The multicenter, prospective randomized Recon study will compare the Avance graft to nerve tubes currently used for bridging peripheral nerve tissue gaps, the Florida-based regenerative medicine company said.
The data from the Recon trial will be used to support an FDA biologic license application the company is pursuing, AxoGen said.
“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. 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,” CEO Karen Zaderej said in a press release.
The 1st patient was enrolled at the Virginia Commonwealth University Medical center, AxoGen said. A second location at the Hospital of the University of Pennsylvania has also started recruiting potential subjects, the company added.
The Avance graft is an off-the-shelf processed human nerve allograft used for bridging severed nerves without requiring a second surgical site, AxoGen said. The nerve graft is currently commercially available in the U.S., but AxoGen hopes to transition the product to an FDA licensed biologic, the company said.
Last June, AxoGen and Brigham and Women’s Hospital in Boston were awarded a pair of grants worth $1.9 million from the U.S. Dept. of Defense to support of their efforts to develop tools to aid in peripheral nerve surgeries. Part of that grant included a study of the Avance nerve graft in an effort to research stem cell therapies to enhance nerve regeneration.