Biomedical company Femasys has successfully completed the first commercial procedure using its innovative FemaSeed intratubal insemination product. FemaSeed, which has received clearance from the U.S. FDA, employs a novel approach to enhance fertilization by precisely delivering sperm directly to the fallopian tube—the natural site of conception. This method is designed to be a primary therapeutic choice for those seeking pregnancy, offering reduced risks compared to more invasive assisted reproduction procedures. With FemaSeed, Femasys wants to offer a new, cost-effective, and potentially safer alternative to traditional methods such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
“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.”
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.”
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.
