Axogen, Inc. (NASDAQ: AXGN) received FDA approval for the Biologics License Application for AVANCE, an acellular nerve scaffold for peripheral nerve discontinuities.
The approval signifies a shift from historical classification to a biologic, strengthening regulatory footing.
Commercial availability of AVANCE is expected in the second quarter of 2026.
FDA Approval
FDA approved the BLA for AVANCE for sensory, mixed, and motor peripheral nerve discontinuities.
Commercial Availability
AVANCE product expected to be commercially available in early second quarter of 2026.
Safety Information
Warnings include monitoring for procedural complications and potential transmission of infectious diseases.
- The FDA approval of AVANCE marks a significant milestone for Axogen, positioning AVANCE as a viable therapeutic option for nerve repair.
- The shift in classification to a biologic highlights the rigorous evaluation of AVANCE for safety and efficacy.
- The approval opens new opportunities for Axogen's present nerve repair use cases.
The approval of the BLA for AVANCE represents a major achievement for Axogen, paving the way for enhanced patient care and treatment options in peripheral nerve repair.