CidaGel is a novel antimicrobial gel that will be evaluated for preclinical studies in preparation for an FDA 510k submission for use in abrogating infection and enhancing dental pulp tissue ingrowth in teeth. Through the process of this award, we will in: Phase-1 TITA will focus on Research and Proof of Validation in collaboration to develop a clear and articulated pathway to translation; Phase-2 focus non-GLP (efficacy) or GLP testing (preliminary biocompatibility testing) and pilot GMP manufacturing/ fill-and-finish of the sterile products; Phase-3 will focus on regulatory strategy and interaction with the FDA.
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