Orchestra Biomed Expands Patient Eligibility for FDA-Approved BACKBEAT Study

Orchestra’s Rollout of the FDA-approved Protocol Update

Announcement

Orchestra Biomed Holdings, Inc., a leading biomedical company elevating excellent technologies to patients via risk-rewarded sharing partnerships, declared its official rollout of a US FDA protocol update. It has prominently extended patients' eligibility criteria important for enrollment in the BACKBEAT study examining AVIM therapy in patients with pacemaker-indicated uncontrolled hypertension without opting for antihypertensive medications. The eligibility criteria consist of patients with Azure dual-chamber or Medtronic astra pacemakers with enough battery life built in for any reason. These two pacemakers, which are the first-ever device implants or already implanted for replacement of an existing pacemaker, are also a New York Heart Association (NYHA) class 1 or class 2 symptomatic heart failure.

Impact of the Protocol Update

Orchestra Biomed has revealed that the BACKBEAT study protocol update elevates the eligibility potential patient numbers at enrolled study centers by more than 24-fold in comparison to the original protocol. This will contribute to the company’s mid-2026 focused completion of enrollment. The company rolled out the updated protocol in its third quarter of 2025, reinforced with full execution predicted to be announced in the fourth quarter.

Views and Statements from the Company’s Leaders

Chairman and CEO of Orchestra Biomed, David Hochman, said, “These extensive eligibility criteria will prominently elevate the number of potential eligible patients for its participation in the BACKBEAT study at enrolled study centers. It will also align the study patient population with the main characteristics of the FDA breakthrough device designation for AVIM therapy. It demonstrates the millions of patient population of the US who require the best therapeutic alternative for managing blood pressure and reducing the risk of unfavorable events such as stroke, heart attack, and heart failure.” Further, “We trust that these updates commence the potential and relevance impact of the BACKBEAT study and help us position ourselves to complete the BACKBEAT study in a certain timeframe.”

MD Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and co-principal investigator of the Backbeat study, Andrea Russo, said, “AVIM therapy on point identifies the needs of the high-risk patients with hypertensive, older individuals who require a pacemaker. It is convenient and reliable than traditional antihypertensive therapies. The potential activation of AVIM therapy during the 10 to 12-year typical device lifecycle of a pacemaker mirrors the transitional and practical potential of this therapy for this patient population.”