FDA Approves Acellular Nerve Allograft-arwx (Avance) for Sensory Nerve Discontinuity

The US Food and Drug Administration (FDA) has approved Axogen’s Biologics License Application (BLA) for acellular nerve allograft-arwx (Avance) for surgical implantation.1,2

As described in a December 3, 2025, press release from the FDA, the peripheral nerve scaffold is approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged 1 month and older. Under the Accelerated Approval pathway, acellular nerve allograft-arwx is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities.1

Of note, continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.2

“This approval represents a meaningful shift from our historical classification as a human tissue product and brings the product in line with FDA’s classification of Avance as a biologic. This milestone clarifies and strengthens our regulatory footing and confirms approval for use of Avance as an acceptable therapeutic option for treating peripheral nerve discontinuities in all of Axogen’s present nerve repair use cases,” Michael Dale, Axogen’s Chief Executive Officer, said in a statement.2

Unlike some current treatments that require surgeons to remove healthy nerve tissue from another part of the patient's body and create a second surgical site, acellular nerve allograft-arwx is made using nerve tissue from deceased donors that has been specially processed to remove cells while preserving the natural structure that helps nerves regrow.1

“Avance eliminates the need for patients to undergo additional surgery to harvest their own nerve tissue for repair,” said Vijay Kumar, MD, Acting Director of the Office of Therapeutic Products, CBER.1 “The agency has exercised regulatory flexibility in expanding the indication for Avance to motor and mixed nerve injuries, and sensory nerves with gaps exceeding 25 mm, through the Accelerated Approval pathway based on a surrogate endpoint that is reasonably likely to predict clinical benefit. The accelerated approval is subject to the requirement that the applicant conduct and submit the results of confirmatory clinical trials.”

The study of acellular nerve allograft-arwx’s efficacy compared implantation of acellular nerve allograft-arwx to collagen nerve cuffs. The study met its primary endpoint for the return of sensory function, showing acellular nerve allograft-arwx’s statistical non-inferiority to comparator nerve cuff.1

The most common adverse reactions reported in clinical trials were procedural pain and increased sensitivity to sensory stimuli, such as touch, temperature, and pain. According to the FDA, patients should be monitored for procedural complications including pain, hyperesthesia, infection, implant site swelling, adhesions, hypertrophic scar formation, impaired motor or sensory function, bleeding and neuroma formation.1

Of note, acellular nerve allograft-arwx is made from human cadaveric tissue and may carry a risk of transmitting infectious agents. No cases of transmission of viral diseases have ever been identified for acellular nerve allograft-arwx. However, the Agency warns all infections thought to be transmitted by acellular nerve allograft-arwx should be reported to the manufacturer.1

“The approved BLA and successful transition of Avance to a biologic regulatory framework should give all stakeholders the assurance that Avance has been rigorously evaluated and determined to be safe, pure, and potent for its intended use, and that its benefits outweigh its known or potential risks,” Dale said in a statement.2

References

1. US Food and Drug Administration. FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity. December 3, 2025. Accessed December 4, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-nerve-scaffold-treatment-sensory-nerve-discontinuity

2. Axogen. Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx). December 3, 2025. Accessed December 4, 2025. https://ir.axogeninc.com/press-releases/detail/1012/axogen-announces-fda-approval-of-biologics-license