Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) supports a multidisciplinary program designed to advance promising strategies and products for tissue engineering and regenerative medicine (TE/RM).

Overview

This Notice of Funding Opportunity (NOFO) solicits cooperative agreement research applications to support APEx. The program is structured around Resource Centers (RCs) and associated Interdisciplinary Translational Projects (ITPs) focusing on therapeutics (including adult stem cell-based treatments), sensors, and diagnostics. RCs will utilize their expertise in clinical, scientific, industrial, regulatory, and commercialization areas to provide technical support, research capacity, administrative infrastructure, and regulatory and commercialization support to the ITPs. This guidance aims to help ITPs complete pre-clinical studies toward the initiation of clinical trials.

During this funding cycle, APEx is expected to complete validation, manufacturing, and preclinical testing of promising products. These products may include, but are not limited to, items for detecting or treating tissue damage resulting from congenital defects, traumatic injury, or chronic disease. Particular encouragement is given to products that support early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, and approaches to reduce or prevent resulting damage.

The anticipated outcome of APEx involves TE/RM products with established regulatory approvals for first-in-human studies, alongside associated clinical study protocols, and synthesis and manufacturing protocols ready for the initiation of clinical trials.

Funding Details

Opportunity Number: RFA-DE-27-002

Agency: National Institutes of Health

Estimated Funding: $6,000,000

Award Ceiling: $4,000,000

Funding Instrument: Cooperative Agreement

Funding Activity Categories: Health

Eligibility

Eligibility details are available in Section III. Eligibility Information within the NOFO.

Ineligible Applicants:

• Non-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.

Eligible Applicant Types Include:

• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• For profit organizations other than small businesses
• Native American tribal organizations (other than Federally recognized tribal governments)
• Small businesses
• Public housing authorities/Indian housing authorities
• Others (clarification available in the "Additional Information on Eligibility" text field)
• City or township governments
• Private institutions of higher education
• County governments
• Public and State controlled institutions of higher education
• Independent school districts
• State governments
• Special district governments
• Native American tribal governments (Federally recognized)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Application Timeline

Posted Date: 2026-05-04-00-00-00

Deadline: 2026-07-10-00-00-00

Contact Information

National Institutes of Health: APEx-NOFO@nih.gov or 301-402-2541

National Institute of Dental and Craniofacial Research (NIDCR): APEx-NOFO@nih.gov