Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy
The next steps are three-month follow-up and database lock, with marketing application plans conditional on positive trial results.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Orchestra BioMed (OBIO) surpassed its enrollment target for the BACKBEAT pivotal trial of Atrioventricular Interval Modulation (AVIM) Therapy, with 330 patients randomized. As of September 30, 2026, enrollment exceeded the target of 316 patients across 81 sites in 13 countries. Conducted with Medtronic, the trial evaluates AVIM Therapy in patients needing pacemakers whose hypertension remains uncontrolled despite medication.
The randomized, double-blind trial compares AVIM Therapy plus continued medication and pacing with continued medication and standard pacing alone. Primary endpoints assess blood-pressure change and device safety at three months. Orchestra BioMed and Medtronic intend to submit primary results for late-breaking presentation consideration in Q2 2027. Assuming positive results, Medtronic plans prompt marketing application submissions to the FDA and other global regulators; commercialization remains subject to regulatory approval.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point330 patients randomized as of September 30, 2026, exceeded the BACKBEAT trial’s 316-patient enrollment target.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Medtronic plans prompt marketing applications to the FDA and other global regulators, assuming positive BACKBEAT results.
- Minor point. Forward-looking: it has not happened yet and may not happen.Primary results are intended for late-breaking presentation consideration at a cardiovascular conference in Q2 2027.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.Commercialization with Medtronic remains subject to regulatory approval.
Key Figures
- Patients randomized
- 330 patients
- As of September 30, 2026; exceeded the 316-patient enrollment target
- Enrollment target
- 316 patients
- Previously announced full enrollment target
- Evaluable subjects
- 284 evaluable randomized subjects
- Specified for the primary endpoint analysis
- Trial footprint
- 81 sites across 13 countries
- BACKBEAT Trial enrollment
- Statistical power
- Greater than 90%
- Protocol-specified power for both primary endpoints
- Detectable aSBP difference
- At least 5 mmHg
- Between-group difference the trial is designed to detect
- Presentation submission timing
- Q2 2027
- Primary endpoint results intended for late-breaking presentation consideration
Key Terms
double-blind medical
primary efficacy endpoint medical
statistical power technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 330 patients randomized as of September 30, 2026, surpassing full trial enrollment target
- Company reiterates prior guidance: primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027
- Data expected to support future marketing application submissions by Medtronic to the FDA and other global regulatory agencies
NEW HOPE, Pa., Oct. 01, 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 medical device companies, today announced that it has surpassed full enrollment in the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”), exceeding its previously announced target of 316 randomized patients. The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication. Hypertension is the most common modifiable risk factor for death worldwide and the most common comorbidity among the pacemaker population.1
The BACKBEAT Trial (NCT06059638) is being conducted with Medtronic plc (“Medtronic”), the Company's strategic collaborator for the BACKBEAT Trial and, subject to regulatory approval, for the commercialization of AVIM Therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication.
- As of September 30, 2026, 330 patients have been randomized in the BACKBEAT Trial at 81 sites across 13 countries.
- The BACKBEAT Trial’s protocol, approved by the U.S. Food and Drug Administration (the “FDA”), specifies 284 evaluable randomized subjects for the primary endpoint analysis, with a total enrollment target of 316 patients to account for potential loss to follow-up.
The BACKBEAT Trial is a global, multi-center, prospective, randomized, double-blind pivotal trial. Patients are randomized 1:1 to AVIM Therapy combined with continued medical therapy and pacing (treatment) or continued medical therapy and standard pacing alone (control). The primary efficacy endpoint of the BACKBEAT Trial is the between-group difference in the change in 24-hour ambulatory systolic blood pressure (“aSBP”) at three-month follow-up from pre-randomization baseline. The primary safety endpoint is freedom from unanticipated serious adverse device events in the AVIM Therapy arm at three-month follow-up. The protocol-specified sample size provides greater than
David Hochman, Chairman & Chief Executive Officer of Orchestra BioMed, commented, “Achieving and surpassing full enrollment of the BACKBEAT Trial is a defining milestone for Orchestra BioMed, for our collaboration with Medtronic and potentially for the millions of high cardiovascular risk patients who remain above blood pressure target despite the medications available to them today. We are grateful for and excited about the enrollment momentum built across our global trial site network over the last year. I want to thank the patients and their families who chose to participate, and the clinical teams and investigators at our trial sites globally whose commitment made this milestone possible. Our focus now turns to completing three-month follow-up, database lock, and the delivery of a rigorous, well-powered data set next spring.”
Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Electrophysiology Therapies operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. Reaching full enrollment in the BACKBEAT Trial brings us a big step closer to understanding whether AVIM Therapy can extend the role of cardiac pacing therapy to include hypertension management for patients at increased cardiovascular risk. We are proud of the collaborative work our team and Orchestra BioMed’s team have done alongside investigators around the world, and we look forward to the primary endpoint results.”
Vivek Reddy, M.D., Executive Chairman of the BACKBEAT Clinical Steering Committee, Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital and Director of Electrophysiology for the Mount Sinai Health System, commented, “Randomized, double-blind evidence is the highest standard by which a new therapeutic modality earns its place in clinical practice, and that is exactly what the BACKBEAT Trial was designed to generate. The pilot data for AVIM Therapy have been exciting, consistent and mechanistically coherent, but the field needs a pivotal trial to answer the question definitively. On behalf of the Steering Committee, I want to recognize the investigators, coordinators and other professionals whose work enabled the trial to reach full enrollment, and I look forward to seeing the three-month primary endpoint results.”
Clinical, Regulatory and Commercial Next Steps
Orchestra BioMed and Medtronic intend to submit the BACKBEAT Trial’s primary endpoint results for consideration as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Assuming positive results from the BACKBEAT Trial, Medtronic plans to submit AVIM Therapy marketing applications to the FDA and other global regulatory agencies promptly.
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 by 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 and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations 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. In MODERATO II, a double-blind, randomized pilot study, AVIM Therapy-treated patients had a mean reduction of 11.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) from pre-randomization baseline at six months, representing a net reduction of 8.1 mmHg versus control patients. At the same time point, the net reduction in office systolic blood pressure (oSBP) was 12.3 mmHg versus control.
Additional MODERATO II data showed an immediate mean oSBP reduction of 13.2 mmHg when AVIM Therapy was activated during setup before randomization, with
The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial 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 two Breakthrough Device Designations 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 timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of regulatory submissions, realizing the clinical and commercial value of the Company’s product candidates, the potential safety and efficacy of the Company’s product candidates, the size of the potential markets for 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, 2025, which was filed with the SEC on March 12, 2026.
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:
Nina Premutico
Orchestra BioMed
npremutico@orchestrabiomed.com
1 World Health Organization, Global Report on Hypertension 2025 (an estimated 1.4B adults aged 30–79 with hypertension in 2024,
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How many patients enrolled in Orchestra BioMed’s BACKBEAT trial?
330 patients had been randomized as of September 30, 2026, surpassing the target of 316 patients. Enrollment spanned 81 sites across 13 countries.
What are the primary endpoints in Orchestra BioMed’s BACKBEAT trial?
The primary endpoints measure blood-pressure change and device safety at three-month follow-up. Efficacy is the between-group difference in change from pre-randomization baseline in 24-hour ambulatory systolic blood pressure, measured during daily activities. Safety is freedom from unanticipated serious adverse device events in the AVIM Therapy arm.
How was Orchestra BioMed’s BACKBEAT trial sample size determined?
The FDA-approved protocol specifies 284 evaluable randomized subjects for primary endpoint analysis, with a 316-patient enrollment target allowing for potential loss to follow-up. The protocol-specified sample size provides greater than 90% statistical power for both primary endpoints and is designed to detect a between-group blood-pressure difference of at least 5 mmHg.