Orchestra BioMed exceeds enrollment in BACKBEAT pivotal trial of AVIM Therapy

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EX-99.1 2 tm2626728d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy · 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. 1, 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 (NYSE: MDT, “Medtronic”), the Company's strategic collaborator for the BACKBEAT T

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