The National Institutes of Health (NIH), specifically through the National Heart, Lung, and Blood Institute (NHLBI), has reissued the SBIR Phase IIB Bridge Awards Funding Opportunity to support the commercialization of biomedical technologies. This program addresses the funding gap small businesses face after completing SBIR/STTR Phase II projects and before securing private investment for product commercialization. These awards assist in advancing promising technologies to the stage of Federal regulatory approval and commercialization. This initiative emphasizes technologies aligned with the NHLBI mission, including cardiovascular, lung, blood, and sleep disorder products, with a competitive preference for projects demonstrating strong commercial potential and third-party investor support.

The purpose of the program is to promote partnerships between small business concerns (SBCs) and third-party investors, ensuring sufficient funding and guidance for the transition from research to marketable products. Projects must build on prior SBIR or STTR Phase II work and demonstrate significant progress and commercial promise. The funding seeks to bridge critical stages, including conducting validation studies, filing regulatory submissions, and preparing for commercialization. Applicants are encouraged to establish credible business plans and secure third-party investor commitments that meet or exceed the requested NHLBI funding.

Eligible applicants are U.S.-based small business concerns with no more than 500 employees and meeting specific ownership requirements. Foreign entities are not eligible, though collaborations with U.S.-based entities are allowed. Applicants must propose projects related to the NHLBI mission and submit applications consistent with NIH guidelines. Required documentation includes a commercialization plan, evidence of third-party funding, and adherence to application-specific requirements. The total funding for a project cannot exceed $3.5 million, with a maximum of $1,166,667 per year recommended, and projects may span up to three years.

Key dates include an open application window starting January 26, 2025, with annual submission deadlines until February 26, 2027. Applicants are encouraged to submit letters of intent early to aid review planning. The program expects rigorous evaluation of technical and business feasibility, emphasizing regulatory milestones, innovation, market need, and financial viability. A well-detailed finance plan outlining independent third-party investor funding is crucial for competitiveness.

Applications must adhere strictly to NIH forms and guidance, including updated FORMS-I, expected to be available at least 30 days before the first due date. Submissions should include detailed descriptions of the project's scientific scope, regulatory plans, and commercialization potential. Review criteria focus on scientific merit, feasibility, significance to NHLBI's mission, and commercialization prospects. The NIH encourages early discussions with NHLBI program contacts to confirm project relevance.

For more information, applicants are directed to NIH resources and NHLBI's dedicated SBIR/STTR guidance. The program represents an opportunity for small businesses to accelerate innovative health solutions from research to impactful clinical applications.