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