Femasys Announces Peer-Reviewed Publication of Positive Data from Prospective, Multicenter Pivotal Trial of FemaSeed® Infertility Treatment

Rhea-AI Summary

Femasys Inc. (NASDAQ: FEMY) announced the publication of positive data from its pivotal trial of FemaSeed® intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine. The trial demonstrated safety and effectiveness of FemaSeed ITI, with high satisfaction ratings from practitioners and patients. The study showed pregnancy rates more than double compared to intrauterine insemination (IUI) for low male sperm count cases, which affects approximately 50% of infertile couples. FemaSeed is positioned as a less invasive and more affordable alternative to in vitro fertilization (IVF) for infertility treatment.

Positive

• Clinical trial demonstrated significantly higher pregnancy rates compared to IUI
• High satisfaction ratings from both practitioners and patients
• Addresses large market opportunity (50% of infertile couples)
• Offers more affordable alternative to IVF

Negative

• None.

Insights

Medical Research Analyst

The publication of FemaSeed's pivotal trial data in a peer-reviewed journal represents a significant milestone. The trial demonstrated pregnancy rates more than double those of traditional IUI for cases involving low sperm count, which affects approximately 50% of infertile couples. The results validate FemaSeed as a potential disruptive technology in the fertility treatment market.

The treatment positions itself strategically between traditional IUI and more expensive IVF procedures, potentially capturing a significant market share in the fertility sector. With high satisfaction ratings from both practitioners and patients, FemaSeed could become a preferred first-line treatment option. The successful trial results strengthen the company's path toward commercialization and potential market adoption.

Trial results demonstrated safety and effectiveness of FemaSeed intratubal insemination with high satisfaction ratings from both practitioners and patients

ATLANTA, Nov. 26, 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, announces the peer-reviewed publication of positive data from its pivotal trial of FemaSeed^® intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and reproductive medicine.

“We are grateful for the renowned investigators from leading academic medical centers and private practices that participated in this landmark trial,” stated Kathy Lee-Sepsick, CEO of Femasys. “Our impressive pivotal data for FemaSeed, showed significantly improved pregnancy rates, over double that of intrauterine insemination (IUI) for low male sperm count, a primary or contributing cause of infertility for approximately 50% of couples. FemaSeed offers a highly effective, first-line solution for women and couples seeking a less invasive and more affordable option than in vitro fertilization (IVF).”

About the Data

The publication titled, “FemaSeed directional intratubal artificial insemination for couples with male-factor or unexplained infertility associated with low male sperm count,” includes positive data from the pivotal trial (Clinicaltrials.gov NCT04968847). The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95%CI: 13.4‒43.1%; n=10/38) and 17.5% per cycle (95%LCB: 7.6%, 95%CI: 5.7‒29.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P=0.041). Safety reports were consistent with IUI. The vast majority of subjects stated they would probably or definitely recommend FemaSeed, and investigator satisfaction was similarly high.

Targeted intratubal insemination of washed spermatozoa using the FemaSeed ITI device is a safe artificial insemination technique that demonstrated high effectiveness for couples with male-factor/unexplained infertility associated with low male sperm count. Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility.¹

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 for the expansion of practice services by enabling healthcare professionals with a more affordable and safer alternative to assisted reproductive methods, such as in vitro fertilization (IVF). FemaSeed received U.S. FDA clearance (September 2023), regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024). At the end of 2023, Femasys concluded a prospective, multi-center, pivotal clinical trial (NCT0468847) for those seeking intratubal insemination with FemaSeed. Positive data was published demonstrating FemaSeed as a safe and effective treatment option to achieve pregnancy in couples with male-factor/ unexplained infertility and low male sperm count.¹ Learn more at www.femaseed.com.

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 and Europe. 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, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue^® and FemVue^® MINI 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. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

Reference
Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12.

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, our ability to establish, maintain, grow or increase sales and revenues, 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, 2023, 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: 
Matt Blazei
IR@femasys.com

Media Contact: 
Kati Waldenburg
Media@femasys.com

FAQ

What were the key results of Femasys (FEMY) FemaSeed pivotal trial in 2024?

The pivotal trial showed FemaSeed achieved pregnancy rates more than double compared to intrauterine insemination (IUI) for low male sperm count cases, with high satisfaction ratings from both practitioners and patients.

How does FemaSeed (FEMY) compare to traditional infertility treatments?

FemaSeed is positioned as a less invasive and more affordable alternative to IVF, while showing higher pregnancy rates than IUI for low male sperm count cases.

What percentage of infertile couples could benefit from Femasys (FEMY) FemaSeed treatment?

FemaSeed could potentially benefit approximately 50% of infertile couples, as low male sperm count is a primary or contributing cause of infertility for this population.