FDA approves Axogen’s nerve repair graft

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Dec 3 (Reuters) – The U.S. Food and Drug Administration has approved Axogen’s nerve repair graft, the health regulator said on Wednesday, paving the way for 12 years of potential market exclusivity in the United States.

Axogen’s Avance Nerve Graft, a human tissue-based product, is designed to repair damaged peripheral nerves without requiring a second surgery to harvest nerve tissue from the patient, thereby reducing complications and supporting faster recovery.

Commercial sales of the licensed Avance product are expected to begin in the early second quarter of 2026. Until then, Avance will continue to be offered under the existing tissue framework, surgical technology company Axogen said in a separate release, confirming the FDA’s approval.

Unlike traditional treatments that require surgeons to harvest healthy nerve tissue from another part of the patient’s body, Avance uses donor nerve tissue that has been carefully processed to remove cells while preserving the natural structure essential for nerve regeneration.

The treatment was previously classified as donated human tissue, but with the FDA approval it will now be considered for the treatment of sensory nerve discontinuities in adults and pediatric patients aged one month and older.

“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,” Axogen CEO Michael Dale said.

The approval could give Avance 12 years of market exclusivity in the U.S. and enable expanded insurance coverage as more doctors begin using it as a standard treatment for peripheral nerve repair, analysts have said.

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

Current alternatives to Avance Nerve Graft include autografts, where surgeons use a patient’s own nerve from another body part to treat damaged peripheral nerves, which can cause additional pain and complications.

Peripheral nerve injuries are damage to the nerves outside the brain and spinal cord. The nerves carry signals between the brain, spinal cord, and the rest of the body, controlling movement, sensation, and bodily functions.

Injury to peripheral nerves can cause symptoms such as pain, numbness, weakness, and loss of function in the affected areas.

(Reporting by Sriparna Roy, Padmanabhan Ananthan and Puyaan Singh in Bengaluru; Editing by Sherry Jacob-Phillips)