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Orchestra BioMed Hits A High Note On Breakthrough Device Designation For AVIM Therapy

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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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