Orchestra BioMed’s Breakthrough: FDA Approves Pivotal Study of BackBeat CNT for Hypertension in Pacemaker Patients

Orchestra BioMed

NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) recently announced the U.S. Food and Drug Administration (“FDA”) 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.

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. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.

“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,” said David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “We believe this innovative therapy has the potential to substantially improve the standard of care for hypertensive pacemaker patients and we look forward to initiating the study before the end of 2023.”

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David Kandzari, M.D., Chief of the Piedmont Heart Institute and Chief Scientific Officer for Piedmont Healthcare, Atlanta, GA and Co-Principal Investigator for the BACKBEAT Study, commented: “Hypertension is the world’s leading modifiable risk for death and affects over one billion people worldwide. While existing pharmaceutical treatments can be effective, more than half of individuals with hypertension do not meet blood pressure treatment goals. A device-based treatment like AVIM therapy has the potential to complement existing standards of care and reduce blood pressure to improve clinical outcome.”

The BACKBEAT pivotal study is a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy in patients who recently underwent a Medtronic dual-chamber cardiac pacemaker implant and have uncontrolled hypertension (“HTN”) despite the use of antihypertensive medications. The study will randomize approximately 500 patients 1:1 to AVIM along with continued medical therapy and pacing (treatment) or continued medical therapy and pacing alone (control). The study’s primary efficacy endpoint is the between group difference in the change of mean 24-hour ambulatory systolic blood pressure (“aSBP”) at three months post randomization. The primary safety endpoint is freedom from unanticipated serious adverse device effects in the treatment arm at three months post-randomization. Double-blind follow up will continue through 12 months to enable collection of additional clinical endpoints. The Company plans to begin enrollment in the BACKBEAT study before the end of 2023, upon completion of standard clinical trial initiation activities, including clinical center Institutional Review Board approvals.

“Hypertension is the most common comorbidity in the pacemaker population, affecting more than 70% of patients. Patients who have pacemakers are generally older and at higher risk for major cardiovascular events. AVIM therapy represents a potentially transformative hypertension treatment for these patients since it can be administered using the same pacemaker they already need and managed by the same physicians already caring for them,” commented Andrea Russo, M.D., Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT Study, “We are excited to participate in the BACKBEAT study, which has been thoughtfully designed to evaluate the safety and efficacy of this novel therapy.”

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The BACKBEAT study IDE was supported by encouraging results from MODERATO II, a prospective, multi-center, randomized, double-blind, pilot study of pacemaker patients with persistent HTN. MODERATO II showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients.

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