The National Institutes of Health (NIH), through its National Heart, Lung, and Blood Institute (NHLBI), offers the SBIR Phase IIB Bridge Awards to facilitate the commercialization of technologies that address critical needs in heart, lung, blood, and sleep disorders. These grants aim to support small business concerns (SBCs) in bridging the significant funding gap between the completion of a Phase II SBIR/STTR project and the initiation of full commercial deployment. Eligible projects must align with the NHLBI mission and show clear potential for regulatory approval and clinical use.
This funding opportunity is structured to advance technologies that have already demonstrated technical feasibility under a prior Phase II SBIR/STTR award. It specifically supports efforts leading to regulatory submissions such as INDs, NDAs, BLAs, PMAs, or 510(k) clearances. Activities may include clinical validation, product development refinement, and regulatory alignment. A critical aspect of the Bridge Award is the encouragement of partnerships between SBCs and third-party investors. Applicants must present a finance plan documenting secured or planned investments equal to or exceeding the NHLBI funding request.
Applicants must be U.S.-based small businesses with 500 or fewer employees and meet specific SBIR/STTR ownership requirements. This NOFO allows for projects up to $3.5 million over three years, with up to $1,166,667 annually. The NHLBI expects to fund approximately five projects per fiscal year, subject to appropriations. Applications are evaluated based on commercial viability, technical merit, prior Phase II progress, and the robustness of third-party investment plans.
The submission process includes an optional letter of intent and a complete application package via NIH ASSIST, Grants.gov Workspace, or institutional systems. Required components include a detailed Commercialization Plan, documentation of third-party funding, letters of support, and regulatory agency communications. NIH has established firm expectations for applicant compliance with application formatting, financial disclosures, and eligibility certification, especially for venture-backed entities.
The most recent deadline was February 26, 2025, with subsequent deadlines on February 26 in 2026 and 2027. The next anticipated cycle is expected to open in January 2026. Awards from this NOFO are expected to begin in December of the same year as submission. While this opportunity is marked expired, NIH may consider late submissions under continuous or late policy provisions on a case-by-case basis, requiring contact with the eRA Service Desk for submission guidance.
This opportunity strongly emphasizes collaboration, commercial strategy, and milestone-driven development. Applicants must clearly define commercialization paths, clinical impacts, and financial strategies to successfully transition technologies from NIH-funded development to market adoption. This makes the SBIR Phase IIB Bridge Award a critical pathway for companies working at the intersection of biomedical innovation and commercialization.
