The National Institutes of Health (NIH), specifically the National Center for Advancing Translational Sciences (NCATS), has announced a funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for Use in Regenerative Medicine" under the UT1/UT2 cooperative agreement mechanism. This initiative is part of the Small Business Technology Transfer (STTR) program, aiming to support small businesses in developing novel extracellular vesicle (EV)-based therapeutic platforms for regenerative medicine. These vesicles, including those derived from stem cells or engineered for specific therapeutic applications, have shown significant potential in repairing tissues and organs, making them promising candidates for regenerative treatments.

The main purpose of this funding opportunity is to overcome the challenges associated with producing and scaling up extracellular vesicles for therapeutic use. Successful applications will focus on addressing large-scale, GMP-grade manufacturing and developing platforms that ensure consistency, purity, and safety of EV products. Applications should also demonstrate therapeutic benefits, particularly in tissue and organ repair, and must consider quality control measures and compliance with FDA guidelines. The goal is to translate these EV-based therapies from preclinical research to clinical applications, potentially leading to FDA approval and commercialization.

The funding opportunity is open to U.S.-based small business concerns (SBCs) that meet the eligibility criteria for the STTR program. Phase I awards offer up to $295,924, while Phase II awards can provide up to $1,972,828, with the potential for budget waivers on approved topics. Projects can range from direct EV therapy using off-the-shelf stem cell-derived vesicles to personalized EVs designed for individual patient needs. This phased funding mechanism includes both early feasibility studies (Phase I) and later-stage optimization and scale-up (Phase II) for EV production and validation.

Applications are accepted annually, with due dates on June 6, 2024, and June 6, 2025. Applicants must submit proposals electronically through the NIH ASSIST system or Grants.gov and are encouraged to submit letters of intent 30 days prior to the application deadline. It's essential that applicants adhere to all submission guidelines, including the SBIR/STTR-specific instructions provided in the application guide.

Projects that focus on liposomes or nanoparticles, or therapeutic areas outside of regenerative medicine, will not be considered responsive to this funding opportunity. Applicants are encouraged to engage with the FDA’s Office of Tissues and Advanced Therapies (OTAT) during the regulatory process to ensure that their platforms are on the path to FDA approval and commercialization.