Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy
Orchestra BioMed announced it has surpassed full enrollment in the BACKBEAT Global Pivotal Trial of AVIM Therapy, with 330 patients randomized as of September 30, 2026, exceeding the prior target of 316. The company reiterated that primary endpoint data will be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027, and the data is expected to support marketing application submissions by Medtronic to the FDA and other regulatory agencies.
Why it matters — Surpassing the enrollment target is a key trial milestone that moves the AVIM therapy forward toward potential regulatory submissions by Medtronic and a major cardiovascular conference presentation in Q2 2027.