Why Neurxstem

Neurxstem delivers regulator-aligned human molecular evidence with a level of precision not achievable in proxy systems.

The platform is the only patented human brain model producing reproducible, federally validated datasets already aligned with the FDA Modernization Act. With a decade-long head start and a peer-reviewed foundation, Neurxstem provides a defensible basis for diagnostics, therapeutics, aging research, and next-generation AI.

Evidence Base

  • 98–99% reproducibility across lines

  • Direct human concordance (p < 10⁻¹⁰⁰)

  • IND-supportive multi-omic datasets

  • A decade of peer-reviewed and federally funded validation

The Sully Family Office Trust has committed significant financial support to advance this work, strengthening the continuity and long-term vision of Neurxstem’s scientific program.

A Decade-Long Head Start

Neurxstem began building human-derived models in 2015—eight years before the FDA made human evidence the regulatory standard for drug submissions.

Today, every therapeutic developer must access human-relevant data; Neurxstem is the only company with validated models, a patent, and NIH/DoD-funded datasets already in place.

Regulator-Aligned Platform

Our data meets the rigor required for IND-enabling studies, offering:

  • Direct human concordance at molecular scale

  • High-precision multi-omic readouts

  • Evidence designed for FDA and EMA pathways

  • 60% attrition reduction and months saved in approval timelines

Strategic Positioning

Neurxstem sits at the intersection of human biology, regulatory-aligned evidence generation, and advanced AI health systems.

Our platform supports multiple verticals—diagnostics, therapeutics, aging, and molecular AI—while remaining grounded in a single validated biological engine. This structure ensures optionality without dilution, enabling long-term defensibility, scientific rigor, and category-defining product development.

Partnership Opportunities

Neurxstem enables collaborations across clinical research, diagnostics, aging, neurodegeneration, and AI health.

The platform supports IND-enabling data generation, mechanism-of-disease research, therapeutic development, and next-generation AI models built on molecular evidence. Opportunities include data partnerships, co-development programs, strategic investment, and integrations with early diagnostic and AI health systems.