Orchestra BioMed Showcases AVIM Therapy as Purpose-Built Solution for Hypertensive Heart Disease at CSI Frankfurt 2025
- FDA Breakthrough Device Designation recently granted for AVIM therapy
- Strategic collaboration with Medtronic, the global leader in cardiac pacing
- Large addressable market of 7.7 million U.S. patients with hypertensive heart disease
- Novel therapeutic approach targeting an underserved patient population
- AVIM therapy still in clinical trial phase, not yet FDA approved
- Limited to patients who require dual-chamber pacemakers
- Success of BACKBEAT pivotal study remains uncertain
Insights
Orchestra BioMed's AVIM therapy shows promise for hypertensive heart disease, building momentum with FDA Breakthrough status and Medtronic partnership.
Orchestra BioMed is positioning its AVIM (atrioventricular interval modulation) therapy as a specialized intervention for hypertensive heart disease, which affects
What makes this development noteworthy is AVIM's targeted mechanism of action - it's designed to reduce cardiac preload and modulate autonomic nervous system responses, potentially offering a more tailored approach to blood pressure management for patients with complex cardiovascular conditions. This represents a more sophisticated approach than conventional hypertension treatments.
The ongoing BACKBEAT global pivotal study, conducted in collaboration with Medtronic, adds substantial credibility to this program. Medtronic's involvement as the global leader in cardiac pacing therapy provides Orchestra BioMed with an established commercialization pathway if the therapy proves successful in clinical trials.
From a market perspective, the focus on patients with uncontrolled hypertension who already require dual-chamber pacemakers creates a clear initial target population. The technology's integration with existing pacemaker systems could facilitate adoption within established electrophysiology practices, potentially lowering implementation barriers.
While this announcement doesn't include clinical trial results, the fact that Orchestra BioMed secured FDA Breakthrough Device Designation suggests the agency recognizes AVIM's potential to address an important unmet medical need. The growing focus on heart failure with preserved ejection fraction (HFpEF) among cardiologists also aligns with current clinical priorities in cardiovascular medicine.
- Presentation underscores unique potential for atrioventricular interval modulation (“AVIM”) therapy to manage blood pressure in older, high-risk patients who have indicators of diastolic dysfunction and progression to heart failure with preserved ejection fraction (“HFpEF”)
- Hypertensive heart disease represents over 7.7 million U.S. patients, the same population with hypertension and elevated cardiovascular risk cited in the recent FDA Breakthrough Device Designation (“BDD”) for AVIM therapy
NEW HOPE, Pa., June 18, 2025 (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 key clinical insights into the role of AVIM therapy for the treatment of high-risk hypertension at the Congenital, Structural, and Valvular Heart Disease Interventions (“CSI”) 2025 Meeting. The data highlight AVIM therapy’s unique potential to address hypertensive heart disease, a significant and under-recognized cardiovascular syndrome that affects a growing segment of the aging hypertension population.
The talk, “Atrioventricular Interval Modulation (AVIM) Therapy for Hypertension and HFpEF,” will be delivered by Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation and clinical advisor to Orchestra BioMed. Dr. Burkhoff will spotlight the clinical utility of AVIM therapy as a novel, device-based approach to blood pressure management designed specifically for patients with hypertensive heart disease. This population has increased risk for major adverse cardiac events and currently lacks sufficient therapeutic options. The presentation will take place on June 18, 2025, at 3:33pm CEST / 9:33am ET as part of the “Interventions for Chronic Heart Failure” session.
Dr. Burkhoff commented, “Hypertensive heart disease is not a singular diagnosis, but a high-risk cardiovascular syndrome driven by longstanding, uncontrolled high blood pressure which significantly increases the likelihood of adverse clinical outcomes such as stroke, myocardial infarction, diastolic dysfunction and progression to heart failure. The data I will review at CSI explore how AVIM therapy may offer a unique treatment specifically catered to this group of patients leveraging a mechanism of action designed to reduce cardiac preload and modulate autonomic nervous system responses to reduce blood pressure and improve cardiovascular function. This represents a potential paradigm shift in how we approach blood pressure management using tailored interventions designed to directly impact the complex pathophysiology of high-risk hypertension.”
The presentation will cover:
- The clinical burden and therapeutic gaps in managing patients with high-risk hypertension and increased risk of heart failure;
- The growing body of clinical and mechanistic evidence demonstrating AVIM therapy’s potential to lower blood pressure and improve cardiac function; and
- Details on the BACKBEAT global pivotal study, currently enrolling patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker. The study is being conducted in collaboration with Medtronic, the global leader in cardiac pacing therapy.
“AVIM therapy was purpose-built to address the complex and underserved needs of patients with hypertensive heart disease, a subgroup often overlooked by conventional therapy,” said Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed. “As a programmable, pacemaker-integrated solution, AVIM therapy has the potential to fit seamlessly into existing electrophysiology practices while opening the door to better outcomes in a large, underserved population. Dr. Burkhoff’s presentation at CSI Frankfurt further reinforces the growing clinical interest in AVIM therapy and highlights the significant opportunity to transform care of hypertensive heart disease, especially given our recently granted BDD status, which applies directly to this patient profile.”
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.
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About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
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Investor Contact
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com
Media Contact
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Orchestra BioMed
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