May 2022: CryoCrate LLC Won a NIH SBIR Phase II Award from NIAID for Innovation of Skin Banking and Transplantation Based on Our First-in-Class Biocompatible Cryopreservation Technology, OdinSol^®

 

Our invention of OdinSol^® cryopreservation media is based on the discovery of a novel and efficient approach to promoting nano-scale cubic ice formation on the surface of cell membranes and cell suspensions, i.e., “Hexagonal-ice Ablation on Nano-scale” effect achieved by using a unique polysaccharide cocktails. This invention brings revolutionary changes to the field of cryopreservation: unprecedently removes the need for any toxic and cell permeating cryoprotectant (e.g., DMSO, glycerol, and ethylene glycol) to cryopreserve cells and tissues. The application of OdinSol^® products also realizes long-term storage of cells and tissues in regular laboratory -80 degree C freezers, and as such, eliminates the requirement of cryogenic liquid nitrogen facilities for long-term storage and facilitates safe and long-distance transportation in dry ice boxes. OdinSol^® removes the need for any animal or human serum or protein product, too. The efficacy of the products has been confirmed through third-party evaluations on human donor skins, neuroendocrine tissues, corneal tissues, iPSC derived bioartificial (e.g., retinal pigment epithelial and 3D neural) tissues, as well as numerous cell types (e.g., iPSC, mesenchymal stem cells, T and CAR-T cells, NK cells, chromaffin cells, differentiated neurons, and insect cell lines). 

This groundbreaking technology will also provide efficient options for biobanking practices associated with the storage of skin grafts from donors or xenotransplants, by considerably simplifying the associated operations and securing the outcome of long-term storage in regular -80°C deep freezers by preventing gradual cell loss. I am leading the team formed by CMO/CRO, leading skin banks and organ procurement organizations, and National Swine Research and Resource Center. The goal is to obtain qualifications associated with GMP production, safety and efficacy testing, to secure FDA 510(k) clearance to pave a path for its clinical adoption.