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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
Office of The Director, National Institutes of Health (OD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
3R44OD020163-02A1S1
Application #
10221208
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Contreras, Miguel A
Project Start
2015-08-16
Project End
2021-08-31
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
2
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Cryocrate, LLC
Department
Type
DUNS #
078602139
City
Columbia
State
MO
Country
United States
Zip Code
65211