02:56 PM EDT, 05/16/2024 (MT Newswires) -- AxoGen ( AXGN ) said Thursday it has started the rolling submission process for a biologics license application for Avance Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves.

The submission to the US Food and Drug Administration includes the complete non-clinical data package, the firm said, adding that it will provide the remaining components in the coming months. It expects to complete the filing in Q3.

AxoGen ( AXGN ) said it will request a priority review status for the application that could reduce the review timeline to 6 months from 10 months, with approval expected around mid-2025.

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