Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

Core Insights - The FDA has approved the Biologics License Application for Axogen's AVANCE, an acellular nerve allograft, marking a significant regulatory milestone for the company [1][4] - AVANCE is indicated for treating sensory, mixed, and motor peripheral nerve discontinuities in patients aged 1 month or older [2][5] - The approval was granted under the FDA's Accelerated Approval pathway, contingent upon confirmatory studies to verify clinical benefits [3][6] Company Overview - Axogen, Inc. is focused on developing and commercializing technologies for peripheral nerve repair, aiming to establish nerve repair as a standard of care [7] - The company's product portfolio includes AVANCE, Axoguard Nerve Connector, Axoguard Nerve Protector, and others, available in multiple countries [8] Regulatory and Market Implications - The transition of AVANCE to a biologic classification strengthens Axogen's regulatory position and confirms its therapeutic use for peripheral nerve discontinuities [4] - Commercial availability of AVANCE is expected in early Q2 2026, while it remains available under the current tissue framework until then [4][6]