Wedoany.com Report-Dec.4, The U.S. Food and Drug Administration announced on Wednesday that it has granted approval to Axogen's Avance Nerve Graft, a biologic product for peripheral nerve repair. The approval provides the potential for up to 12 years of market exclusivity in the United States.

Avance Nerve Graft is a processed human nerve allograft that helps restore function in damaged peripheral nerves without the need for surgeons to remove healthy nerve tissue from another site on the patient's body. This approach aims to reduce surgical complications and support quicker recovery times.

Axogen stated that commercial sales of the newly licensed version of Avance are scheduled to start in the early part of the second quarter of 2026. In the meantime, the product will remain available under its current regulatory framework.

Previously supplied as human tissue, Avance has now been officially classified by the FDA as a biologic. The approval covers its use for repairing sensory nerve discontinuities in adult patients and in children as young as one month old.

"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.

The new status is expected to facilitate broader insurance reimbursement and encourage wider adoption by medical professionals as a standard option for peripheral nerve repair procedures.

Vinay Prasad, chief medical and scientific officer and director of the FDA's Center for Biologics Evaluation and Research, explained: "Avance can bridge gaps in damaged nerves and support nerve function restoration."

Traditional treatment often involves autografts, where surgeons harvest nerve tissue from elsewhere in the patient’s body. That method can lead to additional pain, longer operating times, and potential loss of function at the donor site.

Peripheral nerves transmit signals between the brain, spinal cord, and the rest of the body, controlling movement, sensation, and various organ functions. Damage to these nerves may result in pain, numbness, muscle weakness, or impaired mobility in the affected areas.

The FDA approval marks an important advancement in regenerative medicine for nerve injuries caused by trauma, surgery, or other medical conditions. By offering a ready-to-use, off-the-shelf alternative to autografts, Avance aims to simplify procedures and improve patient outcomes across a wide range of clinical scenarios.

Axogen plans to work closely with healthcare providers and payers following the approval to ensure smooth transition to the biologic version and to expand access for patients who may benefit from this treatment option. The company views the decision as a key milestone that strengthens its leadership position in the field of peripheral nerve repair solutions.