A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities
Latest Information Update: 03 Jan 2026
At a glance
- Drugs Human nerve allograft AxoGen (Primary)
- Indications Peripheral nerve injuries
- Focus Registrational; Therapeutic Use
- Acronyms RECON
- Sponsors AxoGen Inc
Most Recent Events
- 03 Dec 2025 According to an AxoGen Inc media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for AVANCE (acellular nerve allograft-arwx).
- 25 Aug 2025 According to an AxoGen Inc media release, company announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance Nerve Graft by three months to December 5, 2025.
- 25 Feb 2025 The U.S. FDA accepted the filing of the Company Biologics License Application (BLA) for Avance Nerve Graft on November 1, 2024, and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2025. The Company continues to work through the process with the FDA and anticipates approval in September 2025.