The National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, has reissued the Funding Opportunity Announcement (FOA) titled "Catalyze: Product Definition Device Prototype Testing and Design Modification, Diagnostic Disease Target Assay Development and Design Characterization, and Research Tool Testing and Validation (R33 - Clinical Trials Not Allowed)." This FOA offers support for the later stages of prototype testing and design modification, specifically for devices, diagnostics, and research tools that address heart, lung, blood, and sleep (HLBS) diseases. The primary goal is to advance these technologies to the point where they are eligible for further development through the NHLBI Catalyze Preclinical program or other funding sources.

The funding opportunity focuses on projects that have completed early-stage development activities, such as prototype design and initial testing, and are now ready to proceed with more advanced stages of development. This includes product generation, assay development, validation, and large-scale testing of tools, with the aim of creating significant improvements over current technologies. The R33 phase, covered by this FOA, allows for full system integration, in vivo testing, optimization, and preparation for regulatory review. The activities should demonstrate the potential for clinical or research impact and facilitate the transition to preclinical optimization.

Applicants are expected to show novelty in their approach, demonstrating that the proposed product provides a meaningful improvement over existing options for HLBS conditions. They must also provide strong biological rationale, preliminary data, and evidence of unmet clinical or research needs. Key areas of interest include device systems integration, performance testing, assay optimization, and the development of user interfaces for research tools. Proposed projects must address issues such as manufacturing optimization, performance comparison with existing technologies, and regulatory preparedness.

Eligible applicants include higher education institutions, small businesses, nonprofits, and government agencies. Applicants are required to secure cost matching of at least 0.25:1 of federal direct costs for the R33 phase and must include a letter of support confirming the availability of these matching funds. Additionally, they must identify an Accelerator Partner to support product development and commercialization. These partners are expected to provide expertise in regulatory strategy, business development, and market analysis, and their involvement must be documented with a letter of support.

The total project period is limited to two years, with a maximum annual budget of $250,000 in direct costs. Applicants are required to include detailed plans for intellectual property protection and regulatory considerations, even if these strategies are not fully developed. Milestones and timelines must be clearly defined and include specific, measurable, and time-bound objectives. The milestones will be reviewed by NHLBI staff and program officers to ensure that sufficient progress is being made.

This FOA is part of the broader Catalyze initiative, which includes other opportunities for early-stage projects, small molecules, and biologics. The companion FOAs focus on different aspects of product development, allowing applicants to find the appropriate stage and scope for their work. Applications are accepted multiple times per year, with deadlines and review cycles outlined in the FOA. The next application deadline is November 21, 2023.