NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)

The NHLBI SBIR Phase IIB Small Market Awards grant is issued by the National Heart, Lung, and Blood Institute (NHLBI), a component of the U.S. Department of Health and Human Services' National Institutes of Health (NIH). This funding opportunity aims to bridge the significant gap between Phase II Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) awards and commercialization for technologies addressing rare diseases or young pediatric populations. These technologies often struggle to secure private investment due to limited market sizes and high development costs associated with regulatory approval processes. This funding opportunity specifically supports small businesses seeking to advance technologies requiring regulatory clearance or approval, particularly those that serve patient populations with rare diseases (affecting fewer than 200,000 individuals in the U.S.), qualify as Humanitarian Use Devices (less than 4,000 individuals per year), or are targeted for young pediatric populations (ages 0–12). Eligible projects must build directly upon work conducted under a previous SBIR or STTR Phase II award and show significant scientific progress. The program encourages partnerships with third-party investors and strategic collaborators, including patient advocacy groups, to foster commercialization readiness. Applicants may request up to $3,500,000 in total costs for up to three years. Proposals should include a detailed Finance Plan showing a commitment of independent third-party investor funding equal to or exceeding one-third of the total NHLBI funds requested. Funding is intended for research-related elements that advance the technology toward regulatory submission and market readiness. Projects must align with NHLBI’s mission in cardiovascular, lung, blood, or sleep disorders, and may include therapeutics, diagnostics, medical devices, or digital health solutions relevant to these areas. The application process involves submission through NIH systems (ASSIST, Grants.gov Workspace, or institutional S2S). Letters of Intent are due annually on January 26 for three consecutive years starting in 2025. Full applications must be submitted by February 26 each corresponding year. Applications undergo a two-level NIH review process assessing significance, innovation, approach, and commercialization readiness, including the robustness of the third-party investor plan. This opportunity is recurring with next cycles expected annually. Awards are made in December following the February application deadlines, with start dates in that same month. For support, applicants may contact Stephanie Davis (NHLBI) or Meena Rajagopal (NCATS), and are encouraged to consult relevant regulatory guidance and review expectations outlined in the NIH application instructions.