Intero Biosystems pushes human-derived gut organoids as alternative to animal testing

Intero Biosystems, a Denver-based company spun out of the University of Michigan, is offering pharmaceutical and biotech firms a new way to evaluate drug safety: miniature human intestines grown in the lab. The startup’s flagship product, GastroScreen, consists of one-millimetre-wide intestinal organoids that mimic the cellular complexity of the human gut, providing an alternative to traditional animal models that often fail to predict human outcomes.

Founded in 2024, Intero employs seven people and has secured just under ten paying customers. The company raised a $2.3 million pre-seed round last year and reported more than $400 000 in revenue covering the fourth quarter of that year through the third quarter of this year. GastroScreen organoids are shipped in batches of roughly one hundred per tube, and customers can use them as healthy tissue or induce disease-like conditions to test how compounds affect the gut. In addition to the organoids themselves, Intero supplies the nutrient mixes and chemicals needed for cultivation and offers contract research services that include experiment design, data collection, and analysis.

The timing aligns with regulatory shifts in the United States. In April 2025 the Food and Drug Administration announced a plan to cut reliance on animal testing, highlighting organoids, organs-on-chips and AI-based models as viable alternatives. A draft guidance released in March 2026 outlined how developers should validate new approach methodologies, or NAMs, for regulatory submissions. While the guidance does not endorse any specific technology, it creates a pathway for companies like Intero to demonstrate that their models can meet the evidentiary standards required for drug approval.

Intero differentiates its approach by deriving organoids from induced pluripotent stem cells (iPSCs) reprogrammed from adult blood samples. This method contrasts with competitors that rely on tissue harvested during procedures such as colonoscopies. The iPSC source gives Intero the potential to personalize organoids to individual patients and to scale production more efficiently. The company is currently in the second stage of a three-stage validation process. After confirming that GastroScreen contains the key gut tissues, Intero is testing well-known drugs with documented human effects. Early results show expected responses to anti-inflammatory agents and to compounds known to damage intestinal tissue. The final validation stage will compare GastroScreen outcomes directly with existing animal data and clinical trial results, a set of studies already underway with several pharmaceutical partners.

Although Intero does not use artificial intelligence to create its organoids, the firm sees an opportunity to feed AI models with the biological data generated from its experiments. The company plans to license these datasets to both drug developers and AI firms seeking high-quality training material.

Looking ahead, Intero’s immediate focus is on manufacturing scale. Current capacity runs at a few thousand organoids per batch, but the team is automating production with the goal of generating hundreds of thousands per run. Longer-term ambitions include patient-specific organoids for pre-treatment testing and, ultimately, an artificial intestine built on the same manufacturing platform. As the industry moves toward more human-relevant testing methods, Intero’s progress will be watched closely by founders, investors, and regulators alike.