NEW HOPE, Pa. - Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO), a biomedical company, has announced new data on the long-term effectiveness of its atrioventricular interval modulation (AVIM) therapy for patients with hypertension who require pacemakers.
The data, presented at the Innovation in Cardiovascular Interventions (ICI) 2024 Meeting, show a sustained reduction in 24-hour ambulatory systolic blood pressure (aSBP) over an average of 3.6 years.
The MODERATO II study, a European multi-center, double-blind, randomized pilot study, initially found that patients undergoing AVIM therapy alongside antihypertensive medications experienced an 11.1 mmHg reduction in mean aSBP after six months. This was a statistically significant improvement compared to control patients who only received antihypertensive medications.
In a follow-up study of 16 patients from MODERATO II, including both original AVIM therapy recipients and control patients who later crossed over to AVIM therapy, the sustained mean reduction in aSBP was 8.9 mmHg. This matches the reduction observed at the six-month primary endpoint of the original study.
AVIM therapy, delivered via a standard dual-chamber pacemaker, is still investigational and not yet approved by the U.S. Food and Drug Administration. However, Orchestra BioMed has formed a strategic collaboration with Medtronic plc (NYSE:MDT) for the development and potential commercialization of AVIM therapy for hypertensive pacemaker patients.
The company is currently enrolling patients in the BACKBEAT pivotal study, which aims to investigate the efficacy and safety of AVIM therapy in a similar patient population. The primary endpoint of this study will be to assess the reduction in aSBP three months post-randomization.
Hypertension is a major global health concern, affecting an estimated 1.28 billion adults and leading to increased cardiac risks. In the U.S., around 47% of adults are estimated to have hypertension, with a higher prevalence among the elderly and those with cardiac pacemakers.
Orchestra BioMed's business model focuses on developing high-impact technologies and partnering with leading medical device companies for commercialization. Alongside AVIM therapy, the company is also working on other innovations, including the Virtue Sirolimus AngioInfusion Balloon for treating artery disease.
This article is based on a press release statement from Orchestra BioMed.
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