Cooperative Agreement 2151582

SBIR PHASE II: A NOVEL PERIPHERAL NERVE MATRIX PLATFORM FOR SEVERE ACUTE PERIPHERAL NERVE INJURIES -THE BROADER IMPACT /COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT WILL ENHANCE CLINICAL OUTCOMES FOR PATIENTS WITH A TRAUMATIC OR PALLIATIVE PERIPHERAL NERVE INJURY (PNI). IN THE U.S., 20 MILLION PEOPLE SUFFER FROM PNIS, WITH A HIGH PREVALENCE AMONG YOUNG INDIVIDUALS AND A TOTAL ECONOMIC COST TO SOCIETY IN EXCESS OF $150 BILLION PER YEAR. ACUTE PNIS ACCOUNT FOR MORE THAN 500,000 ANNUAL SURGICAL PROCEDURES IN THE U.S AND FREQUENTLY RESULT IN PERMANENT DISABILITY. THIS PROJECT DEVELOPS A PLATFORM TECHNOLOGY WITH THE POTENTIAL TO ADDRESS MANY TYPES OF PNI. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT WILL CREATE A NOVEL NERVE GRAFT/CONDUIT FOR NERVE GAP INJURY REPAIR AND A NERVE CAP. THE PROJECT GOAL IS TO ADVANCE A SOLUTION TO IMPROVE THE NERVE FUNCTIONAL OUTCOME WHILE STILL REDUCING THE TENSION ACROSS THE REPAIR. IT PROVIDES A TISSUE-LIKE MATRIX THAT ALLOWS ALIGNED NERVE GROWTH OUT OF THE FREE NERVE ENDING. THE TECHNOLOGY IS DERIVED FROM DECELLULARIZED PORCINE NERVE TISSUE AND MAINTAINS NATIVE STRUCTURAL AND FUNCTIONAL PROTEINS, PROVIDING AN IDEAL ENVIRONMENT FOR NERVE REPAIR AND REGENERATION. THIS PROJECT CONDUCTS IN-VIVO STUDIES, STERILIZATION DEMONSTRATIONS, AND LYOPHILIZATION. SUPPLY CHAIN SECURITY, PACKAGING DEVELOPMENT, AND TOOLING WILL BE DEVELOPED IN PREPARATION FOR COMMERCIAL LAUNCH. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.