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Femasys | 8-K: Current report

SEC announcement · Mar 20 08:22

FEMY +4.45%

Summary by Moomoo AI

On March 20, 2024, Femasys Inc., a biomedical company specializing in women's health, announced positive topline results from its pivotal trial of the FDA-cleared FemaSeed, a device for treating infertility. The trial focused on severe male factor infertility and demonstrated a 24% pregnancy rate among women using FemaSeed, which is significantly higher than the 6.7% rate for intrauterine insemination (IUI) reported in existing literature. The majority of successful pregnancies occurred after just one FemaSeed procedure, highlighting its potential as a first-line treatment option. The trial concluded early due to FDA clearance received in September 2023, and the device is expected to be commercially available in the first half of 2024. Femasys CEO Kathy Lee-Sepsick emphasized the device's safety profile and its role in expanding accessible and cost-effective treatment options for infertility. The trial's findings support the ongoing commercial launch of FemaSeed, with the first commercial procedure already completed in March 2024.

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