Intero Biosystems Ships Mini Human Intestines to Drugmakers

Intero Biosystems, a Denver startup founded in 2024, is shipping roughly 100 living human intestinal organoids at a time — each about one millimeter across — to pharmaceutical, biotech, food and chemical companies for drug testing. The company raised a $2.3 million pre-seed round last year and generated more than $400,000 in revenue from the fourth quarter of last year through the third quarter of this year, CEO Charlie Childs told TechCrunch.

"We're literally shipping mini living organs in the mail to people," Childs said. The startup has seven employees and just under 10 customers.

By Olivia Hart

The bet rests on a well-documented failure rate. Animal models do not reliably predict human outcomes, and most drugs still fail during development.

Why sell guts instead of mice?

Intero spun out of the University of Michigan. Its founders argue that existing cell models are too simple: they replicate only part of the gut. Intero's organoids contain multiple cell and tissue types found in the human intestine, which the company believes makes them more human-relevant, 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.

The flagship product, GastroScreen, sells alongside consumables — nutrient mixes and experiment chemicals — and fee-for-service studies. Customers can use the organoids as healthy tissue or induce disease-like conditions to test whether a drug candidate harms the gut.

The business, in short:

• Organoid sales in tubes of roughly 100
• Supplies needed to grow and maintain them
• Custom experiments, lab testing and data delivery

What changed in regulation?

Two FDA moves opened the door. In April of last year, the FDA laid out plans to reduce its reliance on animal testing, promoting organoids, organs-on-chips and AI-based computational models as alternatives. In March of this year, the agency issued draft guidance on how developers should validate these new approach methodologies, or NAMs, for regulatory submissions.

That guidance offers a framework but endorses no specific method. Whether a NAM supports a submission depends on the method, its use and the data provided.

Changes in U.S. law allowing non-animal testing methods in some cases have made pharmaceutical companies more willing to explore organoids, Eiken said. Companies once hesitant are now looking to bring the technology in-house, she added.

Who else is doing this?

Intero is not alone. Altis Biosystems develops stem cell-derived intestinal models. InSphero offers patient-derived intestinal organoids for gastrointestinal toxicity testing. MIMETAS takes a different route with organ-on-chip microfluidic systems.

Intero claims two edges: complexity and scalability. Unlike models grown from tissue collected via colonoscopies, GastroScreen derives from induced pluripotent stem cells — adult cells reprogrammed into almost any cell type, generated from a blood sample. Eiken said that approach could personalize models to individual patients and scale production.

Does the evidence exist yet?

Here the story thins out. Asked what evidence shows GastroScreen predicts human drug responses better than animal or cell-based models, Childs said the company is still building it. Intero is in the second stage of a three-stage validation process.

So far, GastroScreen has shown expected responses to drugs that reduce intestinal inflammation and to compounds known to damage the gut, Childs said. The final stage — direct comparison against pharmaceutical companies' existing animal and clinical data — is underway with several pharma partners, using both existing compounds and new candidates.

That means the central claim, better human relevance, remains unproven against clinical data. The takeaway: promising tissue, unfinished proof.

What comes next?

Intero does not use AI to build its organoids. Instead, Childs sees the organoids as a source of biological data for AI models, which the company plans to license to pharmaceutical and AI firms.

Near term, the priority is scale. Intero can currently make a few thousand organoids per batch and wants automated manufacturing to reach hundreds of thousands. Longer term, it aims at personalized medicine — building organoids from a patient's own cells to test drugs before treatment — and, most ambitiously, an artificial intestine.

Intero presented Wednesday at TechCrunch Disrupt in San Francisco, one of 20 startups competing in this year's Startup Battlefield, which runs October 13 to 15. Whether regulators accept organoid data in place of animals will decide if this market grows beyond a niche.