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Axogen RECON Clinical Study Completes Target Enrollment of 220 Subjects
RECON is a pivotal study supporting the Company’s Biologics License Application (BLA) for Avance® Nerve Graft ALACHUA, Fla., July 22, 2020 (GLOBE NEWSWIRE) --
About this update from Axogen, Inc.
[{"type":"text","content":"RECON is a pivotal study supporting the Company’s Biologics License Application (BLA) for Avance® Nerve Graft\nALACHUA, Fla., July 22, 2020 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today 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.\n “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.” The RECON Clinical Study protocol requires a one-year follow-up assessment with an additional three month visit window. With the final subject enrolled in July of 2020, the last patient is expected to complete the study no later than October of 2021. The company anticipates it will provide a preliminary report of trial data in the second quarter of 2022 and expects to file the BLA in 2023. About the RECON Clinical StudyComparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON) is a multicenter, prospective, randomized, subject, and evaluator blinded comparative clinical study of nerve cuffs and Avance Nerve Graft evaluating recovery outcomes for the repair of nerve discontinuities. The study is designed to test for non-inferiority between the static two-point discrimination outcomes for Avance Nerve Graft and nerve cuffs. About Avance Nerve GraftAvance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site. Avance provides structural guidance for regenerating axons, and revascularizes and remodels into the patient’s own tissue. It is available in a variety ...