Axogen Recon Clinical Study Completes Target Enrollment of 220 Subjects
UF Innovate | Sid Martin Biotech alum AxoGen, Inc., a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, announced that its phase 3 pivotal RECONSM Clinical Study supporting its Biologics License Application (BLA) submission for Avance Nerve Graft has reached its enrollment target of 220 subjects. RECON compares Avance Nerve Graft to manufactured conduits in digital nerve injuries with a primary endpoint of return of sensation and secondary endpoints for quality of life and patient satisfaction.
“We are pleased to have reached this important milestone and appreciate the dedication and commitment of each of the participating study teams,” commented Karen Zaderej, chairman, CEO, and president of Axogen. “Completing enrollment for the RECON Study is a critical step in transitioning our Avance Nerve Graft from classification as a section 361 HCT/P tissue product to a section 351 biological product.”
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