1. Orchestra BioMed presents AVIM Therapy at cardiology meeting in Tel Aviv. 2. AVIM Therapy aims to treat uncontrolled hypertension in pacemaker patients. 3. The FDA granted Breakthrough Device Designation to AVIM Therapy and Virtue SAB. 4. AVIM Therapy shows promising clinical reductions in blood pressure. 5. Strategic collaboration with Medtronic enhances commercialization opportunities.
FAQ
Why Bullish?
The presentation showcases strong collaboration and advancements, possibly increasing investor confidence as seen with similar FDA designations resulting in stock price appreciation.
How important is it?
Breakthrough designations and strategic partnerships are vital for OBIO's future, enhancing its market potential significantly.
Why Long Term?
The ongoing developments and FDA designations suggest gradual market penetration and revenue growth over years, akin to other medical companies experiencing long-term success from FDA approvals.
Orchestra BioMed Unveils Key Presentations at ICI Meeting on AVIM Therapy and Virtue SAB
New Hope, PA – December 8, 2025 – Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO), a pioneering biomedical innovation firm, has announced its participation in the 2025 Innovation in Cardiology Intervention (ICI) meeting, scheduled to take place in Tel Aviv, Israel. The company will present three significant discussions, with a focus on advancements in Atrioventricular Interval Modulation Therapy (AVIM Therapy) and the Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB).
Presentations Highlighting Innovative Collaborations
The presentation agenda includes:
- The Power of Partnerships: Orchestra BioMed and Medtronic’s Collaboration to Advance AVIM Therapy to Patients, presented by David Hochman, CEO of Orchestra BioMed, and Robert C. Kowal, M.D., Ph.D., of Medtronic. (December 9, 2025; 14:00 IST / 07:00 AM EST)
- AVIM Therapy for the Treatment of Hypertensive Heart Disease, led by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed. (December 8, 2025; 15:12 IST / 08:12 AM EST)
- Virtue SAB and the Virtue Trial: A Next-Generation, Non-Coated Sirolimus-Eluting AngioInfusion Balloon, presented by Bill Little, Executive Vice President of Corporate Development and Strategy. (December 8, 2025; 14:00 JST / 07:00 AM EST)
AVIM Therapy: A Promising Solution for Hypertension
The AVIM Therapy presentations will emphasize the benefits of the collaboration between Orchestra BioMed and Medtronic. This partnership aims to develop and commercialize AVIM Therapy to address uncontrolled hypertension in patients requiring pacemakers. AVIM Therapy has received FDA Breakthrough Device Designation and is designed to be integrated into existing pacemaker technology, aiming to provide immediate and sustained reductions in blood pressure.
Implications of AVIM Therapy
Research from the MODERATO II double-blind study demonstrated that patients utilizing AVIM Therapy experienced an average reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure after six months. The ongoing BACKBEAT pivotal study continues to assess the safety and efficacy of AVIM Therapy, focusing on patients with systolic blood pressure issues despite medication.
Virtue SAB: A Revolutionary Drug Delivery System
The Virtue SAB presentation will showcase its innovative non-coated drug delivery system for treating coronary artery disease. This angioplasty balloon is designed to deliver a patented extended-release sirolimus formulation, effectively addressing the issue of in-stent restenosis (ISR). It also holds FDA Breakthrough Device Designation for the treatment of coronary ISR and small vessel disease.
Strategic Collaborations Fueling Growth
Orchestra BioMed's dedication to biomedical innovation positions it strongly in the market. With two flagship product candidates—AVIM Therapy and Virtue SAB—the company is poised to capitalize on substantial market opportunities. Together, these therapies represent a significant advancement in treating hypertensive heart disease and achieving better outcomes for patients worldwide.
About Orchestra BioMed
Orchestra BioMed is committed to accelerating high-impact technologies for patient care through strategic partnerships with leading medical device companies. The firm focuses on innovative solutions for pressing health challenges, especially in the fields of cardiology and hypertension.
For more information on Orchestra BioMed and its groundbreaking therapies, please visit www.orchestrabiomed.com or follow on LinkedIn.