Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)
ID: 347582Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $296K

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine" (PAR-23-267) aimed at supporting the development of novel extracellular vesicle (EV)-based therapeutic platforms. This initiative specifically invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grants, focusing on overcoming challenges in the production and manufacturing of EVs for tissue and organ repair, with an emphasis on demonstrating GMP-grade production and facilitating regulatory approval. The funding mechanism includes cooperative agreements (U43/U44), with a budget cap of $295,924 for Phase I and $1,972,828 for Phase II awards, and applications must adhere to stringent guidelines and undergo peer review. Interested applicants can find more information and submit inquiries via the NIH Grants Information email at grantsinfo@nih.gov, with the application deadline set for June 6, 2025.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, through the NIH, has launched a funding opportunity (PAR-23-267) to support the development of novel extracellular vesicle (EV)-based therapeutic platforms for regenerative medicine. This initiative invites U.S. small business concerns to apply for Small Business Innovation Research (SBIR) grants aimed at addressing challenges in the production and manufacturing of EVs for tissue and organ repair. Key objectives include demonstrating GMP-grade production, assessing therapeutic benefits, and facilitating regulatory approval. The funding mechanism, specifically U43 and U44 cooperative agreements, highlights an interest in innovative approaches to harness EVs for therapeutic applications. Grant applications must demonstrate a viable commercialization plan and address the expected commercial impact. Eligible applicants must be U.S.-based and meet specific ownership and size criteria, with a total budget cap of $295,924 for Phase I and $1,972,828 for Phase II awards. The application process requires compliance with stringent guidelines and is subject to peer review focusing on feasibility, significance, and innovation. This effort reflects the NIH's commitment to advancing regenerative medicine through partnerships with small businesses, facilitating innovations aimed at improving therapeutic outcomes for various diseases.
    Similar Opportunities
    Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)" aimed at advancing research in regenerative medicine utilizing adult stem cells. This initiative, supported by the 21st Century Cures Act, encourages small businesses to develop collaborative projects that contribute to the field, although applications are not currently being solicited. With an estimated total program funding of $400,000, interested applicants should prepare for the upcoming Notice of Funding Opportunity (NOFO), with key dates including an estimated synopsis post date of August 1, 2025, and a close date of October 21, 2025. For further inquiries, potential applicants can contact Aron Marquitz, Ph.D., at aron.marquitz@nih.gov or by phone at 301-435-1240.
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" aimed at supporting Small Business Concerns (SBCs) in conducting investigator-initiated exploratory clinical trials related to neurological disorders. This initiative encourages applications for Phase I and II studies focusing on drugs, biologics, devices, and therapies that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), emphasizing the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to foster innovation. The maximum funding amounts are $295,924 for Phase I and $1,972,828 for Phase II projects, with applications required to demonstrate readiness for eventual FDA regulatory approval. Interested applicants can begin submitting proposals on December 5, 2023, with the application deadline set for September 5, 2026; for further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx)" through a cooperative agreement aimed at supporting the development of extramural Resource Centers (RCs) focused on tissue engineering and regenerative medicine (TE/RM). The initiative seeks to foster interdisciplinary translational projects (ITPs) that leverage clinical, scientific, and regulatory expertise to advance therapeutics, diagnostics, and monitoring solutions for tissue damage caused by various health conditions. This funding cycle is particularly significant as it aims to facilitate the validation and preclinical testing of promising TE/RM products, with the goal of achieving regulatory approvals for first-in-human studies. Interested applicants, particularly small businesses with relevant expertise, are encouraged to prepare for future applications, as the estimated synopsis post date is October 7, 2025, with a closing date of November 7, 2025, and an anticipated award date of July 1, 2026. For further inquiries, potential applicants can contact Dr. Scott Verbridge at scott.verbridge@nih.gov or by phone at 301-594-0676.
    NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for small business concerns (SBCs) through the NINDS Exploratory Clinical Trials program (R43/R44), aimed at supporting investigator-initiated exploratory clinical trials related to neurological disorders. This program invites applications for studies that evaluate drugs, biologics, devices, or therapies, generating preliminary data to inform future clinical development, with a focus on enhancing diverse perspectives within research teams. Eligible U.S.-based SBCs can apply for funding caps of up to $295,924 for Phase I and $1,972,828 for Phase II, with applications due by September 5, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-23-311.html.
    Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator- Initiated Studies (UH3 Clincical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is announcing a funding opportunity titled "Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies," aimed at advancing research in regenerative medicine utilizing adult stem cells. This initiative, supported by the 21st Century Cures Act, encourages small businesses to develop collaborative projects, although applications are not currently being solicited. The funding will be provided through a cooperative agreement, with an estimated synopsis posting date of August 1, 2025, and a closing date for applications expected by October 21, 2025. For further inquiries, interested parties can contact Aron Marquitz, Ph.D., at aron.marquitz@nih.gov or by phone at 301-435-1240.
    NIH and CDC Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), in collaboration with the Centers for Disease Control and Prevention (CDC), is offering a Small Business Innovation Research (SBIR) Grant opportunity for United States small business concerns (SBCs) to submit applications for various phases of research and development, including Phase I, Phase II, Direct to Phase II, Fast-Track, and Phase IIB grants. Eligible applicants must possess the necessary research capabilities and technological expertise to support the R&D missions of the NIH and CDC, with a focus on health-related innovations. This funding opportunity is significant as it encourages collaboration among small businesses to advance health research, with applications expected to be solicited following the reauthorization of the SBIR program. Interested parties can reach out to the NIH SEED Office at SEEDinfo@nih.gov or call 301-827-8595 for further information, with the estimated synopsis posting date set for October 1, 2025, and a closing date for applications anticipated on January 5, 2026.
    Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) titled "Miniaturization and Automation of Tissue Chip Systems" (MATChS), aimed at advancing the development of automated and miniaturized microphysiological systems (MPS) for drug discovery and biomedical research. This funding opportunity encourages U.S. small business concerns (SBCs) to propose innovative solutions that enhance the efficiency and reliability of tissue chip technologies, with a focus on reducing complexity and costs while facilitating higher throughput. Approximately $2.15 million is allocated for FY 2024 to support projects that collaborate with NIH staff to achieve defined milestones and pathways to commercialization. Interested applicants must submit their proposals by February 23, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials," aimed at encouraging small businesses to conduct exploratory clinical trials of investigational agents related to neurological disorders. This initiative seeks applications for Phase II Small Business Innovation Research (SBIR) projects, with a budget of up to $3 million over five years, focusing on trials that align with the strategic plan of the National Institute of Neurological Disorders and Stroke (NINDS). The program is designed to foster public-private partnerships to enhance the development and commercialization of innovative therapies, ultimately improving clinical outcomes in neuroscience research. Interested applicants must adhere to a Community Engagement and Research Inclusion (CERI) plan, with the first application deadline set for January 5, 2025, and additional deadlines throughout 2026 and 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Miniaturization and Automation of Tissue Chip Systems (MATChS)" aimed at supporting Small Business Technology Transfer (STTR) applications. This initiative seeks to enhance microphysiological systems that replicate organ functions, focusing on the development of compact, automated systems for real-time analysis of tissue health to improve drug discovery and precision medicine. Eligible U.S.-based small businesses can apply for funding of up to $2.15 million for Phase I and Phase II awards, with proposals required to demonstrate innovation, a clear commercialization strategy, and collaboration with NIH staff. Interested applicants should refer to the full announcement available at NIH Grants and note that the application deadline is February 23, 2026.
    Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering funding through the Exploratory/Developmental Bioengineering Research Grants (EBRG) program, aimed at enhancing biomedical research and clinical care. This initiative encourages innovative applications that focus on developing new capabilities to address challenges in biomedical, preclinical, or clinical settings, with an emphasis on feasibility testing and novel methodologies. The program is particularly significant for advancing cancer research through innovative bioengineering approaches, welcoming proposals from a diverse range of eligible applicants, including universities, nonprofits, and small businesses, especially those representing underrepresented groups. The maximum budget for applicants is $275,000 over two years, with applications due by January 7, 2028. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-25-321.html.