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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2025

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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

    • 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.
    • 06 Sep 2024 According to an AxoGen Inc media release, Company has requested priority review status for this BLA which, if granted, could reduce the review timeline from the standard 10-month to a priority 6-month review timeline from the date the submission is accepted by FDA. Based on this process, we believe we are on track for FDA determination of approvability between April and September of next year.
    • 06 Sep 2024 According to an AxoGen Inc media release, company announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft. The Company anticipates the FDA will notify the company regarding whether the submission is accepted for review and confirm the procedural review timeline (either standard or priority) within approximately the next 60 days.

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