Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)

The U.S. Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Center for Advancing Translational Sciences (NCATS), has released a Notice of Funding Opportunity titled “Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 – Clinical Trial Not Allowed).” This opportunity is issued under the Small Business Technology Transfer (STTR) program and supports both Phase I (UT1) and Phase II (UT2) cooperative agreements. The program builds upon previous NIH and NASA collaborations in the Tissue Chips in Space program, which advanced the miniaturization and automation of tissue chip systems for biomedical research conducted in microgravity. This initiative seeks to translate those advances to Earth-based research by supporting the development of accessible, scalable, and automated tissue chip platforms for drug development and biomedical studies. The purpose of the MATChS program is to accelerate the development of microphysiological systems (MPS) that mimic human organ systems and functions more effectively than traditional two-dimensional cultures or animal studies. These systems are increasingly important as alternatives in drug discovery, regulatory assessment, and precision medicine research, particularly following the FDA Modernization Act 2.0, which reduced reliance on animal testing. However, existing systems require significant resources, specialized expertise, and costly infrastructure. To overcome these barriers, NCATS seeks proposals to design bench-top, portable, automated, and self-contained tissue chip systems. These systems should incorporate real-time biosensing, automated readout capabilities, and integrated data processing to reduce manual intervention while enabling high-throughput, reproducible analyses. The funding opportunity supports a range of activities under the STTR mechanism. Phase I projects may focus on developing key components such as biosensing modules, automation of tissue preculture and loading, perfusion systems, telemetry operations, or methods to maintain three-dimensional tissue constructs. Phase II projects expand to the integration of these components into functional prototypes, development of control software and data systems, establishment of standard protocols, validation, and pre-market end-user testing. The ultimate aim is to provide scalable, mass-producible, and robust platforms that simplify use for researchers, broaden access, and pave the way for commercialization. The cooperative agreement structure means that NIH program staff will work closely with recipients to establish milestones, track progress, and make go/no-go funding decisions at critical stages. The program offers budgets of up to $350,000 in total costs per year for Phase I awards, and up to $2.15 million per year for Phase II projects, depending on justification and eligibility for budget waivers. The expected duration of awards is one year for Phase I and up to two years for Phase II, consistent with statutory STTR guidelines. NCATS anticipates funding two Phase I projects and up to one Phase II project in Fiscal Year 2024. Funding is not open-ended, and continuation from Phase I to Phase II will require demonstration of milestones, feasibility, and commercial potential, subject to review and availability of funds. Matching funds are not required for this opportunity. Eligibility is limited to United States small business concerns (SBCs) that are organized for profit, based in the U.S., and meet federal definitions of small business size and ownership. Foreign institutions are not eligible, nor are non-domestic components of U.S. organizations. For Phase I and II projects under STTR, at least 40 percent of the research must be conducted by the small business, with at least 30 percent performed by a partnering nonprofit research institution. SBC applicants must also comply with SBIR/STTR performance benchmarks related to Phase I-to-Phase II transition rates and commercialization standards, as established by the Small Business Administration. Applications proposing development of tissue models without integration of automation or miniaturization components will be considered non-responsive. Applications must be submitted electronically via Grants.gov and tracked in the NIH eRA Commons. Required registrations include SAM.gov, SBA Company Registry, Grants.gov, and eRA Commons. Letters of intent are encouraged and due by January 22, 2024, but are not binding. Full applications are due February 22, 2024, February 24, 2025, February 23, 2026, and September 4, 2026, all by 5:00 PM local time. Scientific merit review will follow each due date, with advisory council reviews occurring several months later and earliest possible start dates approximately 10 months after submission. The program expires on September 5, 2026. Evaluation will be conducted according to NIH peer review standards, with emphasis on significance, investigator qualifications, innovation, approach, and environment. Specific to this program, reviewers will assess the potential impact of proposed advances on automation, miniaturization, scalability, and adoption of tissue chip systems. Commercialization potential will be particularly important for Phase II and Fast-Track applications. Awardees will be required to attend semi-annual NIH Tissue Chip Consortium meetings and to comply with NIH data management and sharing policies, while retaining STTR data rights for up to 20 years. Contact information for scientific and administrative inquiries is provided: Dr. Dmitriy Krepkiy (dmitriy.krepkiy@nih.gov, 301-451-2232) for scientific questions, Dr. Marilyn Moore-Hoon (marilyn.moorehoon@nih.gov, 301-594-4861) for peer review, and Imoni Washington, J.D. (imoni.washington@nih.gov, 301-435-2939) for grants management.