Opportunity Information: Apply for PAR 23 267
The National Institutes of Health (NIH) is offering a Small Business Innovation Research (SBIR) cooperative agreement opportunity titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)" under funding opportunity number PAR-23-267. This is a discretionary federal funding program in the health area (CFDA 93.350) that focuses on advancing extracellular vesicle (EV) technologies toward practical, scalable therapeutic use in regenerative medicine. The cooperative agreement structure (U43/U44) signals that NIH expects substantial scientific or programmatic involvement during the project, meaning awardees should anticipate a more collaborative relationship with the agency than with a standard grant.
The core purpose of the program is platform-oriented development for EV-based therapeutics rather than single, isolated proof-of-concept experiments. Extracellular vesicles, including both native EVs and engineered EVs, have shown promise for targeted tissue and organ repair because they can carry bioactive cargo and influence cellular responses involved in regeneration. NIH is aiming to help small businesses move these approaches closer to real-world deployment by funding the enabling technologies needed to produce, manufacture, and apply EVs as therapeutic products. In practice, this emphasis on "industrialization and translation" typically points to work like scalable production methods, robust purification and isolation workflows, analytical characterization and quality control strategies, process standardization, reproducibility, stability, formulation, and other manufacturing and product-development hurdles that must be solved before EV therapeutics can credibly progress through the development pipeline.
This opportunity is specifically limited to small business applicants, consistent with the SBIR program. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the notice indicates that certain foreign components may be allowed as defined under the NIH Grants Policy Statement, which generally means limited, well-justified elements of the work could potentially occur abroad if permitted under NIH policy and if clearly necessary for the project. Applicants would need to confirm those details in the full notice and structure their project to remain compliant with the stated eligibility restrictions.
The funding instrument is a phased SBIR cooperative agreement mechanism (U43/U44), which commonly aligns with a development path where earlier work de-risks and validates the approach and later work advances it toward a more mature, product-ready state. Importantly, the opportunity states "Clinical Trials Not Allowed," which means the supported work must stop short of testing in human subjects as a clinical trial. The intent is to strengthen the underlying platform and manufacturing readiness so that EV therapeutic candidates can be positioned for later-stage development, without using this particular award to conduct clinical trial activities.
Key logistics provided in the source information include an original closing date of June 6, 2025, and an award ceiling listed as 295,924 (as presented in the source data). The announcement was created on April 18, 2023. While the expected number of awards is not specified in the provided text, the overall framing makes clear that NIH is looking to stimulate a pipeline of small-business-led, translation-focused EV technology solutions that can reliably generate therapeutic-grade extracellular vesicles suitable for regenerative medicine applications, while addressing practical barriers that often prevent promising EV science from becoming manufacturable, standardized, and ultimately clinically deployable products.Apply for PAR 23 267
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
- This funding opportunity was created on 2023-04-18.
- Applicants must submit their applications by 2025-06-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $295,924.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed)."
What is the funding opportunity number?
The funding opportunity number is PAR-23-267.
Which agency is offering this opportunity?
The National Institutes of Health (NIH) is offering this opportunity.
What program is this offered under?
This is offered under the Small Business Innovation Research (SBIR) program.
What type of award mechanism is being used?
The mechanism is a cooperative agreement using the phased SBIR structure U43/U44.
What does a cooperative agreement (U43/U44) mean for applicants?
A cooperative agreement indicates NIH expects substantial scientific or programmatic involvement during the project. In practical terms, awardees should plan for a more collaborative working relationship with NIH than they would typically have under a standard grant.
What is the main purpose of this opportunity?
The core purpose is to advance extracellular vesicle (EV) technologies toward practical, scalable therapeutic use in regenerative medicine by funding enabling technologies that help EV-based therapeutics move closer to real-world deployment.
Is this opportunity focused on single proof-of-concept studies?
No. The stated emphasis is platform-oriented development for EV-based therapeutics rather than single, isolated proof-of-concept experiments.
What types of extracellular vesicles are relevant to this opportunity?
The opportunity includes extracellular vesicles broadly, including both native EVs and engineered EVs.
Why are extracellular vesicles (EVs) of interest for regenerative medicine?
EVs have shown promise for targeted tissue and organ repair because they can carry bioactive cargo and influence cellular responses involved in regeneration.
What kinds of activities or technology development does NIH appear to be seeking?
Based on the industrialization and translation emphasis, the opportunity points toward work such as scalable production methods, robust purification and isolation workflows, analytical characterization and quality control strategies, process standardization, reproducibility, stability, formulation, and other manufacturing and product-development hurdles needed for EV therapeutics.
Does this opportunity support manufacturing and quality-related work?
Yes. The description highlights manufacturing readiness topics such as scalable production, purification/isolation, analytical characterization, quality control, process standardization, reproducibility, stability, and formulation.
Is the goal to move EV therapeutics toward real-world deployment?
Yes. The overall framing is to move EV approaches closer to practical use by addressing enabling technologies and manufacturing/product-development barriers that often prevent EV science from becoming standardized and manufacturable.
Who is eligible to apply?
This opportunity is specifically limited to small business applicants, consistent with the SBIR program.
Are foreign institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible, as stated in the provided information.
Are any foreign components allowed at all?
The information indicates that certain foreign components may be allowed as defined under the NIH Grants Policy Statement, typically meaning limited and well-justified portions of work could potentially occur abroad if permitted under NIH policy and clearly necessary for the project. Applicants would need to confirm the specific requirements in the full notice and structure the project to comply with eligibility restrictions.
Are clinical trials allowed under this opportunity?
No. The opportunity is explicitly labeled "Clinical Trials Not Allowed," meaning supported work must stop short of testing in human subjects as a clinical trial.
If clinical trials are not allowed, what is the intent of the funding?
The intent is to strengthen the underlying EV platform and manufacturing readiness so EV therapeutic candidates can be positioned for later-stage development, without using this particular award to conduct clinical trial activities.
What is the CFDA number and area?
The program is listed as CFDA 93.350 and is described as a discretionary federal funding program in the health area.
What is the application closing date mentioned in the provided information?
The provided information lists an original closing date of June 6, 2025.
What is the award ceiling listed in the provided information?
The award ceiling is listed as 295,924 (as presented in the source data).
When was this announcement created?
The announcement was created on April 18, 2023.
Is the expected number of awards stated in the provided information?
No. The expected number of awards is not specified in the provided text.
What overall outcomes is NIH trying to stimulate through this program?
The opportunity is framed to stimulate a pipeline of small-business-led, translation-focused EV technology solutions that can reliably generate therapeutic-grade extracellular vesicles suitable for regenerative medicine applications, while addressing practical barriers to manufacturability, standardization, reproducibility, and eventual clinical deployability.
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