-- First in the FemSperm family, the Setup Kit enables gynecologists to offer FemaSeed directly, expanding access ahead of IVF and driving revenue growth --
ATLANTA, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, today announced the introduction of its FemSperm Setup Kit, the first in a planned family of products designed to fully enable gynecologists for FemaSeed Intratubal Insemination. The setup kit includes customized components, such as a pre-configured centrifuge to optimize sperm preparation for use with FemaSeed. By providing a streamlined, in-office solution, Femasys is establishing the foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, expanding patient access to alternatives ahead of IVF and advancing the Company’s commercialization strategy.
“Our FemSperm Setup Kit represents the beginning of a broader family of products designed to fully activate gynecologists to adopt and expand FemaSeed use,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This strategic step strengthens our commercialization pathway by bringing FemaSeed into the hands of the physicians who see patients first, opening new access points for women seeking fertility care and positioning Femasys for scalable revenue growth.”
"With decades of experience in reproductive medicine and as an investigator in the completed FemaSeed trial, I performed the procedure firsthand and know it is ideally suited for gynecologists to perform," said Dr. James Liu, Chief Medical Officer of Femasys and Former Chairman, Department of Obstetrics and Gynecology, University Hospital System, Former Chair, Department of Reproductive Biology, Case Western Reserve University and Former Division Director of Reproductive Endocrinology and Infertility, University of Cincinnati. "Introducing sperm preparation into the gynecology office is a necessary step to enable this pathway. With FemaSeed, fertility care can begin in the gynecologist’s practice, the primary setting for family planning, making treatment more accessible and affordable for women earlier in their fertility journey."
FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by precisely delivering sperm to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed established more than double the pregnancy rates compared to IUI in cases of low male sperm count.1 As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at www.femaseed.com.
About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1
FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025 followed by UK in August 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (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. doi: 10.33140/JGRM.08.02.08.
2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.
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 obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, 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, 2024, 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.
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