FDA 3.0 Modernization Act 2022
MPS Microphysiological Systems
$1.5B Market by 2030
35% CAGR Growth
NAMs New Approach Methodologies
ISTAND FDA Qualification
ICH Harmonization Ready
3Rs Replace Animal Testing
FDA 3.0 Modernization Act 2022
MPS Microphysiological Systems
$1.5B Market by 2030
35% CAGR Growth
NAMs New Approach Methodologies
ISTAND FDA Qualification
ICH Harmonization Ready
3Rs Replace Animal Testing
The Future of Drug Development

Human Biology.
Miniaturized.

Microphysiological systems (MPS) recreating human organ function for FDA 3.0 compliant drug development. Replace animal testing with human-relevant data.

BRAIN HEART LUNG LIVER KIDNEY GUT HUMAN MPS PLATFORM Multi-Organ Linked System MICROFLUIDIC FDA 3.0 COMPLIANT
$1.5B
MPS Market by 2030
35%
Annual Growth Rate
10+
Organ Types Available
90%
Human Predictivity

MPS Core Principles

Engineering human tissue models that recapitulate in vivo physiology.

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Physiological Flow

Microfluidic channels delivering nutrients and drugs under physiologically relevant shear stress and flow rates.

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3D Architecture

Tissue-engineered constructs maintaining native cell-cell and cell-matrix interactions in three dimensions.

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Multi-Organ Linking

Interconnected organ modules enabling systemic ADME-Tox and drug-drug interaction studies.

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Human Primary Cells

Patient-derived or iPSC-derived cells maintaining human-specific drug responses and metabolism.

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Real-Time Monitoring

Integrated sensors for continuous measurement of TEER, oxygen, glucose, and biomarkers.

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Scalable & Reproducible

Standardized manufacturing for consistent, high-throughput drug screening applications.

Available Organ Systems

Comprehensive human tissue models for every drug development need.

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Brain
BBB, Neuro
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Heart
Cardiotox
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Lung
Inhaled, ARDS
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Liver
DILI, CYP450
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Kidney
Nephrotox
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Gut
Absorption
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Vasculature
Angiogenesis
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Bone Marrow
Hematotox

FDA 3.0 Ready

The FDA Modernization Act 2.0 (2022) removed the animal testing mandate, opening the door for MPS as New Approach Methodologies (NAMs).

  • ISTAND qualification pathway
  • ICH M3/S7 guideline acceptance
  • EMA and PMDA alignment
  • Fit-for-purpose validation
US REGULATORY
FDA
EU REGULATORY
EMA
JAPAN
PMDA
HARMONIZATION
ICH

Industry Leaders

Organizations pioneering human MPS technology.

Emulate Leader
Organ-Chip platform with 10+ tissue types, FDA qualified
CN Bio Multi-Organ
PhysioMimix interconnected organ system
TissUse HUMIMIC
Human-on-a-chip multi-organ platform
Mimetas HTS
OrganoPlate high-throughput MPS
Hesperos Pumpless
Serum-free gravity-driven multi-organ
Nortis Kidney
Specialized kidney and vascular MPS

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