Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients

• Orchestra BioMed and Medtronic, Inc., have an exclusive strategic collaboration for development and commercialization of AVIM therapy for hypertensive pacemaker population, which is estimated to be more than 750,000 patients annually worldwide
  

NEW HOPE, Pa., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today 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 (“AVIM”) therapy (also known as BackBeat CNT), 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, Inc. (NYSE: MDT) (“Medtronic”) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population, and Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.

“Our collaboration with Orchestra BioMed will explore how cardiac pacing can go beyond management of bradycardia and conduction disease to treat hypertension as well,” said Robert C. Kowal, M.D., Ph.D., vice president and general manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit. “Our goal is to deliver the best possible outcomes for patients; this study will help us understand the potential role of AVIM therapy in treating hypertension, a major source of cardiovascular illness and a comorbidity in more than 70% of patients receiving pacing therapy.”

Suman Pasupuleti, M.D., from Citrus Cardiology Consultants, the first site to randomize a patient in the BACKBEAT pivotal study, commented: “Blood pressure management with currently available treatments is especially challenging in many elderly patients who also are prone to side effects from medications. This leaves a gap in the care of these patients and increases their risk for heart attack, stroke and heart failure progression. We are excited to be among the first to enroll patients in the BACKBEAT study, which will evaluate the efficacy and safety of this therapy in patients with high blood pressure who also need pacemakers.”