Alachua, Florida-based AxoGen, Inc. announced that the first patient has been treated as part of its ground breaking study of its Avance Nerve Graft.
Avance is an off-the-shelf processed human nerve allograft. It has the potential to significantly change the practice of nerve repair in trauma cases.
The study, called “RECON, ” seeks to compare Avance with nerve tubes for bridging gaps in peripheral nerve tissue. This is a Phase 3 clinical trial.
If successful, Avance will be the first FDA licensed biologic implant for peripheral nerve repair.
Since Avance is an allograft, it is currently commercially available in the United States and several other countries. This study, however, will allow Axogen to market Avance and make claims regarding the efficacy of Avance for peripheral nerve repair.
In May, Axogen announced that the FDA had provided clearance for AxoGen to proceed with the RECON Study after conducting a review of the Study protocols and characterization of Avance Nerve Graft.
“The commencement of the RECON Study is an important milestone in moving Avance Nerve Graft to be the first FDA licensed biologic implant for peripheral nerve repair, ” said Karen Zaderej, President and CEO of AxoGen. “The rigor of the BLA transition process offers an opportunity for AxoGen to develop a significant amount of data on a biological implant for nerve repair while simultaneously allowing us to continue to advance the commercial adoption of Avance Nerve Graft.”
The RECON Study is a multicenter, prospective, randomized study to evaluate recovery outcomes of surgical repairs of peripheral nerve discontinuities. Enrollment of 150 subjects is expected to take 2 years with subjects being followed for 12 months after surgery.
The first patient was enrolled at Virginia Commonwealth University Medical Center by Principal Investigator Jonathan Isaacs, M.D. A second clinical study location, Hospital of the University of Pennsylvania with Principal Investigator L. Scott Levin M.D., FACS has also started recruiting for potential subjects.
