Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution

-- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost effective alternative to IVF --

-- Ongoing uncertainty following recent Alabama Supreme Court Ruling creates continued anticipation with top-line pivotal data expected to be announced during Q1 2024 --

ATLANTA, March 06, 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 and innovative therapeutic and diagnostic products, announces the first commercial procedure using its FemaSeed intratubal insemination product.

“FemaSeed presents an important advancement in women’s health with the availability of FemaSeed, a cost-effective and potentially safer alternative to other traditional infertility treatments,” said Femasys’ CEO Kathy Lee-Sepsick. “This first commercial application of the technology marks a pivotal moment in reshaping female infertility management, particularly in light of the recent legal rulings on frozen embryos by the Alabama Supreme Court. We are enthusiastic about expanding FemaSeed’s availability and anticipate broader acceptance within the medical community as its distinct benefits become more widely recognized.”

FDA-Cleared FemaSeed is a revolutionary approach to enhancing fertilization, as a cost-effective primary therapeutic choice that carries notably reduced risks compared to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Engineered to precisely deliver sperm into the fallopian tube, the site of conception, FemaSeed enables reliable and safe fertilization.

Dr. Andrew Wagner, Women’s OB-GYN PC, Saginaw, Michigan, who completed the first in-office commercial procedure, stated, “This marks a pivotal moment for women pursuing a reliable, readily available frontline alternative for infertility. FemaSeed’s methodical delivery of sperm to the fallopian tubes, where fertilization begins, epitomizes simplicity in its sophistication, offering patients an easily understandable approach.”

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. FemaSeed achieved U.S. FDA clearance (September 2023) and regulatory approval in Canada (April 2023) 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.