Shares of Orchestra BioMed Holdings Inc. (OBIO) are up over 30% at $3.90 in premarket trading Tuesday, on news of the FDA granting Breakthrough Device Designation for atrioventricular interval modulation therapy.
The AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in a global pivotal study, dubbed BACKBEAT, which is being conducted by Orchestra BioMed in collaboration with Medtronic plc (MDT).
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