FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy

Atrioventricular Interval Modulation (“AVIM”) Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk and the specific pacemaker-indicated population being evaluated in the BACKBEAT Trial The addressable U.S. patient population for AVIM Therapy, based on the indications for use specified in its Breakthrough Device Designations, comprises over 7.7 million adults with hypertension despite medication Breakthrough Device Designation supports favorable reimbursement pathways, including potential eligibility for New Technology Add-on Payment (“NTAP”) and Transitional Pass-Through (“TPT”) payment, which can facilitate broader, more timely patient access and provider adoption NEW HOPE, Pa., April 30, 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 global medical device companies, today announced that the FDA has granted a second Breakthrough Device Designation (“BDD”) for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.