Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for damage or discontinuity to peripheral nerves, today announced that the RECON Clinical Study supporting its Biologics License Application (BLA) for Avance Nerve Graft has completed follow-up of study subjects.
RECON reached its enrollment target of 220 subjects in July 2020. The study remains on schedule with a top line study data read-out expected in the second quarter of 2022, followed by filing of the BLA submission in 2023. RECON compares Avance Nerve Graft to manufactured conduits in digital nerve injuries with a primary endpoint of recovery of static two-point discrimination, a measure of sensation, and secondary endpoints for quality of life and subject satisfaction. The BLA will transition Avance Nerve Graft from a human tissue product to a biological product.
“We are pleased to have reached this milestone and thank the study investigators and research teams for their dedication and commitment to this landmark study,” commented Karen Zaderej, chairman, CEO, and president of Axogen. “The RECON study is designed to provide Level 1 clinical data for our BLA, and will provide additional evidence for surgeons in their clinical decision making for the repair of peripheral nerve injuries.”