Orchestra BioMed and Medtronic will present on AVIM Therapy's development for hypertension and share insights on Virtue SAB.
Quiver AI Summary
Orchestra BioMed and Medtronic are collaborating on Atrioventricular Interval Modulation Therapy (AVIM Therapy) for patients with uncontrolled hypertension who require pacemakers. This collaboration will be highlighted in three presentations at the 2025 Innovation in Cardiology Intervention meeting in Tel Aviv, including a discussion on the therapy's potential benefits for hypertensive heart disease and the partnership's strategic strength. AVIM Therapy aims to significantly lower blood pressure and has received FDA Breakthrough Device Designation. Additionally, presentations will cover the Virtue® Sirolimus AngioInfusion™ Balloon, a new drug delivery system for coronary artery disease. Both technologies represent significant market opportunities, targeting widespread conditions that contribute to global health issues.
Potential Positives
- Strategic collaboration with Medtronic, a leading global medical device company, enhances credibility and market access for AVIM Therapy.
- AVIM Therapy has received FDA Breakthrough Device Designation, indicating significant potential for addressing uncontrolled hypertension in a large patient population.
- Presentations at the 2025 Innovation in Cardiology Intervention meeting highlight the company’s innovative therapies, drawing attention from medical professionals and industry stakeholders.
- Both AVIM Therapy and Virtue SAB are positioned within multi-billion-dollar market opportunities, showcasing the company’s potential for substantial revenue growth.
Potential Negatives
- Dependence on Strategic Collaborations: The reliance on Medtronic for the development and commercialization of AVIM Therapy could represent a vulnerability if the partnership encounters challenges or setbacks.
- Investigational Status: Both AVIM Therapy and Virtue SAB are still in clinical trials, which poses risks regarding their eventual approval and market acceptance, potentially delaying revenue generation.
- Market Competition: The therapies are entering competitive markets with existing treatments for hypertension and atherosclerotic artery disease, which may complicate their adoption and success.
FAQ
What is AVIM Therapy?
AVIM Therapy is an investigational bioelectronic treatment designed to lower blood pressure in patients indicated for a pacemaker.
Who are the partners in developing AVIM Therapy?
Orchestra BioMed collaborates with Medtronic for the development and commercialization of AVIM Therapy.
What are the benefits of AVIM Therapy?
AVIM Therapy aims to achieve significant and sustained reductions in blood pressure for hypertensive patients.
What is Virtue SAB?
Virtue SAB is a novel non-coated drug delivery angioplasty balloon system for treating coronary artery disease.
What designation has AVIM Therapy received from the FDA?
AVIM Therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in certain patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$OBIO Insider Trading Activity
$OBIO insiders have traded $OBIO stock on the open market 9 times in the past 6 months. Of those trades, 8 have been purchases and 1 have been sales.
Here’s a breakdown of recent trading of $OBIO stock by insiders over the last 6 months:
- ADVISORS LLC PERCEPTIVE purchased 700,000 shares for an estimated $1,925,000
- DAVID P HOCHMAN (See Remarks) has made 3 purchases buying 31,000 shares for an estimated $90,290 and 0 sales.
- ERIC S FAIN has made 1 purchase buying 5,760 shares for an estimated $15,033 and 1 sale selling 2,683 shares for an estimated $8,183.
- DARREN SHERMAN (See Remarks) purchased 3,000 shares for an estimated $7,860
- ANDREW LAWRENCE TAYLOR (Chief Financial Officer) purchased 2,000 shares for an estimated $5,100
- JASON ARYEH purchased 1,000 shares for an estimated $2,450
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$OBIO Hedge Fund Activity
We have seen 26 institutional investors add shares of $OBIO stock to their portfolio, and 52 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ALYESKA INVESTMENT GROUP, L.P. added 1,365,482 shares (+inf%) to their portfolio in Q3 2025, for an estimated $3,386,395
- PATHSTONE HOLDINGS, LLC added 1,006,018 shares (+inf%) to their portfolio in Q3 2025, for an estimated $2,494,924
- AFFINITY ASSET ADVISORS, LLC added 727,272 shares (+inf%) to their portfolio in Q3 2025, for an estimated $1,803,634
- PERCEPTIVE ADVISORS LLC added 700,000 shares (+15.2%) to their portfolio in Q3 2025, for an estimated $1,736,000
- DAFNA CAPITAL MANAGEMENT LLC added 363,636 shares (+inf%) to their portfolio in Q3 2025, for an estimated $901,817
- VANGUARD GROUP INC added 324,558 shares (+28.0%) to their portfolio in Q3 2025, for an estimated $804,903
- RENAISSANCE TECHNOLOGIES LLC added 211,108 shares (+124.6%) to their portfolio in Q3 2025, for an estimated $523,547
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$OBIO Analyst Ratings
Wall Street analysts have issued reports on $OBIO in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Chardan Capital issued a "Buy" rating on 11/13/2025
- Barclays issued a "Overweight" rating on 11/12/2025
To track analyst ratings and price targets for $OBIO, check out Quiver Quantitative's $OBIO forecast page.
$OBIO Price Targets
Multiple analysts have issued price targets for $OBIO recently. We have seen 3 analysts offer price targets for $OBIO in the last 6 months, with a median target of $11.0.
Here are some recent targets:
- Keay Nakae from Chardan Capital set a target price of $20.0 on 11/13/2025
- Matt Miksic from Barclays set a target price of $11.0 on 11/12/2025
- Yi Chen from HC Wainwright & Co. set a target price of $10.0 on 09/04/2025
Full Release
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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.
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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)
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AVIM Therapy for the Treatment of Hypertensive Heart Disease
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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.
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Virtue SAB and the Virtue Trial: A Next-Generation, Non-Coated Sirolimus-Eluting AngioInfusion Balloon and IDE Coronary ISR Trial vs. AGENT PCB
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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
[email protected]
Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
[email protected]
