Femasys Enables OB/GYNs to Deliver First-Line Fertility Treatment with Initial Commercial Use of FemaSeed® Complete

-- Integrated sperm preparation and intratubal insemination drive earlier intervention and streamlined, in-office care within routine OB/GYN practice --

ATLANTA, May 05, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide, announced today the first revenue-generating commercial use of its fertility portfolio in the OBGYN setting, led by FemaSeed as a first-line infertility treatment. The procedure was supported by FemSperm^®, enabling in-office sperm preparation and advancing the shift of fertility care to women’s primary physician, where earlier intervention can improve access and outcomes.

Infertility impacts an estimated 10 million women in the United States, yet fewer than 1% receive care at specialized fertility centers, highlighting a significant gap in treatment access. This disparity is further underscored by recent CDC data showing U.S. fertility rates declined to record lows in 2025, continuing a long-term downward trend. By enabling fertility care within the OBGYN setting, where most women already receive care, Femasys is addressing this unmet need with earlier access to intervention at a meaningfully lower cost and reduced procedural complexity than IVF. This approach enables OBGYNs to offer a new in-office fertility treatment option, supporting practice growth while shifting the care pathway toward more timely, cost-efficient, and patient-centered treatment.

“Femasys is leading a fundamental shift in fertility care by moving treatment earlier and closer to the patient,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “Following FemaSeed’s earlier than expected U.S. FDA clearance and subsequent clinical validation in infertility centers, the availability of FemSperm now expands our capabilities to include in-office sperm preparation, enabling a complete solution in the OBGYN setting. After an exciting ACOG launch, we are focused on rapidly advancing this new model of care.”

“When I learned of this new end-to-end fertility solution, I immediately recognized the impact it could have for my patients requiring intervention to achieve pregnancy,” said Dr. Finazzo, D.O., of Downriver OBGYN in Trenton, MI. “I am proud to be at the forefront of shifting fertility care into the OBGYN setting with an approach that is easily integrated into clinical practice, well tolerated by patients, and operationally straightforward for staff, including in-office sperm preparation for use with FemaSeed.”

About FemaSeed Complete
FemaSeed^® Complete is a comprehensive first-line fertility solution designed for use in the OB/GYN office. It combines FemaSeed intratubal insemination (ITI) with FemSperm^®, providing an integrated approach to sperm preparation and insemination in a single in-office visit. By streamlining the procedural workflow and eliminating the need for external lab processing or referrals, FemaSeed Complete is designed to expand access to cost-effective fertility care and support earlier intervention in the patient journey. 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 (ITI), a groundbreaking first-step infertility treatment; FemSperm^®, a CLIA waived sperm preparation and analysis product line; and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of 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 2025, the UK in August 2025, and New Zealand in September 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 ongoing.

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, 2025, 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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