Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology

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SUMMARY Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first- in-class biocompatible cryopreservation medium product, trademarked as OdinSol®, that will provide efficient options for biobanking practices associated with storage of skin grafts from donors or xenotransplants. The OdinSol® technology removes the need for any toxic cell permeating cryoprotectant used in all existing tissue cryopreservation methods, considerably simplifies associated operations, and more importantly, secures the outcome of long-term storage in regular -80oC deep freezers by preventing gradual cell loss. Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research organization (WuXi AppTec), academic collaborator (University of Missouri Department of Medicine and National Swine Research and Research Center), to achieve the following milestones: I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows compliance with FDA guidance for 510(k) submission as a storage device for transplantable tissues; II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be superior to existing cryopreservation protocols with respect to preserving viability and function of skin grafts; III. Based on those qualifications, we will complete of the 510(k) submission and finalize of the production line based on further FDA feedback before the end of the project period. We expect future clinical use of the OdinSol® technology within three years after the FDA clearance, providing the skin banking and xenotransplantation industry with a highly efficient biocompatible cryostorage platform.