-- Femasys continues to expand access and market share for its first-line infertility treatment option, FemaSeed^® --

ATLANTA, June 11, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products announces a partnership with Carolinas Fertility Institute (CFI), one of America’s best fertility clinics. Carolinas Fertility Institute will provide the Company’s FemaSeed^® intratubal insemination product as an infertility treatment option to patients throughout its network in North Carolina.

“Our partnership with Carolinas Fertility Institute reflects the growing momentum behind FemaSeed as a meaningful first-line fertility solution,” said Kathy Lee-Sepsick, CEO and Founder of Femasys. “By offering a less invasive and cost-effective option before IVF, we’re helping practices expand their treatment offerings while supporting patients earlier in their fertility journey.”

“At Carolinas Fertility Institute, we are always looking for innovative ways to make fertility care more accessible, effective, and patient-friendly,” said Dr. Tamer Yalcinkaya, Founder and Medical Director of CFI. “FemaSeed offers an exciting new first-line treatment option that complements our mission to provide advanced, yet affordable and less invasive care.”

About FemaSeed

FemaSeed® is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Offering a safe, accessible, and cost-effective first-line treatment, FemaSeed provides a more effective alternative to intrauterine insemination (IUI). In the pivotal clinical trial (NCT0468847), it achieved over double the pregnancy rates of IUI in cases of low male sperm count.¹ FemaSeed is an affordable, less invasive, lower-risk option before IVF. It is authorized for use in the U.S., Europe, UK, Canada, and Israel. Learn more at www.femaseed.com.

About Femasys

Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of disruptive, accessible, 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-line infertility treatment and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data show FemaSeed is over twice as effective as traditional IUI, for low male sperm count, with a comparable safety profile, and high patient and practitioner satisfaction.¹

FemBloc^® permanent birth control, the first and only non-surgical, in-office alternative to centuries-old surgical sterilization, expects full regulatory approval in Europe mid-year 2025. Commercialization of this highly cost effective, convenient and significantly safer approach, will begin in Spain through engaged partnerships followed by 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.

About Carolinas Fertility Institute

Carolinas Fertility Institute (CFI) is a leading fertility center serving patients across North Carolina and the Southeast. With locations in Winston-Salem, Greensboro, and Charlotte, CFI offers personalized, evidence-based reproductive care including IVF, IUI, fertility preservation, and advanced diagnostic services. The Institute is led by renowned reproductive endocrinologists and is dedicated to providing compassionate, high-quality treatment with a focus on affordability, accessibility, and patient success. CFI’s mission is to help individuals and couples achieve their dreams of parenthood with expertise, innovation, and empathy. Learn more at www.carolinasfertilityinstitute.com.

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: market and other conditions; 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 ability to raise sufficient capital for such model and plans; 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.

Contacts: 

Investors: 
IR@femasys.com 

Media Contact: 
Media@femasys.com