News

Being supported by the R44 Award from the NIH Office of Research Infrastructure Programs (ORIP), CryoCrate LLC worked with our patent attorney and nationalized the PCT filing of the InstaVitria^® ultra-fast cooling technology in multiple countries or regions, to secure the IP protection associated with the tissue engineering and transplantation market. In 2023, both China and India granted a patent for this technology.

With the backing of an R44 Award from NIH National Eye Institute (NEI), CryoCrate LLC worked with our patent attorney and extended the PCT filing for the IcyEye technology to numerous countries and regions, particularly those with a substantial need for donor tissues. Notably, in October 2023, India granted a patent for this technology.

Working at the Precision Medicine Center, CryoCrate verified the efficiency of our OdinSol^® technology in the cryopreservation of both CAR-T and NK cells in regular deep freezers without any toxic and cell-permeating cryoprotectant. The use of OdinSol^® also considerably increased the post-thaw cytotoxicity of these “living drugs” for killing cancer cells, mostly likely due to the fact that the removal of the conventional use of DMSO for CAR-T and NK cell cryopreservation also prevents the oxidization effect of this small molecule cryoprotectant. We received this Phase II SBIR award from NCI to support the establishment of the GMP production line for the variant of OdinSol® medium for CAR-T cell cryopreservation and perform animal studies on humanized mice to demonstrate its capability of facilitating the practice of the ideal allogenic CAR-T cell transfusion.

Based on the discovery of “Hexagonal-ice Ablation on Nano-scale (HAN)” working mechanism, our invention of the OdinSol^® cryopreservation media enables long-term and efficient cryopreservation of human skin grafts without any small molecule cell permeating cryoprotectant (e.g., DMSO, glycerol or ethylene glycol) that has been unfortunately required by all existing cryopreservation medium products in the market. OdinSol^® also enables long-term storage of tissues in regular deep freezers (-80°C) and removes the need for liquid nitrogen facilities (typically between -196°C and - 120°C). Upon completing the successful third-party evaluation performed by AlloSource, one of the leading skin banks in the US, and working with the School of Medicine of Univ. of Missouri, we secured a $1.8 NIH SBIR Phase II award from NIH NIAID to establish GMP production line, complete biocompatibility assays and secure FDA 510(k) clearance to pave the path to both industrial and clinical adoption. 

CryoCrate LLC in collaboration with our regulatory consultant (Cardinal Health), co-inventor and co-developer Dr. Peter Koulen (the director of UMKC Vision Research Center), CMO and CRO groups, local eye bank and OPO partners, won a NIH SBIR Direct Phase II award from the National Eye Institute. Based on the FDA feedback of our pre-510(k) submission, the goal of this project is to secure FDA clearance, finalize the production line of the IcyEye^® technology, which enables eye banks to practice long-term cryopreservation of donor corneas and disrupt the global corneal transplantation market.

CryoCrate executive team successfully attended the 2020 NIH Innovation & LSS Conferences and presented the following video. Click here to view.

This award is an administrative supplementary support for our ongoing SBIR Phase II award, to address the special NIH RFA for “NOT-AG-20-008, Alzheimer’s-focused administrative supplements for NIH grants that are not focused on Alzheimer’s disease” from NAI. The project aims to modify the design of the InstaVitria^® system to achieve vitrification cryopreservation of 3D central nervous system cell constructs that are used as models for drug discovery in Alzheimer’s disease and other neural degenerative symptoms and as an emerging clinical strategy for associated new cyto-therapies. This approach will remove the need for any toxic cryoprotectant for cryopreservation of these tissues and significantly minimize tissue damage caused by traditional cryopreservation methods.

CryoCrate, collaborating with the School of Medicine of Univ. of Missouri at Columbia, won a NIH SBIR Phase I award for cryopreservation of skin grafts from NIAID. Skin allograft transplantations are currently utilized for numerous clinical applications. In such applications, donor tissues are now typically utilized as “expensive bandages”, i.e. for temporary coverage, thereby requiring painful and damaging follow-on autotransplantation procedures. With tremendously improved skin graft cryopreservation methods coupled with use of HLA matching based on artificial intelligence network, future tissue banking platforms can potentially provide grafts to be used as permanent and definitive treatment for patients, thereby bringing high impact to clinical applications and the healthcare industry. To achieve this goal, our InstaVitria^® system will be further modified and improved to possess the capability of processing large skin grafts. The long-term goal of this project is to establish a new type of skin banks to supply skin grafts globally.

CryoCrate collaborating with Dr. Peter Koulen, the director of UMKC Vision Research Center, won a NIH SBIR phase II award from the NIH Office of Research Infrastructure Programs (ORIP). The goal of this project is to develop a new platform technology and produce a universal device system for efficient cryopreservation of human donors and bioartificial tissues. Continuing our Phase I studies, we will finalize a device product as a direct vitrification system, InstaVitria^®, which achieves high efficiency in cryopreservation of these tissues without using any cryoprotectant. The success of the project will bring a significant impact on tissue transportation (e.g., corneal transplantation) and tissue engineering technologies (e.g. artificial retinal tissue production).

Dr. Han as the clinical PI collaborating with Dalton Cardiovascular Research Center and College of Engineering at the University of Missouri won a Coulter Translational Research Partnership award to develop a novel organ freezing medium that enables one-week storage of organs at -20°C (i.e. in regular lab freezer), using rat hearts as the model. If this technology can be translated to human hearts, it will potentially solve the severe management issues caused by the relatively short shelf-life of donor hearts (4-6 hour in hypothermia) and saves thousands of lives in the USA alone each year.

CryoCrate collaborating with the Dean of the College of Engineering at the University of Missouri at Columbia won a NIH SBIR phase I award from the NIH Office of Research Infrastructure Programs (ORIP). A novel system, based on the modification of the design of InstaVitria^® technology will be developed to enable significantly higher efficiency (over 90% post-thaw viability) than the existing stem cell cryopreservation method, while removing the need for animal or human origin products (e.g., serum or albumin) and minimizes the cryoprotectant concentration to 1-2%. The method also potentially prevents issues generated by donor variation that impairs various regenerative medicine applications.

CryoCrate collaborating with the National Swine Research and Resource Center at the University of Missouri at Columbia won a USDA NIFA SBIR phase I award. The novel method will solve the long existing issues in the cryopreservation of lipid rich porcine embryos, and remove the need of delipidation for pig embryo handling and processing for any storage protocol. The technology will potentially open a new market for long-term storage of pig embryos, which has never existed but can reach the same value as that for bovine embryos: each year, hundreds of thousands of bovine embryos are cryopreserved and distributed. It can potentially bring significant impact on embryo transfer and breeding improvement market for pigs.

CryoCrate received a convertible note from Centennial Investors, a local investor group in Columbia MO. The note will be used to establish a production line of C80EZ^®, hire a business team, establish an online sales platform, and cover other business expenses.

Dr. Han collaborating with MU Research Reactor and won a MU Fast-track award for studies and practices in building GMP production of cryopreservation media. The award covered various tests for potential 510(K) clearance for a novel cryopreservation medium, including pH values, sterility, osmolarity, endotoxin and stability.

Dr. Han collaborating with the School of Medicine at the University of Missouri at Columbia won a Coulter Translation Research Partnership Award. The project initiated the R&D activities that resulted in the invention of the IcyEye^® kit (see Technology for details).

CryoCrate collaborating with the UMKC Vision Research Center won its first NIH SBIR phase I award from the NIH Office of Research Infrastructure Programs (ORIP). The project initiated the R&D activities that resulted in the invention of the InstaVitria^® (see Technology for details) for tissue cryopreservation.

Dr. Han collaborating with Dr. Michael Roberts, a member of the National Academic of Sciences, to develop a novel cryopreservation media and procedure to enable long-term storage and safe shipment of both epiblast and naïve type stem cells at temperatures near -80°C (e.g. in a deep freezer or dry ice box). The project initiated the R&D activities that resulted in the invention of C80EZ^® media (see Technology for details).