By Rob Curran
Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing for a speedier review.
The New Hope, Pa., company said Tuesday it received the FDA's Breakthrough Device Designation for an atrioventricular interval modulation therapy. Orchestra's device is an implantable pacemaker that uses conduction-system pacing to reduce high blood pressure in patients with uncontrolled hypertension, increased risk of an artery-hardening condition, and certain heart problems.
Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the device use described in the FDA's designation.
"Patients at higher risk for mortality and morbidity associated with high blood pressure are the core of the population we are actively enrolling in the Backbeat global pivotal study of hypertensive pacemaker-indicated patients in collaboration with Medtronic," said Chairman and Chief Executive David Hochman in a statement.
Orchestra BioMed has a partnership with pacemaker producer Medtronic for development and commercialization of AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients.
Shares of Orchestra rose 30% to $3.70 premarket.
Write to Rob Curran at rob.curran@dowjones.com
(END) Dow Jones Newswires
April 22, 2025 08:02 ET (12:02 GMT)
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