Orchestra BioMed Holdings announced that the FDA has approved a significant protocol update for its BACKBEAT global pivotal study, dramatically expanding patient eligibility criteria and increasing the potentially eligible patient pool by more than 24-fold. The update supports the company's mid-2026 target for completing enrollment in the study evaluating AVIM therapy for uncontrolled hypertension in pacemaker-indicated patients.
Expanded Patient Eligibility Criteria
The FDA-approved protocol update broadens eligibility to include patients with Medtronic Astra or Azure dual-chamber pacemakers with sufficient battery life implanted for any reason, encompassing both first device implants and replacement devices. Additionally, the updated criteria now include patients with New York Heart Association class I or class II symptomatic heart failure.
"These expanded eligibility criteria significantly increase the pool of potentially eligible patients available for enrollment in the BACKBEAT study at participating study centers," said David Hochman, Chairman and CEO of Orchestra BioMed. "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."
Clinical Evidence and Study Design
AVIM therapy has demonstrated promising results in pilot studies. The MODERATO II double-blind, randomized pilot study showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients. Clinical results also demonstrate improvements in cardiac function and hemodynamics beyond blood pressure reduction.
The BACKBEAT study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker.
Implementation Timeline and Strategic Positioning
Orchestra BioMed initiated rollout of the updated protocol in the third quarter of 2025, with full implementation expected in the fourth quarter. The company estimates that millions of U.S. patients could benefit from better therapeutic options to manage elevated systolic blood pressure and reduce the corresponding higher risk of heart attack, stroke, heart failure and other cardiovascular events.
"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," commented Andrea Russo, M.D., Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services at Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT study. "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."
Breakthrough Device Designation and Partnership Strategy
AVIM therapy has received Breakthrough Device Designation from the FDA for using cardiac physiologic pacing to treat uncontrolled hypertension in patients who have preserved left ventricular systolic function and are at increased cardiovascular risk. Orchestra BioMed has established a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy, leveraging the partnership-enabled business model that focuses on risk-reward sharing with leading medical device companies.
