Grant name: Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine
Funding organization: National Institutes of Health (NIH)
Total funding amount: Up to $1,972,828 for Phase II
Duration: Phase I (6 months), Phase II (2 years)
Primary objective: Support development of novel extracellular vesicle-based therapeutic platforms for regenerative medicine
Key stakeholders: Small business concerns (SBCs) in the U.S.
Funding source: NIH SBIR program
Significance: Addresses challenges in tissue and organ repair using EVs
Grant frequency: New opportunity
Eligible organization types: Small business concerns (SBCs)
Qualifications: Organized for profit, place of business in the U.S.
Ownership: More than 50% owned by U.S. citizens or permanent residents
Employee count: Not more than 500 employees
Partnership requirements: Joint ventures must meet specific ownership criteria
Previous relationship with funder: Not specified
Primary focus areas: Development of EV-based therapeutics for tissue and organ repair
Target beneficiaries: Patients requiring regenerative medicine solutions
Geographic coverage: United States
Expected outcomes: GMP-grade production of EVs, therapeutic validation
Sustainability expectations: Focus on commercialization and regulatory approval
Technical expertise: Knowledge in EV biology and regenerative medicine
Infrastructure: Capable of GMP-grade production
Quality standards: Compliance with NIH and FDA regulations
Risk management: Not specified
Budget range: Up to $295,924 for Phase I, up to $1,972,828 for Phase II
Eligible costs: Direct costs, indirect costs, fees
Matching fund requirements: Not specified
Payment schedule: Not specified
Application deadlines: June 6, 2025
Earliest start date: June 6, 2023
Expiration date: June 7, 2025
Compliance with NIH Grants Policy Statement
Required registrations: SAM, eRA Commons, Grants.gov
Data protection: Not specified
Application submission through Grants.gov
Follow SBIR/STTR application instructions
Letter of intent: Not required but encouraged
Focus on IND enabling therapeutic platforms
Regulatory engagement with FDA recommended for Phase II applications
Not specified