RECON achieved its Primary Endpoint, a critical milestone toward transitioning Avance Nerve Graft to a licensed biologic and further supporting the expanded adoption of Avance
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced topline results from its RECON Clinical Study comparing Avance Nerve Graft to conduits in digital nerve injuries. The Phase 3 pivotal study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data. This data will support the company’s Biologics License Application (BLA) submission in the second half of 2023.
Additional analysis of the study data found:
Avance demonstrated statistical superiority for return of sensory function (measured by static two-point discrimination) as compared to conduits in gaps greater than 12 mm (p-value 0.021).
Avance demonstrated statistical superiority for time to recovery of static two-point discrimination as compared to conduits, returning normal sensation* up to 3 months earlier in gaps greater than 10 mm (p-value 0.037).
Conduit repairs were observed to have an increased likelihood of persistent and unresolved nerve pain with an incidence of 9 (8%) conduit subjects as compared to 2 (2%) Avance subjects.
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