Orchestra BioMed publishes clinical data on blood pressure therapy

Orchestra BioMed Holdings Inc. (NASDAQ: OBIO) announced the publication of clinical data in the Journal of the American College of Cardiology: Clinical Electrophysiology showing favorable blood pressure and hemodynamic effects of its AVIM therapy.

The study analyzed pressure-volume loop data from 16 hypertensive pacemaker-indicated subjects and 32 subjects from the MODERATO II study receiving chronic AVIM therapy. Results showed AVIM therapy reduced systolic blood pressure by an average of 17.1 mmHg with right ventricular pacing and 19.2 mmHg with conduction system pacing, compared to 1.7 mmHg with standard dual-chamber pacing.

The therapy demonstrated statistically significant improvements in left ventricular hemodynamics. End-diastolic volume decreased by 12.6 mL and 18.6 mL respectively, while end-systolic volume decreased by 11.0 mL and 14.1 mL, compared to increases with standard pacing. Cardiac stroke work decreased by 1,596 mL and 1,870 mL respectively, with minimal impact on stroke volume.

AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study conducted in collaboration with Medtronic Inc. (NYSE: MDT). The companies estimate over 750,000 patients annually receive pacemakers worldwide and also have hypertension.

The therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk. Orchestra BioMed estimates this population comprises over 7.7 million patients in the United States.

The study was published in the peer-reviewed journal and included analysis of both acute and chronic effects of the therapy on cardiovascular function in pacemaker patients with uncontrolled hypertension.

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