Orchestra BioMed Holdings Inc. (OBIO) announced it is targeting completion of enrollment for its BACKBEAT Global Pivotal Trial by the end of the third quarter of 2026, with primary endpoint data presentation planned for the second quarter of 2027.
The company and its strategic collaborator Medtronic plc (MDT) plan to submit primary endpoint results for consideration as a late-breaker at a major cardiology conference in Q2 2027. The BACKBEAT trial is evaluating Atrioventricular Interval Modulation Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medications.
The Food and Drug Administration approved a reduction in the trial’s sample size to 284 evaluable randomized subjects, with total enrollment targeting 316 patients to account for potential loss to follow up. The primary efficacy and safety endpoints remain powered at greater than 90% statistical power at the revised sample size.
The trial is designed to detect a between-group difference of at least 5 mmHg in 24-hour ambulatory systolic blood pressure. The sample size change reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, following FDA approval of a protocol amendment received on May 8, 2026.
Medtronic plans to submit an AVIM Therapy-related marketing application for FDA approval after primary endpoint data analyses and reports are complete, assuming primary safety and efficacy endpoints are met. The company would subsequently pursue global regulatory approvals.
"We are delighted to provide clarity on the anticipated overall timeline for the BACKBEAT Trial," said David Hochman, chairman and chief executive officer of Orchestra BioMed.
AVIM Therapy has received FDA Breakthrough Device Designations for treatment of uncontrolled hypertension in patients with increased cardiovascular risk.