NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) said it expects to complete enrollment in its pivotal BACKBEAT clinical trial by the end of the third quarter of 2026, positioning the company and partner Medtronic to present primary data in 2027 as they pursue FDA approval for a pacemaker-based hypertension therapy.
The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy, or AVIM Therapy, in patients with uncontrolled hypertension who already require pacemakers.
The companies reported that they plan to submit primary endpoint data for presentation at a major cardiovascular conference in the second quarter of 2027. Assuming the study meets its primary safety and efficacy endpoints, Medtronic plans to pursue FDA and international regulatory approvals afterward.
The updated timeline follows FDA approval earlier this month of an amendment reducing the trial’s sample size to 284 evaluable randomized patients, with a total enrollment target of 316 participants accounting for potential follow-up losses.
Orchestra BioMed said the revised trial design maintains more than 90% statistical power for both primary endpoints, including measuring changes in 24-hour ambulatory systolic blood pressure after three months.
The study is designed to detect at least a 5 mmHg difference in systolic blood pressure between treatment groups.
The protocol amendment was approved May 8 under the FDA’s Breakthrough Devices program, which is intended to accelerate development and review of technologies addressing serious medical conditions.
Chief Executive Officer David Hochman said the revised enrollment targets reflected alignment between the company, Medtronic, and federal regulators while maintaining the trial’s statistical rigor.
“We believe BACKBEAT has the potential to be a landmark pivotal trial that can open up an entirely new therapeutic modality for patients at increased risk from high blood pressure and hypertensive heart disease,” Hochman said.
Robert Kowal, vice president and general manager for cardiac pacing therapies at Medtronic’s cardiac rhythm management unit, stated that the companies are evaluating whether pacing technology can be extended beyond rhythm disorders into hypertension treatment for high-risk patients.
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