NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has exceeded its enrollment target in a pivotal hypertension trial conducted with Medtronic, moving the companies toward primary endpoint data expected next spring that could support regulatory filings for a pacemaker-based therapy.
The BACKBEAT Global Pivotal Trial had randomized 330 patients as of Sept. 30, surpassing its 316-patient enrollment target. The study is evaluating Atrioventricular Interval Modulation Therapy, or AVIM Therapy, in patients who require pacemakers and continue to have uncontrolled hypertension despite medication.
The trial is being conducted at 81 sites across 13 countries. Its FDA-approved protocol calls for 284 evaluable randomized patients for the primary endpoint analysis, while the higher enrollment target was intended to account for potential loss to follow-up.
Patients are randomized 1:1 to receive AVIM Therapy alongside continued medical treatment and pacing, or continued medical treatment with standard pacing alone.
The primary efficacy endpoint measures the difference between the groups in the change in 24-hour ambulatory systolic blood pressure three months after randomization. The study is designed to detect a difference of at least 5 mmHg and provides greater than 90% statistical power for both primary endpoints.
The primary safety endpoint measures freedom from unanticipated serious adverse device events in the AVIM Therapy group at three months.
With enrollment complete, Orchestra BioMed is shifting its focus to three-month follow-up, database lock and preparation of the primary endpoint data.
“Our focus now turns to completing three-month follow-up, database lock, and the delivery of a rigorous, well-powered data set next spring,” Chief Executive Officer David Hochman said.
Orchestra BioMed and Medtronic plan 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.
The trial could also determine whether Medtronic advances AVIM Therapy toward regulatory review. Under the companies’ collaboration, Medtronic plans to submit marketing applications to the U.S. Food and Drug Administration and other global regulators if the pivotal study produces positive results.
“For decades, cardiac pacing has been foundational in the management of rhythm disorders,” Robert C. Kowal, vice president and general manager for cardiac pacing therapies in Medtronic’s Electrophysiology Therapies operating unit, said. “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.”
The randomized, double-blind trial is intended to test whether modifying atrioventricular timing through a pacemaker can lower blood pressure in a population already receiving cardiac pacing and antihypertensive medication.
Vivek Reddy, executive chairman of the trial’s clinical steering committee and director of cardiac arrhythmia services at Mount Sinai Fuster Heart Hospital, characterized the pivotal study as the test needed to determine whether earlier findings translate into a clinically meaningful treatment effect.
“The pilot data for AVIM Therapy have been exciting, consistent and mechanistically coherent, but the field needs a pivotal trial to answer the question definitively,” Reddy said.
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