The U.S. Food and Drug Administration has approved Axogen’s Avance Nerve Graft, a milestone that gives the regenerative medicine company up to 12 years of potential market exclusivity in the U.S. The product, made from processed human donor tissue, is designed to repair damaged peripheral nerves without the need for harvesting nerve tissue from the patient, a major advancement in nerve surgery.

Avance is the first nerve repair graft of its kind to be classified as a biologic rather than as human tissue. This shift opens the door to broader reimbursement and clinical adoption. 

“This approval represents a meaningful shift from our historical classification as a human tissue product and brings the product in line with the FDA’s classification of Avance as a biologic,” said Axogen CEO Michael Dale.

According to the FDA, Avance works by using donor nerve tissue that has been specially processed to remove cells while maintaining the natural scaffolding needed for regeneration. 

“Avance can bridge gaps in damaged nerves and support nerve function restoration,” said Vinay Prasad, chief medical and scientific officer at the FDA’s Center for Biologics Evaluation and Research.

The agency approved Avance to treat sensory nerve discontinuities in both adults and children as young as one month old. Axogen said commercial sales of the licensed product will begin in early Q2 2026, though it will continue to be offered under current tissue regulations until then.

Peripheral nerve injuries affect the nerves outside the brain and spinal cord, often causing pain, numbness, and muscle weakness. Traditional treatments rely on autografts, transplanting a patient’s own nerves, which can lead to pain and complications from additional surgery. By eliminating that step, Avance may reduce recovery time and risks, potentially setting a new standard for peripheral nerve repair. Analysts expect that FDA approval and exclusivity could allow Axogen to expand insurance coverage and adoption in hospitals nationwide.

Citations:

Reuters. “FDA approves Axogen's nerve repair graft.” Reuters, 3 December 2025, https://www.reuters.com/business/healthcare-pharmaceuticals/fda-approves-axogens-nerve-repair-graft-2025-12-03/. Accessed 3 December 2025.