Rendering of the BackBeat therapy from an Orchestra BioMed YouTube demonstration.

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial.

BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker.

New Hope, Pennsylvania-based Orchestra BioMed has the backing of medtech giant Medtronic in this effort. The companies announced a strategic collaboration to develop and commercialize AVIM therapy for pacemaker patients in July 2022. Under the collaboration, Medtronic offers development, clinical and regulatory support for the BACKBEAT trial.

Medtronic also contributed to a $110 million Series D at Orchestra BioMed, which soon went public through a SPAC merger.

If approved, Medtronic holds exclusive global rights to commercialize AVIM-enabled pacing systems for the target population. Orchestra BioMed would share in the revenues generated from Medtronic sales of the 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, chair, CEO 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.”

More about the Orchestra BioMed BACKBEAT study

The global, multi-center, prospective, randomized, double-blind study investigates the efficacy and safety of AVIM therapy. It evaluates patients who recently underwent a Medtronic dual-chamber cardiac pacemaker implant. These subjects have uncontrolled hypertension despite the use of antihypertensive medications.

Orchestra BioMed said the study intends to 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 has a primary efficacy endpoint of the between-group difference in change of mean 24-hour ambulatory systolic blood pressure (aSBP) at three months post-randomization. Primary safety is freedom from unanticipated serious adverse device events in the treatment arm at three months post-randomization. The double-blind follow-up continues through 12 months to enable the collection of additional clinical endpoints.

Orchestra BioMed plans to begin enrollment in the BACKBEAT study before the end of 2023.

The company said results from its MODERATO II study of pacemaker patients supported the BACKBEAT IDE win. Patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP. It also demonstrated a 12.3 mmHg reduction in office systolic blood pressure (oSBP) at six months compared to control.

Dr. David Kandzari, chief of the Piedmont Heart Institute in Atlanta, serves as co-principal investigator for BACKBEAT. He stressed that hypertension, “the world’s leading modifiable risk for death,” affects over 1 billion people worldwide.

“While existing pharmaceutical treatments can be effective, more than half of individuals with hypertension do not meet blood pressure treatment goals,” Kandzari said. “A device-based treatment like AVIM therapy has the potential to complement existing standards of care and reduce blood pressure to improve clinical outcome.”