Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
MWN-AI** Summary
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has announced significant presentations related to its innovative therapies at the 2025 Innovation in Cardiology Intervention (ICI) meeting in Tel Aviv, Israel. The event will showcase their collaborative efforts with Medtronic for the development of Atrioventricular Interval Modulation (AVIM) Therapy, targeted at treating uncontrolled hypertension in patients indicated for a pacemaker, and the Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB).
The presentations will highlight the ongoing strategic partnership between Orchestra BioMed and Medtronic, with key figures like CEO David Hochman and Medtronic's Robert C. Kowal discussing AVIM Therapy's clinical potential in hypertensive heart disease. Notably, AVIM Therapy is designed as a firmware upgrade for pacemakers that promises substantial and sustained reductions in blood pressure. Clinical studies have shown encouraging results, including a notable reduction in systolic blood pressure among treated patients.
Additionally, Orchestra BioMed will introduce the Virtue SAB, which represents a novel approach in drug delivery for coronary artery disease. This first non-coated balloon device, developed to combat in-stent restenosis, has previously shown promising three-year clinical data. Bill Little from Orchestra will present insights related to its design and clinical trial data, including its FDA Breakthrough Device Designation for several cardiovascular conditions.
Both flagship product candidates hold immense commercial potential, with AVIM Therapy addressing a critical unmet need in managing hypertension, a leading global health risk, and Virtue SAB targeting significant opportunities in coronary and peripheral artery diseases. As the Company continues its pivotal clinical trials, this collaboration with Medtronic reinforces its commitment to advancing cutting-edge medical solutions.
MWN-AI** Analysis
Orchestra BioMed (NASDAQ: OBIO) recently made headlines by announcing key presentations at the 2025 Innovation in Cardiology Intervention (ICI) meeting regarding its collaborative advancements in Atrioventricular Interval Modulation (AVIM) Therapy and the Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB). This strategic partnership with Medtronic aims to target the growing market for patients suffering from uncontrolled hypertension, a high-risk condition that affects millions.
The presentations underscore the operational strength of this collaboration and the promising clinical applications of AVIM Therapy for hypertensive heart disease, particularly in patients indicated for pacemakers. The FDA's Breakthrough Device Designation for AVIM signifies its potential impact on patient outcomes, particularly given that approximately 7.7 million Americans struggle with uncontrolled hypertension. The ongoing BACKBEAT study further lends credibility by evaluating its safety and efficacy in lowering blood pressure.
On the other hand, Virtue SAB also shows great promise as an innovative approach to drug delivery in the treatment of coronary artery disease. Unlike traditional drug-coated balloons, the non-coated design of the Virtue SAB effectively delivers sirolimus through an extended-release formulation, which could enhance outcomes in coronary intervention, especially in cases of in-stent restenosis.
Investors should monitor Orchestra BioMed closely, as the commercial success of both AVIM Therapy and Virtue SAB could unlock multi-billion dollar market opportunities. The partnership with a giant like Medtronic not only provides credibility but also a pathway to rapid market penetration pending successful trial outcomes. With a robust pipeline and strategic advantages in place, Orchestra BioMed presents a compelling case for investment in the biomedical innovation sector. However, potential investors should remain aware of the typical clinical trial risks that accompany the development of medical device therapies.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients indicated for a pacemaker
NEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced three presentations at the 2025 Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv, Israel, including two presentations focused on Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and one focused on Virtue ® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”).
The AVIM Therapy presentations will highlight the structure and operational strength of the Company’s strategic collaboration with Medtronic, plc (NYSE: MDT, “Medtronic”), as well as the therapy’s potential clinical utility in hypertensive heart disease.
- The Power of Partnerships: Orchestra BioMed and Medtronic’s Collaboration to Advance AVIM Therapy to Patients , presented by David Hochman, Chairman and Chief Executive Officer of Orchestra Biomed and Robert C. Kowal , M.D., Ph.D., Vice President and General Manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit (December 9, 2025; 14:00 IST / 07:00 AM EST)
- AVIM Therapy for the Treatment of Hypertensive Heart Disease , presented by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation, Orchestra Biomed (December 8, 2025; 15:12 IST / 08:12 AM EST)
The Virtue SAB presentation will provide insights into the novel design of this first non-coated drug delivery system for coronary artery disease treatment, as well as the Virtue IDE trial focused on coronary in-stent restenosis.
- Virtue SAB and the Virtue Trial: A Next-Generation, Non-Coated Sirolimus-Eluting AngioInfusion Balloon and IDE Coronary ISR Trial vs. AGENT PCB , presented Bill Little, Executive Vice President of Corporate Development and Strategy (December 8, 2025; 14:00 JST / 07:00 AM EST)
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue ® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .
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 is evaluating 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.
About Virtue SAB
Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center, prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.
Investor Contact:
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com
Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
kkirkellis@orchestrabiomed.com
FAQ**
How does the strategic collaboration between Orchestra BioMed and Medtronic plc. MDT enhance the development and commercialization efforts for AVIM Therapy in treating uncontrolled hypertension?
What role does Medtronic plc. MDT play in the FDA's Breakthrough Device Designation for AVIM Therapy, and how does it affect the therapy's potential market entry timeline?
Can you elaborate on any specific innovations in AVIM Therapy that differentiate it from other hypertension treatments being developed by Medtronic plc. MDT?
How does the success of AVIM Therapy potentially impact Orchestra BioMed's future collaborations with Medtronic plc. MDT and other industry partners?
**MWN-AI FAQ is based on asking OpenAI questions about Orchestra BioMed Holdings Inc Com (NASDAQ: OBIO).
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