Orchestra BioMed to Host R&D Day Featuring Clinical Insights and Development Plans for AVIM Therapy and Virtue® SAB

Orchestra BioMed (OBIO) will host an R&D Day on November 12, 2026, focused on AVIM Therapy and Virtue SAB.

Rhea-AI Summary

Orchestra BioMed (OBIO) will host an R&D Day on November 12, 2026, focused on AVIM Therapy and Virtue SAB. The event begins at 3:00 p.m. ET in New York City and will be webcast live.

Company leaders and cardiologists will discuss uncontrolled hypertension in patients indicated for pacemakers, restenosis in coronary stent interventions, and the therapies’ potential to address these needs. Sessions will cover the BACKBEAT and Virtue pivotal trials, the Medtronic collaboration, upcoming clinical milestones and commercial potential. A replay will be available afterward on the company’s investor website.

Key Terms

restenosis, pivotal trials

2 terms

restenosis medical

"restenosis in coronary stent interventions"

Recurrence of narrowing inside a blood vessel at or near the site of a previous procedure intended to open it (such as angioplasty or stent placement). It most often results from tissue growing back into the vessel (neointimal hyperplasia), vessel wall recoil, or progression of the underlying disease, and it reduces blood flow through the treated segment.

pivotal trials medical

"BACKBEAT and Virtue pivotal trials"

Pivotal trials are the large, definitive clinical studies designed to show whether a drug or medical device works and is safe enough for regulatory approval. Investors watch them like a final exam for a product: passing typically clears the way to sell the therapy and generate revenue, while failing can delay or block approval and sharply reduce a company's value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company leadership, leading cardiologists and trial investigators to discuss unmet patient needs, BACKBEAT and Virtue pivotal trials, and upcoming milestones; in person in New York City and via live webcast

NEW HOPE, Pa., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an R&D Day on November 12^th, 2026, at 3:00pm ET in New York City. The event will also be available via live webcast.

Orchestra BioMed leadership will be joined by key leading cardiologists to discuss the clinical and treatment burden associated with uncontrolled hypertension in pacemaker-indicated patients and restenosis in coronary stent interventions, as well as the potential for AVIM Therapy and Virtue SAB to address these unmet needs. The program will also highlight key upcoming clinical milestones and explore the commercial potential of AVIM Therapy and Virtue SAB.

R&D Day Agenda

3:00 PM | Opening Remarks
Led by David Hochman, Chairman and Chief Executive Officer

3:10 PM | AVIM Therapy, BACKBEAT Pivotal Trial & Medtronic Strategic Collaboration
Led by David Hochman & Avi Fischer, MD, Senior Vice President, Medical Affairs & Innovation
Physician Speakers:

• Vivek Reddy, MD, Executive Chairman of the BACKBEAT Trial Steering Committee, Director of Cardiac Arrhythmia Services, Mount Sinai Hospital and the Mount Sinai Health System
• Marat Fudim, MD, Associate Professor of Cardiology, Advanced Heart Failure, Duke University Medical Center

4:20 PM | Virtue SAB & Virtue Pivotal Trial
Led by Darren Sherman, President & Chief Operating Officer
Physician Speakers:

• Dean Kereiakes, MD, Virtue Trial Co-PI, Chairman of The Christ Hospital Heart and Vascular Institute, The Christ Hospital Health Network
• Allen Jeremias, MD, Virtue Trial Co-PI, Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, New York and an Executive Director for Optimizing PCI

5:15 PM | Q&A Closing Remarks
Moderated by David Hochman and Darren Sherman

Registration and Webcast Information

The R&D Day will be held in person in New York City and streamed via live webcast, and available for replay following the event.

• In-person attendance: Please register here. Space is limited, and the Company may not be able to accommodate all requests. In-person registrations are subject to written confirmation, and venue and event details will be provided upon confirmation.
• Live webcast: Please register here to access the live webcast. A replay will be available on the Investors section of Orchestra BioMed’s website following the event.

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. The BACKBEAT Global Pivotal Trial evaluating AVIM Therapy has completed enrollment.

AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by 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 and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough Device Designations.

Virtue SAB is a first-of-its-kind, non-coated drug delivery Angioinfusion balloon system designed to infuse a large liquid dose of 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 in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. The Virtue Pivotal Trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis is currently enrolling patients.

For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.

Investor Contact:
Silas Newcomb
Orchestra BioMed
snewcomb@orchestrabiomed.com

Media Contact:
Nina Premutico
Orchestra BioMed
npremutico@orchestrabiomed.com