The National Institutes of Health (NIH), through its National Center for Advancing Translational Sciences (NCATS), has announced a new Small Business Innovation Research (SBIR) funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for Use in Regenerative Medicine" under funding opportunity number PAR-23-267. This initiative seeks to advance the development of extracellular vesicle (EV)-based therapeutic platforms, which hold great promise for tissue and organ repair in regenerative medicine. The focus of the program is to overcome the current challenges associated with the production, manufacturing, and use of EVs as therapeutics. These vesicles, released from cells, can be engineered or derived from stem cells, offering significant potential for specific and targeted therapies in regenerative medicine.

The funding opportunity will support small business concerns (SBCs) through both Phase I and Phase II grants, helping them bring innovative EV-based therapeutic platforms closer to clinical application and commercialization. Specific focus areas include developing technology to facilitate large-scale Good Manufacturing Practice (GMP) production of EVs and ensuring the therapeutic platforms meet FDA regulatory standards. The initiative encourages projects to demonstrate therapeutic benefits, particularly for tissue and organ repair and wound healing. Phase I projects should focus on initial proof-of-concept studies, while Phase II applications are expected to address the optimization, refinement, and scale-up of the technology platform, with an emphasis on ensuring quality control and meeting regulatory approval milestones.

To be eligible, applicants must be U.S.-based small businesses, as defined by the Small Business Administration (SBA), with fewer than 500 employees. The program supports multiple types of applications, including Fast-Track, Direct to Phase II, and resubmissions, and does not allow clinical trials. Award budgets for Phase I are capped at $295,924, while Phase II awards may reach up to $1,972,828. In certain approved topics, budgets may exceed these caps. Projects should focus on the regenerative applications of EVs, avoiding topics like liposome or nanoparticle therapeutics, which are not responsive to this opportunity.

Applicants are encouraged to submit letters of intent 30 days prior to the due dates, which fall annually on June 6 until 2025. Proposals must be submitted electronically through NIH's ASSIST system or Grants.gov. Key evaluation criteria include the significance of the proposed technology, the investigators' expertise in EVs and regenerative medicine, innovation in therapeutic platform development, and the overall approach to overcoming manufacturing and commercialization hurdles. The review process will assess the commercial potential of the proposed platforms and their ability to meet regulatory standards.

This funding opportunity is designed to help advance innovative technologies in the rapidly growing field of EV-based therapies, with the ultimate goal of improving patient outcomes in regenerative medicine. Potential applicants should ensure they follow all NIH and SBIR-specific submission requirements closely, as non-compliance could delay or disqualify applications from review.