Naturemiri, LLC — Department of Health and Human Services SBIR Phase I: 100

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Summary AbstractDental implants are becoming an increasingly popular option vsdenturesbridgesand other dentalprosthetics due to greater patient satisfaction and better longterm outcomesHoweverosseointegrateddental implants require stronghealthy bone for implantation to be successfulWhile success rates forosseointegrated dental implants are relatively higha drastic increase in the number of implantationprocedures is expected to occur due to the increasing popularity of the procedure with patients and cliniciansas well as demographic factors such as an increased number of aging and elderly patients that require dentalprosthesesFailed dental implantations can lead to a significant cost and care burden to patients and to thehealthcare systemand initial failures often mean that additional attempts at implantation in the same site arenot possibleTogetherthese factors signal the need for a clinical tool that will increase the rate ofosseointegrated dental implant successparticularly in patients who are at higher risk for failure due to theinadequate presence of highquality bone in which to place the implantNaturemiRILLC has developed anovel method of microRNAmiRinhibition using a biologically native molecule composed of nucleic acids witha unique secondary structureallowing it to bind and degrade or sequester mature miRsThe inhibition ofbinding mature miRs to their mRNA targets alters protein production in the cellIt has been established in ourpreliminary studies and previously published reports that miRa inhibits osteogenic differentiation andincreases the proinflammatory responseOur Phase I project goal is to demonstrate that by inhibiting miRa in vitro and in an animal modelwe can increase rates of osteogenesis and enhance the quality ofregrown boneDuring Phase Iwe will analyze bone hardnessmineral contentand density during osteogenicdifferentiation and in an artificial woundhealing modelWe also intend to demonstrate that the nucleic acidbased composition of our inhibition method negates the risk of systemic toxicity a concern that exists with theuse of synthetically modified oligonucleotide miR inhibition methodsPhase I success will set the stage for alarger Phase II demonstration project focused on largerscale testing and validation of the envisioned new toolfor the dental clinic an antimiRainfused collagen sponge that could be used in tooth extractionprocedures in anticipation of future osseointegrated dental implantationSuccess will also establishtherapeutic proof of concept for this new miR inhibition methodultimately opening the door for an importantrange of additional therapeutic applications in the dental field and beyondNaturemiRI s experienced team ofdental researchers is established and wellsuited to address the scientific questions regarding the proposedapplicationNaturemiRI leadership also includes a small but experienced business development team that isworking diligently on commercialization activities regarding the many potential applications of this technologyProject NarrativeNearlyof adults ageshave lost at least one permanent toothand by ageof adults havelost all of their permanent teethAlthough dental implants have about asuccess ratean aging populationand the trending increase in the number of these procedures necessitates that additional work be done toimprove success rates and mitigate adverse health effects that can arise from implantation failuresThis SBIRproject is focused on a new technology designed to significantly reduce implant failures by stimulating alveolarbone regenerationimprove healthcare outcomes and quality of life while reducing treatment costs