FEMY Femasys Inc

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 that the Company has received its second order from its strategic distribution partners after successfully completing its first commercial FemaSeed® procedures in Europe. Members of the Femasys team traveled to Madrid to in-service healthcare practitioners on the innovative FemaSeed infertility treatment, designed to enhance natural fertilization by precisely delivering sperm into the fallopian tube where conception occurs.

“We are thrilled to receive another order from our distribution partners in Spain exemplifying their confidence after successful completion of FemaSeed treatment procedures,” stated Kathy-Lee Sepsick, Femasys CEO commented, “The need for a lower cost infertility treatment prior to in vitro fertilization is ever so important particularly in the public sector where women often have to wait years to receive an IVF. We are going to continue working tirelessly to provide our first-line solution to as many women in the U.S. and across the world as possible.”

Earlier in September, Femasys announced its strategic distribution partnerships for FemaSeed and FemVue in Spain. Comercial Medico Quirurigca, SA (CMQ) will distribute the products in northern Spain and Durgalab will distribute them in the south.

About Spanish Infertility Market

According to the European registries by the European Society of Human Reproduction and Embryology (ESHRE)1, Spain has the most in vitro fertilization (IVF) clinics with 244 facilities in Europe. Additionally, Spain ranks second in intrauterine (IUI) insemination cycles using husband sperm and holds the top position for IUI cycles using donor sperm.

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.

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, 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: CORE IRMatt BlazeiIR@femasys.com

Media:CORE IR Kati WaldenburgMedia@femasys.com

1 ART in Europe, 2019: results generated from European registries by ESHRE, Human Reproduction, 2023, 38(12), 2321–2338, https://doi.org/10.1093/humrep/dead197, October 17, 2023.