NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) said the U.S. Food and Drug Administration granted a second Breakthrough Device Designation for its AVIM Therapy, expanding its potential use to patients with uncontrolled hypertension despite medication who also require a pacemaker.
The company announced that the designation complements an earlier Breakthrough Device Designation and together covers both a broader population of patients with uncontrolled hypertension at elevated cardiovascular risk and the pacemaker-indicated population being studied in the BACKBEAT global pivotal trial.
AVIM Therapy is being developed in collaboration with Medtronic (NYSE: MDT), which holds rights to commercialize the therapy in pacemaker-indicated patients and retains a right of first negotiation to expand those rights to broader hypertension populations.
The company said the combined indications represent an addressable U.S. population of more than 7.7 million adults with hypertension that remains uncontrolled despite medication.
The FDA’s Breakthrough Devices Program is intended to expedite development and review of technologies that may provide more effective treatment for serious or life-threatening conditions.
The designation may also support access to reimbursement pathways, including New Technology Add-on Payment and Transitional Pass-Through programs, which can accelerate provider adoption and patient access.
Chief Executive Officer David Hochman said the designation aligns with the population being studied in the BACKBEAT trial and supports the company’s clinical and regulatory strategy.
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