Orchestra BioMed Holdings Inc.

Orchestra BioMed Holdings has surpassed full enrollment in the BACKBEAT Global Pivotal Trial of AVIM Therapy, with 330 patients randomized as of September 30, 2026, exceeding the previously announced target of 316. The trial is evaluating Atrioventricular Interval Modulation Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medication, and is being conducted with Medtronic, the company's strategic collaborator for the trial and, subject to regulatory approval, for commercialization of AVIM Therapy. Enrollment reached 330 patients at 81 sites across 13 countries, while the FDA-approved protocol specifies 284 evaluable randomized subjects for the primary endpoint analysis, with the 316-patient target accounting for potential loss to follow-up. Orchestra BioMed reiterated prior guidance that primary endpoint data will be submitted for late-breaking presentation consideration at a major cardiovascular conference in the second quarter of 2027, and assuming positive results, Medtronic plans to submit AVIM Therapy marketing applications to the FDA and other global regulatory agencies promptly. The trial's primary efficacy endpoint is the between-group difference in the change in 24-hour ambulatory systolic blood pressure at three-month follow-up from pre-randomization baseline, and the protocol-specified sample size provides greater than 90% statistical power to detect a between-group difference of at least 5 mmHg.

Orchestra BioMed announced that its BACKBEAT global pivotal trial, conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by the end of the third quarter of 2026, with primary data presentation targeted for the second quarter of 2027. The company reported a cash balance of $110 million as of June 30, 2026, providing projected runway into the fourth quarter of 2027, following $35 million in strategic capital from Medtronic and Ligand during the quarter. AVIM Therapy received a second FDA Breakthrough Device Designation, now covering both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial. The Virtue pivotal trial for coronary in-stent restenosis is advancing with further site activations and patient enrollments. Orchestra BioMed will host an R&D Day on November 12, 2026, in New York City to review both programs.