Orchestra BioMed's AVIM therapy gets FDA Breakthrough Device Designation for hypertension.

Orchestra BioMed has received FDA Breakthrough Device Designation for AVIM therapy to treat uncontrolled hypertension in high cardiovascular risk patients. The company will host a satellite symposium at the Heart Rhythm Society conference, featuring presentations on clinical results demonstrating AVIM's ability to reduce systolic blood pressure and improve cardiac function. The symposium will also include a presentation on the ongoing BACKBEAT global pivotal study, a strategic collaboration with Medtronic.

Orchestra BioMed (Nasdaq: OBIO) has received FDA Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating uncontrolled hypertension in high cardiovascular risk patients. This designation, granted by the U.S. Food and Drug Administration (FDA), recognizes the potential of AVIM therapy to significantly improve outcomes for patients with serious or life-threatening conditions.

The AVIM therapy, delivered through an implantable pacemaker system, is designed for patients with preserved left ventricular systolic function and uncontrolled hypertension, despite using anti-hypertensive medications. The FDA Breakthrough Device Designation (BDD) applies to an estimated 7.7 million U.S. patients, significantly expanding the potential market beyond just pacemaker-indicated patients.

The BDD status provides tangible benefits, including accelerated FDA review timelines, enhanced agency communication, and priority processing. Additionally, it opens up premium reimbursement pathways through Medicare's New Technology Add-on Payment (NTAP) and Transitional Pass-Through payment programs, which can overcome initial reimbursement hurdles for innovative medical technologies.

The BACKBEAT global pivotal study, a strategic collaboration with Medtronic (NYSE: MDT), is currently enrolling pacemaker-indicated patients with uncontrolled hypertension. The study aims to demonstrate AVIM therapy's ability to reduce systolic blood pressure and improve cardiac function. The symposium at the Heart Rhythm Society conference will feature presentations on the clinical results and the ongoing BACKBEAT study.

Orchestra BioMed's strategic collaboration with Medtronic, the global leader in cardiac rhythm management, provides valuable development support and commercial infrastructure for AVIM therapy. Medtronic holds the right of first negotiation to expand its licensing agreement beyond the initial pacemaker patient focus to the broader hypertension market, potentially transforming the commercial opportunity.

The addressable market is substantial, with 7.7 million potential U.S. patients meeting the BDD criteria. The AVIM approach using conduction system pacing represents a novel device-based intervention for hypertension, traditionally managed pharmaceutically. This creates a differentiated therapeutic option for patients with medication options or medication intolerance.

While commercial revenue remains dependent on successful clinical outcomes and regulatory clearance, the BDD status enhances both regulatory and reimbursement pathways, which will ultimately determine market adoption of this innovative therapeutic approach.

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[1] https://www.stocktitan.net/news/OBIO/orchestra-bio-med-receives-fda-breakthrough-device-designation-for-dw5cdbljldpd.html