# Establishment of a First-in-Class Biocompatible and Efficient Cryopreservation Technology Platform for the Next Generation of Cell-Based Therapeutics in Regenerative Medicine and Drug Discovery

> **NIH NIH R44** · CRYOCRATE, LLC · 2024 · $940,821

## Abstract

SUMMARY
Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first-
in-class biocompatible cryopreservation medium product, trademarked as OdinSol®, that provides enabling and
efficient options for biobanking urgently needed for the development and implementation of cell-based
therapeutics and tissue engineering in personalized medicine.
The OdinSol® technology removes the need for any toxic cell permeating cryoprotectant used in nearly all
existing cryopreservation methods, secures long-term storage in regular -80oC deep freezers, and significantly
improves the cryopreservation efficiency for cell-based therapeutic materials (e.g., iPSC-derived cells or tissues).
Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with
our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research
organization (WuXi AppTec), academic co-inventor (University of Missouri – Kansas City Vision Research
Center), to achieve the following milestones:
I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows
 compliance with FDA guidance for 510(k) submission as a storage device for transplantable tissues;
II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be
 superior to existing cryopreservation protocols with respect to preserving viability and function of
 novel cell-based therapeutic materials for regenerative medicine;
III. 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 future clinical use of the OdinSol® technology within three years after the FDA clearance, providing
the regenerative medicine industry with a highly efficient biocompatible cryostorage platform.

## Key facts

- **NIH application ID:** 10823211
- **Project number:** 1R44OD035392-01A1
- **Recipient organization:** CRYOCRATE, LLC
- **Principal Investigator:** Xu Han
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $940,821
- **Award type:** 1
- **Project period:** 2024-09-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10823211

## Citation

> US National Institutes of Health, RePORTER application 10823211, Establishment of a First-in-Class Biocompatible and Efficient Cryopreservation Technology Platform for the Next Generation of Cell-Based Therapeutics in Regenerative Medicine and Drug Discovery (1R44OD035392-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10823211. Licensed CC0.

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