# Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback

> **NIH NIH R44** · CRYOCRATE, LLC · 2021 · $753,985

## Abstract

SUMMARY
Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a novel
corneal cryopreservation technology, trademarked as IcyEye®, with international patent protection. IcyEye® is a
kit that includes an efficient cryopreservation medium, C80EZ®, that prevents ice recrystallization during storage
at approx. -80oC and a novel mechanical device that physically separates cell damaging ice crystals from tissues
during freezing. Combining both mechanisms of action, this kit uniquely enables long-term (at least 6 months)
storage of corneas through cryopreservation in regular -80°C freezers with post-thaw endothelial cell viability
and tissue quality unprecedently meeting and exceeding clinical criteria for transplantation. The clinical use of
this novel technology will not only improve tissue quality for transplantation and the efficiency of eye bank
operations in general, but will also allow eye banks to maintain normal operations during any future health care
crises similar to the current COVID-19 pandemic.
A pre-510(k) meeting with the FDA for the potential submission took place recently. Based on FDA feedback for
the IcyEye® technology to gain the associated clearances, in this project we organized the collaboration with our
regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan and Plas-tech), contract
research organization (Catalent), academic co-inventor (University of Missouri – Kansas City Vision Research
Center), and three local eye bank partners, to achieve the following milestones:
I. The production of IcyEye® kits meets GMP qualifications required for 510(k) submission;
II. The biocompatibility assessment shows compliance with FDA guidance and the in vitro and in vivo
 evaluation of safety and efficacy using a standard animal model demonstrates IcyEye® technology to
 be equivalent to existing refrigeration protocols; and
III. The in vitro evaluation of safety and efficacy using human corneas demonstrates IcyEye® technology
 to be equivalent to existing refrigeration protocols.
Based on those qualifications, we will complete the 510(k) submission and finalize of the production line based
on further FDA feedback before the end of the project period. We expect extensive clinical use of the IcyEye®
technology within three years after FDA clearance, providing the industry with improved donor tissue quality and
higher operational efficacy for both domestic and international use.

## Key facts

- **NIH application ID:** 10326323
- **Project number:** 1R44EY033254-01
- **Recipient organization:** CRYOCRATE, LLC
- **Principal Investigator:** Xu Han
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $753,985
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10326323

## Citation

> US National Institutes of Health, RePORTER application 10326323, Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback (1R44EY033254-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10326323. Licensed CC0.

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