BACKBEAT Timeline Update Reinforces Momentum to Pivotal Trial Data Presentation and Regulatory Submissions by Medtronic

Orchestra BioMed Investor Relations Blog | May 2026

Orchestra BioMed recently announced updates to the target timeline for the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”). These important updates provide clarity on the plan for pivotal data presentation as well as Medtronic’s FDA marketing application for Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension despite anti-hypertensive medications in patients who are also indicated for a pacemaker.

Our POV

Last week, we announced that we are targeting completion of enrollment in the BACKBEAT Trial by the end of the third quarter of 2026, as well as alignment with our strategic collaborator, Medtronic, to pursue a submission of primary endpoint results for a late-breaking presentation at a major cardiology conference in the second quarter of 2027, assuming primary endpoints are met.

The updated timeline is supported by FDA approval of a reduction in the BACKBEAT Trial sample size to a target of 284 evaluable randomized subjects, with a total enrollment target of 316 patients accounting for potential loss to follow-up. Importantly, the trial’s primary efficacy endpoint, measured by between-group difference in 24-hour ambulatory systolic blood pressure at three-month follow-up, and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at three-month follow-up) remain robustly powered (>90% statistical power) at the revised sample size. The revised sample size maintains greater than 90% statistical power for the primary endpoints and, with respect to efficacy, is designed to detect a between-group difference of at least 5 mmHg in 24-hour ambulatory systolic blood pressure. This means the streamlined trial design remains rigorously data-driven and appropriately sized to evaluate AVIM Therapy’s safety and efficacy.

This update reflects meaningful progress across the AVIM Therapy program, including continued global enrollment momentum, alignment with Medtronic on the anticipated regulatory timeline, and FDA approval of a protocol amendment that streamlines the trial’s sample size while maintaining strong statistical power for the primary safety and efficacy endpoints. It also reflects the importance of AVIM Therapy’s two FDA Breakthrough Device Designations given that the updated BACKBEAT Trial timeline communication was supported by FDA approval of the updated trial design following interactive discussions between FDA, Medtronic, and Orchestra BioMed under the provisions of the Breakthrough Device program.

Why It Matters: Clear Path Toward Pivotal Data

The BACKBEAT Trial is evaluating the safety and efficacy of AVIM Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medications — a population that already requires a permanent pacemaker implant and is also typically at increased risk from elevated systolic blood pressure for cardiovascular events (heart attack and/or stroke) and cardiovascular conditions (heart failure) despite existing treatment options.

Partnership-Driven Execution and Responsibility & Reward Sharing 

AVIM Therapy is being developed in collaboration with Medtronic, the global leader in cardiac pacing therapies, for the treatment of uncontrolled hypertension in patients who are indicated for a pacemaker. Through this collaboration, Orchestra BioMed is advancing a patented, first-of-its-kind therapeutic approach through a double-blind, randomized prospective global pivotal trial while leveraging Medtronic’s deep expertise and global commercial leadership in cardiac rhythm management and cardiac pacing therapy. 

The updated timeline reflects continued coordination among Orchestra BioMed, Medtronic and the FDA as we work toward completion of enrollment, analysis of pivotal data, and the potential future regulatory submission process. It also highlights key role and responsibility delineation in the framework of Orchestra BioMed’s strategic collaboration with Medtronic. Under the terms of the strategic collaboration agreement, Medtronic is responsible for global regulatory submissions in addition to device manufacturing and all commercial activities (sales, marketing, distribution and support). This planned shift in responsibility to Medtronic is central to Orchestra BioMed’s partnership-driven business model as is OBIO sharing meaningfully in Medtronic’s future AVIM Therapy-enabled device revenue through structured royalties. As previously communicated, Orchestra BioMed is expected to receive $500 to $1,600 from every AVIM Therapy-enabled device sold by Medtronic worldwide, assuming no changes to existing pacemaker device reimbursement worldwide.

Looking Ahead

With enrollment targeted for completion by the end of Q3 2026 and a planned late-breaking clinical trial submission in Q2 2027, the BACKBEAT Trial continues to represent a major value-driving opportunity for Orchestra BioMed.

More broadly, this update reinforces the Orchestra BioMed approach: advance high-impact cardiovascular technologies through rigorous clinical development, alignment with strategic partners to support future commercialization, and execution against milestones that can create meaningful value for patients, physicians, and shareholders.

- Team OBIO

Published May 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 enrollment, timing, implementation, results and design of the BACKBEAT Trial, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy, the potential safety and efficacy of AVIM Therapy, the ability of Medtronic to accelerate clinical development, and the benefits of the strategic partnership with 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.