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Materna Medical has commercialized the Milli vaginal dilator for vaginismus and painful sex, FDA-cleared and available over-the-counter. Its second product, Ellora™ (formerly "Materna Prep"), is in a pivotal EASE trial at over 20 top US hospitals to reduce pelvic floor injuries during labor; results from feasibility studies show up to 60% reduction in pelvic muscle damage compared to controls. The EASE study will support an FDA De Novo submission in summer 2025.
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