Orchestra BioMed Targeting BACKBEAT Trial Enrollment Completion By End of Q3 2026 and Data Presentation in Q2 2027
- Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026
- Orchestra BioMed and Medtronic plc, the Company’s strategic collaborator for the BACKBEAT Trial, intend to submit primary endpoint results for consideration as a late-breaker at a major cardiology conference in Q2 2027
- Medtronic plans to submit AVIM Therapy-related marketing application for FDA approval after primary endpoint data analyses and reports are complete and pursue subsequent global regulatory approvals, assuming primary safety and efficacy endpoints are met
NEW HOPE, Pa. -- Orchestra BioMed Holdings, Inc., a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, announced an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy (AVIM Therapy) in pacemaker-indicated patients with uncontrolled hypertension despite medications. The Company is targeting completion of enrollment by the end of the third quarter of 2026. Further, the Company and Medtronic, its strategic collaborator for the BACKBEAT Trial and the commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, plan to submit the primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Lastly, assuming primary safety and efficacy endpoints are met, Medtronic plans to submit a marketing application for FDA approval after primary endpoint data analyses and reports are complete, and subsequently to pursue global regulatory approvals.
The updated BACKBEAT Trial timeline is supported by FDA approval of a reduction in the sample size for the clinical trial to a target total of 284 evaluable randomized subjects with the total enrollment target of 316 patients accounting for potential loss to follow up. The primary efficacy endpoint (between-group difference in 24-hour ambulatory systolic blood pressure “aSBP" at 3-month follow up) and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at 3-month follow up) remain robustly powered (>90% statistical power) at the revised sample size for the trial. The sample size is designed to detect a between group difference of at least 5 mmHg in aSBP. The change in sample size reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, and follows FDA approval of an amendment to the BACKBEAT Trial protocol received on May 8, 2026 by Orchestra BioMed.
David Hochman, Chairman, Chief Executive Officer of Orchestra BioMed, commented, “We are delighted to provide clarity on the anticipated overall timeline for the BACKBEAT Trial, which reflects ongoing global enrollment momentum and FDA alignment with a streamlined sample size that remains highly powered to assess AVIM Therapy’s efficacy and safety at the 3-month primary endpoints. We believe BACKBEAT has the potential to be a landmark pivotal trial that can open up an entirely new therapeutic modality for patients at increased risk from high blood pressure and hypertensive heart disease.”
Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Cardiac Rhythm Management operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. With the BACKBEAT Trial, Medtronic and Orchestra BioMed are investigating whether AVIM Therapy can extend the benefits of pacing to the field of hypertension management in high-risk patients. This update reflects our shared confidence in progress toward the completion of enrollment, the submission of data to the FDA, and the presentation of clinical evidence.”
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. 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 two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
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