Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
Rhea-AI Summary
Orchestra BioMed (Nasdaq: OBIO) announced three presentations at the 2025 Innovation in Cardiology Intervention (ICI) meeting in Tel Aviv on December 8–9, 2025. Two talks cover AVIM Therapy—highlighting the strategic collaboration with Medtronic and clinical potential for hypertensive heart disease—and one covers the Virtue Sirolimus AngioInfusion (Virtue SAB) balloon and the Virtue IDE trial for coronary in-stent restenosis.
Speakers and times: David Hochman and Robert Kowal on the Orchestra–Medtronic partnership (Dec 9, 14:00 IST / 07:00 AM EST); Avi Fischer on AVIM Therapy (Dec 8, 15:12 IST / 08:12 AM EST); Bill Little on Virtue SAB and the Virtue Trial (Dec 8, 14:00 JST / 07:00 AM EST).
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Key Figures
Market Reality Check
Peers on Argus
OBIO fell 6.58% while several biotech peers also declined (e.g., SGMO -6.08%, GLSI -2.4%, PLX -1.7%, CYBN -0.17%), though THTX rose 0.89%. Sector moves appear mixed rather than a unified rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 26 | Inducement grants | Neutral | +1.5% | Inducement stock options to 12 new hires under Nasdaq Rule 5635(c)(4). |
| Nov 11 | Conference participation | Positive | +8.5% | Management attending late-2025 healthcare investor conferences and webcasts. |
| Nov 10 | Q3 2025 earnings | Neutral | -0.8% | Reported Q3 results, strengthened liquidity, and outlined pivotal trial funding. |
| Nov 03 | Business update call | Positive | +1.3% | Call to discuss Medtronic and Ligand deals, BACKBEAT and Virtue SAB progress. |
| Oct 28 | Virtue SAB deal | Positive | -4.0% | $30M Terumo ROFR and preferred equity for Virtue SAB coronary program. |
Recent news has generally aligned with price moves; a notable divergence occurred when a positive $30M Virtue SAB strategic deal coincided with a -4.05% drop.
Over the last few months, Orchestra BioMed reported Q3 2025 results, highlighted $147.6 million in gross proceeds and commitments, and extended cash runway into Q4 2027 to support BACKBEAT and Virtue SAB pivotal trials. Strategic activity included a new $30 million Virtue SAB agreement with Terumo and expanded collaboration with Medtronic. The company also scheduled investor conferences and a business update call. Today’s ICI meeting presentations on AVIM Therapy and Virtue SAB fit into this pattern of emphasizing its partnered cardiovascular programs and pivotal trial execution.
Regulatory & Risk Context
An effective S-3 resale registration was filed on Oct 31, 2025, covering up to 8,027,890 shares for selling stockholders. The company may receive up to $7.3 million only if a Ligand warrant is exercised for cash at $3.67 per share; it receives no proceeds from stockholder resales.
Market Pulse Summary
This announcement spotlights Orchestra BioMed’s AVIM Therapy for hypertensive heart disease and its Virtue SAB program through three presentations at the 2025 ICI meeting. It reinforces earlier disclosures about pivotal trials and strategic collaborations with Medtronic and Terumo. Investors may track how these therapies progress in the BACKBEAT and Virtue IDE trials, as well as the impact of the existing S-3 resale registration covering 8,027,890 shares and potential warrant proceeds of $7.3 million.
Key Terms
atrioventricular interval modulation therapy medical
AI-generated analysis. Not financial advice.
- 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
What will Orchestra BioMed (OBIO) present about AVIM Therapy at ICI on December 9, 2025?
When and who presents AVIM Therapy for hypertensive heart disease at ICI (OBIO)?
What is the Virtue SAB presentation by Orchestra BioMed (OBIO) about at ICI on Dec 8, 2025?
Which companies are involved in Orchestra BioMed's ICI presentations for OBIO?
How can investors use the OBIO ICI presentations to assess product progress?
