- 8.9 mmHg mean reduction in 24-Hour ambulatory systolic blood pressure at average of 3.6 years from initiation of AVIM therapy in patients who participated in the MODERATO II study
- Orchestra BioMed is actively enrolling patients in the BACKBEAT pivotal study of AVIM therapy in hypertensive pacemaker patients
NEW HOPE, Pa., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the presentation of new data demonstrating the long-term effect of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) on generating clinically-meaningful reductions in 24-hour ambulatory systolic blood pressure (“aSBP”) in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. The data were presented by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation of Orchestra BioMed in a scientific session at the Innovation in Cardiovascular Interventions (“ICI”) 2024 Meeting.
“People who suffer from hypertension face a lifelong burden of blood pressure management. This is particularly relevant in the pacemaker-indicated population of older patients who have a higher risk of other co-morbidities and adverse clinical outcomes,” commented Dr. Fischer. “These new long-term follow up data demonstrate AVIM therapy’s ability to drive a substantial and sustained reduction in 24-hour ambulatory systolic blood pressure, the gold standard, and most accurate measure of hypertension. Seeing substantial sustained ambulatory blood pressure reductions in patients treated with AVIM therapy for over three and a half years on average reinforces our confidence in the potential of this novel therapy to have a clinically meaningful and long-lasting beneficial effect on hypertensive pacemaker patients.”
Reduction in aSBP measured at 6 months from randomization and therapy activation was the primary endpoint of the MODERATO II study, a European multi-center, double-blind, randomized pilot study involving 47 subjects. Patients randomized to AVIM therapy and antihypertension medication in that study experienced an 11.1 mmHg (p