fischer, MD, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed, will showcase AVIM Therapy as a novel, device-based therapeutic approach targeting hypertensive heart disease progression and its potential to redefine standards of care. Dr. Fischer commented, “This keynote presentation reflects the growing global recognition of AVIM Therapy as a novel, device-based therapy, poised to reshape the future of hypertension care. Hypertension is the principal driver of diastolic dysfunction, which accelerates the development of heart failure. Despite widespread use of antihypertensive therapies, many patients continue to progress along the disease pathway, underscoring the importance of novel therapeutic approaches. The collective body of AVIM Therapy clinical data demonstrates its potential to directly modulate the progression of hypertensive heart disease, offering the potential to intervene earlier in the course of the disease to improve long-term outcomes, transform patient care, and ultimately create lasting value for all stakeholders.” The keynote presentation will provide a comprehensive overview of clinical and mechanistic AVIM Therapy results from pilot and long-term follow-up studies, highlighting the therapy’s consistent favorable clinical impact on blood pressure and cardiac function: Immediate, substantial, and sustained blood pressure reduction MODERATO I pilot study: 24-hour ambulatory systolic blood pressure (“aSBP”) reduced by 11.6 mmHg at 1 day and 10.1 mmHg at 3 monthsMODERATO II pilot study: 24-hour aSBP reduced by 15.6 mmHg at 1 day and 11.1 mmHg at 6 months, as well as an office systolic blood pressure reduction of 17.5 mmHg at 24 months Favorable impact on cardiac hemodynamics after 24 months of treatment (MODERATO I) Significant reductions in heart rate and end-diastolic volumeNo significant changes in end-systolic volume or ejection fraction, supporting safety Improvement in echocardiographic measures of diastolic function (MODERATO II) Significant increases in e’ and E/A ratio, indicating improved myocardial relaxation and diastolic compliance Potential to halt hypertensive heart disease progression Long-term follow-up demonstrates sustained blood pressure reduction with reversibility of effect and absence of rebound hypertension upon deactivationFavorable effects were reproducible after a 7-day washout period followed by reactivation, underscoring durability and reliability About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM Therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the implementation and design of the BACKBEAT pivotal study, the potential efficacy and safety of the Company’s commercial product candidates, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs and strategic partnerships. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission on March 31, 2025, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com
Second-generation delivery device offers cost-effective alternative to hospital care benefiting patients, providers and payors Worsening heart failure is among the top three indications for hospitalizations in the elderly BURLINGTON, Mass., Oct. 8, 2025 /PRNewswire/ — SQ Innovation, Inc….
FAYETTEVILLE, Ark., Oct. 7, 2025 /PRNewswire/ — HeartX, powered by HealthTech Arkansas and MedAxiom — along with dozens of leading cardiovascular programs around the country — has selected the seven startup healthcare companies that will participate in the 2025 accelerator program….
