Orchestra BioMed’s AVIM Therapy Cuts Systolic BP by 13.2 mmHg, 89% Sustained Control
Orchestra BioMed’s AVIM Therapy reduced mean office systolic blood pressure by 13.2 mmHg in the MODERATO II trial, with 97% of patients achieving at least a 5 mmHg drop and 89% maintaining aSBP below 140 mmHg at six months. The BACKBEAT pivotal trial is now enrolling with Medtronic.
1. MODERATO II Trial Data
The MODERATO II randomized, prospective, double-blind trial demonstrated that AVIM Therapy delivered an immediate mean reduction of 13.2 mmHg in office systolic blood pressure, with 97% of patients achieving at least a 5 mmHg drop. At six months, mean ambulatory systolic blood pressure was 125.2 mmHg, with 89% of patients below the 140 mmHg target and sustained reductions observed through 3.6 years in a sub-cohort.
2. BACKBEAT Global Pivotal Trial
Orchestra BioMed is actively enrolling its BACKBEAT Global Pivotal Trial in collaboration with Medtronic, targeting pacemaker-indicated patients with uncontrolled hypertension using AVIM Therapy activation. This study will assess long-term efficacy and safety in a larger population similar to MODERATO II.
3. Hemodynamic Pressure-Volume Findings
A clinical pressure-volume loop study showed AVIM Therapy acutely reduced systolic blood pressure by lowering cardiac preload and effective arterial elastance without affecting contractility. Significant reductions were recorded in end diastolic volume, end diastolic pressure, end systolic volume and total peripheral resistance across both conduction system and right ventricular pacing lead locations.
4. Regulatory Status and Market Opportunity
AVIM Therapy holds FDA Breakthrough Device Designation for uncontrolled hypertension in pacemaker patients, addressing an estimated 7.7 million U.S. patients. Orchestra BioMed’s pipeline also includes the Virtue Sirolimus AngioInfusion Balloon, targeting multi-billion-dollar global markets in coronary and peripheral artery disease.