AxoGen Submits BLA to FDA for Avance Nerve Graft®

By Bobby Samwell • Friday, September 06 15:14 • Permanent Link

Axogen, Inc. (NASDAQ: AXGN) has recently 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 notification from the FDA regarding the acceptance for review and the procedural review timeline within approximately the next 60 days. Avance Nerve Graft previously received regenerative medicine advanced therapy (RMAT) designation from the FDA.

Axogen has also requested priority review status for the 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, the company believes it is on track for FDA determination of approvability between April and September of next year.

Axogen is a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries. The company's platform for peripheral nerve repair features a comprehensive portfolio of products used across various applications and surgical specialties, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and the surgical treatment of pain.

Some of the key products in Axogen's portfolio include Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Avive+ Soft Tissue Matrix™, and Axoguard Nerve Cap®. These products are available in the United States, Canada, the United Kingdom, South Korea, and several other European and international markets.

The company's CEO and director, Michael Dale, expressed pride in the significant progress made towards the regulatory transition of Avance from a tissue to a biologic and emphasized the continuous collaboration with the FDA as they review the application.

Axogen is dedicated to restoring peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and healthcare providers. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves, and Axogen plays a vital role in addressing diverse patient needs in peripheral nerve repair. Today the company's shares have moved -1.7% to a price of $13.02. For more information, read the company's full 8-K submission here.

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