AUXILIUM BIOTECHNOLOGIES INC. — Department of Health and Human Services SBIR Phase I: NINDS

Description

Peripheral Nerve Injury (PNI) occurs in 3% of all trauma cases and 30% of combat injuries to the extremities, resulting in a loss of five million working days each year and costs of $150 billion annually in the U.S. The standard of care in the clinic is a nerve autograft from the patients’ leg. The NeuroSpan Bridge is a unique, biomimetic, multi-channel scaffold that maintains linearity throughout the structure, thus accelerating and guiding regenerating axons precisely to their targets on the distal end of the transected nerve. It has been extensively tested in gaps up to 3cm-long and demonstrated superiority to existing devices in a short-gap animal model, and superiority to nerve autograft in a long-gap animal model. This project will put in place a program to finalize pre-clinical studies, submit an IDE application to the FDA and carry out a feasibility clinical study followed by 510(k) application. The proposed project brings together experts in peripheral nerve injury, axonal regeneration, neurology, neurosurgery and bioengineering to develop a practical, cost-effective, consistent, and transnationally relevant medical device for the treatment of peripheral nerve injury.