NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced new data published in JACC: Clinical Electrophysiology demonstrating the potential of its atrioventricular interval modulation (AVIM) therapy to reduce blood pressure and improve heart function in patients with uncontrolled hypertension who also require a pacemaker.
Data Validates Favorable Hemodynamic Impact
The findings come from acute and chronic pressure-volume loop studies, considered the gold standard in assessing cardiac performance. Results showed statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance, and stroke work, without negatively affecting stroke volume or heart contractility.
In a 16-patient invasive study and a 32-patient noninvasive subgroup from the MODERATO II trial, 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 a modest 1.7 mmHg reduction with standard pacing. Long-term therapy showed sustained decreases in blood pressure and ventricular volumes, indicating favorable remodeling of the heart muscle.
Clinical Community Recognition
“Pressure-volume loop analysis is regarded as the gold standard for assessing systolic and diastolic function as well as reverse remodeling,” said Dr. Daniel Burkhoff, director of heart failure and hemodynamics research at the Cardiovascular Research Foundation. “These results provide powerful insights on the impact of AVIM therapy to both decrease blood pressure and favorably impact ventricular end-diastolic volume without compromising cardiac output or increasing workload.”
Yuval Mika, executive vice president of bioelectronic therapies at Orchestra BioMed, added that the findings underscore AVIM’s potential to “reshape the standard of care for higher-risk patients with uncontrolled hypertension in the pacemaker population and beyond.”
Strategic Collaboration with Medtronic
AVIM therapy has FDA Breakthrough Device Designation and is being evaluated in the global pivotal BACKBEAT study, conducted in collaboration with Medtronic (NYSE: MDT). More than 750,000 patients worldwide receive pacemakers each year, and a significant portion also suffer from hypertension. Orchestra BioMed estimates over 7.7 million U.S. patients could ultimately benefit from the therapy.
The peer-reviewed publication strengthens the evidence base for AVIM therapy as Orchestra BioMed and Medtronic advance toward regulatory approvals and future commercialization.
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