ATLANTA, March 19, 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 CNY Fertility, a national provider of fertility services across the U.S. CNY Fertility will provide the Company’s FemaSeed intratubal insemination product as an infertility treatment option to patients throughout its network of 11 locations.

“We are thrilled to partner with CNY Fertility, a prominent infertility group, to continue to expand access of our FemaSeed infertility treatment to those seeking a first-line fertility solution,” said Femasys CEO Kathy Lee-Sepsick. “By providing FemaSeed to CNY Fertility, we are supporting their commitment to delivering exceptional care and helping patients navigate their fertility journey with confidence.”

Dr. Robert Kiltz, Founder and Director of CNY Fertility stated, “Our mission at CNY Fertility is to offer comprehensive, affordable, high-quality fertility solutions for our patients. We believe FemaSeed is an innovative technology that expands options for our patients seeking the latest advancements to grow their family.”

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 offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.¹ It serves as an affordable, less burdensome and lower-risk first step before IVF. 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. The Company, a U.S. manufacturer, has received regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed^® Intratubal Insemination, a groundbreaking first-line infertility treatment, is FDA-cleared and approved in Europe, UK, Canada and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.¹ FemVue^®, a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv^®, a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, UK, Canada and Israel.

FemBloc^® permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The revolutionary FemBloc delivery system is approved in Europe and the proprietary blended polymer has been recommended for approval, which is expected mid-year 2025. For U.S. FDA approval, the FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.² FemCath^® and FemChec^®, diagnostic products for FemBloc’s ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

About CNY Fertility
CNY Fertility is a leading fertility clinic known for its affordable and accessible fertility treatments. With a commitment to excellence in care and a comprehensive suite of services, CNY Fertility helps individuals and couples achieve their dreams of parenthood. Unique in its affordability, inclusiveness, accessibility, geographic reach, professional expertise, and personal service, CNY Fertility has helped create more than 30,000 lives since its opening in 1997 and is expanding its capability to give this gift to many more people. Learn more at www.cnyfertility.com.

References

¹ Liu, 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.

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.

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, 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: 
IR@femasys.com

Media Contact: 
Media@femasys.com