Orchestra BioMed Holdings, Inc. (NASDAQ: OBIO) watched its shares soar Tuesday, as the company, a biomedical concern accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration granted approval of an investigational device exemption (“IDE”) to initiate the global pivotal BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) study evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.
Said Orchestra CEO David Hochman, “We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker. Achieving this milestone a little over a year after starting our strategic collaboration with Medtronic is a significant accomplishment for our company.”
Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring.
OBIO shares hiked $1.10, or 13%, Tuesday to $9.54, while those for MDT fell 14 cents to $82.60.