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

The National Institutes of Health, part of the U.S. Department of Health and Human Services, is a leading federal agency responsible for biomedical and public health research in the United States. Through its Small Business Innovation Research program, NIH supports domestic small businesses in developing innovative technologies that address critical health challenges. The Phase IIB Strategic Breakthrough Award is a continuation of this mission, specifically targeting projects that have already progressed through earlier SBIR or STTR phases and require additional support to reach commercialization. This opportunity is forecasted and intended to give applicants time to prepare competitive submissions. The primary purpose of the Phase IIB Strategic Breakthrough Award is to address the well-known funding gap between the conclusion of Phase II research and the point at which a product becomes commercially viable. This gap, often referred to as the “Valley of Death,” is particularly pronounced in the medical biotechnology sector, where regulatory requirements, complex product development, and extended timelines can delay market entry. The award provides additional financial support for projects that require significant time, resources, and effort, including those involving clinical research tools, behavioral interventions, regulatory approvals, or sophisticated instrumentation. Funding under this program is intended to advance technologies toward commercialization, with an emphasis on projects that demonstrate strong technical merit and commercial potential. While specific award amounts are not provided in the forecast notice, applicants must be prepared to demonstrate substantial financial commitment. A key requirement of this opportunity is that applicants must provide matching funds of at least 100 percent of the requested NIH funding. This requirement ensures that recipients have secured non-SBIR/STTR resources to support the transition from research to market-ready products. Eligibility is limited to United States small business concerns that have previously received an NIH SBIR or STTR Phase II award. Additionally, only one Phase IIB Strategic Breakthrough award may be issued per project. The opportunity supports renewal or resubmission applications, specifically Type 2 applications, submitted within the first six due dates following the expiration of the original Phase II budget period. Applicants are encouraged to form collaborative partnerships that bring together diverse expertise to strengthen the proposed project. The submission process for this opportunity will follow NIH standard application procedures under the R44 activity code. While applications are not yet being accepted, the forecast indicates that prospective applicants should begin preparing by developing collaborations and refining their project proposals. Applicants will ultimately be required to submit a comprehensive application package that includes detailed research plans, commercialization strategies, and evidence of matching funds. Evaluation criteria are expected to include scientific and technical merit, feasibility, commercialization potential, and alignment with NIH mission priorities. Key timeline elements for this opportunity include an estimated posting date of June 1, 2026, and an estimated application due date of September 5, 2026. Awards are anticipated to be made around March 1, 2027, with project start dates expected in April 2027. As a forecasted opportunity, this notice serves as an early engagement mechanism, allowing applicants to prepare well in advance of the official solicitation release. Interested applicants can contact NIH SEED, the Small Business Education and Entrepreneurial Development office, for additional information and guidance.

Ensure availability of at least 100 percent matching funds and demonstrate strong commercialization readiness to address the Valley of Death