Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed for the Treatment of Infertility - Seite 2

The majority of adverse events were reported as mild (n=127 subjects, 216 cycles). 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.

About Pivotal Trial (NCT04968847)

The prospective, multi-center, unblinded pivotal trial evaluated the safety and efficacy of FemaSeed for artificial insemination in women with male factor, unexplained, or tubal factor infertility, as well as other female specific infertility factors. The trial evaluated multiple cohorts, including those with severe male factor infertility (1 million to 20 million TMSC). The primary endpoints were to determine the effectiveness (pregnancy rate) and safety over a period of seven weeks post-FemaSeed procedure. Women were permitted to receive multiple FemaSeed procedures, not to exceed six attempts. The trial was concluded prior to completing full enrollment due to the achievement of FDA clearance for FemaSeed under the 510(k) pathway.

About FemaSeed

FemaSeed is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It is intended to be a first-line therapeutic choice for infertile women, men, and couples seeking pregnancy through insemination, offering a safe, accessible, and cost-effective approach. FemaSeed is a revolutionary device that allows healthcare professionals an ability to expand practice services with a more affordable and safer alternative to assisted reproductive methods, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). FemaSeed received U.S. FDA clearance (September 2023) and regulatory approval in Canada (April 2023). At the end of the fourth quarter of 2023, Femasys concluded a prospective, multi-center, unblinded pivotal clinical trial (NCT04968847) for those seeking intratubal insemination with FemaSeed. Adverse events were consistent with intrauterine insemination (IUI). Efficacy analysis focused on severe male factor (1 million to 20 million TMSC). In this population, pregnancy rate was 24% by subject (n=42) and 16% by cycle (n=62) after FemaSeed. 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 This topline data provides strong support for the on-going commercial launch, currently in progress. Femasys successfully completed the first commercial procedure using its innovative FemaSeed intratubal insemination device in March 2024. Learn more at www.femaseed.com.