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 global medical device companies, today announced an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy ("AVIM Therapy") in pacemaker-indicated patients with uncontrolled hypertension despite medications. The Company is targeting completion of enrollment by the end of the third quarter of 2026. Further, the Company and Medtronic, its strategic collaborator for the BACKBEAT Trial and the commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, plan to submit the primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Lastly, assuming primary safety and efficacy endpoints are met, Medtronic plans to submit a marketing application for FDA approval after primary endpoint data analyses and reports are complete, and subsequently to pursue global regulatory approvals.

The updated BACKBEAT Trial timeline is supported by FDA approval of a reduction in the sample size for the clinical trial to a target total of 284 evaluable randomized subjects with the total enrollment target of 316 patients accounting for potential loss to follow up. The primary efficacy endpoint (between-group difference in 24-hour ambulatory systolic blood pressure "aSBP" at 3-month follow up) and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at 3-month follow up) remain robustly powered (>90% statistical power) at the revised sample size for the trial.  The sample size is designed to detect a between group difference of at least 5 mmHg in aSBP. The change in sample size reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, and follows FDA approval of an amendment to the BACKBEAT Trial protocol received on May 8, 2026 by Orchestra BioMed.