- VivoSim Labs (VIVS) debuts its NAMkind™ technology suite after FDA's announcement to phase out animal testing.
- The company targets the $10 billion animal testing market with more predictive and ethical methods.
- VivoSim projects a 50% reduction in drug development costs and clinical trial failures related to liver toxicity.
VivoSim Labs, Inc. (VIVS) has emerged from stealth mode, aiming to transform the drug development landscape with its revolutionary NAMkind™ technology. This innovative suite is designed to replace traditional animal testing with more predictive and ethically sound methodologies, in line with the FDA's recent initiative to phase out animal testing requirements.
The FDA's announcement on April 10 has opened a lucrative market opportunity exceeding $10 billion for VivoSim. The company's cutting-edge technology focuses on human organ model-based lab testing and AI-powered computational modeling. These models include physical organoid wet lab models of liver and intestine made using cells from human donors, providing more comprehensive data than traditional human clinical trials.
With its liver and intestinal toxicology insights, VivoSim's technology promises to cut liver toxicity-related clinical trial failures by 50% or more. The company also anticipates reducing development costs per approved drug by half. This strategic move positions VivoSim as a leader in the shift towards non-animal New Approach Methodologies (NAM) in pharmaceutical research and development.
FDA Commissioner Martin A. Makary has endorsed AI-based computational modeling and human organ model-based lab testing as part of this transition, creating a favorable regulatory environment for VivoSim's offering. The company aims to leverage this momentum to capture early market share and deliver on its promise of safer, more cost-effective drug development.