NUSHORES BIOSCIENCES LLC — Department of Health and Human Services SBIR Phase I: 100

Description

Project SummaryCurrent bone grafting techniques for functional rehabilitation with dental implants have limitationshighcostdifficulties with fixation and stabilizationinsufficient bone regenerationhigh morbidity using autogenous block grafts and prolonged healing of up tomonthsExisting synthetic bone fillers cannot match defect shape and volumeare weakly resorbedif at allare not easily and quickly modifiable in size and shape during surgerycannot promote early and enhanced neovascularization and osseointegrationand are poorly suited for advanced reconstructionCurrent technologies cannot be modulated to match existing bone architecturea critical feature for improved healingAlthough pre implant reconstructive surgeries are commonly performedan estimatedof patients are unable to receive dental implants due to these limitationsWe propose to prove that our NuCressTM scaffold is a revolutionary advancement in bone healing and a transformational technology for dentistsperiodontists and oral surgeonsWe seek to prove in preclinical studies that dental implants or other bone regeneration treatments for tooth salvage treatments can be performed at a fraction of the cost and healing times required for today s technologiesWe propose to demonstrate the ability of our technology to support regeneration of mineralized tissues that recapitulate the mechanicalphysical and biological properties of craniofacial bones and corresponding microenvironmentsto facilitate improved dental implant successWe hypothesize that the NuCressTM scaffold technology will outperform currently available options in rabbit and canine bone regeneration modelsAfter producing optimized scaffolds with enhanced porosity similar to calvarial bonewe will compare the NuCressscaffold to a predicate and untreated control groups in models of critical sized calvarial defectsin an established sinus modelan established pre clinical socket modelan established pre clinical segmental defect modeland an established pre clinical dental implant modelSuccessful Phase I and II SBIR studies will lead to first in human trials in dental implant patients and seek FDA approval to provide a superior option to facilitate improved dental implant success ! !Project NarrativeCurrent bone grafting techniques for dental implants have limitationshigh costdifficulties with fixation and stabilizationinsufficient bone regenerationhigh morbidity using autogenous block grafts and prolonged healing of up tomonthsAlthough pre implant reconstructive surgeries are commonly performedan estimatedof patients are unable to receive dental implants due to these limitationsWe propose to prove that our bone filler scaffold is a revolutionary advancement in bone healing and a transformational technology for dentistsperiodontists and oral surgeons by conducting preclinical studies that are essential before approval for use in humans !