Intero Biosystems Urges Drugmakers to Test on Human Intestines, Not Animals

Intero Biosystems is selling lab-grown human intestines to drugmakers as regulators push for alternatives to animal testing, while the startup works to scale production and expand its organoid technology.

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Drug development has long relied on animal models, but differences between species mean that what works in animals doesn't always translate to humans, and most drugs still fail during development. Intero Biosystems, a Denver-based startup, is developing human intestinal organoids, lab-grown tissue that mimics the gut, as another way to study how drugs and other compounds might affect the human body before they are tested on people. Researchers and pharmaceutical companies are increasingly looking for models that better reflect human biology to complement and reduce their reliance on animal testing.

Intro, which came out of the University of Michigan, says its organoids differ from simpler models that replicate only part of the intestine. They contain several types of cells and tissues found in the human gut, which the company believes makes them a human-relevant model for testing drugs and other compounds, co-founder and CTO Madeline Eiken told TechCrunch.

"Most drugs fail in clinical trials, and I think it's pretty easy to understand that we're not mice and we're not flat sheets of cells," Aiken says.

The startup's flagship product, GastroScreen, is an organoid model of the human intestine that it sells to pharmaceutical, biotech, food and chemical companies for testing drugs and other compounds. Each organoid is about a millimeter across, and the company ships roughly 100 devices at a time in a tube, said Charlie Childs, co-founder and CEO. Customers can use them as models of healthy gut or create disease-like conditions to test the tissue's response to different compounds.

"We're literally sending people tiny live organs through the mail," Childs said.

Beyond the organoids themselves, Intro sells the supplies needed to grow and work with them, such as the nutrient mix that feeds the cells and the chemicals used in experiments. It also conducts studies for clients, including designing custom experiments, performing laboratory tests and presenting the resulting data. Much of this work focuses on drug safety and disease research. For example, a client can expose organoids to a drug candidate to see if it can damage the gut or use organoids to model the state of the gut to see how the tissue responds to a compound.

Founded in 2024, the startup now has seven employees and fewer than 10 customers after raising $2.3 million last year. The managing director of the company noted: From the fourth quarter of last year to the third quarter of this year, it generated more than 400 thousand dollars in revenue.

Regulatory changes have also helped spur interest in alternatives to animal testing. In April of last year, the US Food and Drug Administration (FDA) presented plans to reduce its reliance on animal testing in drug production and promoted alternatives including organoids, organs-on-chips (small devices that mimic the functions of organs) and artificial intelligence-based computational models as potential alternatives.

In March of this year, the FDA released a draft guidance that outlines how drug developers should validate New Approach Methods, or NAMs, a term for non-animal testing methods, when using them to support regulatory submissions. This guide provides a framework for validation but does not endorse any specific method. Whether a NAM can support a transmission depends on factors including the method, how it is used, and the data provided.

Changes in US laws that allow drug developers to use non-animal testing methods in some cases have made pharmaceutical companies more willing to explore technologies like organoids, Aiken told TechCrunch. Companies that were once hesitant about the technology are now looking to get organoids inside, he added.

Intro is not alone in trying to make human-relevant models of the gut. Altis Biosystems develops stem cell-derived intestinal models, while InSphero provides patient-derived intestinal organoids for gastrointestinal toxicity testing. Other peers, such as MIMETAS, take a different approach to organ-on-a-chip technology by using microfluidic systems to recreate aspects of the environment inside human tissues.

Intro says it differentiates itself from competitors in the complexity and scalability of its model. Unlike intestinal models that are grown from tissue collected through procedures such as colonoscopy, GastroScreen is derived from induction. Pluripotent stem cells, which are mature cells that have been reprogrammed to become any cell type, can be generated from a blood sample, Aiken explained. He added that this approach gives the startup the potential to customize its models for different patients and make manufacturing easier.

When asked what evidence shows that GastroScreen can predict human drug responses more accurately than existing animal or cellular models, Childs said the company is still building that evidence and is now in the second phase of a three-step validation process. After first showing that GastroScreen contains key tissues from the human gut, Intro is now testing drugs known to have well-documented effects in humans. Childs told TechCrunch that GastroScreen showed the expected responses to drugs that reduce gut inflammation and to compounds that damage the gut. In the final step, the company will compare GastroScreen results directly with existing animal and clinical data from drug companies. Childs said these studies are ongoing with several pharmaceutical companies, using existing compounds and new drug candidates.

Intro does not use artificial intelligence to build its organoids. Instead, Childs sees an opportunity to use organoids to generate biological data needed by AI models, and the company plans to license such datasets to pharmaceutical and AI companies.

In the short term, Intro is focused on scale production. It can now make a few thousand organoids at a time, and so is trying to automate production, with the goal of producing hundreds of thousands per batch, according to Childs. Longer term, he wants to move toward personalized medicine, using patient cells to create organoids that can test different drugs before treatment. Its most ambitious goal is an artificial intestine, a vision that Childs says will emerge based on the scale of production and patient-specific data generated through its organoid technology.

Intro took the stage earlier Wednesday at TechCrunch Disrupt, where it is one of 20 startups competing for this year's Startup Battlefield title. Join us for the rest of the action: Disrupt runs from October 13-15 in downtown San Francisco.

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Keith Park is a reporter for TechCrunch focusing on technology, startups and venture capital in Asia. He was previously a financial journalist at Mergermarket covering M&A, private equity and venture capital.

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