- Axogen Inc (NASDAQ: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.
