BACKBEAT Pivotal Trial Surpasses Full Enrollment: A Defining Milestone for AVIM Therapy

Orchestra BioMed Investor Relations Blog | October 2026

With 330 patients randomized across 81 sites in 13 countries, the BACKBEAT Global Pivotal Trial has surpassed its full enrollment target, moving AVIM Therapy toward primary endpoint data expected in the second quarter of 2027.

Our POV

Last week, Orchestra BioMed announced that the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) has surpassed its full enrollment goal, with 330 patients randomized as of September 30, 2026, against a previously announced target of 316. The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients whose blood pressure remains uncontrolled despite medication. The trial is being conducted with Medtronic, the global leader in cardiac pacing therapies and our strategic collaborator for both the trial and, subject to regulatory approval, the commercialization of AVIM Therapy in this patient population.

Exceeding full enrollment marks the transition from securing sufficient patient participation in the trial to delivering the pivotal data, expected in Q2 2027, that can support marketing application submissions to the FDA and other global regulatory agencies by Medtronic. We are profoundly grateful to the patients and families who chose to participate and to the investigators, coordinators and clinical teams whose commitment made this possible.

The BACKBEAT Trial: Path to Pivotal Data and Medtronic Regulatory Submissions

• 330 randomized patients recruited from 81 sites across 13 countries

• Greater than 90% statistical power for both 3-month primary efficacy and safety endpoints

• Primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027

• Medtronic marketing submissions to FDA and global regulatory agencies promptly thereafter

Why It Matters: The Patient Need

Hypertension is the #1 modifiable risk factor for death worldwide, affecting as many as 1.4 billion adults. It is also the most common comorbidity among pacemaker patients, affecting as many as 85% of that patient population. Despite available medications, a large percentage of patients remain above blood pressure target, and this problem is especially pronounced in the older, higher-risk population that receives pacemakers.

AVIM Therapy is designed to address this gap by adding new therapeutic capabilities to the pacemaker these patients already need. It delivers a bioelectronic treatment that is designed to lower blood pressure immediately, substantially and persistently, independent of medication adherence. The FDA has granted AVIM Therapy two Breakthrough Device Designations.

As Medtronic’s Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Electrophysiology Therapies operating unit, observed, “the trial brings the field a step closer to understanding whether cardiac pacing can extend into hypertension management for these patients.”

Partnership-Driven Execution

Reaching this milestone shows the Orchestra BioMed–Medtronic strategic collaboration working in practice. Our team developed AVIM Therapy and built the IP estate comprising approximately 150 issued patents globally. We also led the design and clinical execution of the BACKBEAT Trial, while the global Medtronic presence in cardiac pacing helped build and support the site network. Medtronic will be positioned to drive global regulatory approvals, commercial manufacturing, and commercialization worldwide, assuming the trial results are positive. This is the partnership model Orchestra BioMed was built on: pairing our entrepreneurial development capabilities with a market leader’s commercial infrastructure to accelerate the delivery of a potentially potent new therapy to patients.

Looking Ahead

Our focus now turns to completing three-month follow-ups for all randomized patients, locking the database, and delivering a rigorous, well-powered data set. Following the planned late-breaking presentation in the second quarter of 2027, Medtronic intends to promptly submit marketing applications for AVIM Therapy to the FDA and other global regulatory agencies.

Completing enrollment of the BACKBEAT Trial is a major milestone that matters for Orchestra BioMed, for our collaboration with Medtronic, and potentially for the millions of patients with uncontrolled hypertension. We look forward to the next major milestone of pivotal trial data as well as the many more value-creating events that can follow.

- Team OBIO
Published October 2026

Forward-Looking Statements

Certain statements included in the content contained in or accessible through this blog post (the “Content”) 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 of the reporting of primary endpoint results from the BACKBEAT Trial; the timing and outcome of any conference presentation and regulatory submissions; the potential safety and efficacy of AVIM Therapy; the size of the potential market for AVIM Therapy; the realization of the clinical and commercial value of the Company’s product candidates; the ability of the Company’s partnerships to accelerate clinical development; and the benefits of the strategic partnership between the Company and Medtronic. These statements are based on various assumptions, whether or not identified in the Content, 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 the Content. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made in the Content, except as required by law.