September 2019: CryoCrate LLC Won a NIH SBIR Phase II Grant to Produce, Test and Commercialize “INSTAvitria®”, a Novel Tissue Cryopreservation Device System.

The National Institutes of Health (NIH) has awarded a Phase II Small Business Innovation Research (SBIR) Grant to CryoCrate. CryoCrate CTO and President Dr. Xu Han is the Principal Investigator. This award is competitive follow-on funding based on previous collaborative work between CryoCrate and UMKC supported by an SBIR Phase I NIH award. That previous work explored the capability of a novel, ultra-fast cryopreservation technique that could help meet far-reaching clinical needs in ophthalmology and a number of other fields of medicine. The new two-year award is for $1,566,168 including a subcontract to UMKC’s Vision Research Center. Peter Koulen, Ph.D., professor of ophthalmology at the UMKC School of Medicine and director of basic research at the UMKC Vision Research Center is the subcontract PI.

With current techniques, many types of cells and tissues, including cornea tissues, cannot be preserved at all or lose their function when subjected to the freeze-thaw process of cryopreservation. Thus far, traditional methods of cryopreservation have been unsuccessful in preserving and storing human corneas. Corneas need to contain very high numbers of functioning cells to be present and function properly following transplantation. Current cornea refrigeration procedures are only effective for 10 to 14 days. As with other areas of transplantation, time is a primary limiting factor to the success of a program. Surgeons world-wide currently perform more than 240,000 corneal transplants a year to address a wide range of eye diseases. Researchers and physicians, however, estimate as many as 10 million patients could benefit from the procedure if enough viable tissue was available.

The new NIH SBIR Phase II grant allows Drs. Han and Koulen to further develop an upgraded ultra-fast cooling system, INSTAvitria®, that is equally effective in the cryopreservation of whole corneas and large bioartificial tissue. This would enable long-term storage of the tissues without any chemical cryoprotectants and could make them more readily available when and where needed for clinical use and research.

An international patent filing PCT/US19/26162 was processed, with Dr. Xu Han as the leading inventor and CryoCrate LLC as the owner.