Intero Biosystems sends customers tubes holding roughly 100 lab-grown gut models, each about one millimeter across, according to co-founder and CEO Charlie Childs. Called GastroScreen, these human intestinal organoids let companies investigate the effects of drugs and other compounds before testing them in people.
The Denver-based startup is tackling a longstanding limitation of drug research. Animal models have long been part of development, but species differences mean a result in animals won’t necessarily carry over to humans. Most drugs still fail during development. Researchers and pharmaceutical companies are increasingly seeking models that reflect human biology more closely, both to supplement animal testing and to rely on it less.
A University of Michigan spinout, Intero grows tissue that mimics the human gut. The company says its organoids include several intestinal cell and tissue types, whereas simpler models reproduce only part of the gut. Intero believes that mix makes its organoids a more human-relevant model for testing drugs and other compounds, co-founder and CTO Madeline Eiken told TechCrunch.
“Most drugs fail clinical trials, and I think it’s pretty easy to appreciate that we are neither mice nor flat layers of cells,” Eiken said.
Whether GastroScreen predicts human drug responses better than existing animal or cell-based models is still an open question. Asked for evidence of that advantage, Childs said Intero is still building it. Validation has reached the second of three stages: after showing that the model contains key human-gut tissues, the company is testing well-known drugs with documented effects in people.
So far, drugs that reduce intestinal inflammation and compounds known to damage the gut have produced the expected responses, Childs told TechCrunch. The final stage calls for a direct comparison between GastroScreen results and pharmaceutical companies’ existing animal and clinical data. Childs said studies involving several pharmaceutical companies are underway, using both existing compounds and new drug candidates.
Pharmaceutical, biotech, food, and chemical companies buy GastroScreen to test drugs and other compounds. They can keep the organoids in a healthy state or induce disease-like conditions, then examine the tissue’s response.
“We’re literally shipping mini living organs in the mail to people,” Childs said.
For instance, testing a drug candidate on the organoids could help a customer assess potential gut damage. A study could instead use organoids that model a gut condition to investigate how that tissue responds to a compound.
Intero also sells materials for growing and using the organoids, including nutrient mixes that feed the cells and chemicals for experiments. Customers can commission studies, too: the company designs custom experiments, carries out lab tests, and delivers the data. Drug safety and disease research account for much of that work.
Intero says its model stands apart in complexity and scalability. GastroScreen starts with induced pluripotent stem cells rather than intestinal tissue collected through a procedure such as a colonoscopy, Eiken explained. These adult cells have been reprogrammed so they can become almost any cell type and can be generated from a blood sample. Eiken said this route could make production easier to scale and allow Intero to personalize models to different patients.
Competing gut models take several forms. Altis Biosystems develops intestinal models derived from stem cells; InSphero offers patient-derived intestinal organoids for gastrointestinal toxicity testing. MIMETAS uses organ-on-chip technology, with microfluidic systems recreating aspects of the environment inside human tissues.
Since its founding in 2024, Intero has grown to seven employees and just under 10 customers. Last year, it raised a $2.3 million pre-seed round. Childs put revenue at more than $400,000 for the period spanning the fourth quarter of last year through the third quarter of this year.
The startup took the stage earlier Wednesday at TechCrunch Disrupt as one of 20 companies competing for this year’s Startup Battlefield title. Disrupt runs October 13 to 15 in downtown San Francisco.
Regulation is also helping draw attention to non-animal testing. Last April, the U.S. Food and Drug Administration (FDA) outlined plans to reduce its reliance on animal testing in drug development. The potential alternatives it highlighted included organoids, AI-based computational models, and organs-on-chips, small devices that mimic organ functions.
This March, FDA draft guidance addressed how developers should validate non-animal testing methods, known as new approach methodologies or NAMs, for regulatory submissions. Its validation framework doesn’t endorse a specific method. A NAM’s suitability for a submission depends on which method is used, how it is applied, and the supporting data.
According to Eiken, U.S. legal changes that permit non-animal testing in some cases have made pharmaceutical companies more receptive to exploring organoids and similar technologies. She told TechCrunch that companies previously hesitant about organoids are now considering bringing them in-house.
AI isn’t used to build Intero’s organoids. Instead, Childs sees an opportunity to use the organoids to generate biological data that AI models need. Intero plans to license those datasets to pharmaceutical and AI companies.
Increasing output is the immediate priority. Childs said Intero currently produces a few thousand organoids at a time and is working on manufacturing automation to reach hundreds of thousands per batch.
Further ahead, Intero wants to use patients’ own cells to grow organoids for personalized medicine, potentially testing different drugs before treatment. Its most ambitious aim is an artificial intestine. Childs said that effort would draw on the production scale and patient-specific data developed through the organoid technology.
