Acellular nerve allograft
| Clinical data | |
|---|---|
| Trade names | Avance |
| Other names | acellular nerve allograft-arwx |
| License data | |
| ATC code |
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| Legal status | |
| Legal status | |
Acellular nerve allograft, sold under the brand name Avance, is a peripheral nerve scaffold.[1][2]
The most common adverse reactions include procedural pain and increased sensitivity to sensory stimuli, such as touch, temperature, and pain (hyperesthesia).[2]
Acellular nerve allograft was approved for medical use in the United States in December 2025.[1][2]
Medical uses
Acellular nerve allograft is indicated for the treatment of people with sensory nerve discontinuity and mixed and motor nerve discontinuity.[2]
Acellular nerve allograft is made using nerve tissue from deceased donors (cadavers) that has been specially processed to remove cells while preserving the natural structure that helps nerves regrow.[2]
Society and culture
Legal status
Acellular nerve allograft was approved for medical use in the United States in December 2025.[3][4]
The US Food and Drug Administration granted approval of acellular nerve allograft to Axogen.[2]
References
- ^ a b c "Avance". U.S. Food and Drug Administration (FDA). 3 December 2025. Retrieved 28 December 2025.
- ^ a b c d e f g "FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity". U.S. Food and Drug Administration (FDA). 3 December 2025. Retrieved 5 December 2025. This article incorporates text from this source, which is in the public domain.
- ^ "BLA Approval: acellular nerve allograft-arwx". U.S. Food and Drug Administration.
- ^ "Axogen Announces FDA Approval of Biologics License Application for AVANCE (acellular nerve allograft–arwx)" (Press release). Axogen. 4 December 2025. Retrieved 5 December 2025 – via GlobeNewswire.
Further reading
- Ansaripour A, Thompson A, Styron JF, Javanbakht M (January 2024). "Cost-effectiveness analysis of Avance allograft for the treatment of peripheral nerve injuries in the USA". Journal of Comparative Effectiveness Research. 13 (1) e230113. doi:10.57264/cer-2023-0113. PMC 10842286. PMID 38031842.
- Mathot F, Rbia N, Thaler R, Bishop AT, van Wijnen AJ, Shin AY (August 2020). "Introducing human adipose-derived mesenchymal stem cells to AvanceⓇ nerve grafts and NeuraGenⓇ nerve guides". Journal of Plastic, Reconstructive & Aesthetic Surgery. 73 (8): 1473–1481. doi:10.1016/j.bjps.2020.03.012. PMC 7375015. PMID 32418840.
- Peters BR, Wood MD, Hunter DA, Mackinnon SE (March 2023). "Acellular Nerve Allografts in Major Peripheral Nerve Repairs: An Analysis of Cases Presenting With Limited Recovery". Hand. 18 (2): 236–243. doi:10.1177/15589447211003175. PMC 10035101. PMID 33880944.
External links
- Clinical trial number NCT01809002 for "Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON)" at ClinicalTrials.gov
- Clinical trial number NCT00948025 for "A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options (CHANGE)" at ClinicalTrials.gov
- Clinical trial number NCT01526681 for "Registry of Avance Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction (RANGER)" at ClinicalTrials.gov