A complete human brain,
grown to order.

Primary NAICS

541714

PSC

AN12

Reproducibility

98–99%

Patent

U.S. — Issued

The NEURXSTEM Neural Organoid Platform (NNOP™) is the only issued U.S. patent covering functional genomic human brain models. It is not a cortical organoid or a region-limited system — each model carries retina, cortex, midbrain, hindbrain, cerebellum, spinal cord, and a functioning blood–brain barrier, built from neurons, astrocytes, oligodendrocytes, vascular endothelial cells, and microglia. 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

▸Whole-brain architecture spanning retina to spinal cord in one networked model
▸Full cell repertoire — neurons, astrocytes, oligodendrocytes, vascular endothelial cells, microglia
▸Matched transcriptomic, metabolomic, and phenotypic datasets per batch
▸Standardized batch production with documented QC
▸500+ validated disease biomarkers available for panel design
▸Stratification by ancestry, sex, and molecular subtype
▸Delivery as frozen plate, live culture, or dataset-only
▸Model customization scoped to a specific research question

02Engagement Model

Frozen plate

Cryopreserved organoid plates shipped for in-house assay work on the recipient's timeline.

Live culture

Maintained organoid cultures supplied for programs requiring live-tissue readouts.

Dataset-only

Matched multi-omic datasets licensed without physical material, for computational and AI programs.

QC & reproducibility

Every batch carries standardized quality control; 98–99% reproducibility across lines and replicates.

03Federal Relevance

The platform's human concordance (p < 10⁻¹⁰⁰ vs. clinical Alzheimer's tissue) positions it against NIH institutes (NIA, NINDS, NIMH, NIDA), DoD medical research programs, FDA new-approach-methodologies review, and VA ORD — all of whom are moving toward human-data standards under the FDA Modernization Act. Pathways include SBIR/STTR, BAAs, OTAs, grants and cooperative agreements, and open-market R&D contracts.

04Applicable Codes

541714R&D in Biotechnology (except Nanobiotechnology)

AN12R&D — Medical: Biomedical (Applied Research)

AN13R&D — Medical: Biomedical (Advanced Development)

AN21R&D — Medical: Drug Dependency (Basic Research)

AN31R&D — Medical: Alcohol Dependency (Basic Research)

A complete human brain,grown to order.

A complete human brain,
grown to order.