Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy
Key Highlights
- ➤BACKBEAT trial randomized 330 patients, exceeding its 316-patient enrollment target
- ➤Primary endpoint data targeted for late-breaking presentation consideration in Q2 2027
- ➤Medtronic plans FDA and global marketing applications if trial results are positive
- ➤Trial designed to detect at least 5 mmHg between-group aSBP difference
Expert Statements
David Hochman, Chairman & Chief Executive Officer of Orchestra BioMed
“Achieving and surpassing full enrollment of the BACKBEAT Trial is a defining milestone for Orchestra BioMed, for our collaboration with Medtronic and potentially for the millions of high cardiovascular risk patients who remain above blood pressure target despite the medications available to them today.”
David Hochman, Chairman & Chief Executive Officer of Orchestra BioMed
“Our focus now turns to completing three-month follow-up, database lock, and the delivery of a rigorous, well-powered data set next spring.”
Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Electrophysiology Therapies operating unit
“Reaching full enrollment in the BACKBEAT Trial brings us a big step closer to understanding whether AVIM Therapy can extend the role of cardiac pacing therapy to include hypertension management for patients at increased cardiovascular risk.”
Vivek Reddy, M.D., Executive Chairman of the BACKBEAT Clinical Steering Committee, Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital and Director of Electrophysiology for the Mount Sinai Health System
“Randomized, double-blind evidence is the highest standard by which a new therapeutic modality earns its place in clinical practice, and that is exactly what the BACKBEAT Trial was designed to generate.”
* 330 patients randomized as of September 30, 2026, surpassing full trial enrollment target * Company reiterates prior guidance: primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027 * Data expected to support future marketing application submissions by Medtronic to the FDA and other global regulatory agencies NEW HOPE, Pa., Oct. 01, 2026 (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 medical device companies, today announced that it has surpassed full enrollment in the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”), exceeding its previously announced target of 316 randomized patients. The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication. Hypertension is the most common modifiable risk factor for death worldwide and the most common comorbidity among the pacemaker population.(1)
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