Establishment of a First-in-Class Biocompatible and Efficient Cryopreservation Technology Platform for the Next Generation of Cell-Based Therapeutics in Regenerative Medicine and Drug Discovery

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 provides enabling and efficient options for biobanking urgently needed for the development and implementation of cell-based

therapeutics and tissue engineering in personalized medicine. The OdinSol® technology removes the need for any toxic cell permeating cryoprotectant used in nearly all existing cryopreservation methods, secures long-term storage in regular -80oC deep freezers, and significantly improves the cryopreservation efficiency for cell-based therapeutic materials (e.g., iPSC-derived cells or tissues).

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 co-inventor (University of Missouri – Kansas City Vision 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 novel cell-based therapeutic materials for regenerative medicine; 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 regenerative medicine industry with a highly efficient biocompatible cryostorage platform.