Femasys announces topline data from trial of FemaSeed for infertility

Femasys announces topline data from its FemaSeed Localized Directional Insemination for artificial insemination pivotal trial. The trial investigated its FemaSeed product in women with a variety of infertility factors with the primary efficacy analysis focused on the severe male factor infertility. FemaSeed, engineered to enhance fertilization by precisely delivering sperm into the fallopian tube, the site of conception, demonstrated 24% of women became pregnant after FemaSeed with severe male factor. In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination with male factor. Although permitted to have multiple FemaSeed attempts, the majority of women who became pregnant did so after the first FemaSeed procedure. The poor IUI pregnancy rates for this infertility segment usually necessitates assisted reproductive approaches, such as in vitro fertilization or intracytoplasmic sperm injection. The majority of adverse events were reported as mild. No new safety concerns were observed through the seven-week follow-up. All adverse events were consistent with those known for IUI. The pivotal trial was concluded prior to completing full enrollment due to Femasys receiving FDA clearance for FemaSeed under the 510(k) pathway in September 2023. The approved labeling includes women or couples wishing to become pregnant by way of intratubal insemination.