Orchestra BioMed presents data showing sustained blood pressure drops

Orchestra BioMed Holdings, Inc. (NASDAQ: OBIO) presented clinical data at the HRX Live 2025 Meeting demonstrating that its AVIM therapy maintained blood pressure reductions for years after activation and could be reactivated after treatment cessation.

The company announced results from long-term follow-up of patients treated with atrioventricular interval modulation therapy. A group of 16 patients who participated in the MODERATO II trial showed sustained 24-hour ambulatory systolic blood pressure reductions of 8.9 mmHg over an average follow-up period of 3.6 years.

When AVIM therapy was deactivated for seven days, patients' blood pressure returned to baseline levels of 133.1 mmHg, consistent with their original hypertension baseline of 132.2 mmHg. No rebound hypertension was observed during the washout period.

Upon reactivation after the seven-day washout, blood pressure was immediately reduced to 124.4 mmHg. The company reported no statistically significant difference in therapeutic effects between 6-month treatment, chronic 3.6-year follow-up, and post-reactivation measurements.

The findings were published simultaneously in Heart Rhythm O₂ during Dr. Avi Fischer's presentation at the conference innovation summit.

Orchestra BioMed maintains a strategic collaboration with Medtronic (NYSE: MDT) to develop and commercialize AVIM therapy for treating uncontrolled hypertension in patients requiring pacemakers. The therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk.

The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM therapy in patients with systolic blood pressure above target despite anti-hypertensive medication who are indicated for dual-chamber cardiac pacemakers.

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