Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)

The U.S. Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Center for Advancing Translational Sciences (NCATS), is offering funding under the program titled Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed). This opportunity is designed to support small business concerns (SBCs) under the Small Business Innovation Research (SBIR) mechanism using cooperative agreements. The program focuses on developing automated, portable, and miniaturized systems for tissue chip technology, building upon lessons learned from the NIH Tissue Chips in Space program, which explored automation and miniaturization under microgravity conditions in collaboration with NASA and the Center for Advancement of Science in Space. The purpose of this funding opportunity is to create benchtop, self-contained systems capable of maintaining three-dimensional tissue constructs while reducing the costs, time, and labor typically required to operate current microphysiological systems. The funded projects are expected to advance tissue chip technology to achieve greater accessibility, usability, and scalability for drug development, biomedical research, and regulatory decision-making. Proposals must demonstrate the ability to integrate automated sensing, monitoring, and data acquisition methods into tissue chip platforms to reduce reliance on manual handling, expand throughput, and provide real-time, reproducible outputs. Both Phase I and Phase II awards are supported, including Fast-Track and Direct-to-Phase II pathways, depending on project readiness. Applications may focus on components or integrated systems. Eligible Phase I projects may propose biosensing technologies, automated fluid handling, telemetry operations, and preculture automation. Phase II awards may involve integration of prototypes, validation testing, software development for system control, and demonstration of user-friendly, scalable designs that support long-term use. Successful projects should result in compact, reliable instrumentation that allows wider adoption of tissue chip systems in biomedical research. Applicants must also outline milestones and go/no-go decision points, as cooperative agreements involve substantial NIH oversight, including milestone planning, monitoring, and project adjustments. This notice of funding opportunity is open exclusively to U.S. small business concerns that meet SBIR eligibility requirements, including size, ownership, and operational criteria. Foreign institutions and foreign components are not eligible. Eligible applicants must be organized for profit, maintain primary operations in the United States, and have fewer than 500 employees, including affiliates. Additionally, program directors or principal investigators must primarily be employed by the small business at the time of award and throughout the project. Applicants must complete all registrations in SAM.gov, Grants.gov, SBA Company Registry, and eRA Commons before submission. No cost sharing or matching funds are required. The application process requires submission through NIH’s ASSIST platform, Grants.gov Workspace, or an approved institutional system-to-system solution. A Letter of Intent was requested by January 22, 2024, though it is not binding or required. Full application deadlines occur on February 22, 2024; February 24, 2025; February 23, 2026; and September 4, 2026, with peer review and funding decision cycles following NIH’s review process. Applications are due by 5:00 PM local time of the applicant organization. The opportunity expires on September 5, 2026, as extended by NOT-TR-26-004. Review criteria emphasize significance, innovation, approach, investigator qualifications, and the project environment. Reviewers will assess whether proposed technologies can make tissue chips more accessible and impactful in drug development and biomedical research. Projects will be scored based on feasibility, potential for commercialization, milestones, and contribution to NIH priorities. Awardees will also be required to participate in semi-annual NIH Tissue Chip Consortium meetings and comply with NIH data management and sharing policies, although SBIR data rights allow awardees to retain generated data for up to 20 years. Progress will be closely monitored by NIH staff under the cooperative agreement structure. Contacts for this program include Dmitriy Krepkiy, Ph.D. (Scientific/Research Contact, dmitriy.krepkiy@nih.gov, 301-451-2232), Marilyn Moore-Hoon, Ph.D. (Peer Review Contact, marilyn.moorehoon@nih.gov, 301-594-4861), and Imoni Washington, J.D. (Grants Management Contact, imoni.washington@nih.gov, 301-435-2939). General submission questions may be directed to the eRA Service Desk or Grants.gov support. Interested applicants are encouraged to contact NIH staff prior to submission to ensure alignment with program goals and requirements.