The National Heart, Lung, and Blood Institute (NHLBI) has announced funding opportunity RFA-HL-26-019 under its Catalyze Product Definition program. This initiative supports early-stage development of medical devices, diagnostics, and research tools addressing diseases within the NHLBI mission, including heart, lung, blood, and sleep (HLBS) disorders. The program aims to transition discoveries from basic science into preclinical development by providing funding for prototype design, diagnostic assay development, and testing research tools.

The grant employs a phased award structure: the R61 phase focuses on initial prototype design, disease target identification, and feasibility testing, while the R33 phase emphasizes optimization, advanced testing, and regulatory alignment. Applicants are expected to define measurable milestones for each phase. Transition to the R33 phase is contingent on achieving R61 milestones and securing cost-matching funds of at least 0.25:1 non-federal contributions.

Eligible applicants include higher education institutions, nonprofits, small businesses, and local governments. Non-domestic entities and foreign organizations may participate as components of U.S. organizations. Each project must address unmet medical needs and provide preliminary data supporting its scientific rationale. Applications proposing clinical trials, therapeutic agents, or biomarker development will not be considered responsive to this opportunity.

Applications should include a detailed project narrative, IP and regulatory strategies, a timeline with milestones, and plans for engaging an Accelerator Partner for commercialization support. Budgets for the R61 and R33 phases are capped at $300,000 annually in direct costs, with a total combined project period of three years. Participants must demonstrate access to project management resources and address issues of reproducibility and rigor in experimental designs.

Key dates include an earliest submission date of January 11, 2025, and an initial application deadline of February 11, 2025, with subsequent deadlines through October 2027. Awards are contingent on NIH appropriations, with up to eight new awards anticipated annually. Selected projects will benefit from NHLBI's Catalyze Coordinating Center's resources for regulatory and commercialization guidance.

Applications will be reviewed for significance, innovation, feasibility, and alignment with NHLBI's priorities. Strong proposals will demonstrate scientific merit, a clear regulatory pathway, and a robust plan for commercialization. Further details and guidance are available from NHLBI contacts, and applicants are encouraged to consult with NHLBI staff before submission.