NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has reported new clinical evidence suggesting its atrioventricular interval modulation (AVIM) therapy may significantly improve heart function in patients with hypertension and diastolic dysfunction (DD), two leading contributors to heart failure with preserved ejection fraction (HFpEF).
The findings, now published in JACC: Advances, stem from a retrospective, treatment-blinded analysis of MODERATO II trial participants. Researchers found AVIM therapy not only lowered blood pressure but also improved key measures of diastolic function — an advancement with potential implications for millions at risk of HFpEF.
Over six months, patients receiving AVIM saw office systolic blood pressure drop by 12.1 mmHg and ambulatory readings fall by 8.3 mmHg. Echocardiographic data also showed significant gains in myocardial relaxation and compliance, with notable increases in e′ velocity and the E/A ratio.
“There is a clear clinical link between long-standing hypertension, diastolic dysfunction, and the eventual development of HFpEF, yet few interventions are available that effectively target this pathway,” said Dr. Marat Fudim of Duke Health, the study’s lead author. He added that the therapy’s dual impact on blood pressure and ventricular compliance “points to the potential for disease modification and reverse remodeling.”
Dr. Avi Fischer, Orchestra BioMed’s Senior Vice President of Medical Affairs and Innovation, noted that the progression from uncontrolled hypertension to HFpEF is “a costly and growing healthcare burden” with limited treatment options. He said AVIM’s device-based approach could enable earlier intervention by addressing both elevated systolic pressure and impaired diastolic function.
AVIM therapy is now being tested in the BACKBEAT global pivotal study, conducted with Medtronic, to support potential U.S. regulatory approval for pacemaker-indicated patients with uncontrolled hypertension.
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