Avance Repairs Peripheral Nerves Biologically

Avance received FDA approval in December 2025 for treating nerve injuries in children and adults.

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Avancenervegraft

The Peripheral Nerve Injury Problem

Peripheral nerve injuries affect hundreds of thousands of people every year. Trauma, surgery, tumors, diabetes, infections, and chemical exposure can damage peripheral nerves. These nerves carry signals between the brain and the rest of the body. When a nerve breaks or a gap forms, sensation and movement can be lost. A finger might become numb. An arm might weaken. A limb might lose protective sensation, making infection and injury more likely.

Historically, treatment options were limited. Surgeons could try to reconnect nerves directly or use autografts. Autografts are nerve segments taken from the patient's own body. But autografts require a second surgery. They sacrifice function at the site where tissue was removed. They work poorly for large gaps. They don't work when the patient lacks healthy nerve tissue to use.

For decades, patients with nerve gaps had few options. On December 3, 2025, the FDA approved Avance, an acellular nerve scaffold made by Axogen. This approval is significant. Avance is now available for nerve gaps in adults and children as young as one month old.

How Avance Supports Nerve Regeneration

Avance is made from human donor nerve tissue. It goes through a special processing method. This processing removes cells and cellular debris that could cause rejection. It keeps the three-dimensional structure of the nerve. The result is a biologic scaffold with tiny hollow channels called endoneurial tubes. These tubes guide new nerve fibers as they grow across the injury gap.

Beyond the structural support, Avance contains bioactive laminin. Laminin is a protein found naturally in nerve tissue. It actively promotes nerve fiber growth. Laminin binds to growing nerve fibers and allows them to extend through the scaffold.

The processing also removes growth-inhibiting molecules called chondroitin sulfate proteoglycans. Laboratory and animal studies show that removing these molecules increased axon regeneration. Nerve fibers could grow through longer distances.

Axogen tests the quality of each Avance graft carefully. Histology assays confirm that cellular debris is removed. Testing verifies endoneurial tube size and quality. A proprietary bioassay confirms that laminin remains active and potent.

Clinical Evidence From Rigorous Trials

Avance's FDA approval was supported by clinical evidence. The RECON trial studied 220 patients with nerve injuries. The trial measured sensory function using a two-point discrimination test. This test checks whether patients can feel two separate touch points.

Twelve months after nerve repair with Avance, patients showed improvement in sensation. This clinical evidence supported FDA approval for multiple uses. Avance is now approved for sensory nerve gaps up to and exceeding 25 millimeters. It is approved for mixed nerve injuries. It is approved for motor nerve injuries.

Avance development has involved surgical collaboration for more than a decade. Nearly 250 peer-reviewed papers document nerve regeneration outcomes and techniques.

Expanding Access To Nerve Repair

Avance addresses a critical healthcare gap. Many patients with nerve injuries lack access to surgical options that restore function. Avance makes biologic nerve repair available to more people.

The scaffold comes in multiple sizes. Surgeons can match the graft precisely to the patient's nerve. This precision improves the chance of successful regeneration.

The pediatric approval is particularly significant. Nerve injuries in children from trauma or surgery can affect development. Having an approved biologic option that works in infants and young children expands treatment possibilities.

Avance will be commercially available in early 2026. Axogen is working to help surgical centers implement nerve repair programs using this new technology.

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