Auxilium Inc

THE NEUROSPAN BRIDGE: A DEVICE FOR PERIPHERAL NERVE REPAIR - 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.

SBIR PHASE I: AN AEROGEL WOUND DRESSING MATERIAL PLATFORM WITH MECHANICAL FLUID MANAGEMENT, BIOFILM PREVENTION, AND PH BASED INFECTION DETECTION PROPERTIES -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT IS A NOVEL WOUND DRESSING MATERIAL FOR IMPROVING CHRONIC WOUND CARE BY MITIGATING SEVERAL BIOLOGICAL AND MICROBIAL FACTORS THAT AFFECT HEALING. CHRONIC WOUNDS AFFECT NEAR 50 MILLION PATIENTS IN DEVELOPED COUNTRIES OFTEN LEADING TO PERSISTENT INFECTIONS, PROLONGED INFLAMMATION, AND INCREASED HEALTHCARE COSTS. APPROXIMATELY 80% OF INFECTIONS ARE ASSOCIATED WITH BACTERIAL BIOFILMS THAT DELAY HEALING AND REQUIRE FREQUENT INTERVENTIONS. CURRENT SOLUTIONS OFTEN RELY ON REACTIVE INFECTION MANAGEMENT AND FREQUENT DRESSING CHANGES. THIS PROJECT PROPOSES A NOVEL WOUND DRESSING WITH OPTIMAL POROSITY TO ENABLE OXYGEN EXCHANGE WHILE CREATING A PATHOGEN BARRIER, INTEGRATED WITH REAL-TIME DETECTION OF INFECTION INDICATED BY A RAPID COLOR CHANGE. THE PLATFORM OFFERS A POTENTIAL SOLUTION FOR IMPROVING THE MANAGEMENT OF ACUTE WOUNDS, CHRONIC WOUNDS, SURGICAL SITES, AND BURN, WITH A TOTAL ESTIMATED $200M ANNUAL MARKET. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT SEEKS TO DEVELOP AND VALIDATE AN AEROGEL-BASED BIOMATERIAL COMBINING FLUID MANAGEMENT, BIOFILM PREVENTION, AND RAPID INFECTION DETECTION PROPERTIES INTO A SINGLE PLATFORM. THE INNOVATION RELIES ON THE INTEGRATION OF A BIOPOLYMER AEROGEL MATERIAL WITH A MULTI-LAYER DESIGN. THE PRIMARY LAYER AIMS TO PROMOTE TISSUE REGENERATION WHILE BLOCKING MICROBIAL INFILTRATION, AND THE SECONDARY LAYER AIMS TO ABSORB WOUND FLUID WHILE PROVIDING A VISUAL INDICATOR OF INFECTION. THE PROPOSED TECHNOLOGY DEVELOPMENT WILL OPTIMIZE THE AEROGEL?S PORE STRUCTURE FOR EFFECTIVE BIOFILM PREVENTION, REFINE THE INFECTION-SENSING MECHANISM FOR RELIABLE DETECTION IN UNDER A MINUTE, AND ENSURE THE MECHANICAL DURABILITY NEEDED FOR CLINICAL USE. IF SUCCESSFUL THIS PROJECT WILL DEMONSTRATE PRECLINICAL SAFETY AND EFFECTIVENESS, WITH SCALABLE PILOT PRODUCTION METHODS FOR A PROTOTYPE WOUND DRESSING MATERIAL, THAT REDUCES INFECTION-RELATED COMPLICATIONS, MINIMIZES DRESSING CHANGES, AND IMPROVE HEALING OUTCOMES. 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.- SUBAWARDS ARE NOT PLANNED FOR THIS AWARD.

RBDG RURAL BUSINESS COOP RURAL ENTERPRISE GRANT

RBDG RURAL BUSINESS COOP RURAL ENTERPRISE GRANT

RBDG RURAL BUSINESS COOP RURAL ENTERPRISE GRANT