Recent updates and view no how the FDA views New Approach Methodologies (NAMs) to improve data translatability from the lab to patients.

We present patient-derived endometrial organoids as a sensitive and scalable model for reproductive toxicity screening, aligning with FDA and NIH priorities for human-based NAMs.

To advance fibroid research, Opal Therapeutics has developed lab-grown uterine organoids and cells from menstrual effluent and tissue biopsies. These models offer a suite of research tools to closely mimic how fibroids behave in the body and allow researchers to test how different drugs affect both healthy and fibroid-affected cells.

The FDA’s shift toward organoid-based and AI-powered drug testing marks a new era in biotech. Opal Therapeutics is leading in women’s health with our uterus-in-a-dish platform—using patient-derived uterine organoids to model diseases like endometriosis and fibroids with human-relevant precision.

Rodents don’t have a menstrual cycle, yet they remain the gold standard in drug discovery—despite their poor track record in predicting outcomes for women. Even the FDA has called for alternatives, as 30% of drug recalls stem from female-specific adverse effects, costing billions and putting lives at risk.

If pad and tampon companies want better-performing products, they need to ditch the blue liquid and start testing with something that actually behaves like menstrual blood.

For chronic gynecological disorders like endometriosis and fibroids, hysterectomies are the go-to strategy. However, the long-term repercussions for women are profound including increased risk of cardiovascular diseases, increased risk of premature menopause, and decreased cognitive and mental health. Why aren’t there more alternatives?