Orchestra BioMed announces initiation of BACKBEAT study of AVIM therapy

Orchestra BioMed Holdings (OBIO) announced the first patient was randomized in the BACKBEAT pivotal study in late December 2023. The BACKBEAT pivotal study will evaluate the efficacy and safety of atrioventricular interval modulation therapy, for the treatment of pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure. Orchestra BioMed and Medtronic (MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. “We are thrilled to announce the initiation of the BACKBEAT pivotal study. This is an essential milestone as we evaluate how this therapy may benefit pacemaker patients who confront the mortality and morbidity risks of elevated blood pressure,” commented David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. “We have activated multiple clinical sites and are screening patients in the U.S. and Europe. We are grateful to the clinical sites, our team and Medtronic for their dedication to finalizing all the study initiation deliverables. Most importantly, we are thankful to the patients who will participate in this landmark study.”