Axogen receives FDA approval of BLA for Avance nerve allograft under Accelerated Approval pathway

Axogen, Inc.

FDA approved Biologics License Application for Avance (acellular nerve allograft) for sensory, mixed, motor nerve discontinuities in adults and pediatric patients 1 month+.
Indications for sensory gaps >25mm and mixed/motor gaps approved under Accelerated Approval pathway; continued approval depends on confirmatory studies.
Commercial launch of licensed Avance expected early Q2 2026; product remains available under current tissue framework until then.
CEO Michael Dale says approval strengthens regulatory footing and confirms Avance as safe, pure, potent therapeutic option.

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