Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026. “We are pleased with CHMP’s positive recommendation based on the robust clinical evidence from SEQUOIA-HCM that demonstrated the safety and efficacy of MYQORZO in patients with oHCM, and we are accelerating commercial readiness activities accordingly,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Given the urgency to bring new treatment options to the European oHCM patient community, pending the final European Commission decision, we look forward to making MYQORZO available to patients in Europe.” “This positive opinion from the CHMP is an important milestone toward bringing a new treatment option with distinct attributes to patients with oHCM,” said Iacopo Olivotto, M.D., Head of the Cardiomyopathy Center and Professor of Cardiovascular Medicine at the University of Florence, Italy. Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review. About SEQUOIA-HCM The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1 The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 ml/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 ml/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002). The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF). Treatment emergent serious adverse events occurred in 5.6% and 9.3% of patients on MYQORZO and placebo, respectively. Core lab echocardiographic LVEF was observed to be
Coronary/Structural Heart
Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System, Pioneering Treatment for Aortic Regurgitation in China
HONG KONG, Dec. 12, 2025 /PRNewswire/ — Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from…
Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio’s commercial platform. PLANO, Texas, Dec. 11, 2025 /PRNewswire/ — Vesalio, a leader in thrombectomy solutions, today announced FDA 510(k) clearance and the upcoming U.S. commercial launch of…
Heartflow FFRCT Analysis Delivers Prognostic Power and Significant Cost Savings in New Analyses of Over 90,000 Patients with Coronary Artery Disease
Lesion-specific FFRCT predicts individual cardiovascular outcomes and delivers greater-than-modeled cost savings for real-world population in FISH&CHIPS analyses from England’s National Health ServiceMOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than 90,000 patients conducted by the National Health Service (NHS) in England, representing the largest fractional flow reserve (FFRCT) study ever conducted. The data, presented today at the European Society of Cardiology’s European Association of Cardiovascular Imaging (EACVI) conference in Vienna, provide the strongest real-world evidence to date that Heartflow FFRCT Analysis derived from coronary computed tomography angiography (CTA) improves diagnostic decision-making, predicts future cardiovascular events, and delivers substantial, system-wide cost savings. “These real-world data show that coronary CTA plus Heartflow FFRCT Analysis brings both clinical and economic value when utilized in a large health system,” said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. “The introduction of Heartflow FFRCT Analysis into the NHS resulted in fewer avoidable tests, lower inpatient and outpatient costs, and substantial overall savings for both the hospitals and patients. It’s a compelling example of how noninvasive AI-powered technology can reshape care pathways at scale.” Lesion-Specific Heartflow FFRCT Analysis Predicts Individual Cardiovascular OutcomesIn a nationwide analysis of 7,836 patients who underwent FFRCT in the FISH&CHIPS study, investigators evaluated the prognostic value of Heartflow FFRCT Analysis across individual outcomes, including myocardial infarction (MI), cardiovascular mortality, all-cause mortality, and revascularization. Key findings include:1 The lower the FFRCT values, the higher the risk of MI, revascularization, cardiovascular death, and all-cause death, independent of traditional cardiovascular risk factors.Patients with the lowest FFRCT values faced a four-fold increased risk of heart attack and a three-fold increased risk of cardiovascular death.Lesion-specific FFRCT (measured just beyond a specific stenosis) was the strongest predictor in the study of MI and revascularization, compared to distal vessel FFRCT (measured at the end of the artery). Heartflow FFRCT Analysis Delivers Greater-Than-Expected Cost SavingsA separate analysis of FISH&CHIPS data evaluated the cost-effectiveness of incorporating Heartflow FFRCT Analysis into the diagnostic pathway for stable CAD. The findings showed that the national program:2 Reduced downstream cardiovascular testing, including invasive coronary angiography.Increased appropriate revascularization and improved revascularization ratios.Produced £1,042 GBP ($1,394 USD) in per-patient cost savings at two years, substantially exceeding the cost savings modeled by NHS and the National Institute for Health and Care Excellence (NICE) during initial assessment and adoption. This suggests a potential £25 million GBP ($33.45 million USD) cost savings per year for the health system.Demonstrated cost savings beginning in the first year, with benefits persisting in lifetime modeling. “These data provide compelling real-world evidence underscoring the clinical value of lesion-specific Heartflow FFRCT Analysis to provide precise, localized physiological assessments,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “We now see that lesion-specific FFRCT insights can also help predict which patients are most likely to experience future events, enabling clinicians to tailor care earlier with greater precision and reduce costs.” These analyses are the latest to demonstrate the prognostic power of the Heartflow One platform, the most accurate noninvasive AI-enabled CAD assessment technology, including RoadMap™ Analysis, FFRCT Analysis and Plaque Analysis. Insights from FISH&CHIPS add to a growing body of evidence demonstrating the clinical and economic value of the Heartflow One platform providing superior patient outcomes in patients with confirmed CAD.3,4 A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025 provided strong validation of total plaque volume-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death.5 Heartflow One provides an integrated workflow that empowers physicians to improve care by enabling a faster, more optimal diagnosis to avoid unnecessary tests. About FISH&CHIPSFISH&CHIPS, the largest FFRCT study conducted to date, is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFRCT to a coronary CTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a coronary CTA+FFRCT diagnostic pathway was clinically useful and safe compared to a standard-of-care diagnostic chest pain pathway using coronary CTA alone. Two-year data were published in May 2025 in Nature Medicine, showing improved care efficiency with a reduction in unnecessary invasive and noninvasive cardiac tests using coronary CTA and Heartflow FFRCT versus coronary CTA alone. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. 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 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com ‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾1 Bell et al. AHA 2025.2 Fairbairn et al. EACVI 2025. 3 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 20244 Douglas PS, et al. The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023;8(10):904–914. doi:10.1001/jamacardio.2023.25955 Fairbairn et al. AHA 2025.
Two-Year Cardiac Study Published in JHLT Reveals Long-Term Survival Benefits with Advanced Heart Preservation
Study published in the Journal of Heart and Lung Transplantation investigating the use of the Paragonix SherpaPak marks the first time a preservation device has demonstrated significant improvements in survival following heart transplantation. WALTHAM, MA. December 9, 2025 – Paragonix Technologies, a pioneer in organ transplant technologies and services, announced […]
Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart
-Picard Medical / SynCardia Systems LLC mark historic milestone as a patient reaches 2,900 days of continuous support with the SynCardia Total Artificial Heart — the longest timeframe in the world ever recorded- TUCSON, Ariz., Dec. 09, 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 total artificial heart approved by both the U.S. FDA and Health Canada, proudly marks a new milestone in the field of mechanical circulatory support with a patient living over eight years or 2,900 days with a SynCardia™ Total Artificial Heart (STAH), the longest timeframe that a patient has ever lived on an artificial heart. “This achievement shows the life-changing impact of the SynCardia Total Artificial Heart, offering not only a bridge to transplant but also durable long-term support, to support life far beyond the typical time span for patients waiting for a donor heart,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical. “In this case, the STAH demonstrates long-term durability and reliability as well as fills a life-saving gap for patients who would otherwise have no viable options. Building on this foundation of long-term success, Picard Medical is now developing the Emperor, its next generation of fully implantable, artificial heart systems to broaden access and provide greater flexibility for long-term support worldwide.” About the Patient A 46-year-old patient, facing end-stage heart failure, received the SynCardia Total Artificial Heart on December 9, 2017 at the Institute for Cardiovascular Diseases, Dedinje hospital (also known as “IVDK Dedinje Hospital”) in Belgrade, Serbia. Today, eight years later, this patient continues to live supported by the SynCardia Total Artificial Heart, reaching more than 2,900 days of extended life, with most of those days spent at home with family and loved ones. The dedication of the medical team at IVDK Dedinje Hospital, combined with SynCardia’s technology, continues to make a profound difference in this patient’s journey. Long-term Success Concentrated in Serbia Serbia continues to lead the world in long-duration support with the SynCardia Total Artificial Heart. The five longest supported patients globally are all from IVDK Dedinje Hospital in Belgrade, with one patient supported for about eight years, another for more than four years, a third for more than three years, and two additional patients each supported for just under three years. These extraordinary cases reflect the strength of the clinical program in the region and the dedication of Serbian cardiac surgeons and transplant teams at IVDK Dedinje Hospital, who have advanced the SynCardia Total Artificial Heart at an exceptional level. 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 press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Journal of Cardiac Failure December Issue Showcases Innovations in Transplant Care, Digital Therapeutics, and Global Heart Failure Treatment Strategies
WASHINGTON, Dec. 9, 2025 /PRNewswire/ — The December issue of the Journal of Cardiac Failure (JCF), now available, offers a robust lineup of original research, expert consensus, and clinical insights that explore heart failure (HF) through a multidisciplinary, inclusive, and globally…
Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)
GOTHENBURG, Sweden, Dec. 8, 2025 /PRNewswire/ — Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration…
Solid Biosciences to Showcase Proprietary Next-Generation Capsid AAV-SLB101 and Cardiac Gene Therapy Pipeline at the 22nd Global CardioVascular Clinical Trialists (CVCT) Forum
CHARLESTOWN, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it will present data from its next-generation, proprietary capsid AAV-SLB101 and its cardiac gene therapy pipeline at the Global CardioVascular Clinical Trialists (CVCT) Forum taking place December 8-10, 2025, in Washington, D.C. Gabriel Brooks, M.D., Solid’s Chief Medical Officer, will exhibit a poster, deliver two presentations and participate in two panel discussions. Dr. Brooks has also been selected as a CVCT faculty member. Additionally, Nicolas Christoforou, Ph.D., Solid’s Head of Discovery and Translational Development, will deliver a presentation on the preclinical development of a gene therapy for catecholaminergic polymorphic ventricular tachycardia (CPVT) and participate in a panel discussion. The CVCT Forum is an annual, invite-only workshop that aims to cultivate a multi-stakeholder exchange to enhance clinical trials, streamline regulatory approval processes, and facilitate the implementation of trial-based evidence. “We will present data illustrating the potential of our precision genetic approach to cardiac diseases, with a specific focus on the benefits of our proprietary, rationally designed capsid, AAV-SLB101,” said Dr. Brooks. “We look forward to discussing our findings with the community of scientists and trialists as we come together with the goal of transforming the future of cardiovascular disease treatments.” Poster: Title: AAV-SLB101: A Next-Generation Rationally Designed Capsid Demonstrates Highly Potent Cardiac Tropism and Initial Clinical Safety Presentations: Gene-Based Cardiac Therapy Part 1The Basics Title: AAV-SLB101: A Next-Generation Rationally Designed Capsid Demonstrates Highly Potent Cardiac Tropism and Initial Clinical SafetyPresenter: Dr. Gabriel Brooks Gene-Based Cardiac Therapy Part 2The Trials and Beyond Title: Cardiac Gene Therapy – An Industry Prospective: Drive to Inflection PointPresenter: Dr. Gabriel Brooks Title: Preclinical Development of a Gene Therapy Strategy for Patients with Catecholaminergic Polymorphic Ventricular TachycardiaPresenter: Dr. Nicolas Christoforou on behalf of Silvia Priori, M.D., Ph.D., Professor of Cardiology at the University of Pavia and Director of the Molecular Cardiology Unit at the IRCCS Maugeri in Pavia, Italy Panel Discussions: The CVCT Multi-Stakeholder Think Tank DebateGene-Based Cardiac Therapy Part 1 Title: The Basics. What it Needs to Get Gene Therapy Innovations into Clinical Stage?Panelist: Dr. Gabriel Brooks The CVCT Multi-Stakeholder Think Tank DebateGene-Based Cardiac Therapy Part 2 Title: How are We Getting Around Specific Gene Therapy Clinical Trial Challenges?Panelists: Drs. Gabriel Brooks and Nicolas Christoforou Following completion of the conference, presentations will be available on the Scientific Publications & Presentations page of the Our Science section of the Company website, or by clicking here. About Solid BiosciencesSolid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the Company; the ability to successfully achieve and execute on the company’s goals, priorities and achieve key clinical milestones; the Company’s pipeline of capsid products, including SLB-101, and programs for neuromuscular and cardiac diseases, including its SGT-003 candidate and other clinical and pre-clinical programs and expectations for clinical development, initiation and enrollment in clinical trials, dosing, availability of clinical trial data and potential accelerated approval;; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s ability to advance and license AAV-SLB101 and advance SGT-003 and its other clinical and preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its capsid libraries and product candidates; compete successfully with other companies that are seeking to develop capsids, capsid libraries, Duchenne, Friedreich’s ataxia and other neuromuscular and cardiac treatments and gene therapies;, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. Solid Biosciences Investor Contact:Nicole AndersonDirector, Investor Relations and Corporate CommunicationsSolid Biosciences Inc.investors@solidbio.com Media Contact:Glenn SilverFINN Partnersglenn.silver@finnpartners.com
Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients indicated for a pacemaker NEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced three presentations at the 2025 Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv, Israel, including two presentations focused on Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and one focused on Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”). The AVIM Therapy presentations will highlight the structure and operational strength of the Company’s strategic collaboration with Medtronic, plc (NYSE: MDT, “Medtronic”), as well as the therapy’s potential clinical utility in hypertensive heart disease. The Power of Partnerships: Orchestra BioMed and Medtronic’s Collaboration to Advance AVIM Therapy to Patients, presented by David Hochman, Chairman and Chief Executive Officer of Orchestra Biomed and Robert C. Kowal, M.D., Ph.D., Vice President and General Manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit (December 9, 2025; 14:00 IST / 07:00 AM EST)AVIM Therapy for the Treatment of Hypertensive Heart Disease, presented by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation, Orchestra Biomed (December 8, 2025; 15:12 IST / 08:12 AM EST) The Virtue SAB presentation will provide insights into the novel design of this first non-coated drug delivery system for coronary artery disease treatment, as well as the Virtue IDE trial focused on coronary in-stent restenosis. Virtue SAB and the Virtue Trial: A Next-Generation, Non-Coated Sirolimus-Eluting AngioInfusion Balloon and IDE Coronary ISR Trial vs. AGENT PCB, presented Bill Little, Executive Vice President of Corporate Development and Strategy (December 8, 2025; 14:00 JST / 07:00 AM EST) 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, 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. 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 is evaluating 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. About Virtue SAB 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™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com



