In a milestone decision on December 3, 2025, the U.S. Food and Drug Administration (FDA) officially approved a Biologics License Application (BLA) for AVANCE®, a processed human nerve scaffold developed by Axogen, for treating peripheral nerve discontinuities in both adults and pediatric patients, including infants aged as young as one month.
What is AVANCE and Who Is It For
AVANCE is an acellular nerve allograft, meaning it uses specially processed nerve tissue from human donors to create a flexible, sterile scaffold that surgeons can implant to bridge gaps in injured peripheral nerves.
It’s indicated for Sensory nerve discontinuities (both small gaps ≤ 25 mm and larger gaps > 25 mm) and Mixed nerve discontinuities (sensory + motor) and pure motor nerve discontinuities
Why This Matters
Until now, many peripheral-nerve injuries required autografts — surgical removal of a healthy nerve from elsewhere in the patient’s body to repair the damaged nerve. That approach involves a second surgical site, extra recovery, and sometimes long-term complications or loss of function at the donor site.
With AVANCE, surgeons can instead use an “off-the-shelf” donor-derived graft. Because the scaffold preserves the micro-architecture of a natural nerve, the tiny tubular pathways that guide regenerating nerve fibers, it aims to support nerve regrowth and restore function without requiring a second invasive procedure.
Moreover, the FDA’s approval reflects a shift: AVANCE has transitioned from a “human tissue product” classification to a formally approved biologic, a regulatory milestone that may improve confidence among surgeons, insurers, and patients.
Safety, Conditions & Next Steps
The approval was granted under the FDA’s Accelerated Approval pathway for larger sensory gaps and for mixed/motor nerve repairs. This means that while evidence (e.g. improvement in sensory function measured by static two-point discrimination) was deemed sufficient to predict clinical benefit, continued approval will depend on confirmatory clinical trials.
Reported risks and adverse reactions include procedure-related pain, increased sensitivity or hyperesthesia, and the theoretical risk of disease transmission because the graft comes from donor human tissue.
Common side-effects observed in trials: about 4% of patients experienced procedural pain and 3% hyperesthesia.
The company anticipates the commercially licensed version of AVANCE will be available in the U.S. beginning early in the second quarter of 2026. In the interim, the product remains accessible under the existing “tissue” framework.
Wider Implications for Nerve Injury Treatment
The FDA’s approval of AVANCE marks a significant evolution in the standard of care for peripheral nerve injuries, potentially offering a safer, more accessible, and less invasive option compared with traditional nerve-harvesting autografts.
Because AVANCE is now regulated as a biologic, the regulatory clarity may facilitate broader adoption by surgeons and increase reimbursement support from insurers, key factors that could make nerve repair more widely available to patients globally.
For patients, from infants to adults, who suffer from traumatic nerve injuries, this could mean improved chances of restoring sensation or motor function with fewer complications and a shorter recovery path.
