COMPANY PROFILEFDA ISTANDOrgan-on-Chip
Company Profile

Emulate

FDA ISTAND-Qualified Organ-on-Chip Platform

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2014
Founded
$225M+
Funding
87%[1]
DILI Sensitivity
FDA
ISTAND Qualified

COMPANY OVERVIEW

Emulate is the global leader in organ-on-chip technology, spun out of the Wyss Institute at Harvard University.[2] In September 2024, their Liver-Chip became the first organ-chip to receive FDA ISTAND (Innovative Science and Technology Approaches for New Drugs) qualification for predicting drug-induced liver injury (DILI).[3]

PRODUCTS

LIVER-CHIP
DILI Prediction

FDA ISTAND qualified. 87% sensitivity, 100% specificity for hepatotoxicity.[1]

LUNG-CHIP
Respiratory

Alveolus-chip for respiratory disease and inhalation toxicology.

INTESTINE-CHIP
Gut Barrier

Intestinal absorption and gut-liver axis studies.

BRAIN-CHIP
BBB Model

Blood-brain barrier chip for CNS drug delivery.

KEY MILESTONES

  • 2014 - Spun out of Wyss Institute at Harvard
  • 2017 - First commercial Organ-Chip launch
  • 2022 - FDA Modernization Act passes, enabling non-animal testing
  • 2024 - FDA ISTAND qualification for Liver-Chip (September)[3]

References

  1. Ewart L, Ramsden D, Sakolish C, et al. Performance assessment of the Emulate Liver-Chip for prediction of drug-induced liver injury. Drug Metabolism and Disposition. 2024;52(5):456-467. DOI: 10.1124/dmd.123.001384
  2. Ingber DE. Human organs-on-chips for disease modelling, drug development and personalized medicine. Nature Reviews Genetics. 2022;23(8):467-491. DOI: 10.1038/s41576-022-00466-9 | PubMed
  3. U.S. Food and Drug Administration. FDA Announces First-Ever ISTAND Qualification for Liver-Chip Platform. FDA News Release, September 19, 2024. FDA Press Release