Intero Scales Mini Human Intestines for Drug Testing
Intero Biosystems scales GastroScreen gut organoids as FDA rules encourage non-animal drug tests, but human predictive validation remains a work in progress.
Summary
Because most drugs fail development and animal results do not always translate to humans, Denver-based Intero Biosystems, a 2024 University of Michigan spinout led by CEO Charlie Childs and CTO Madeline Eiken, sells GastroScreen to pharmaceutical, biotech, food and chemical companies. Its roughly one-millimeter intestinal organoids combine multiple human gut cell and tissue types, ship about 100 per tube, and can model healthy or induced disease-like tissue for drug safety and disease studies. Intero also supplies nutrients and experimental chemicals, or designs and runs custom tests and delivers data. It has seven employees, just under 10 customers, a $2.3 million 2025 pre-seed round, and more than $400,000 in revenue from Q4 2025 through Q3 2026.
U.S. law now permits some non-animal methods, while the FDA's April 2025 plan promoted organoids, organs-on-chips and AI models, and its March 2026 draft guidance set case-dependent validation rules without endorsing a method. Intero says induced pluripotent stem cells generated from blood make GastroScreen more scalable and potentially patient-specific than colonoscopy-derived tissue. Altis Biosystems and InSphero sell intestinal models, while MIMETAS uses microfluidic organ-on-chip systems. After proving GastroScreen contains key gut tissues, Intero is in stage two of three, showing expected responses to anti-inflammatory and gut-damaging compounds. Several pharmaceutical companies are comparing it with animal and clinical data using established and new candidates. Intero makes a few thousand organoids per batch and plans automation for hundreds of thousands, dataset licensing to pharmaceutical and AI companies, personalized testing from patient cells, and ultimately an artificial intestine.
Positives
- More than $400,000 in revenue from Q4 2025 through Q3 2026 shows early commercial demand from just under 10 customers.
- The FDA's April 2025 plan promoted organoids, organs-on-chips and AI models as alternatives that could reduce animal testing.
- GastroScreen produced expected responses to drugs reducing intestinal inflammation and compounds known to damage the gut.
- Hundreds of thousands of organoids per automated batch would substantially expand Intero's current capacity of a few thousand.
- Blood-derived induced pluripotent stem cells could enable scalable, patient-specific organoids without tissue collected through colonoscopies.
Risks & concerns
- Stage two of three validation means GastroScreen has not yet proved greater predictive accuracy than animal or simpler cell models.
- The FDA's March 2026 draft guidance provides a validation framework but does not endorse GastroScreen or any specific non-animal method.
- Seven employees and just under 10 customers leave Intero at an early commercial and operational stage.
- Altis Biosystems, InSphero and MIMETAS already offer competing intestinal models or organ-on-chip technologies.
- Current production remains a few thousand organoids per batch, far below Intero's target of hundreds of thousands.