NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

SBIR topic PA-27-101 (U.S. Department of Health and Human Services – NIH), Phase II. Open to U.S. small businesses. Opens: August 5, 2026. Closes: April 6, 2027. Background The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs (also known as America's Seed Fund) are major sources of early-stage funding for U.S. technology development and commercialization. NIH SBIR and STTR awards support projects through multiple phases: Phase I: Establish the technical merit and feasibility of the proposed R&D. Phase II: Continue R&D to advance toward commercialization. After Phase II, NIH expects small business concerns (SBCs) to fully commercialize the product or technology using non-SBIR/STTR funds (federal or non-federal). However, biomedical projects may need additional support because of a significant funding gap between Phase II and commercialization (known as the "Valley of Death"). This is a particular challenge for technologies that need regulatory approval, use new complex manufacturing methods, or target small markets. What this NOFO supports This SBIR Phase IIB Strategic Breakthrough NOFO provides previous NIH SBIR or STTR Phase II recipients support to bridge the gap between the Phase II and commercialization. Applicants must secure 100% third-party matching funds for the proposed Phase IIB Strategic Breakthrough award project. SBCs must demonstrate not less than 100% matching funds from: new private capital (e.g. another company, venture capital firm or other private investor) OR new funding awarded by a government agency (other than a Phase I or II SBIR or STTR award) OR any combination of the above Phase II recipients should consider the Commercialization Readiness Pilot (CRP) program when they need additional technical assistance and/or later-stage R&D, but do not have third-party matching funding and/or require a significant amount of the work to be outsourced. The CRP program can also support small…