NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced that new data supporting the potential of Atrioventricular Interval Modulation (AVIM) Therapy in managing hypertensive heart disease, which was featured in a keynote address at the Georgia Innovation Summit in Tbilisi, Georgia, on October 10, 2025.
The presentation, led by Avi Fischer, MD, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed, outlined how AVIM Therapy—a device-based approach—may address the progression of hypertensive heart disease and improve long-term cardiovascular outcomes.
Orchestra BioMed and Medtronic plc (NYSE: MDT) are jointly developing and commercializing AVIM Therapy for uncontrolled hypertension in patients indicated for a pacemaker, a population estimated at more than 750,000 people globally each year. The therapy has also received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with elevated cardiovascular risk, a group estimated to include more than 7.7 million individuals in the United States.
“This keynote presentation reflects the growing global recognition of AVIM Therapy as a novel, device-based therapy, poised to reshape the future of hypertension care,” said Dr. Fischer. “Hypertension is the principal driver of diastolic dysfunction, which accelerates the development of heart failure. Despite widespread use of antihypertensive therapies, many patients continue to progress along the disease pathway, underscoring the importance of novel therapeutic approaches. The collective body of AVIM Therapy clinical data demonstrates its potential to directly modulate the progression of hypertensive heart disease, offering the potential to intervene earlier in the course of the disease to improve long-term outcomes, transform patient care, and ultimately create lasting value for all stakeholders.”
The presentation summarized findings from pilot and long-term follow-up studies that show favorable outcomes on both blood pressure and cardiac function:
- Immediate and Sustained Blood Pressure Reduction:
In the MODERATO I study, 24-hour ambulatory systolic blood pressure (aSBP) was reduced by 11.6 mmHg after one day and 10.1 mmHg at three months. In the MODERATO II study, 24-hour aSBP was reduced by 15.6 mmHg after one day and 11.1 mmHg at six months, with office systolic blood pressure reduced by 17.5 mmHg after 24 months. - Improved Cardiac Function:
After 24 months of treatment, patients demonstrated reductions in heart rate and end-diastolic volume with no significant change in end-systolic volume or ejection fraction. Echocardiographic data from MODERATO II also showed increases in e’ and E/A ratio, indicating improved myocardial relaxation and diastolic compliance. - Durable and Reversible Effects:
Long-term follow-up showed that the blood pressure-lowering effects of AVIM Therapy were durable, reversible upon deactivation, and reproducible after reactivation—underscoring consistency and safety.
Orchestra BioMed said these findings highlight the potential of AVIM Therapy to address hypertensive heart disease progression and reshape treatment paradigms for patients with high cardiovascular risk.
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