Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)

The funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)" is issued by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), under the Department of Health and Human Services. This initiative is designed to support small U.S.-based businesses in developing novel extracellular vesicle (EV)-based therapeutic platforms specifically for use in regenerative medicine. This includes the production, manufacturing, and therapeutic application of both native and engineered EVs. The program provides financial support via SBIR cooperative agreements (U43 for Phase I and U44 for Phase II) and focuses on EV platforms intended for tissue and organ repair, including wound healing. The grant aims to address major bottlenecks in EV-based therapy development such as GMP-grade production, scalability, and specificity of targeting. Applicants must demonstrate the feasibility and therapeutic potential in Phase I and refine, scale, and validate these platforms in Phase II. Eligibility is limited to U.S. small business concerns that meet specified ownership, organizational, and operational criteria. This includes entities directly owned and controlled by U.S. citizens or permanent residents, qualifying Indian tribes, Alaska Native Corporations, or Native Hawaiian Organizations. Applicants must also meet specific performance benchmarks related to the transition and commercialization rates of prior SBIR awards. Foreign entities and components are not eligible to apply. Applications must be submitted through NIH’s ASSIST system, Grants.gov Workspace, or an institutional S2S system. Submission includes a letter of intent (due 30 days before the application deadline), a complete application adhering to the SBIR/STTR instructions, a commercialization plan, milestone timelines, and data management plans. Applications not conforming to the outlined requirements will not be accepted. The funding limits are $295,924 for Phase I and $1,972,828 for Phase II, with potential waivers allowing for up to $325,000 and $2 million respectively. Project durations are limited to 6 months for Phase I and 2 years for Phase II. Matching is not required. Review criteria include significance, innovation, approach, investigator qualifications, and environment. Milestones, commercialization plans, and regulatory engagement with FDA are particularly emphasized for successful applications. For further guidance, interested applicants can contact scientific officers Dr. Christine Happel and Dr. Meena Rajagopal or grants management contact Imoni Williams. The funding opportunity opens on May 6, 2023, with the latest application deadline on October 6, 2025. This grant does not support clinical trials and is not offered on a rolling basis but is recurring with structured due dates.

Contact NIH early if applying for amounts exceeding standard caps Ensure commercial potential and regulatory strategy are clearly articulated Include specific, measurable milestones and timelines