Summary The mission of CryoCrate LLC (www.CryoCrate.com) is to develop new platform cryopreservation technologies for applications in life science and clinical practice. With recent rapid advances in cell-based tissue engineering and regenerative medicine, as well as continued development of transplantation technologies, there has always been an urgent need for clinically practical methods and efficient devices for cryopreservation of large stocks of bioartificial and donor tissues. In the Phase I period of this project, we successfully established a novel ultra-fast cooling method (106K/min on cellular level) for small tissues. In the Phase II period, we will: 1) design an upgraded device system that achieves the same efficiency for cryopreservation of the whole corneas and large bioartificial tissues and facilitate their clinical and research use; 2) produce the device as a mature product by working with a professional manufacturer (Gateway Discovery Products LLC) and cGMP consultant (Cardinal Health); and 3) test the post-thaw in-vitro viability and functionalities of the corneas and bioartificial retinal tissues, and conduct in-vivo animal studies on rabbits (Vision Research Center at UMKC). After achieving these milestones, we will work with our eye bank collaborator (Saving Sight), current distributor (Mayflower Bioscience), and potential strategic partner (Thermo Fisher Scientific) to introduce the product to corneal transplantation and tissue engineering markets.

Narrative The long-term vision of CryoCrate LLC related to this project is to develop a new platform technology and commercialize a universal device system for efficient cryopreservation of human donor and bioartificial tissues. Continuing our Phase I studies, we will finalize a device product as a direct vitrification system that achieves high efficiency in cryopreservation of these tissues.