Orchestra BioMed shares surge on FDA breakthrough designation

Investing.com -- Shares of Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO) soared over 30% after the company announced receiving the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy. The designation is expected to expedite the development and review process for AVIM therapy, which is designed to reduce blood pressure in patients with uncontrolled hypertension.

The FDA’s recognition comes as a significant endorsement of AVIM therapy’s potential to improve treatment for over 7.7 million U.S. patients with increased cardiovascular risk and uncontrolled hypertension. AVIM therapy is currently under evaluation in the BACKBEAT global pivotal study, in collaboration with Medtronic , plc (NYSE:MDT), focusing on patients with uncontrolled hypertension despite medication use.

The breakthrough designation is particularly noteworthy as it not only accelerates FDA engagement but also opens potential pathways for higher reimbursement levels for AVIM-enabled devices in the future. This could facilitate more timely access to the technology and support provider adoption and patient access.

David Hochman, Chairman and CEO of Orchestra BioMed, expressed the company’s delight at receiving the designation, highlighting the potential of AVIM therapy to offer a differentiated solution for hypertension management in a broad population. The FDA’s Breakthrough Devices Program aims to support the development of medical technologies that can significantly improve patient outcomes for serious or life-threatening conditions.

Orchestra BioMed’s strategic collaboration with Medtronic, a leader in cardiac pacing therapies, aims to develop and commercialize AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. With Medtronic’s right of first negotiation to expand its licensing agreement, the partnership could potentially extend to global commercialization rights for AVIM therapy in the broader hypertensive patient population without pacemaker indications.

The breakthrough designation could also support favorable reimbursement pathways, including eligibility for increased inpatient reimbursement through the New Technology Add-on Payment (NTAP) and outpatient Transitional Pass-Through payments (TPT) under Center for Medicare & Medicaid Services (CMS) programs.

The FDA’s Breakthrough Device Designation represents a key milestone for Orchestra BioMed as it continues to work closely with the FDA, Medtronic, and the clinical community to maximize the impact of AVIM therapy on hypertension management.

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