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
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
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
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Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'pending,' 'intend,' 'believe,' 'suggests,' 'potential,' 'hope,' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof and those other risks and uncertainties described in the section titled 'Risk Factors' in our Annual Report on Form 10-K for the year ended
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