Overview
- Avance is authorized for adult and pediatric patients aged one month and older to treat sensory, mixed, and motor peripheral nerve discontinuities.
- Indications for sensory gaps longer than 25 mm and for mixed and motor nerves were cleared under the FDA’s Accelerated Approval pathway with confirmatory studies required to verify clinical benefit.
- Axogen expects the licensed product to be commercially available in early second quarter 2026, while Avance remains available under the current tissue framework until then.
- The donor-derived scaffold is designed to bridge nerve gaps without harvesting a patient’s own nerve, using processed human nerve tissue that preserves structure for regeneration.
- Product labeling warns of potential transmission of infectious agents from human tissue and lists procedural pain and hyperesthesia as the most common adverse reactions, and analysts say approval could enable up to 12 years of U.S. market exclusivity.