ATLANTA, April 18, 2024 (GLOBE NEWSWIRE) -- 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, today announces its CEO and Founder Kathy Lee-Sepsick has met with several members of Congress to discuss the current women’s healthcare landscape. Further, Lee-Sepsick is raising awareness of Femasys and the status of its reproductive products in light of the recently announced women’s health initiative from the White House. In mid-March President Biden released an executive order, which calls for a $200M investment in research for women’s health and a coordinated approach from more than 20 federal government agencies in addition to the $100M investment announced in November 2023.
“Women’s health remain vastly underserved and underfunded but we are encouraged by the interest our solutions have received during recent meetings with members of Congress,” remarked Lee-Sepsick. “I am proud to be a female-founder and to lead Femasys as we develop revolutionary technologies that provide a continuum of care that are safe, affordable and accessible to women. It is our goal to empower women throughout their reproductive journey by delivering innovative options to meet their needs.”
Femasys provides minimally-invasive solutions that share delivery platforms. It has four commercially available products: FemaSeed® – FDA-cleared, intratubal insemination, FemVue® – contrast-generating device, FemCath® – selective delivery catheter, and FemCerv® – endocervical tissue sampler. And its current lead product candidate in late-stage clinical development is FemBloc® – permanent birth control.
The Company recently announced topline data from its FemaSeed pivotal trial, which investigated FemaSeed in women with a variety of infertility factors with the primary efficacy analysis focused on the male factor infertility. FemaSeed demonstrated 24% of women became pregnant after FemaSeed with male factor (1 million to 20 million total motile sperm count (TMSC)). Although permitted to have multiple FemaSeed attempts, the majority of women who became pregnant did so after the first FemaSeed procedure.
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. 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, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® 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. For more information visit 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:
Gene Mannheimer
IR@femasys.com
Media Contact:
Kati Waldenburg
Media@femasys.com
