FDA Expands Breakthrough Designation for Orchestra BioMed's AVIM Therapy — Orchestra BioMed Holdings, Inc.

Event summary

FDA granted Orchestra BioMed a second Breakthrough Device Designation for AVIM Therapy, expanding its use to patients with uncontrolled hypertension despite medication and an indication for a pacemaker.
The addressable U.S. patient population for AVIM Therapy is 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.
Orchestra BioMed is conducting the BACKBEAT Global Pivotal Trial in collaboration with Medtronic to evaluate AVIM Therapy's safety and efficacy.

The big picture

Orchestra BioMed's expanded Breakthrough Device Designation for AVIM Therapy positions it to address a significant unmet need in hypertension treatment. The strategic collaboration with Medtronic, a global leader in cardiac pacing therapies, enhances its ability to navigate regulatory hurdles and accelerate commercialization. This development underscores the growing importance of bioelectronic therapies in managing cardiovascular diseases.

What we're watching

Regulatory Advantage: How the expanded Breakthrough Device Designation will accelerate AVIM Therapy's regulatory approval and market access.
Commercialization Pathway: Whether the favorable reimbursement pathways will facilitate broader adoption of AVIM Therapy by healthcare providers.
Clinical Trial Progress: The pace at which the BACKBEAT Global Pivotal Trial progresses and its potential impact on AVIM Therapy's commercialization strategy.