Orchestra BioMed (Nasdaq:OBIO) announced today that it randomized the first patient in a clinical trial of its AVIM therapy.
The company’s BackBeat CNT atrioventricular interval modulation (AVIM) therapy treats pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. New Hope, Pennsylvania-based Orchestra Biomed’s BACKBEAT pivotal study evaluates the efficacy and safety of AVIM therapy.
A patented bioelectronic therapy, AVIM is administered using a standard dual-chamber pacemaker. Orchestra BioMed designed it to immediately, substantially and persistently reduce blood pressure.
The company formed a strategic collaboration around its AVIM therapy with Medtronic in July 2022. If approved, Medtronic has exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Under the agreement, Orchestra BioMed shares in the revenues generated by these technologies.
“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 Dr. Robert C. Kowal, VP and GM of Cardiac Pacing Therapies at Medtronic. “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.”
More about the Orchestra BioMed BACKBEAT trial
BACKBEAT evaluates AVIM in patients who recently underwent implantation of a Medtronic dual-chamber cardiac pacemaker.
Orchestra BioMed expects to continue site activations throughout 2024. It targets a total of approximately 80 centers in the U.S. and Europe for the trial. The company plans to randomize approximately 500 patients 1:1 to AVIM or continued medical therapy and standard pacing alone.
The trial has a primary efficacy endpoint of a statistically significant reduction in daily average blood pressure. The primary safety endpoint will determine at three months post-randomization whether AVIM-treated patients experience serious adverse device effects that are not anticipated with cardiac pacing. Orchestra BioMed plans double-blind follow-up through 12 months.
Orchestra BioMed is conducting the trial under FDA investigational device exemption (IDE).
“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, chair, CEO 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.”
