Limited Competition: NIH Research Evaluation and Commercialization Hubs (REACH) (SB0 Clinical Trial Optional)

The NIH Research Evaluation and Commercialization Hub (REACH) program will accelerate the creation of small businesses and the transition of discoveries originating from academic research into products that improve patient care and enhance health. REACH Hubs foster the technology development and commercial availability of therapeutics, preventatives, diagnostics, devices, and research tools that address unmet patient and public health needs across the entire NIH mission. Applicants are encouraged to focus on building robust entrepreneurial ecosystems in the areas of highest U.S. burden of disease and disability and areas that historically attract lower levels of private biomedical capital investment. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The REACH program will function as a Phase 0 Proof-of-concept Partnership pilot program in accordance with Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81) and reauthorized through FY2031 by Section 10 of the Small Business Innovation and Economic Security Act of 2026 (P.L. 119-83). The program aims to strengthen and de-risk technology development projects through a team-based approach that addresses downstream requirements and provides access to product development and commercialization expertise (scientific, regulatory, reimbursement, business, legal, intellectual property, project management, market research, manufacturing, and commercialization). 

Candidate technology development projects should have moved beyond scientific discovery into the early stages of product development. As a guiding principle, projects should focus on a potential commercial product that requires additional research, development, or validation to demonstrate feasibility and proof of concept, positioning it to become competitive for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award. Although every technology development project is unique, broad guidelines for different types of projects are as follows:

• Small Molecule Therapeutics: The compound is at the lead optimization or preclinical stage. The target is known, and/or there is some method or assay to determine its effect.
• Biologics or Cell Based Therapies: The biologic or cell population has been identified and some reasonable method of development, sourcing, manufacture, or proliferation is proposed. Mechanism of action has been determined to a sufficient level that there is a reasonable understanding of the product to be developed or tested in the project.
• Interventional Medical Device: Physiologic experiments have been conducted or reported in the literature, providing rationale for prototype development. The proposal includes prototype development and testing, either on the bench or in animals. 
• Diagnostic Medical Device/IVD/MDx: The proposal includes prototype development and some method of testing.
• Research Tools: The tool should address a clear unmet research need or demonstrate commercially meaningful differentiation with alternative methods. The proposal should include measurable technical endpoints and validation. 
• Health IT, Software, Apps, and Algorithms: The project should be beyond the concept stage with an existing prototype or code base supported by prior evidence. The proposal should include measurable technical endpoints and validation to demonstrate efficacy, utility, usability, or readiness for commercialization.

The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including academic, non-profit, and industry sectors), provide entrepreneurial educational opportunities for innovators, and create cultural and systemic changes to more rapidly transform breakthrough innovations into products that will have health, economic, and societal impact.

The new REACH Hubs are expected to apply what has been learned from prior NIH proof-of-concept programs (https://seed.nih.gov/portfolio/reach#publications) to train innovators and help promising academic technologies advance efficiently toward SBIR/STTR competitiveness, small business formation, follow-on investment, and commercial translation.