— In the severe male factor cohort, findings show that 24% of women became pregnant after FemaSeed —
— FemaSeed cycle-specific pregnancy rates were more than double historical intrauterine insemination (IUI) rates —
— The majority of people who successfully conceived required only one FemaSeed treatment —
— No new safety concerns reported —
ATLANTA, March 20, 2024 (Globe Newswire) — Femasys Co., Ltd. (NASDAQ: FEMY) is a leading biomedical company focused on addressing the critical unmet needs of women around the world with a broad portfolio of innovative, in-office therapeutic and diagnostic products. Today, we announced topline data from FemaSeed Localized Directional Insemination for artificial insemination. A very important trial (NCT04968847). The study investigated the company’s FemaSeed product in women with a variety of infertility factors, with the primary efficacy analysis focused on severe male factor infertility. FemaSeed is designed to promote fertilization by precisely delivering sperm into the fallopian tubes, the site of conception, and is designed to promote fertilization by precisely delivering sperm to the fallopian tubes, which are the site of conception. It was demonstrated that 24% of women with had become pregnant. In contrast, the literature for intrauterine insemination (IUI) with male factors (>1 million TMSCs) states that the pregnancy rate per cycle is 6.7%.1 Although you are allowed to receive FemaSeed more than once, the majority of women who become pregnant did so after their first FemaSeed treatment. Her IUI pregnancy rate in this infertile segment is low, so assisted reproductive approaches such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are usually required.
“These impressive top-line results for the now FDA-approved FemaSeed, while confirming its safety profile, represent a significant advance in infertility treatment. Sperm counts are rapidly increasing around the world. The high overall pregnancy rate with severe male factors, which is decreasing and an important and increasing part of infertility, makes it a viable option as a first-line option before expensive and invasive assisted reproductive technologies such as in vitro fertilization. It confirms FemaSeed’s position as a treatment option and ICSI,” said Kathy Lee-Sepsick, CEO and Founder of Femasys. “This pivotal trial has accumulated substantial prospective data supporting the safety and efficacy of FemaSeed as a breakthrough in artificial insemination. We are one step closer to achieving our goal of empowering healthcare professionals to expand their services by providing easy-to-use and cost-effective alternatives. Capital injection at the end of 2023 will help fund the expansion of our services through the second half of 2025. We are executing on our commercial plans to make FemaSeed available to women and their doctors in the United States in the first half of this year.”
The majority of adverse events were reported to be mild (n=127 subjects, 216 cycles). No new safety concerns were observed through 7 weeks of follow-up. All adverse events were consistent with known adverse events of IUI. This pivotal trial ended before full enrollment was completed as Femasys received FDA approval for FemaSeed under his 510(k) pathway in September 2023. Approved labeling includes women or couples wishing to conceive through intratubal insemination.
About Pivotal Trial (NCT04968847)
Prospective, multicenter, open-label, pivotal trial evaluated the safety and efficacy of FemaSeed® Used for artificial insemination in women with male factor, unexplained or tubal factor infertility, and other female-specific infertility factors. The study evaluated multiple cohorts of patients with severe male factor infertility (1 million to 20 million TMSCs). The primary endpoint was to determine efficacy (pregnancy rate) and safety over her 7 weeks following FemaSeed treatment. Women were allowed to receive multiple her FemaSeed treatments, no more than 6 times. This trial ended before full enrollment was completed as her FDA approval of FemaSeed under the 510(k) pathway was achieved.
About Femaced
Femaced® This is a revolutionary advance in artificial insemination, designed to facilitate fertilization by precisely delivering sperm into the fallopian tubes, the natural site of conception. It is intended to be a first-line treatment option for infertile women, men, and couples seeking to conceive through insemination, providing a safe, accessible, and cost-effective approach. FemaSeed is an innovative device that enables healthcare professionals to expand their clinical services with more affordable and safer alternatives to assisted reproductive technologies such as in vitro fertilization (IVF) and microinsemination (ICSI) . FemaSeed received US FDA clearance (September 2023) and Canadian regulatory approval (April 2023). At the end of Q4 2023, Femasys completed a prospective, multicenter, open-label, pivotal clinical trial (NCT04968847) in patients seeking intratubal insemination with FemaSeed. Adverse events were consistent with intrauterine insemination (IUI). Efficacy analyzes focused on the severe male factor (1 million to 20 million TMSCs). In this population, pregnancy rates after FemaSeed were 24% by subject (n=42) and 16% by cycle (n=62). In contrast, the literature for intrauterine insemination (IUI) with male factors (>1 million TMSCs) states that the pregnancy rate per cycle is 6.7%.1 This topline data provides strong support for the ongoing commercial launch. In March 2024, Femasys successfully completed its first commercial procedure using its innovative intrafallopian insemination device, FemaSeed. Learn more about. www.femased.com.
About Femasis
Femasys is committed to addressing the critical unmet needs of women around the world with a broad portfolio of in-office, innovative therapeutic and diagnostic solutions, including leading innovative product candidates and FDA-cleared products. A major biomedical company focused onFemaced® Intrafallopian insemination is an innovative infertility treatment designed to deliver sperm directly to the site where pregnancy occurs and is FDA cleared and regulatory approved in Canada.fem block® The permanent contraceptive method, in late-stage clinical development, is the first and only non-surgical, in-office permanent contraceptive method intended to be a significantly lower cost and safer option for women than long-standing surgical alternatives. The company is developing complementary diagnostic products, has received regulatory approval for sale in the United States, Canada, and other former U.S. territories, and is ready for commercialization with in-house manufacturing capabilities. .Diagnostic products include FemVue® For fallopian tube assessment using ultrasound that can be used in conjunction with FemCath®intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, a cervical tissue sampler for cervical cancer diagnosis.Learn more about www.femasys.comor follow us X, Facebook, and linkedin.
reference
- Duran et al. (2002) Intrauterine insemination: a systematic review of the determinants of success. Human Reproduction, Volume 8, No. 4, Pages 373-384.
Forward-looking statements
This press release contains forward-looking statements that are subject to significant risks and uncertainties. Forward-looking statements include words such as “may,” “will,” “should,” “expected,” “plans,” “anticipated,” and “could”. , can be identified by terms such as “pending,” “intending,” and “considering.” “Suggestion,” “possibility,” “hope,” “continuation,” or the negative of these terms, or other similar expressions. However, not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond the Company’s control, are difficult to predict and may differ from actual results. results may differ materially from our expectations. Additionally, certain forward-looking statements are based on assumptions about future events that may not prove to be accurate. Factors that could cause actual results to differ include: our ability to develop and advance our current product candidates and programs and successfully initiate, enroll and complete clinical trials; the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates and other positive results; Estimates regarding the overall market served by our products and product candidates. the impact of delays in commercializing our products and product candidates or commercializing our products, including FemaSeed; business models and strategic plans for our products, technologies and operations, including their implementation; and the other risks and uncertainties described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the SEC. certainty. The forward-looking statements contained in this press release are made as of the date hereof, and Femasys undertakes no obligation to update such information except as required by applicable law. yeah.
contact address:
Investor:
Gene Mannheimer
IR@femasys.com
Media contact:
Kati Waldenberg
Media@femasys.com
