Project Grant R44OD035392

Award Date 9/15/24
Completion Date 8/31/26
Dollars Obligated $941K
Funding Federal Agency
Office of the Director
Federal Grant Program
93.351
Assistance Type
Project Grant
Place of Performance
Columbia, MO 65211, USA
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The key objectives of this project are: (I) Producing the company's proprietary Odinsol cryopreservation medium to meet GMP qualifications and demonstrate biocompatibility for FDA 510(k) submission as a storage device for transplantable tissues; (II) Evaluating the in vitro and in vivo safety and efficacy of the Odinsol technology to demonstrate superior performance in preserving viability and function of novel cell-based therapeutic materials compared to existing cryopreservation protocols; and (III) Completing the FDA 510(k) submission and finalizing the production line based on further FDA feedback, with the goal of enabling clinical use of the Odinsol technology within three years after regulatory clearance. This project builds upon the company's previous SBIR and Coulter Foundation awards to develop and optimize their innovative cryopreservation solutions.

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