Intero Biosystems Ships Mini Human Guts to Drugmakers — SkimNews

Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- Intero Biosystems sells GastroScreen, a human intestinal organoid model roughly one millimeter across that it ships in batches of about 100 per tube to pharmaceutical, biotech, food, and chemical companies for drug safety and disease research.
- Intero Biosystems generated more than $400,000 in revenue from Q4 last year through Q3 this year, employs 7 people, and has just under 10 customers after raising a $2.3 million pre-seed round last year.
- The FDA laid out plans in April of last year to reduce reliance on animal testing in drug development, then in March of this year issued draft guidance on validating new approach methodologies such as organoids, organs-on-chips, and AI-based computational models.
- Intero Biosystems competes with Altis Biosystems, InSphero, and MIMETAS, but says its induced pluripotent stem cell-derived approach lets it personalize models to specific patients and scale production more easily than colonoscopy-derived alternatives.
- Intero is in the second of three validation stages, having shown GastroScreen contains key gut tissues and now testing well-known drugs with documented human effects; the final stage will compare results directly against pharmaceutical companies' existing animal and clinical data.
- Intero Biosystems makes a few thousand per run today and is automating manufacturing toward batches of hundreds of thousands of organoids, with a longer-term ambition of building a patient-specific artificial intestine.
Why it matters: With the FDA's March draft guidance now spelling out how organoids can support regulatory submissions and U.S. law letting drug developers use non-animal methods in some cases, co-founder Madeline Eiken said pharma companies once hesitant about the technology are now bringing organoid testing in-house — opening a commercial lane for startups whose iPSC-derived models can scale and be personalized.
Ask SkimNews



