Author: Ken Dropiewski

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

TriSalus Life Sciences to Host Virtual KOL Event to Discuss the TriNav Infusion System for the Treatment of Symptomatic Thyroid Disease on December 15, 2025

WESTMINSTER, Colo.–(BUSINESS WIRE)–TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (“TriSalus” or the “Company”), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, announced today that it will host a virtual key opinion leader (KOL) event on Monday, December 15, 2025 […]

Study Leverages Vivalink’s Biometrics Data Platform to Uncover Connection Between Seizures and Cardiac Function

Ochsner Health study explores how continuous cardiac monitoring can help assess seizure-related health risks and guide treatment decisions for patients with epilepsy    Campbell, Calif. – Dec. 4, 2025 – Vivalink, a leading provider of digital healthcare solutions, is supporting a hospital-based study at Ochsner Health in New Orleans, LA, […]

Atraverse Medical Secures FDA 510(k) Clearance for HOTWIRE™ RF Generator & Fully Integrated Transseptal Access System

Atraverse Medical also approaches first 2,000 successful clinical procedures using the company’s innovative HOTWIRE™ radiofrequency (RF) guidewire.    [San Diego, CA – December 3, 2025] — Atraverse Medical, a medical device company pioneering next-generation left-heart access technology, has received 510(k) clearance from the U.S. FDA for its fully integrated HOTWIRE™ Transseptal […]

Edwards Lifesciences Reaffirms Strategy for Sustainable, Differentiated Growth at Annual Investor Conference

Innovation with Purpose, Powered by Science, Centered on Patients: Edwards’ Commitment to Drive Value for the Healthcare Ecosystem IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) will outline its patient-focused strategy and share financial guidance during its annual investor conference. Entering 2026 with momentum for sustainable differentiated growth, Edwards is uniquely positioned with […]

VALVOSOFT®, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking

LEVALLOIS-PERRET, France–(BUSINESS WIRE)–Cardiawave, a pioneering medtech company developing non-invasive ultrasound therapy (NIUT) for aortic stenosis, has received CE Certificate for Valvosoft®, the world’s first non-invasive therapeutic alternative to treat Severe Symptomatic Aortic Stenosis (sSAS), a serious, degenerative and fast-growing disease due to population aging, which remains without a solution for […]

Delcath Systems Announces Publication of 10-Year Single-Center Experience with Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma

QUEENSBURY, N.Y.–(BUSINESS WIRE)–Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of a retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany. The study, titled “Survival […]

Lexeo Therapeutics to Host Virtual Key Opinion Leader Event at the 22nd Global Cardiovascular Clinical Trialists (CVCT) Forum

NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced plans to host a virtual event, “A Clinician’s Perspective: Holistic Approach to Managing PKP2-Associated Arrhythmogenic Cardiomyopathy,” at the 22nd Global Cardiovascular Clinical Trialists (CVCT) Forum on Tuesday, December 9th at 3 PM ET. The session will feature a discussion with Dr. Victoria Parikh, M.D., who is Associate Professor of Cardiovascular Medicine at Stanford University and Director of the Stanford Center for Inherited Cardiovascular Disease, and an expert clinician scientist who cares for people living with PKP2-associated arrhythmogenic cardiomyopathy (PKP2-ACM). Analysts and investors can join the live event by registering on the News & Events page on Lexeo’s website. A replay will be archived on the investor section of Lexeo’s website following the event. About Lexeo TherapeuticsLexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated. The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including LX2006 in Friedreich ataxia (FA), LX2020 in plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. Media Response:Media@lexeotx.com Investor Response:Carlo Tanzi, Ph.D.ctanzi@kendallir.com

Elucid Gains Broad CMS Reimbursement of Coronary Plaque Analysis Using PlaqueIQ™

New CPT I Code, OPPS and MPFS Decisions Recognize Significant Clinical Value Across Care Settings BOSTON–(BUSINESS WIRE)–Elucid has announced new Hospital Outpatient Prospective Payment (OPPS) and Physician Fee Schedule (PFS) decisions from the U.S. Centers for Medicare & Medicaid Services (CMS) that establish significant reimbursement for coronary plaque analysis using PlaqueIQ […]