Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility

-- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed --

-- FemaSeed pregnancy rate by cycle was more than double historic intrauterine insemination (IUI) rate --

-- Of those with a successful pregnancy, a majority required only one FemaSeed procedure --

-- No new safety concerns were reported --

ATLANTA, March 20, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announces topline data from its FemaSeed Localized Directional Insemination for artificial insemination pivotal trial (NCT04968847). 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 (1 million to 20 million total motile sperm count (TMSC)). In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).¹ 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 (IVF) or intracytoplasmic sperm injection (ICSI).

“These impressive topline results for our now FDA-cleared FemaSeed, demonstrate significant progress in the treatment of infertility, while confirming its safety profile. The high overall rate of pregnancy for severe male factor, a significant and growing segment of infertility with sperm counts sharply declining around the world, supports FemaSeed’s positioning as a first-line treatment option, prior to costly and invasive assisted reproductive procedures, such as IVF and ICSI,” remarked Kathy Lee-Sepsick, CEO and founder of Femasys. “The pivotal trial amassed substantial prospective data in support of the safety and efficacy of FemaSeed as a groundbreaking advancement in artificial insemination. We are one step closer to achieving our goal of providing healthcare professionals with an ability to expand practice services by offering our safe, accessible, and cost-effective alternative to assisted reproductive approaches. With the infusion of capital at the end of 2023 providing funding into the second half of 2025, we are executing on our commercial plan to make FemaSeed available in the first half of this year to women and their physicians in the U.S.”