The U.S. Food and Drug Administration has approved Axogen’s Avance Nerve Graft for repairing damaged peripheral nerves, granting the product potential twelve-year market exclusivity as commercial sales target early 2026.
FDA Grants Approval for Nerve Repair Biologic
The FDA said Wednesday that it approved Axogen Inc.’s human tissue–based Axogen’s Avance Nerve Graft for treating sensory nerve discontinuities in adults and children as young as one month. The decision shifts the product from its earlier classification as donated human tissue to a biologic regulated under the agency’s Center for Biologics Evaluation and Research.
Axogen confirmed the approval in a separate statement, noting that Avance will continue to be available under existing tissue rules until licensed commercial sales begin in the early second quarter of 2026.
“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.
Product Aims to Reduce Surgeries and Complications
Avance is designed to repair damaged peripheral nerves without requiring a second surgery to harvest a patient’s own nerve tissue. The graft uses donor nerve tissue processed to remove cells while preserving the natural structure needed for nerve regeneration.
“Axogen’s Avance Nerve Graft can bridge gaps in damaged nerves and support nerve function restoration,” said Vinay Prasad, chief medical and scientific officer and director of the FDA’s Center for Biologics Evaluation and Research.
Current alternatives, such as autografts that use a patient’s own healthy nerve from another body part, can lead to added pain and complications, clinicians say. Analysts expect the biologic designation to support broader insurance coverage and greater adoption as surgeons seek options that avoid additional incisions.
Market Impact and Clinical Need
With approval secured, Axogen may receive up to twelve years of market exclusivity in the United States, a period that could influence competition and pricing in the peripheral nerve repair sector. The company said expanded access may help standardize the treatment as more physicians adopt biologic grafts.
Peripheral nerve injuries, which affect nerves outside the brain and spinal cord, interrupt signals that control movement, sensation, and bodily functions. These injuries can cause pain, numbness, weakness, and loss of function, often requiring intervention to restore mobility and reduce long-term impairment.
Axogen’s Avance Nerve Graft’s entry into the regulated biologics market is expected to shape future approaches to nerve repair as the company prepares manufacturing and distribution for its 2026 launch.
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