Orchestra BioMed gets FDA Breakthrough Device Designation for AVIM therapy and IDE approval for Virtue SAB trial

Orchestra BioMed Holdings, Inc.

FDA granted Breakthrough Device Designation for AVIM therapy; covers >7.7M U.S. hypertension patients.
AVIM therapy BDD may expedite FDA review and support higher reimbursement (NTAP/TPT).
FDA approved IDE amendment for Virtue SAB randomized trial vs AGENT paclitaxel DCB for coronary ISR.
Virtue Trial plans 740 patients across 75 U.S. centers; targeting H2 2025 start.
Virtue SAB pilot showed 12-month TLF 2.8% and 6-month late lumen loss 0.12mm.

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