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Company unveils patented technology designed to help maintain healthy blood flow during vascular procedures Backed by Sofinnova MD Start and led by experienced medtech entrepreneurs and cardiologists PARIS–(BUSINESS WIRE)–Tulyp Medical, a Paris-based startup developing a medical device for intelligent pressure-driven perfusion, emerged from stealth and announced it has submitted its […]
Study results further differentiate sotagliflozin from SGLT inhibitors and cardiac myosin inhibitorsTHE WOODLANDS, Texas, Nov. 04, 2025 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from three studies of sotagliflozin will be presented during upcoming medical meetings. Two studies will be presented at the American Heart Association’s (AHA) Scientific Sessions 2025, being held November 7-10 at the Ernest N. Morial Convention Center in New Orleans, Louisiana, and online, while the third study will be presented at the Hypertrophic Cardiomyopathy Society (HCMS) Scientific Sessions, which this year is conducting its conference at AHA’s Scientific Sessions. “We believe that these presentations will further position sotagliflozin, a dual SGLT 1 and 2 inhibitior, as a class of medication different from any other on the market,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “As additional data is presented at December’s CVCT 2025 and beyond, we expect to build on the compelling findings being presented at HCMS and AHA.” Details of the three presentations are as follows: Dual SGLT1 and 2 Inhibition with Sotagliflozin Ameliorates Adverse Cardiac Remodeling and Diastolic Dysfunction in Mice with HCM Due to Tropomyosin E180E Mutation — an oral presentation Friday, November 7th, 3:00 – 3:10 p.m. CT, New Orleans Ernest N. Morial Convention Center R02-R03, presented by Fuzhong Qin, M.D., Ph.D., Professor, Boston University Chobanian and Avedisian School of Medicine, Boston, MA.SOTA-P-CARDIA: A Randomized Trial of Sotagliflozin in HFpEF patients without diabetes — an oral presentation at a Late-breaking Science Session on Saturday, November 8th, 2:20 – 2:28 p.m. CT, New Orleans Ernest N. Morial Convention Center Room 211-213, presented by Juan Jose Badimon, Ph.D., Professor of Medicine and Director of the Atherothrombosis Research Unit at the Cardiovascular Institute, The Mount Sinai School of Medicine, New York, NY.Effects of major adverse cardiovascular events in persons treated with sotagliflozin: Prespecified pooled analyses of the Phase 3 type 2 diabetes program — a poster presentation Saturday, November 8th, 2:30 – 3:30p.m. CT, New Orleans Ernest N. Morial Convention Center Clinical Science Zone #2, presented by Darren K. McGuire, M.D., M.H.Sc., Professor of Internal Medicine, Division of Cardiology, UT Southwestern Medical Center, Dallas, TX. About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM).About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, HCM, obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com
KIRKLAND, Wash., Nov. 04, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced its participation in the American Heart Association (AHA) Scientific Sessions 2025, to be held November 7–10 in New Orleans. Kestra’s participation will include a late-breaking science presentation titled Primary Results from the Post-Approval Study of a Next Generation Wearable Cardioverter Defibrillator System (ACE-PAS Trial), scheduled for Monday, November 10 at 8:44 a.m. CT in Session 211–213. The ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS) is a contemporary study designed to evaluate real-world experience with a next-generation wearable cardioverter defibrillator system. Enrolling more than 20,000 patients across the U.S., ACE-PAS represents the largest prospective WCD study conducted to date. Primary endpoints include overall shock conversion success and inappropriate shock rate, with additional measures evaluating first shock conversion success, median daily wear time, and false alarm rate. The study’s selection for AHA’s late-breaking science program underscores how wearable defibrillator therapy, and data-driven insights, are advancing the way clinicians approach cardiac recovery and risk protection. “Being selected for a late-breaking presentation at AHA reflects both the clinical importance of the ACE-PAS study and the growing recognition of Kestra’s next-generation technology,” said Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies. “As the cardiac recovery landscape evolves, we’re redefining how wearable monitoring and therapy integrates with connected care and digital health innovation—advancing patient protection and delivering deeper clinical insight.” At booth #4617, attendees can explore the Kestra Cardiac Recovery System®, anchored by the ASSURE® Wearable Cardioverter Defibrillator, uniting proven patient protection with the clinical insights providers need to optimize guideline-directed medical therapy, implantable cardioverter defibrillator evaluation, and long-term recovery. In addition to the late-breaking presentation, Kestra will host live demonstrations and discussions throughout the meeting, featuring an immersive in-booth experience that highlights the company’s leadership in advancing connected, data-driven solutions for cardiac recovery. About Kestra Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
PALO ALTO, Calif. and NEEDHAM, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) — Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, announced today that the Company will present data from its anti-CD47 research at the American Heart Association (AHA) Annual Scientific Session 2025, taking place in New Orleans, Louisiana, November 7 – 10, 2025. AHA Abstracts Cardioprotection in a Rat Model of Ischemic Injury by a Novel Anti-CD47 Fusion Protein Presentation: Sa3080 (Heart Failure, Cardiomyopathy & Pulmonary Hypertension)Time: Saturday, November 8th at 10:30am CTPresenting Author: Pierre E. Signore, PhD Anti-CD47 Therapy Induces Early Macrophage-Specific Transcriptomic Changes Associated with the Resolution of Inflammation in a Murine Model of Atherosclerosis Presentation: Su4023 (Genetics and Genomics)Time: Sunday, November 9th at 11:30am CTPresenting Author: Derek Klarin, MD The posters will be available on the Bitterroot Bio website after the presentations. About Bitterroot BioBitterroot Bio, Inc. is a pioneer in the field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research seeks to uncover critical roles that immune modulators play in the progression of cardiovascular disease. By targeting these diseases in this novel way, Bitterroot Bio’s mission is to transform the lives of patients suffering from cardiovascular diseases. For more information, please visit https://www.brbio.com or follow us on Facebook LinkedIn, or X. Media Contact: Pablo Fenton (Bitterroot Bio), media@brbio.com
Data to highlight the precision of AI-powered Heartflow Plaque Staging framework in predicting long-term cardiovascular outcomesMOUNTAIN VIEW, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it will present new late-breaking data highlighting the clinical and economic value of Heartflow Plaque Analysis at the American Heart Association (AHA) Scientific Sessions 2025, taking place November 7-10 in New Orleans. The late-breaking Plaque Analysis data evaluate risk prediction with Heartflow Plaque Staging* and will remain under embargo until the featured science presentation, “Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction” on Sunday, November 9, at 12:30 p.m. CST. Timothy Fairbairn, M.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital NHS Foundation Trust, and Associate Professor at the University of Liverpool, will present the study. With seven abstracts at this year’s AHA Scientific Sessions, Heartflow is significantly advancing the scientific foundation for Plaque Analysis as a key advance guiding cardiovascular risk prediction and personalized treatment. As the established leader in AI-driven coronary care, Heartflow continues to invest in high-quality research to benefit all stakeholders in the healthcare system, fully demonstrating the utility of the Heartflow One platform in transforming CAD into a manageable disease. “Heartflow’s presentations at the AHA Scientific Sessions reflect our ongoing investment in clinical research to validate Plaque Analysis with Heartflow Plaque Staging, empowering cardiologists to personalize treatment plans using non-invasive precision technology,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “By providing AI-driven insights into plaque quantification, we’re helping clinicians see the full picture of coronary artery disease and building more effective pathways for diagnosis, management, and prevention.” Heartflow’s data presentations at AHA will include: Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction Session: Pan Vascular Interventions: Anatomy and Interventions Across Various Vascular BedsPresenter: Timothy Fairbairn, M.D.Date: Sunday, November 9Time: 12:30-12:38 p.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 5 Improvements in Diagnostic and Therapeutic Cardiovascular Risk Assessment Through Total Plaque Volume Burden: An Analysis of the FISH&CHIPS StudyFinalist for the Quest Diagnostics Early Career Investigator Award for Preventive Cardiovascular Medicine Research Session: Quest Diagnostics Early Career Investigator Award for Preventive Cardiovascular Medicine Research CompetitionPresenter: Shyon Parsa, M.D., Internal Medicine Resident at Stanford University HospitalDate: Sunday, November 9Time: 10:30-10:40 a.m. CSTLocation: 208-209 Population Changes in AI Coronary Plaque Volumes over 7 Years Session: New Frontiers in Cardiovascular Risk: Trends and Drivers in Cardiovascular Mortality and OutcomesPresenters: Allen Taylor, M.D., F.A.C.C., F.A.H.A., Chairman of Cardiology, MedStar Heart and Vascular Institute and Professor of Medicine at Georgetown University and Matthew Budoff, M.D., Professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical CenterDate: Saturday, November 8Time: 10:30-11:30 a.m. CSTLocation: Population Science Zone AI-enabled Plaque Phenotype Analysis of Coronary Computed Tomography Angiography Findings in Patients with Nonacute Chest Pain using FFRCT: Results from the PRECISE Trial Session: Imaging Insights from Multicenter Clinical TrialsPresenter: Jonathon Leipsic, M.D., F.R.C.P.C., M.S.C.C.T., Professor and Chair of Radiology and Professor of Cardiology at the University of British ColumbiaDate: Saturday, November 8Time: 11:34-11:39 a.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 8 Cost-Effectiveness of AI-Enabled Coronary Plaque Analysis for Management of Stable Coronary Artery Disease Session: Transforming Cardiac Imaging and Risk Assessment Through AIPresenter: Daniel D’Attilio, Director, Healthcare Economics and Outcomes Research, HeartflowDate: Saturday, November 8Time: 12:36-12:41 p.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 4 Statin Use Mitigates Androgen Deprivation Therapy-Associated Coronary Atherosclerosis in Prostate Cancer: A Secondary Analysis of the REVELUTION Randomized Clinical Trial Session: Cardiac Amyloidosis and Cardiometabolic ConundrumsPresenter: Marly van Assen, Ph.D., Co-director of the Translational Laboratory for Cardiothoracic Imaging and Artificial Intelligence, Head of CT and AI Research, and Assistant Professor, Emory UniversityDate: Saturday, November 8Time: 2:27-2:32 p.m. CSTLocation: Clinical Science Zone 2‚ Moderated Digital Poster 19 Accelerated Coronary Atherosclerosis Following Relugolix Versus Leuprolide Androgen Deprivation Therapy in Men with Prostate Cancer (REVELUTION): An Open-Label Randomized Controlled Trial Session: Where Cancer and Cardiovascular Disease Collide: Risks, Disparities, and Evolving EvidencePresenter: Marly van Assen, Ph.D., Co-director of the Translational Laboratory for Cardiothoracic Imaging and Artificial Intelligence, Head of CT and AI Research, and Assistant Professor, Emory UniversityDate: Saturday, November 8Time: 3:15-3:20 p.m. CSTLocation: Population Science Zone‚ Moderated Digital Poster 12 Heartflow invites AHA attendees to a Heart Theater Symposium exploring how AI-driven plaque quantification is transforming CAD management: AI-Plaque Analysis: The Paradigm Shift in CAD Management Moderator: Seth Martin, M.D., M.H.S., FAHA, Professor of Medicine and Cardiologist at Johns Hopkins School of MedicinePanelists: Fatima Rodriguez, M.D., F.A.C.C., Section Chief of Preventive Cardiology and Associate Professor in the Division of Cardiovascular Medicine at Stanford University, and Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical SchoolDate: Sunday, November 9Time: 3:15-4:00 p.m. CSTLocation: Heart Theater 1 *Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework and its safety and effectiveness have not been reviewed by the FDA. 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 nearly 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 110 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 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 96%.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, GDPR, HIPAA, CCPA, 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. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com
TUCSON, Ariz., Nov. 03, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first U.S. and Canadian commercially-approved total artificial heart, today announced it will exhibit at the annual meeting of the American Heart Association (AHA) being held November 7th through 10th in New Orleans, Louisiana. At the annual meeting of the AHA, Picard will showcase its SynCardia™ Total Artificial Heart (or “STAH”), which is the most widely used and extensively studied artificial heart in the world, at booth #3408. Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, Inc. commented, “We are excited to attend the annual meeting of the American Heart Association to share the latest developments related to our innovative and life-saving artificial heart, the Syncardia Total Artificial Heart, or STAH. We look forward to having discussions with physicians and attendees at AHA about patient eligibility, the latest clinical data and helpful resources, and sharing insights from patients who have had real-world experiences with the STAH.” About the American Heart Association (AHA) and its Annual Meeting #AHA25 brings together the full spectrum of cardiovascular science—from foundational science and translational breakthroughs to clinical trials and real-world application. Each year, thousands of professionals come together to exchange ideas, build lasting collaborations, and accelerate progress in cardiovascular health on a global scale. The AHA has grown into the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. A shared focus on cardiovascular health unites its more than 35 million volunteers and supporters as well as its more than 3,300 employees. Learn more here. The AHA has invested more than $6 billion in research, making it the largest not-for-profit funding source for cardiovascular and cerebrovascular disease research next to the federal government. About Picard Medical and SynCardia Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov. Forward-Looking Statements This release may contain forward-looking statements within the meaning of federal securities laws. Such statements are based on current expectations and are subject to risks and uncertainties that may cause actual results to differ materially. The Company undertakes no obligation to update or revise any forward-looking statements. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
PALO ALTO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that ten moderated digital posters will be shared at the American Heart Association (AHA) Scientific Sessions 2025, taking place in New Orleans, LA from November 7 – 10, 2025. Moderated Digital Posters: Acoramidis Effect on All-Cause Mortality in Patients with p.V142I (V122I) Variant ATTR-CM: Findings from the ATTRibute-CM StudyPresenter: Marianna Fontana, M.D., University College London, UKDate/time: Saturday, November 8 at 3:15 pm CT Acoramidis Reduces All-Cause Mortality and First Cardiovascular Hospitalization in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from the ATTRibute-CM StudyPresenter: Prem Soman, M.D., Ph.D., University of Pittsburgh School of Medicine, U.S.Date/time: Saturday, November 8 at 9:15 am CT Acoramidis Reduces All-Cause Mortality and Cardiovascular-Related Hospitalizations Through Month 42 in Transthyretin Amyloid Cardiomyopathy Across All Pre-specified Patient SubgroupsPresenter: Lily Stern, M.D., Cedars-Sinai Heart Institute, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Acoramidis Lowers NT-proBNP in a Larger Proportion of ATTRibute-CM Study Participants with Transthyretin Amyloid Cardiomyopathy Compared with Placebo, Independent of Atrial Fibrillation StatusPresenter: Mathew Maurer, M.D., Columbia University Irving Medical Center, U.S.Date/time: Saturday, November 8 at 9:15 am CT Demographic Disparities in Tafamidis Treatment and Clinical Outcomes Across the United StatesPresenter: Nicole Cyrille-Superville, M.D., Atrium Health Sanger Heart & Vascular Institute Kenilworth, Charlotte, NC, U.S.Date/time: Saturday, November 8 at 12:15 pm CT Geographic Disparities in Transthyretin Amyloid Cardiomyopathy Prevalence in United States VeteransPresenter: Sandesh Dev, M.D., Southern Arizona VA Health Care System, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Serum Transthyretin Levels at Day 28 are Associated with Cardiovascular Outcomes: Insights from the ATTRibute-CM StudyPresenter: Nitasha Sarswat, M.D., UChicago Medicine, U.S.Date/time: Sunday, November 9 at 3:15 pm CT Acoramidis Improved Clinical Outcomes, Function, Quality of Life and NT-proBNP in Patients with Transthyretin Amyloid Cardiomyopathy Regardless of Atrial Fibrillation Status at BaselinePresenter: Richard Cheng, M.D., University of Washington, Seattle, WA, U.S.Date/time: Sunday, November 9 at 3:15 pm CT Acoramidis Reduces the Risk of All-Cause Mortality and Cardiovascular-Related Hospitalization Compared with Placebo in Participants with Transthyretin Amyloid Cardiomyopathy and Early-Stage Heart Failure Regardless of Atrial Fibrillation History: Insights from ATTRibute-CM Presenter: Ronald Witteles, M.D., Stanford University School of Medicine, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Vutrisiran Healthcare Resource Utilization, Costs, Discontinuation, and Mortality: A Retrospective Database Analysis Presenter: Nicole Bart, M.D., Ph.D., St Vincent’s Hospital Sydney, AUDate/time: Monday, November 10 at 10:45 am CT About Attruby™ (acoramidis) INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATION Adverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBioBridgeBio Pharma (BridgeBio; Nasdaq: BBIO) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube. BridgeBio Media Contact:Bubba Murarka, Executive Vice President, Corporate Developmentcontact@bridgebio.com (650)-789-8220 BridgeBio Investor Contact:Chinmay Shukla, Senior Vice President, Strategic Financeir@bridgebio.com
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA* submission. “We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,” commented Vice Chairman and CEO, Wayne Paterson. The PARADIGM Trial is co-chaired by Dr. Michael J. Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital, Texas and Professor Stephan Windecker, Chairman of the Department of Cardiology at Bern University Hospital, Switzerland. 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 aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients across the Unites States, Europe and Canada 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. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). *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. **Subject to Institutional Review Board (IRB) approval 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 intent for the PARADIGM Trial. 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, neither ATL or Anteris 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 Relationsinvestor@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200 Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D.Blueprint Life Science Group+1 917 330 4269 Website www.anteristech.comX @AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
American Heart Association consortium advances development of evidence-based health tech solutions CHICAGO and OXFORD, England, Oct. 31, 2025 /PRNewswire/ — Brainomix, a global leader and pioneer of AI-powered imaging tools in stroke and lung fibrosis, today announced it has joined the…
SUNNYVALE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. “CardiAMP cell therapy has shown evidence of benefit for ischemic heart failure patients with elevated markers of heart stress, despite being on optimized medical therapy,” said Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF II Trial National Co-Principal Investigator. “We look forward to offering patients the opportunity to participate in this important study and potentially contributing to the evidence that may enable this therapy to be more broadly available.” “We are pleased that the UW School of Medicine and Public Health has completed their first enrollment in our ongoing Phase 3 CardiAMP HF II clinical trial,” said Peter Altman, PhD, CEO of BioCardia. “The leadership of this prestigious cardiology center strengthens our trial. We share the vision of providing specialized medicine that translates into personalized care for improved patient outcomes. Dr. Amish Raval, who has served as our CardiAMP HF II Trial Co-National Principal Investigator since the trial’s inception, is a valued world leader in both basic science and translation of biotherapeutic interventions in cardiology. We are proud to partner with the University of Wisconsin, as well as our other CardiAMP HF II clinical sites, as they strive to provide the best in care for patients diagnosed with ischemic heart failure.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study1. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF consisting of all cause death, nonfatal major adverse cardiac events, and a validated quality of life measure. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP who are the focus of the CardiAMP HF II study. Advances in this therapeutic approach for this trial include using the cell population analysis at screening to define treatment doses and improvements to the Helix system including the FDA approved Morph DNA steerable platform. About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis, treating microvascular dysfunction. The CardiAMP Cell Therapy clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: https://www.BioCardia.com. Forward-Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. References: Raval A, on behalf of the CardiAMP HF Investigators. A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Scientific Sessions, March 30, 2025. CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
