
Focus Area
UEI YL6SLG1JKB37 · CAGE 7FF36
Focus Area 02 · NAICS 541714
Human evidence,
from target to IND.
Federal history
NIH SBIR R44-DA051281
NEURXSTEM applies the NNOP™ platform to disease-specific programs across Alzheimer's, Parkinson's, aging and senescence, migraine, autism, opioid and substance use disorder, neuroinflammation, and glymphatic function. Direct concordance with human clinical tissue gives programs evidence aligned with FDA human-data expectations under the FDA Modernization Act, rather than the animal-model approximations that have driven decades of failed CNS translation. Animal models do not predict human brain disease — and that gap has driven decades of failed CNS translation. NEURXSTEM replaces approximation with human biology: patented whole-brain organoids that generate reproducible, regulator-grade molecular data.
01Scope of Work
- ▸Target identification against human brain organoid models
- ▸Mechanism-of-action validation across disease-relevant cell types
- ▸Early diagnostic and companion biomarker development
- ▸IND-supportive dataset generation aligned with FDA human-data expectations
- ▸Disease modeling for Alzheimer's, Parkinson's, migraine, autism, and opioid/substance use disorder
- ▸Neuroinflammation and glymphatic function assay design
- ▸Custom study design around a sponsor's specific hypothesis
- ▸Data packages formatted for regulatory and publication use
02Engagement Model
Custom organoid study
A defined study scoped to a sponsor's disease model, endpoints, and timeline.
Biomarker panel development
Candidate biomarkers screened and validated against the organoid platform's 500+ marker library.
Mechanism-of-action validation
Target engagement and pathway data generated across the platform's full cell repertoire.
IND-supportive data packages
Datasets structured for regulatory submission and human-data context under the FDA Modernization Act.
03Federal Relevance
This focus area is built for NIH institutes with disease-specific mandates (NIDA, NIA, NINDS, NIMH), DoD medical research programs addressing CNS and substance-use conditions, BARDA, and FDA's new-approach-methodologies initiatives. NEURXSTEM's public federal research record includes NIH SBIR award R44-DA051281 (NIDA, HEAL initiative) for neural organoid platform development in substance and opioid use disorder. Pathways include SBIR/STTR, BAAs, OTAs, grants and cooperative agreements, and open-market R&D contracts.
04Applicable Codes
541714R&D in Biotechnology (except Nanobiotechnology)
AN13R&D — Medical: Biomedical (Advanced Development)
AN21R&D — Medical: Drug Dependency (Basic Research)
AN31R&D — Medical: Alcohol Dependency (Basic Research)
AN12R&D — Medical: Biomedical (Applied Research)