Orchestra BioMed (NASDAQ: OBIO) has announced the roll out of an FDA-approved protocol update that enables a significant expansion in patient eligibility criteria for enrollment of its BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.
According to Orchestra, the protocol update increases the eligible potential patient pool by more than 24-fold as compared to the original protocol and supports the company’s mid-2026 target for completion of enrollment.
David Hochman, chairman and CEO of Orchestra, commented, “These expanded eligibility criteria significantly increase the pool of potentially eligible patients available for enrollment in the BACKBEAT study at participating study centers. They also better align the study patient population with the key characteristics of the FDA Breakthrough Device Designation for AVIM therapy, which we estimate represents a patient population of millions of U.S. patients who need better therapeutic options to manage elevated systolic blood pressure and the corresponding higher risk of heart attack, stroke, heart failure and other morbid and mortal events. We believe these updates reinforce the relevance and potential impact of the BACKBEAT study as well as better position us to complete the BACKBEAT study in a timely manner.”
Andrea Russo, MD, Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT study, remarked, “Unlike traditional antihypertensive therapies, AVIM therapy has been designed specifically to address the needs of the older, higher risk hypertensive patients who often also need a pacemaker. The ability to activate AVIM therapy during the 10 to 12-year typical device lifecycle of a pacemaker reflects the practical and transformative potential of this therapy for this group of patients. With expanded patient eligibility criteria, the BACKBEAT study population will now better encompass a real-world population of older, pacemaker-indicated patients with uncontrolled hypertension and increased cardiovascular risk.”
