Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)

The NHLBI Catalyze Program provides comprehensive support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing, while developing translational researchers fluent in product development and entrepreneurship. This Catalyze Product Definition initiative provides early stage translational support for activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat Heart, Lung, Blood, and Sleep (HLBS) diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, identify disease targets and generate experimental design, and identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, modifying design features with user feedback, diagnostic product generation, exploration of assay components, characterization of load design, and research tool improvement with large trial testing and data integration. Following successful completion of the program, potential products are expected to be poised for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative is part of a suite of innovation grants to advance projects to meet entry criteria for the NHLBI Catalyze Preclinical Program.