Femasys’ FemaSeed FDA Clearance Brings Timely Access to a First-Line Infertility Treatment Option as an Alternative to IVF

-- Femasys readies for the commercial launch of FemaSeed in the U.S. amidst the uncertainty following the Alabama Supreme Court Ruling on how to handle embryos used for in vitro fertilization (IVF) --

-- Femasys to announce top-line data from recently completed pivotal clinical trial for FemaSeed in first quarter 2024 --

ATLANTA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic products, today highlighted that its FemaSeed intratubal insemination product, a revolutionary approach to enhancing fertilization, is expected to serve as a first-line therapeutic option that is substantially lower cost with significantly less risk than assisted reproductive methods, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). FemaSeed has been designed to deliver sperm reliably and safely, directly into the fallopian tube where conception occurs.

“Femasys remains committed to providing accessible and affordable options and the timing of FemaSeed’s launch is particularly relevant given the uncertainty following the Alabama Supreme Court ruling on February 16^th. Following our substantial cash infusion in the fourth quarter 2023, we are now funded into the second half of 2025 and on track to make FemaSeed, available later this year to women and their doctors, as a first-line treatment option that does not involve handling of embryos,” said Femasys’ CEO Kathy Lee-Sepsick.

About FemaSeed

FemaSeed is an innovative infertility treatment designed to deliver sperm to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for those seeking pregnancy. FemaSeed is less invasive and more affordable than assisted reproduction procedures, such as IVF or ICSI. In 2023, FemaSeed achieved U.S. FDA clearance (September) and regulatory approval in Canada (April) for patients seeking insemination. At the end of the fourth quarter of 2023, Femasys completed a pivotal clinical trial (“LOCAL” trial) for those seeking intratubal insemination with a specific focus on male factor infertility, a contributing factor in approximately 40-50% of infertility cases. Top line data from this study is planned for release first quarter 2024 and will support the commercial launch targeted for the first half of 2024.