The US Food and Drug Administration has authorized a Biologics License Application for Avance, an acellular nerve allograft developed to support reconstruction of sensory, mixed, and motor peripheral nerve gaps in patients as young as 1 month. The agency granted accelerated approval for sensory nerve gaps greater than 25 mm and for mixed and motor nerve discontinuities, supported by static 2-point discrimination outcomes in smaller sensory gaps that were determined to reasonably predict clinical benefit based on shared pathophysiology. Continued approval will require confirmatory evidence from post-marketing clinical studies.

Commercial distribution of the licensed product is expected in the second quarter of 2026. Until that time, Avance will continue to be supplied under the existing tissue framework.

The product’s safety profile includes procedural risks such as pain, hyperesthesia, infection, implant-site swelling, impaired sensory or motor function, bleeding, hypertrophic scarring, and neuroma formation. As a human tissue–derived product, Avance carries a theoretical risk of transmitting infectious agents, including viral pathogens and prion diseases. Reported adverse events occurring in at least 2% of patients included procedural pain at 4% and hyperesthesia at 3%.

Source: Axogen