NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) revealed promising new findings on its atrioventricular interval modulation (AVIM) therapy during a late-breaking presentation at the Technology and Heart Failure Therapeutics (THT) 2025 Conference in Boston, MA. The analysis, based on data from the MODERATO II study, offers critical insights into how AVIM therapy improves diastolic dysfunction—a key factor in the development of heart failure—while also reducing systolic blood pressure in hypertensive patients.
Addressing the Root Causes of Heart Failure
Hypertension is a major driver of diastolic dysfunction, particularly in older adults. Both conditions contribute to the structural and functional deterioration of the heart, often leading to heart failure. Dr. Marat Fudim, an advanced heart failure cardiologist at Duke Health, delivered the presentation and highlighted AVIM therapy’s ability to impact early stages of this progression.
“For many patients with long-standing hypertension, the heart undergoes changes that impair its ability to relax and refill properly,” explained Dr. Fudim. “This analysis of MODERATO II data demonstrates that AVIM therapy not only lowers systolic blood pressure but also enhances diastolic function and promotes favorable ventricular remodeling. These findings underscore the opportunity to intervene earlier in high-risk patients to prevent heart failure.”
Key Findings from MODERATO II
The retrospective, treatment-blinded analysis assessed the impact of AVIM therapy over six months, targeting systolic blood pressure (SBP) and diastolic dysfunction (DD) markers. Among 36 patients with sufficient echocardiographic data, 61% had evidence of diastolic dysfunction. Key results include:
- Significant SBP Reductions – Patients with diastolic dysfunction (DD+) treated with AVIM therapy experienced office SBP reductions of 12.1 mmHg and ambulatory SBP reductions of 8.3 mmHg, compared to negligible or worsening SBP outcomes in control groups.
- Improved Markers of Diastolic Function – AVIM-treated patients showed marked improvements in critical Echo measures, including enhanced left ventricular relaxation (higher e’) and better passive filling of the heart (increased E/A ratio).
These findings suggest that AVIM therapy not only addresses high blood pressure but also improves how the heart fills and functions, providing dual benefits for patients at risk of heart failure.
Looking Beyond Blood Pressure
The late-breaking data presented at THT reinforce AVIM therapy’s potential as a multifaceted treatment. Unlike conventional interventions, AVIM therapy combines systolic blood pressure reduction with direct improvements in diastolic function, offering hope for a new standard of care for hypertensive patients with heart dysfunction.
“The broader view of AVIM therapy’s benefits is particularly exciting,” said Dr. Avi Fischer, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed. “For patients with uncontrolled hypertension and diastolic dysfunction—especially those at risk for heart failure—AVIM therapy could redefine treatment strategies. We envision earlier interventions that not only control blood pressure but also directly combat cardiovascular deterioration.”
A Vision for the Future
Orchestra BioMed is now advancing its investigation of AVIM therapy through the ongoing BACKBEAT global pivotal study. This robust, double-blind, randomized trial aims to further delineate AVIM therapy’s role in managing hypertension and its associated cardiovascular consequences. Dr. Fischer anticipates that the study will provide additional data to propel the therapy toward broader clinical adoption.
By addressing both hypertension and its downstream effects, AVIM therapy holds significant promise as a preventive tool in cardiovascular care. If successful, it could pave the way for earlier intervention, better outcomes, and a new paradigm in the fight against heart failure.
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