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Yesterday’s FDA Breakthrough Device Designation News

Apr 23, 2025 4:45:00 AM / by Orchestra BioMed posted in Regulatory

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OBIO | YESTERDAY’S FDA BREAKTHROUGH DEVICE DESIGNATION NEWS

Yesterday, we shared exciting news that Orchestra BioMed has been awarded FDA Breakthrough Device Designation for our novel AVIM therapy. If you missed the announcement, here’s a quick overview of this significant clinical and regulatory milestone:

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AVIM Therapy Breakthrough Device Designation Shareholder Implications

Apr 22, 2025 2:30:00 AM / by Orchestra BioMed posted in Regulatory

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OBIO | AVIM Therapy Breakthrough Device Designation Shareholder Implications

This week marks a major milestone for Orchestra BioMed that has potentially significant implications for the commercial potential of AVIM therapy that OBIO is pursuing with its strategic partner, Medtronic.

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