September 2021: CryoCrate LLC Won a NIH SBIR Phase II Grant for Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit, IcyEye®

 

Please review corneal-cryopreservation for the background information. Currently, 30% qualified corneal tissues (over 28,000 per year) donated in the US are transplanted overseas. The quality of those tissues, after an extended period of transportation and processing, requires significant improvement. Over 20,000 corneas collected in other countries or regions (mostly in EU and Sri Lanka) and transplanted internationally each year have similar quality issues.

Currently, there are no commercial technologies on the worldwide stage that would allow corneal tissue to be cryopreserved for clinical use. With the potential of our INSTAvitria® technology, corneas for domestic uses can be stored without cryoprotectants and in liquid nitrogen facilities, but the use of liquid nitrogen storage and transportation equipment still limits the international applications. IcyEye® technology unprecedently enables efficient long-term storage of corneas in regular deep freezers and facilitates safe shipping in regular dry ice boxes. The clinical adoption of CryoCrate’s IcyEye technology will not only fundamentally solve these operational issues but also open the door to significantly increased exportation of USA corneas internationally and save the sight of millions of patients worldwide.

Previous support from a Coulter Foundation award allowed the CryoCrate team to develop the prototype of IcyEye®, with international patent protection. A pre-510(k) meeting with the FDA for the potential submission took place recently. To gain associated clearances from FDA and based on their feedback , we organized collaboration with our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan and Plas-tech), contract research organization (WuXiAppTech), academic co-inventor (University of Missouri – Kansas City Vision Research Center), and three local eye bank partners, to achieve the following milestones:

  1. The production of IcyEye® kits meets GMP qualifications required for 510(k) submission.
  2. 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.
  3. 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 of 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 the FDA clearance, providing the industry with improved donor tissue quality and higher operational efficacy domestically and internationally.