Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
NHLBI Catalyze funds early-stage medical device prototypes, disease target ID, & assay development for heart, lung, blood, & sleep disorders, aiming to prep projects for further testing.
Funder: National Institutes of Health
Due Dates: June 18, 2025 (New/Renewal/Resubmission/Revision) | August 21, 2025 (AIDS) | October 21, 2025 (New/Renewal/Resubmission/Revision) | December 22, 2025 (AIDS) | Additional cycles through December 2027
Funding Amounts: Up to $300,000 direct costs/year for R61 and R33 phases; max 3 years total (≤2 years per phase); R33 phase requires 0.25:1 non-federal cash match.
Summary: Early-stage translational support for medical device prototype design/testing, disease target identification, and assay/tool development for heart, lung, blood, and sleep disorders.
Key Information: Clinical trials are not allowed; R33 phase requires cost matching and an Accelerator Partner for commercialization guidance.
Description
This opportunity, offered by the National Heart, Lung, and Blood Institute (NHLBI) under the NIH Catalyze Program, supports early-stage translational research to advance medical device prototypes, identify diagnostic disease targets, develop associated assays, and create research tools for heart, lung, blood, and sleep (HLBS) disorders. The program is structured as a phased R61/R33 award, designed to help projects reach a stage suitable for preclinical testing or further development with federal or private partners.
The R61 phase funds initial prototype development, disease target identification, and pilot testing of research tools. The R33 phase supports further development, validation, and optimization, including user feedback, large-scale testing, and data integration. The ultimate goal is to position products for in vivo testing and subsequent preclinical or clinical development.
Clinical trials are not permitted under this opportunity. Projects focused on therapeutic agent development or biomarker discovery are not eligible (see companion NOFOs for those areas).
