Study to compare Company’s proprietary processed human nerve allograft to hollow tubes for bridging gaps in peripheral nerve tissue.
ALACHUA, FL, May 4, 2015 – AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company dedicated to the $1.6 billion peripheral nerve repair market, announced today that the U.S. Food and Drug Administration (FDA) has given AxoGen clearance to proceed with the “RECON Study” to support an Investigational New Drug Application. The RECON Study is a multicenter, prospective, randomized study to evaluate recovery outcomes of surgical repairs of peripheral nerve discontinuities. The Phase 3 clinical trial will compare AxoGen’s Avance® Nerve Graft, an off-the-shelf processed human nerve allograft, to hollow tubes for bridging gaps in peripheral nerve tissue and will support the FDA biologic license application (“BLA”) being pursued by the Company.
Pursuant to an enforcement discretion granted by the FDA, Avance® Nerve Graft is currently commercially available while it is transitioned to a biologic product. The FDA provided clearance to AxoGen to proceed with the RECON Study after conducting a period of review of the Study protocols and characterization of Avance® Nerve Graft. The Company intends to move forward promptly with the RECON Study and anticipates that patient enrollment will begin in the second half of 2015.
“We believe that Avance® Nerve Graft will be the first FDA licensed biologic implant for peripheral nerve repair,” said Karen Zaderej, AxoGen President and CEO. “The BLA process is rigorous and includes an in-depth review of the basic science, manufacturing, non-clinical testing and clinical outcomes of our human nerve allograft. The transition process has provided AxoGen the unique opportunity to establish the developmental and quality system infrastructure required to earn a biologic product designation while simultaneously executing the commercialization of Avance® Nerve Graft.”