NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced a major expansion to the patient eligibility criteria for its ongoing BACKBEAT study, aimed at evaluating the effectiveness of its AVIM™ therapy in managing uncontrolled hypertension among pacemaker recipients. The protocol update, approved by the U.S. Food and Drug Administration (FDA), is expected to significantly accelerate enrollment and enhance the trial’s real-world relevance.
The updated guidelines now allow screening of a broader patient base—including anyone with or scheduled to receive a Medtronic Astra™ or Azure™ dual-chamber pacemaker, whether newly implanted or as a replacement. Eligibility has also been extended to patients with New York Heart Association (NYHA) Class I or II symptomatic heart failure.
With these revisions, Orchestra BioMed estimates that the pool of eligible participants across study centers will grow more than 24-fold compared to the original protocol. The company began implementing the expanded criteria during Q3 2025, with full rollout anticipated by the fourth quarter. The timeline for enrollment completion remains targeted for mid-2026.
“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. He added that the revisions align more closely with the population identified under the FDA’s Breakthrough Device Designation for AVIM therapy—an estimated millions of U.S. patients facing elevated systolic blood pressure and heightened cardiovascular risk.
AVIM therapy, a pacemaker-based intervention, is designed to meet the needs of older patients with persistent hypertension—a demographic often already requiring pacemaker implantation. Unlike conventional pharmacologic therapies, AVIM leverages device-based intervention over the typical 10 to 12-year life span of a pacemaker, offering a novel pathway for blood pressure control.
Dr. Andrea Russo, Co-Principal Investigator of the BACKBEAT study and Academic Chief of Cardiology at Cooper University Hospital, underscored the clinical significance of the update. “With expanded patient eligibility criteria, the BACKBEAT study population will now better encompass a real-world population of older, pacemaker-indicated patients with uncontrolled hypertension and increased cardiovascular risk,” she said.
The BACKBEAT study remains a pivotal component of Orchestra BioMed’s strategic efforts to demonstrate AVIM therapy’s safety, efficacy, and practical utility in managing one of the most widespread and treatment-resistant health challenges among older adults.
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