Orchestra BioMed Holdings, Inc. (OBIO) Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its atrioventricular interval modulation (AVIM) therapy. The company's shares were more than 25% up in pre-market.
BDD status provides accelerated FDA engagement and reviews for AVIM therapy. It also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future.
The BDD is for a pacemaker to deliver AVIM therapy to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease (ASCVD) risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications, the company said in a statement.
AVIM therapy is currently being evaluated in the BACKBEAT pivotal study conducted in partnership with Medtronic.
Orchestra BioMed stock had closed at $2.85, down 0.35% on Monday. It has traded in the range of $2.49-$8.87 in the last 1 year.
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