Project Grant SB1DE028213

COMMERCIALIZATION READINESS FOR BONE FILLER SCAFFOLD DEVICE TO AID IN DENTAL APPLICATIONS AND RECONSTRUCTION - PROJECT SUMMARY CURRENT BONE GRAFTING TECHNIQUES FOR FUNCTIONAL REHABILITATION WITH DENTAL IMPLANTS HAVE LIMITATIONS - HIGH-COST, DIFFICULTIES WITH FIXATION AND STABILIZATION, INSUFFICIENT BONE REGENERATION, HIGH MORBIDITY USING AUTOGENOUS BLOCK GRAFTS AND PROLONGED HEALING OF UP TO 9 MONTHS. EXISTING SYNTHETIC BONE FILLERS CANNOT MATCH DEFECT SHAPE AND VOLUME, ARE WEAKLY RESORBED IF AT ALL, ARE NOT EASILY AND QUICKLY MODIFIABLE IN SIZE AND SHAPE DURING SURGERY, CANNOT PROMOTE EARLY AND ENHANCED NEOVASCULARIZATION AND OSSEOINTEGRATION; AND ARE POORLY SUITED FOR ADVANCED RECONSTRUCTION. CURRENT TECHNOLOGIES CANNOT BE MODULATED TO MATCH EXISTING BONE ARCHITECTURE - A CRITICAL FEATURE FOR IMPROVED HEALING. ALTHOUGH PRE-IMPLANT RECONSTRUCTIVE SURGERIES ARE COMMONLY PERFORMED, AN ESTIMATED 7% OF PATIENTS ARE UNABLE TO RECEIVE DENTAL IMPLANTS DUE TO THESE LIMITATIONS. THE NUCRESS SCAFFOLD HAS SHOWN IN ANIMAL STUDIES THAT IT IS A BETTER ALTERNATIVE FOR THESE AUTOGRAFTS, DUE TO ITS CONTROLLABLE SHAPE AND FORM, ENHANCED BONE FORMATION AND EARLY NEOVASCULARIZATION, SHELF-LIFE STABILITY AND TOLERANCE OVER A RANGE OF STORAGE CONDITIONS, AND A COMPOSITION THAT INCLUDES ONLY COMPONENTS THAT HAVE RECEIVED FDA CLEARANCE FOR USE IN OTHER DEVICES OR ARE IN PROCESS OF CLEARANCE. IN SITU, THE SCAFFOLD SWELLS TO LOCK INTO PLACE IN THE BONE DEFECT, ELIMINATING THE NEED FOR SPECIAL INSTRUMENTS TO SECURE IT. THESE SCAFFOLDS COULD REDUCE COSTS AND CONVALESCENT TIME, BENEFITING MILLIONS OF PATIENTS. NIDCR-FUNDED FAST TRACK SBIR RESULTS DEMONSTRATE SUPERIOR AND FAST BONE REGENERATION BY THE NUCRESSTM BONE FILLER SCAFFOLD FOR CRANIOMAXILLOFACIAL APPLICATIONS IN PRE-CLINICAL ANIMAL STUDIES, SETTING THE STAGE FOR THE NEXT STEP OF COMMERCIALIZATION TO BENEFIT PATIENTS. INTEGRAL TO COMMERCIALIZATION IS FDA APPROVAL FOR THE NUCRESSTM SCAFFOLD AS A DENTAL MEDICAL DEVICE (REQUIRED) AND CLINICAL TRIALS (HIGHLY DESIRABLE). THESE ESSENTIAL STEPS REQUIRE IMPLEMENTING AND FINALIZING MANUFACTURING PRACTICES TO MEET FDA MANUFACTURING REGULATIONS (AIM 1), PERFORMING BIOCOMPATIBILITY AND CHEMICAL CHARACTERIZATION/RISK ASSESSMENT STUDIES, AS WELL AS ANIMAL STUDIES PER FDA GUIDANCE TO COMPARE PERFORMANCE OF THE NUCRESSTM SCAFFOLD TO A PREDICATE DEVICE AND UNTREATED CONTROL GROUP IN CRITICAL-SIZED ALVEOLAR RIDGE DEFECT MODEL (AIM 2), TRANSITION FROM PRODUCTION FOR RESEARCH TO PRODUCTION FOR PATIENT TREATMENT IN CLINICS (AIM 3), AND PLANNING AND PREPARING FOR CLINICAL TRIALS IN THE FUTURE (AIM 4). THE PROPOSED TEAM HAS THE EXPERTISE AND EXPERIENCE BACKED BY ACADEMIC AND CLINICAL LEADERS, GLOBALLY RECOGNIZED CONTRACT RESEARCH ORGANIZATIONS, AND CONSULTANTS SUCCESSFULLY FULLING FDA STUDIES AND NIDCR-SUPPORTED CLINICAL STUDY SUCCESSES.