NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) released new data at the HRX Live 2025 Meeting in Atlanta showing that its atrioventricular interval modulation (AVIM) therapy produces durable blood pressure reductions in patients with uncontrolled hypertension, with effects that are sustainable, reversible, and reproducible over multiple years.
The findings, simultaneously published in Heart Rhythm O₂, suggest that AVIM therapy could emerge as a programmable, device-based treatment option for patients whose hypertension remains resistant to drug regimens.
In a follow-up of patients originally enrolled in the MODERATO II trial, those who received AVIM therapy sustained average 24-hour ambulatory systolic blood pressure (aSBP) reductions of 8.9 mmHg over 3.6 years (p<0.001). Importantly, the therapy’s effects proved reversible: when deactivated for a seven-day washout, blood pressure returned to baseline levels without evidence of rebound hypertension. Upon reactivation, reductions were immediately restored, with aSBP falling significantly to 124.4 mmHg (p<0.002).
No statistical differences were found between blood pressure outcomes at six months, 3.6 years, and after therapy reactivation, reinforcing the consistency of the treatment effect.
“These results add to the growing body of promising data supporting AVIM therapy’s potential role as a novel and programmable treatment option for patients whose hypertension remains uncontrolled despite existing medical regimens,” said Dr. Avi Fischer, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed, who presented the data at the conference.
The company noted that these findings further strengthen confidence in the ongoing BACKBEAT global pivotal study, which is evaluating the therapy’s potential to halt the progression of hypertensive heart disease. If successful, AVIM therapy could address a significant unmet need for millions of patients worldwide living with uncontrolled hypertension.
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