The startup Intero Biosystems, spun out of the University of Michigan and based in Denver, is developing laboratory-grown organoid models of human intestines to help pharmaceutical and life sciences companies test compounds before moving them into human trials. The company is betting that a model simulating human intestinal tissue could reveal effects that do not appear clearly in animal models or simplified cell layers.
The company’s main product, GastroScreen, consists of organoid tissues, each approximately one millimeter in diameter, typically shipped in a tube containing about 100 models. Customers can use them as models of healthy intestines or induce disease-like conditions in them, then expose them to different drugs or compounds to measure response or intestinal toxicity.
A Multitissue Model for Drug Testing
Intero says its models contain multiple types of cells and tissues found in the human intestine, rather than simulating a limited part of the organ. Alongside the models, the company sells the supplies needed to culture and operate them, such as nutrient mixtures and chemicals used in experiments. It also conducts custom studies for customers, including experiment design, testing, and data delivery.
According to the article, pharmaceutical companies use these models to screen whether a drug candidate could harm the intestines or to study how tissue simulating a disease condition responds to a particular compound. The technology also targets biotechnology, food, and chemical companies.
Regulatory Momentum, but Adoption Has Not Been Settled
Market interest coincides with moves by the U.S. Food and Drug Administration to reduce reliance on animal testing. In April of last year, the agency introduced initiatives encouraging alternatives such as organoid models, organs-on-chips, and artificial-intelligence-based computational models. In March of this year, it issued draft guidance explaining how to validate new non-animal testing methodologies when they are used to support regulatory submissions.
However, the guidance does not endorse any particular method, and acceptance of any methodology depends on the method used, the data provided, and the purpose of the test. Therefore, growing regulatory interest does not mean that GastroScreen has become an approved replacement for animal or clinical testing.
What Has Been Proven So Far?
Intero says it has completed the first validation stage by demonstrating that the model contains the core tissues of the human intestine. It is currently working on the second stage, in which it is testing drugs known to have effects in humans. The company said GastroScreen showed expected responses to drugs that reduce intestinal inflammation and to compounds known to damage the intestines.
The third stage, which is still underway with several pharmaceutical companies, will compare the model’s results directly with existing animal and clinical data, using known compounds and new drug candidates. The company acknowledges that it is still building the evidence to prove that the model predicts human responses more accurately than current animal or cellular models.
Expansion and Future Potential
Intero was founded in 2024, has seven employees, and has slightly fewer than 10 customers after raising a $2.3 million seed round last year. The company said it generated more than $400,000 in revenue between the fourth quarter of last year and the third quarter of this year.
The company currently produces a few thousand organoid models per batch and is working to automate manufacturing to reach hundreds of thousands. It also plans to license the biological datasets it produces to pharmaceutical and artificial intelligence companies, rather than using artificial intelligence to build the organs themselves. In the longer term, it aims to create customized models from patients’ cells to test drugs before treatment, ultimately pursuing the more ambitious vision of developing an artificial intestine.
Intero competes in this field with companies such as Altis Biosystems and InSphero, alongside the organs-on-chips solutions developed by MIMETAS. Its stated differentiator is the combination of multitissue composition, the ability to produce models from induced stem cells, and scalability and customization. However, the regulatory and clinical value of these advantages will remain tied to the results of direct comparisons with animal and clinical data.