Axogen Aces Phase 3 Study For Avance Nerve Graft

Axogen Inc AXGN announced topline results from its RECON Clinical Study comparing Avance Nerve Graft to conduits in digital nerve injuries.
Avance 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.
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 US marketing application in 2H 2023.
Avance demonstrated statistical superiority for return of sensory function (measured by static two-point discrimination) 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 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.
Price Action: AXGN shares are up 17.3% at $9.69 during the market session on the last check Thursday.