Orchestra BioMed surpasses enrollment target in BACKBEAT pivotal trial of AVIM hypertension therapy
OBIO•Orchestra BioMed said 330 patients had been randomized in its BACKBEAT pivotal trial as of Sept. 30, 2026, exceeding the planned enrollment level. Primary endpoint results are slated for consideration at a cardiovascular conference in Q2 2027.
1. Trial enrollment completed
Orchestra BioMed surpassed full enrollment in the BACKBEAT pivotal trial of its AVIM Therapy for uncontrolled hypertension in pacemaker patients. A total of 330 patients had been randomized as of Sept. 30, 2026, exceeding the planned enrollment level intended to support the primary analysis; results have not yet been presented.
2. Results and next steps
The company said the data are slated for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027. Positive results could support Medtronic marketing application submissions to the FDA and other regulators.
