Axogen Nerve Graft Clinical Study Yields Promising Results

The Journal of Hand Surgery (JHS) has published new clinical results for the use of Alachua, Fla.-based Axogen Inc.’s Avance nerve graft for repair of peripheral nerve injuries in the upper extremity. Axogen is a regenerative medicine company that provides peripheral nerve repair technology.

JHS included outcomes data for 51 peripheral nerve repairs across 12 leading U.S. surgical institutions (including level 1 trauma, academic, military and community centers, as well as ambulatory surgery centers). Outcomes were reported for surgical repairs performed on ulnar, median, and digital nerves with nerve tissue gaps ranging from 5 mm to 50 mm in length. Repairs of 5 mm to 14 mm in length demonstrated 100 percent meaningful recovery, 15 mm to 29 mm a 74 percent meaningful recovery, and 30 mm to 50 mm a 90 percent meaningful recovery, according to the journal.

“‘Meaningful recovery’ is a term that was defined from the historical references standards for successful or meaningful outcomes based on the Medical Research Council’s classification for outcomes following nerve injury,” Axogen’s Senior Vice President of Business Strategy and Marketing Jill F. Schiaparelli explained to Medical Product Outsourcing. It describes the recovery of practical use of the hand (or other affected area) rather than just the appearance of healing of the nerve.

“This study confirms the results that we have observed at our clinical practice for upper extremity nerve repair over the last several years,” noted Gregory Buncke, M.D., plastic surgeon, co-director of The Buncke Clinic in San Francisco, Calif., and an author of the JHS publication. “Avance nerve graft offers a viable option for the repair of peripheral nerve defects across a range of gap lengths for both motor and sensory nerves and offers the benefit of eliminating a second surgical incision for nerve harvest.”

The publication is based on the upper extremity nerve injury subgroup of the RANGER Study, which the company reports is the largest, multi-center, multi-surgeon study focused on the treatment of peripheral nerve discontinuities. Initiated in 2007, RANGER tracks outcomes in contemporary clinical practice from the use of Avance nerve graft, a nerve allograft processed using the Avance processing technique. Previous results from the RANGER Study, published in the journal Microsurgery in January this year, demonstrated that across all nerve injury locations and gap lengths, 87 percent of those repaired using Avance nerve graft reported meaningful recovery.

An allograft uses human tissue from a donor (as opposed to an autograft, which uses tissue from the patient). The Avance allograft is intended for bridging peripheral nerve discontinuities, and reportedly provides surgeons a readily available nerve graft to repair peripheral nerves damaged by traumatic injury or removed during surgical procedures.