Orchestra BioMed receives Breakthrough Device Designation for its hypertension therapy

Orchestra BioMed therapy receives FDA designation: ©Arakillustrations - stock.adobe.com

Orchestra BioMed Holdings Inc. (Nasdaq: OBIO) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its atrioventricular interval modulation (AVIM) therapy, a novel pacemaker-based treatment aimed at reducing blood pressure in patients with uncontrolled hypertension and elevated cardiovascular risk.

The designation applies to an implantable system using conduction system pacing to deliver AVIM therapy. It targets patients with preserved left ventricular systolic function who continue to experience high blood pressure despite medication, or who are unable to tolerate standard anti-hypertensive drugs. Orchestra BioMed estimates that more than 7.7 million Americans may be eligible under these criteria.

“We are delighted to have received FDA Breakthrough Device Designation for AVIM therapy which has the potential to offer a differentiated, advantageous solution for hypertension management in a broad population,” said David Hochman, chairman and CEO of Orchestra BioMed. “The FDA Breakthrough Device Designation recognizes the potential of this unique therapy to benefit a significantly expanded number of patients who are not indicated for a pacemaker but who also have uncontrolled hypertension and increased cardiovascular risk.”

AVIM therapy is currently under evaluation in the BACKBEAT global pivotal study, conducted by Orchestra BioMed in collaboration with Medtronic. The study is enrolling patients already indicated for pacemaker implantation who also suffer from uncontrolled hypertension — a key subgroup for which the company believes the therapy may offer the most significant clinical benefits.

Robert C. Kowal, MD, vice president and general manager of Cardiac Pacing Therapies at Medtronic, said: “We are very pleased that AVIM therapy received Breakthrough Device Designation, a recognition of the potential of AVIM therapy to address unmet needs in hypertension management. Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population.”

The FDA’s Breakthrough Devices Program is intended to expedite the development and review of medical technologies that offer significant advantages over existing treatments for serious or life-threatening conditions. The designation also opens potential pathways for enhanced reimbursement through Medicare programs, such as the New Technology Add-on Payment and Transitional Pass-Through payments, which could speed adoption and access.

Orchestra BioMed and Medtronic entered into a strategic partnership to co-develop and potentially commercialize AVIM therapy for patients with pacemaker indications. Medtronic retains the right of first negotiation to expand this collaboration to patients without pacemaker needs—a far broader market, should clinical results continue to be favorable.

With the FDA’s designation now in hand, Orchestra BioMed aims to work closely with regulators and its industry partners to accelerate AVIM therapy’s path toward broader clinical use.