VivoSim Announces Emergence from Stealth Mode To Provide Technologies for FDA Turn Away from Animal Models, $10B+ Market
Rhea-AI Summary
VivoSim Labs (Nasdaq: VIVS) has emerged from stealth mode to revolutionize drug development with its NAMkind™ services suite, following FDA's announcement to phase out animal testing requirements. The company's technology focuses on liver and intestinal toxicology using human organ model-based lab testing and AI-powered computational modeling.
The company aims to disrupt the $10B+ animal testing market with more predictive and ethically sound methods. VivoSim's liver model has demonstrated industry-best correlation rates with known clinical failures, and the company projects it can reduce clinical trial failures due to liver toxicity by 50% or more.
The technology utilizes physical organoid wet lab models created from human donor cells, combined with AI-driven predictions for liver toxicity, intestinal toxicity, and permeability. VivoSim believes its approach could reduce drug development costs per approved drug by 50% across the industry.
Positive
- Targeting $10B+ market opportunity in animal testing replacement
- Industry-best correlation rate in liver toxicity testing
- Projected 50% reduction in drug development costs per approved drug
- Technology aligns with new FDA initiative to phase out animal testing
- Potential to reduce clinical trial failures by 50% or more
Negative
- Pre-revenue company emerging from stealth mode
- Faces execution risks in commercializing new technology
- Operating in highly regulated pharmaceutical industry
Insights
VivoSim strategically enters $10B+ market as FDA phases out animal testing, offering potentially superior predictive drug development models.
VivoSim Labs' emergence from stealth mode represents a perfectly timed market entry, coming just two weeks after the FDA's April 10th announcement to phase out animal testing requirements in favor of new approach methodologies (NAM). This timing positions the company to capture share in a $10B+ animal testing market that faces significant disruption.
The company's NAMkind™ technology combines two powerful approaches: physical organoid models created using human donor cells and AI-powered in silico predictions for liver and intestinal toxicity. During development testing, their liver model demonstrated what they describe as an "industry best correlation rate with known clinical failures" across control compounds. This addresses a critical industry pain point where unexpected liver toxicity leads to late-stage clinical failures or post-market withdrawals.
The potential impact is substantial, with VivoSim claiming they believe they can reduce drug development costs by 50% across the industry and cut liver toxicity-related failures by 50% or more. Their intestinal models aim to provide novel readouts that could help reduce side effects like nausea in cancer patients and potentially enable more optimal chemotherapy dosing.
FDA Commissioner Makary's statement specifically endorses "AI-based computational modeling, human organ model-based lab testing, and real-world human data" - approaches that align perfectly with VivoSim's technology stack. This regulatory tailwind creates immediate market demand for validated NAM solutions, with VivoSim positioned as an early mover.
While the technology shows promise in development testing, the article doesn't provide information on commercial validation, current customers, or revenue projections. Success will depend on their ability to deliver on performance claims and pharmaceutical industry adoption rates of these new methodologies.
VivoSim's NAM technology could transform pharmaceutical R&D by reducing clinical failures while aligning with FDA's pivot away from animal testing.
Drug development faces a potential paradigm shift with VivoSim's market entry. Toxicity issues, particularly in liver, remain among the most expensive and problematic failure points in pharmaceutical R&D, often emerging late in clinical development when costs are highest and patient impact most severe.
What makes VivoSim's approach particularly valuable is their comprehensive technology stack that includes both physical organoid wet lab models using human donor cells and sophisticated AI-powered in silico predictions. This combination generates data that the company describes as "much richer and more extensive information than is possible with data from human clinical trials."
For pharmaceutical companies, the economic case is compelling - reducing development costs per approved drug by half would represent a transformative improvement in R&D productivity. The intestinal models offer benefits beyond safety testing by potentially optimizing candidate selection to minimize gastrointestinal side effects that frequently limit treatment adherence and dosing, especially in oncology.
The FDA's announcement creates not just an opportunity but a regulatory imperative for pharmaceutical companies to adopt NAM solutions. Commissioner Makary's vision that these approaches can "get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices" signals unprecedented regulatory support.
VivoSim states they are "launching to fill in the much-needed gap in commercially available solutions" - timing that suggests they're positioned to capture early market share as pharmaceutical companies scramble to adapt to evolving regulatory requirements. The company's dual focus on both liver and intestinal toxicity models addresses multiple critical failure points in drug development, potentially offering a comprehensive solution rather than a point product.
SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company”) announced that it has emerged from stealth mode to dramatically impact drug discovery and development.
VivoSim will offer liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of the FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA’s push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim’s market adoption, disrupting a >
As FDA Commissioner Martin A. Makary M.D., M.P.H. said in FDA’s announcement: “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use. By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices.”
VivoSim’s models include physical organoid wet lab models of liver and intestine made using cells from human donors. VivoSim is developing what it believes will be industry-best in silico predictions of liver tox, intestinal tox, and permeability. Artificial intelligence (AI) models in VivoSim’s NAMkind™ services suite will be trained on an extensive set of proprietary, real world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials.
VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by
In development testing, VivoSim’s NAMkind liver model produced liver toxicology results across a wide set of positive and negative control compounds that resulted in an industry best correlation rate with known clinical failures. As a result of the inability to fully predict liver toxicity, a number of drugs today still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by
VivoSim’s NAMkind intestine models can deliver readouts that are today not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient’s needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges.
The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve this according to FDA Commissioner Makary’s vision. VivoSim is delivering on the promise of this vision, and will use its proprietary methods and cutting edge capabilities for NAMkind models that displace use of animals and provide superior outcomes for its pharmaceutical customers, ultimately delivering for on the end goal of providing better solutions for patients.
The new website can be accessed at https://vivosim.ai/.
Forward Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events.
Contact:
Lesley Guilmette
lesley@aldenmc.com
FAQ
What is the market size that VivoSim Labs (VIVS) is targeting with its NAM technology?
How much can VivoSim's technology reduce drug development costs?
What are the key components of VivoSim's NAMkind™ services suite?
By what percentage does VivoSim expect to reduce liver toxicity-related failures in clinical trials?
