Orchestra BioMed Holdings, Inc. announced on October 1, 2026, that it has surpassed the full enrollment target for its BACKBEAT Global Pivotal Trial. As of September 30, 2026, the company reported that 330 patients had been randomized, exceeding the previously announced target of 316 patients.
The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy (AVIM Therapy) in pacemaker-indicated patients with uncontrolled hypertension who are on medication. The study is a global, multi-center, prospective, randomized, and double-blind trial. Patients are randomized 1:1 to receive AVIM Therapy combined with continued medical therapy and pacing or continued medical therapy and standard pacing alone.
As of the reporting date, the trial had enrolled patients at 81 sites across 13 countries. The protocol, approved by the U.S. Food and Drug Administration (FDA), specifies 284 evaluable randomized subjects for the primary endpoint analysis. The total enrollment target of 316 patients was set to account for potential loss to follow-up.
The primary efficacy endpoint of the trial is the between-group difference in the change in 24-hour ambulatory systolic blood pressure at three-month follow-up. The primary safety endpoint is freedom from unanticipated serious adverse device events in the AVIM Therapy arm at three-month follow-up. The protocol is designed to detect a between-group difference of at least 5 mmHg in systolic blood pressure with greater than 90% statistical power.
Orchestra BioMed and its strategic collaborator, Medtronic plc, intend to submit the primary endpoint results for consideration as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Assuming positive results, Medtronic plans to submit marketing applications to the FDA and other global regulatory agencies.
