Orchestra BioMed Announces Second FDA Breakthrough Device Designation For AVIM Therapy Specific To Patients With Uncontrolled Hypertension Despite Use Of Medications, Along With An Indication For A Pacemaker

Together, the two BDDs for AVIM Therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT Global Pivotal Trial ("BACKBEAT Trial"), which Orchestra BioMed is conducting in collaboration with Medtronic (NYSE:MDT). This additional BDD supports strategic optionality for the clinical, regulatory and commercial reimbursement strategies for AVIM Therapy for both the pacemaker population and potential future expansion populations with uncontrolled hypertension and increased cardiovascular risk.

"We are pleased to receive this additional Breakthrough Device Designation from the FDA. We believe it is directly aligned with the patient population being studied in our ongoing BACKBEAT Trial which we are executing in collaboration with Medtronic," said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. "Continued alignment from the FDA, alongside our strategic relationship with Medtronic and accelerated enrollment in the BACKBEAT Trial, puts us in a strong position to advance AVIM Therapy to pivotal trial results."

Orchestra BioMed has a strategic collaboration with Medtronic, the global market leader in cardiac pacing therapies, for development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. Under the terms of the existing collaboration agreement, Medtronic holds the right of first negotiation to expand its licensing agreement with Orchestra BioMed to obtain global rights to commercialize AVIM Therapy for the treatment of uncontrolled hypertension in patients that do not have an indication for a pacemaker.

The FDA Breakthrough Devices Program, which reflects the FDA's commitment to device innovation and protecting public health, is designed to expedite the development of and provide priority review for innovative medical technologies that have the potential to significantly improve outcomes for patients with serious or life-threatening conditions. To be eligible for this designation, a device must demonstrate the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. In addition, the device must meet at least one of the following criteria: it must represent breakthrough technology, have no approved or cleared alternatives, offer significant advantages over existing options, or be determined by the FDA to be in the best interest of patients.

Beyond regulatory acceleration, the BDD may also support favorable reimbursement pathways, including eligibility for incremental inpatient reimbursement through the New Technology Add-on Payment and outpatient Transitional Pass-Through payments under the Centers for Medicare & Medicaid Services programs. These mechanisms may help facilitate more timely access to breakthrough technologies while supporting provider adoption and patient access.