Orchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT
Rhea-AI Summary
Orchestra BioMed (Nasdaq: OBIO) announced two conference presentations at THT (Mar 3, 2026) and CRT (Mar 8, 2026) on AVIM Therapy, a pacemaker-based approach for hypertension, diastolic dysfunction and heart failure.
Presenters will share pilot data showing sustained systolic blood pressure reductions, improved hemodynamics, ventricular remodeling, and ongoing BACKBEAT pivotal study progress.
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News Market Reaction – OBIO
On the day this news was published, OBIO declined 0.46%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum data flags mixed moves among biotech peers (e.g., AVTX up, MOLN down) with sector-wide rotation marked as false. With OBIO’s own direction unspecified and only isolated peer news (e.g., GLSI), the setup points to company-specific drivers rather than a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 19 | Investor conferences | Neutral | -0.5% | Management participation in two March 2026 institutional investor conferences. |
| Feb 13 | Inducement grants | Neutral | +0.3% | Stock options for 120,000 shares granted to nine new employees. |
| Jan 12 | Vivasure proceeds | Positive | -2.9% | Company expects up to $21M in cash from Vivasure acquisition. |
| Jan 09 | Vivasure acquired | Neutral | -0.8% | Haemonetics acquisition of Vivasure valued up to €185M (~$215M). |
| Dec 08 | AVIM presentations | Positive | -0.2% | Multiple AVIM Therapy and Virtue SAB presentations at the ICI cardiology meeting. |
Positive strategic and clinical news (AVIM presentations, Vivasure proceeds) previously coincided at times with negative short-term price reactions, while neutral items like conferences and inducement grants saw smaller, mixed moves.
Over the last six months, Orchestra BioMed reported several corporate and strategic developments. In December 2025, the company highlighted AVIM Therapy and Virtue SAB presentations at the ICI meeting. In January 2026, it disclosed up to $21 million in expected proceeds tied to Vivasure’s acquisition and filed an 8-K on that event. February updates focused on inducement grants and participation in institutional conferences. Today’s THT/CRT AVIM Therapy presentations extend this pattern of showcasing its cardiovascular technology platform.
Regulatory & Risk Context
An effective resale registration filed on October 31, 2025 covers up to 8,027,890 shares for selling stockholders. Orchestra BioMed does not receive proceeds from these resales; it would receive up to $7.3 million only if the Ligand warrant, exercisable at $3.67 per share, is exercised for cash.
Market Pulse Summary
This announcement highlights new AVIM Therapy data and presentations at the THT and CRT 2026 meetings, emphasizing sustained systolic blood pressure reductions and long-term follow-up approaching four years in pacemaker-indicated hypertensive patients. In context of prior AVIM-focused conference activity and expected Vivasure-related cash proceeds, the news reinforces Orchestra BioMed’s focus on device-based hypertension and heart failure solutions. Investors may monitor future pivotal study readouts, partnership updates, and related regulatory disclosures for clearer impact.
Key Terms
atrioventricular interval modulation therapy medical
hfpEF medical
hemodynamics medical
ventricular remodeling medical
autonomic nervous system medical
systolic blood pressure medical
pacemaker-based medical
myocardial infarction medical
AI-generated analysis. Not financial advice.
NEW HOPE, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced two presentations that will be given at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings highlighting the potential for the Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program in hypertensive heart disease and heart failure patients.
Presentation at THT 2026
Atrioventricular Interval Modulation Therapy: A Device-Based Therapy for Hypertension and Diastolic Heart Failure (Tuesday, March 3, 2026, at 10:20am ET)
- Presenter: David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Co-Principal Investigator for the BACKBEAT global pivotal study (“BACKBEAT Study”)
- Dr. Kandzari will present mechanistic and clinical data highlighting the potential application of AVIM Therapy to treat diastolic dysfunction, a precursor of heart failure with preserved ejection fraction (“HFpEF”). The presentation will highlight pilot study data demonstrating sustained systolic blood pressure reductions associated with delivery of AVIM Therapy alongside improvements in cardiac hemodynamics, ventricular remodeling, and echocardiographic measures of diastolic function.
Dr. Kandzari commented, “AVIM Therapy has the potential to offer a new treatment paradigm that leverages active implantable devices with a long, established clinical history. The BACKBEAT Study, which continues to accelerate and build momentum, is focused on evaluating the potentially compelling benefit of this novel, always-on therapy for hypertension in pacemaker-indicated patients. In parallel, pilot study clinical and mechanistic results demonstrate that modulation of the atrioventricular interval drives hemodynamic and autonomic nervous system function impact that could help patients with HFpEF, a population with limited therapeutic options. Together, the presentations at the THT and CRT meetings underscore that AVIM Therapy has the future potential to benefit both hypertensive heart disease and heart failure patients.”
Presentation at CRT 2026
Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension (Sunday, March 8, 2026, at 9:18am ET)
- Presenter: Dan Burkhoff, MD, PhD, Director, Heart Failure, Hemodynamics and MCS Research, Cardiovascular Research Foundation
- Dr. Burkhoff will summarize the robust body of pilot study clinical evidence demonstrating sustained and reproducible systolic blood pressure reductions associated with delivery of AVIM Therapy, along with improvements in hemodynamics, ventricular remodeling, and stable long-term outcomes in pacemaker-indicated patients with hypertension.
Dr. Burkhoff added, “In pilot studies, AVIM Therapy demonstrated an immediate reduction in systolic blood pressure that starts upon treatment activation and persists through nearly four years of follow-up. Long-term washout pilot study data demonstrating reproducible blood pressure reduction without evidence of disease progression further highlight the unique potential clinical utility of this therapy. Sustained blood pressure control in higher risk, older, comorbid patients that does not require additional patient adherence to daily medications can have important clinical impact in a population where blood pressure management is essential to reducing the risk of stroke, myocardial infarction, and heart failure.”
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 non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of 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 in-stent restenosis, 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 will 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.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
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 THT on March 3, 2026?
What does Orchestra BioMed (OBIO) say about AVIM Therapy results at CRT on March 8, 2026?
How is the BACKBEAT pivotal study for OBIO described in the March 3, 2026 announcement?
What pilot study clinical effects of AVIM Therapy does Orchestra BioMed (OBIO) report?
Could AVIM Therapy address heart failure with preserved ejection fraction (HFpEF) according to OBIO's presentations?
What is the clinical significance of AVIM Therapy for older, comorbid hypertensive patients per OBIO (OBIO)?
