AxoGen (AXGN) Initiates BLA Submission for Avance Nerve Graft

Core Viewpoint - AxoGen, Inc. has initiated a rolling submission of a Biologics License Application (BLA) for its Avance Nerve Graft to the FDA, with completion expected by Q3 2024, aiming for potential approval by mid-2025 [1][4]. Company Developments - The initial submission includes a complete non-clinical data package, with remaining clinical and manufacturing components to be submitted in the coming months [1]. - The Avance Nerve Graft is designed to bridge severed peripheral nerves without the complications of a second surgical site [1]. - The product received Regenerative Medicine Advanced Therapy designation from the FDA in 2018, allowing for a priority review that could shorten the FDA review period from 10 months to 6 months [4]. Product Portfolio - AxoGen offers several products aimed at restoring nerve function, including: - Axoguard Nerve Connector, used for tensionless repair of severed peripheral nerves [5]. - Axoguard Nerve Protector, which protects damaged peripheral nerves and reinforces nerve reconstruction [5]. - Axoguard Nerve Cap, designed to protect peripheral nerve ends and reduce the development of symptomatic neuroma [6]. - Avive+ Soft Tissue Matrix, a multi-layer amniotic membrane allograft for tissue protection during healing [6][7]. Market Performance - Over the past six months, AXGN shares have increased by 1.5%, while the industry has risen by 24.9% and the S&P 500 by 17.5% [2].