Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)
About
This Notice of Funding Opportunity (NOFO) solicits cooperative agreement research applications to support a multidisciplinary program titled "Accelerating Product Excellence in Innovation and for Clinical Adoption" (APEx), that will facilitate advancement of promising strategies and products for tissue engineering and regenerative medicine (TE/RM). APEx will be composed of Resource Centers (RCs) and associated Interdisciplinary Translational Projects (ITPs) in the area of therapeutics (including adult stem cell-based treatments), sensors, and diagnostics. RCs will capitalize on their available clinical, scientific, industrial, regulatory and commercialization expertise, to deliver technical support, research capacity, administrative infrastructure and regulatory and commercialization support to the ITPs and guide them to complete pre-clinical studies toward initiation of clinical trials. During this funding cycle, APEx will complete validation, manufacturing, and preclinical testing of the most promising products, which may include, but are not limited to products for detecting or treating tissue damage caused by congenital defect, traumatic injury, or chronic disease. Products that support early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, as well as approaches to reduce or prevent resulting damage, are especially encouraged. The outcome of APEx will be TE/RM products with their regulatory approvals in place for first-in-human st.
The Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) program is a federal cooperative agreement opportunity designed for multidisciplinary teams developing tissue engineering and regenerative medicine (TE/RM) products. This grant supports Resource Centers and Interdisciplinary Translational Projects (ITPs) focused on advancing promising strategies and products in therapeutics (including adult stem cell-based treatments), sensors, and diagnostics toward clinical adoption. APEx is ideal for organizations with clinical, scientific, industrial, regulatory, and commercialization expertise seeking to complete validation, manufacturing, and preclinical testing of innovative products. Eligible products address tissue damage from congenital defects, traumatic injuries, or chronic diseases, with special emphasis on early detection of chronic pathologies and biomarker monitoring approaches. The program provides technical support, research capacity, administrative infrastructure, and regulatory and commercialization guidance to move promising products toward first-in-human clinical trials. This is an exceptional opportunity for established research institutions, medical device developers, and biotech organizations positioned to translate cutting-edge TE/RM innovations into regulated therapeutic products that can enter clinical evaluation.
Funding Facts
● Applications openDeadline
July 10, 2026
Award Amount
Up to $4M
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $4M
Deadline
2026-07-10
Grant Type
federal
Application Cycle
Annual (Deadline: July 10, 2026)
Best For
Research institutions, medical device companies, and biotech organizations with tissue engineering and regenerative medicine expertise seeking to advance products toward clinical trials
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Frequently Asked Questions
Who is eligible for Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)?
Eligible applicants must be U.S.-based organizations and institutions. Non-domestic (non-U.S.) entities and foreign components are not eligible. Applicants must have the clinical, scientific, industrial, regulatory, and commercialization expertise to serve as Resource Centers or participate in Interdisciplinary Translational Projects. For comprehensive eligibility requirements, refer to Section III. Eligibility Information in the official Notice of Funding Opportunity (NOFO) or contact the NIH program officer directly.
How much funding does Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed) provide?
Funding for APEx ranges from N/A to $4,000,000, depending on the scope and nature of the proposed Resource Centers and Interdisciplinary Translational Projects. Actual award amounts vary by funding cycle and project requirements. Applicants should consult the current NOFO for specific budget guidelines and anticipated funding levels.
How do I apply for Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)?
Applications are submitted through the NIH grants submission system as cooperative agreement research applications. Applicants must prepare a research proposal outlining their Resource Center capabilities or Interdisciplinary Translational Project, including pre-clinical study plans, regulatory strategy, and commercialization pathway. The application deadline is July 10, 2026. For detailed submission instructions, proposal requirements, and technical assistance, visit the official NIH APEx NOFO page or contact the relevant NIH institute or center.
What can Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed) funding be used for?
APEx funding supports validation, manufacturing, and preclinical testing of tissue engineering and regenerative medicine products. Eligible uses include research and development of therapeutics (including adult stem cell-based treatments), sensors, and diagnostics for detecting or treating tissue damage. Funding also covers technical support, regulatory guidance, commercialization support, and administrative infrastructure to advance products toward clinical trial initiation. Products targeting congenital defects, traumatic injury, chronic disease, and early detection of pathologies are especially encouraged.
Last updated: July 5, 2026