This upcoming NIH and CDC grant will invite eligible US small businesses to apply for SBIR funding for innovative research requiring clinical trials, pending program reauthorization.
Funder: National Institutes of Health
Due Dates (Anticipated): September 2026 (Full application deadline, projected)
Funding Amounts: Award ceiling not specified; 100% matching funds required; typical duration/project size varies by project scope.
Summary: Provides additional funding to U.S. small businesses with prior NIH SBIR/STTR Phase II awards to bridge the commercialization gap for high-impact biomedical technologies.
Key Information: Only one Phase IIB Strategic Breakthrough award per project; applications must demonstrate at least 100% matching funds.
This opportunity supports United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award. The goal is to provide additional funding for projects that require extraordinary time and resources to commercialize, particularly those needing regulatory approval, complex instrumentation development, clinical research tools, or behavioral interventions. This award is intended to help bridge the "Valley of Death"—the funding gap between the end of Phase II support and market access—by supporting further R&D efforts necessary for commercialization.
The program is administered by the National Institutes of Health (NIH) and covers a wide range of health-related research areas across multiple NIH Institutes and Centers. Only one Phase IIB Strategic Breakthrough award is permitted per project, and applicants must provide at least 100% matching funds.