Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed® for the Treatment of Infertility
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From a medical standpoint, the reported pregnancy rate of 24% for women undergoing FemaSeed procedures in the context of severe male factor infertility is a significant finding. Traditional intrauterine insemination (IUI) has been a less invasive and more affordable first-line treatment for infertility, but its effectiveness in severe male factor cases has been limited. The typical IUI success rates are much lower, with literature citing around 6.7% per cycle. FemaSeed's approach, which involves direct delivery of sperm into the fallopian tube, seems to mimic more closely the natural process of fertilization and may offer a less invasive alternative to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), which are more complex and costly procedures.
Furthermore, the fact that a majority of successful pregnancies occurred after just one FemaSeed procedure suggests a potential cost-saving benefit. This could be of great interest to healthcare providers and patients who are balancing the financial implications of fertility treatments. However, it's important to consider the long-term success rates and potential risks associated with this new method, as well as the limited scope of the trial, which may not fully represent the broader population.
From a market perspective, Femasys Inc.'s announcement of the FDA-cleared FemaSeed product represents a notable development in the fertility industry. The successful trial and subsequent FDA approval could position FemaSeed as a competitive player in the market, offering a cost-effective and less invasive alternative to traditional assisted reproductive technologies (ART). This is particularly relevant given the global decline in sperm counts and the increasing demand for fertility treatments.
The potential for FemaSeed to become a first-line treatment option could disrupt the current ART market dynamics, appealing to a segment of the population that may have otherwise opted for more expensive and invasive procedures such as IVF or ICSI. Femasys Inc.'s strategic move to secure funding through the end of 2023, with plans to commercialize FemaSeed in the first half of the year, indicates a strong market entry strategy. Investors and stakeholders in the fertility sector should monitor adoption rates and patient outcomes closely, as these will be critical in assessing the long-term impact on Femasys Inc.'s financial performance and market share.
Analyzing the biotechnological implications of Femasys Inc.'s FemaSeed, this innovation could be a game-changer in the field of reproductive medicine. The technology's ability to improve fertilization outcomes by delivering sperm directly to the site of conception is a notable advancement. The successful trial results suggest that FemaSeed could address a significant unmet need for couples facing severe male factor infertility, potentially reducing the reliance on more invasive ART procedures.
The industry should note the speed with which Femasys received FDA clearance under the 510(k) pathway, which is typically reserved for medical devices demonstrating substantial equivalence to an already legally marketed device. This expedited approval could set a precedent for similar future technologies looking to enter the market. The emphasis on safety, with no new concerns reported, aligns with industry norms and regulatory expectations, potentially easing the pathway for adoption by healthcare providers.
-- In the severe male factor cohort, findings show
-- 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
“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.”
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
About Femasys
Femasys is 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 solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. For more information visit www.femasys.com, or follow us on X, Facebook, and LinkedIn.
Reference
- Duran et al. (2002) Intrauterine insemination: a systematic review on determinants of success. Human Reproduction, vol.8, no. 4, pp. 373-384.
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 December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Contacts:
Investors:
Gene Mannheimer
IR@femasys.com
Media Contact:
Kati Waldenburg
Media@femasys.com
FAQ
What is the primary focus of Femasys Inc.'s FemaSeed product?
What was the pregnancy rate in women with severe male factor infertility after using FemaSeed?
What percentage of women who became pregnant required only one FemaSeed procedure?
Were there any new safety concerns reported during the trial?
When is Femasys planning to make FemaSeed available in the U.S.?
