NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has presented key clinical insights into its atrioventricular interval modulation (AVIM) therapy for high-risk hypertension during the Congenital, Structural, and Valvular Heart Disease Interventions (CSI) 2025 Meeting. The presentation, which took place on June 18, underscored the potential of AVIM therapy to transform the management of hypertensive heart disease, a condition affecting over 7.7 million patients in the U.S.
Delivered by Dr. Daniel Burkhoff, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at the Cardiovascular Research Foundation, the session focused on the therapeutic capabilities of AVIM therapy for older, high-risk patients exhibiting diastolic dysfunction and progressing to heart failure with preserved ejection fraction (HFpEF). The device-based therapy offers a novel mechanism of action designed to reduce cardiac preload, manage autonomic responses, and lower blood pressure, addressing a patient population with limited treatment options.
“Hypertensive heart disease is a complex cardiovascular syndrome that increases patients’ likelihood of major events such as stroke and heart failure,” explained Dr. Burkhoff during the presentation. “AVIM therapy presents a potential paradigm shift by directly targeting the pathophysiology of high-risk hypertension.”
The discussion also highlighted clinical evidence backing AVIM therapy’s ability to improve cardiac function and reduce blood pressure. Additionally, the presentation detailed the BACKBEAT global pivotal study, now enrolling patients with uncontrolled hypertension in need of dual-chamber pacemakers. Conducted in collaboration with Medtronic, this study aims to further expand understanding of AVIM’s efficacy and safety.
Dr. Avi Fischer, Senior Vice President of Medical Affairs at Orchestra BioMed, described the technology as a programmable, pacemaker-integrated solution with the potential to enhance outcomes in a large, underserved patient population. He emphasized that AVIM therapy aligns with electrophysiology practices, offering a tailored approach to address the unique challenges of hypertensive heart disease.
The company’s innovative approach has garnered growing interest within the medical community, especially following the U.S. FDA’s recent Breakthrough Device Designation for AVIM therapy, specifically targeted at high-risk hypertension patients.
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