The Latest Cardiac and Vascular News
Building on the Merck Foundation’s longstanding commitment to advancing access to high-quality health care, new national initiative supports grants to 11 organizations across the country RAHWAY, N.J.–(BUSINESS WIRE)–The Merck Foundation announced today the launch of the Collaborative for Equity in Cardiac Care, a $22 million, five-year initiative aimed at enhancing […]
PROWL Registry evaluates the Pounce™ Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Updated safety and performance data from 160 patients with symptomatic infrainguinal vessels will be shared. EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in […]
SOUTH JORDAN, Utah, Nov. 03, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial. Results of the AVG cohort were presented during the Late-Breaking Clinical Trials session at the annual VIVA Foundation3 Venous Endovascular Interventional Strategies (VEINS) conference held in Las Vegas, NV.
NEW HOPE, Pa., Nov. 03, 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 that company management will host a business update call on Wednesday, November 12th at 8:00 AM ET. The business update will focus on recent significant clinical, strategic and financing developments, including the Company’s additional strategic investment from and collaboration expansion with Medtronic, its new strategic capital relationship with Ligand, its new right of first refusal agreement with Terumo, acceleration of enrollment in the BACKBEAT pivotal study of AVIM Therapy, the initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial. Conference Call DetailsWednesday, November 12, at 8:00 AM Eastern Time Toll Free: 877-407-9039International: 201-689-8470Conference ID: 13756518Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1738644&tp_key=c80bc7995c About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.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
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
Data show consistent efficacy, safety, and tolerability findings across multiple clinical trials that evaluated self-administered etripamilMONTREAL and CHARLOTTE, N.C., Nov. 03, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that new data analyses surrounding its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT), etripamil nasal spray, consistently showed efficacy and a favorable safety profile across multiple studies comprising the global development program. The poster, “Combined Efficacy, Safety, and Test Dose Tolerability of Etripamil for Acute Paroxysmal Supraventricular Tachycardia (PSVT) Across Multiple Clinical Trials,” will be presented on Monday, November 10 (10:30–11:30 AM CST) at the American Heart Association Scientific Sessions 2025, in New Orleans, La. The data will be presented by James Ip, M.D., Professor of Medicine and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Department of Medicine, New York Weill Cornell-Presbyterian Hospital. Key Findings: Analysis of data from 622 unique enrolled patients across multiple trials showed consistent efficacy of etripamil across multiple study phases, types of trial design, and geographic regions, with etripamil treatment showing similarly greater conversion rates for symptomatic PSVT episodes compared with placebo arms.Across studies, the median time to conversion in patients self-administering etripamil was 18.5 minutes (95% CI: 15.7 to 21.0 minutes).The Kaplan-Meier estimate, from the pooled data for conversion of PSVT to sinus rhythm (SR) by 30 minutes of drug administration, was 59.6% (range: 53.6% to 64.3%). By 60 minutes post-administration, etripamil conversion rates rose to 63.2% to 75.1% across studies.Safety data from over 1,050 etripamil-treated patients were favorable, consistently shown, and characterized by predominantly mild, transient, and nasal-site localized adverse events.The low rate of test-dose failures (1.4%) among over 1,100 patients administered etripamil in SR further indicates the consistent tolerability of etripamil. “These results show the consistent efficacy, with onset soon after self-administration, and safety of etripamil nasal spray across a wide range of studies and patient populations,” said David Bharucha, M.D., PhD, FACC, Chief Medical Officer of Milestone. “The potential for patients to self-administer etripamil and achieve rapid termination of symptomatic PSVT episodes would represent a meaningful advance in the management of PSVT, a condition that frequently leads to emergency room visits and causes significant burden for patients.” Study Methods This analysis involved a systematic review of randomized-controlled and open-label trials evaluating etripamil in adult patients with documented PSVT. Studies were selected based on their focus on self-administered etripamil for acute termination of symptomatic PSVT episodes, with inclusion criteria encompassing patients aged 18 years or older with a history of PSVT confirmed by electrocardiogram (ECG). These studies included: Phase 2: NODE-1; Phase 3: NODE-301 (Parts 1 and 2 [RAPID] and its extensions); and NODE-302 and NODE-303 (open-label extensions). A New Drug Application (NDA) for CARDAMYST is currently being evaluated by the U.S. Food & Drug Administration (FDA) which has set a new Prescription Drug User Fee Act (PDFUA) target date of December 13, 2025. About Etripamil Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil for the treatment of an abnormal heart rhythm, paroxysmal supraventricular tachycardia or PSVT. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: expectations in regards to etripamil’s efficacy; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; the timing of the PDUFA date; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com
MIAMI, Nov. 03, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Peter A. Soukas, M.D., as Chief Medical Officer to advance its mission to deliver best-in-class tools for carotid intervention.
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
– Mark Quick Appointed Chief Financial Officer, Bringing Extensive Public Company Capital Markets Expertise — Current CFO, Stefano Picone, will take on a Transitional Strategic Role to Support Leadership Continuity During Growth Phase — Leadership additions follow submission of next-generation Novasight™ to the FDA for 510(k) clearance -TORONTO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Conavi Medical (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced strategic leadership changes aligned to the Company’s planned commercial launch and expansion in the United States.Conavi has submitted its next generation Novasight Hybrid IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, and is actively building the infrastructure required to support a successful U.S. launch in the largest market for intravascular imaging globally.As part of these preparations, Conavi has appointed Mark Quick as Chief Financial Officer, bringing strong capital-markets expertise from senior roles at publicly traded life sciences and medtech companies. He will oversee financial strategy and investor engagement as Conavi prepares for launch in the United States.Stefano Picone will take on a transitional strategic role with the Company as the Chief Strategy Officer. Having successfully guided Conavi through its go-public transaction, first public equity financing, and organizational scale-up, Mr. Picone now shifts focus to strategic execution and ensuring continuity as the Company advances through this commercial scale-up period.“We are entering a very exciting chapter for Conavi as we prepare for broader U.S. adoption of our hybrid imaging platform,” said Thomas Looby, Chief Executive Officer of Conavi Medical. “Mark brings the ideal financial and strategic mindset to help guide our U.S. launch and expand our presence in the capital markets. Stefano’s leadership over the past decade has been instrumental in establishing the corporate foundation we stand on today, and we are grateful for his significant financial stewardship and continued support as we execute on Conavi’s long-term growth and value-creation strategy. With these leadership enhancements and U.S. expansion activities advancing, we are confident we have the right team, capabilities, and focus in place to deliver success in the United States and create long-term value for shareholders.”“Conavi has a differentiated and highly compelling technology platform,” said Mark Quick, Chief Financial Officer of Conavi Medical. “I’m excited to join at this stage of growth and look forward to working with the team to advance a strong financial, operational, and capital markets strategy as the Company prepares for commercialization.”Mark Quick — Chief Financial OfficerMr. Quick is a seasoned finance executive with more than 20 years of experience in the medical technology and life sciences sectors. Prior to joining Conavi, he held senior financial leadership roles with publicly traded companies on Nasdaq, where he led capital markets strategy, budgeting and forecasting, financial reporting, and corporate development initiatives. Earlier in his career, Mr. Quick served as a sell-side equity research analyst at Canaccord Genuity, where he covered the medical device industry. Mr. Quick holds a Bachelor of Science in Mechanical Engineering from the University of Massachusetts, Amherst, and an International Master of Business Administration from the University of South Carolina.About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com.Cautionary Statement Regarding Forward-Looking InformationThis news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to transitions in the Company’s strategic leadership, Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S. and other U.S. expansion activities.These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.Contact:Investors: Christina Cameron, IR@conavi.com
