FEMY Femasys Inc

Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing the significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, invites investors to join management in a Fireside Chat with Jones Trading Analyst Catherine Novack to discuss the current treatment landscape for infertility treatment in women. Those interested in attending the event, which will be held virtually TODAY, March 21, 2024 at 1PM ET, may register here.

Femasys CEO Kathy Lee-Sepsick and Chief Medical Officer James Liu, M.D. will focus on the current treatment options in the infertility services market, including Femasys’ FDA-authorized FemaSeed device for intratubal insemination. During the event, speakers will also examine emerging trends and technology that have contributed to the growing utilization of assisted reproductive technology (ART), as well as headwinds such as rising costs of IVF in the current climate.

Ms. Lee-Sepsick is the founder of Femasys and has nearly three decades of experience as a senior executive in the medical technology industry. She is the lead inventor of the technologies at Femasys and remains committed to advancing much needed technology in women’s health. Prior to his role at Femasys, Dr. Liu has served as Chairman, Department of Obstetrics and Gynecology at University Hospital Health System, the Chair, Department of Reproductive Biology at Case Western Reserve University, and the Division Head, Reproductive Endocrinology and Infertility at the University of Cincinnati.

About FemaSeedFemaSeed® 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 is intended to be a first-line therapeutic choice for infertile women, men, and couples seeking pregnancy through insemination, offering a safe, accessible, and cost-effective approach. FemaSeed is a revolutionary device that allows healthcare professionals an ability to expand practice services with a more affordable and safer alternative to assisted reproductive methods, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). FemaSeed received U.S. FDA clearance (September 2023) and regulatory approval in Canada (April 2023). At the end of the fourth quarter of 2023, Femasys concluded a prospective, multi-center, unblinded pivotal clinical trial (NCT0468847) for those seeking intratubal insemination with FemaSeed. Adverse events were consistent with intrauterine insemination (IUI). Efficacy analysis focused on severe male factor (1 million to 20 million TMSC). In this population, pregnancy rate was 24% by subject (n=42) and 16% by cycle (n=62) after FemaSeed. In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).1 This topline data provides strong support for the on-going commercial launch, currently in progress. Femasys successfully completed the first commercial procedure using its innovative FemaSeed intratubal insemination device in March 2024. Learn more at www.femaseed.com.

About FemasysFemasys 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.

Reference

1. Duran et al. (2002) Intrauterine insemination: a systematic review on determinants of success. Human Reproduction, vol.8, no. 4, pp. 373-384.

Forward-Looking StatementsThis 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, 2022 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 MannheimerIR@femasys.com

Media Contact:Kati WaldenburgMedia@femasys.com