Femasys Inc. said the U.S. Food and Drug Administration granted a modular premarket approval pathway for its FemBloc investigational permanent birth control device, a step intended to streamline the regulatory process in the United States.
The modular PMA pathway allows key components of FemBloc’s submission to be reviewed by the FDA before final clinical data are available, the Atlanta-based company said. FemBloc uses a patented delivery system to place a blended polymer into both fallopian tubes, where it degrades and induces natural scar tissue formation for permanent occlusion. The procedure is designed to be performed in an OB/GYN office without anesthesia, incisions, or recovery time.
Femasys is advancing FemBloc toward U.S. approval through the ongoing FINALE pivotal trial. The company’s CEO and founder, Kathy Lee-Sepsick, said the regulatory pathway provides a framework to move the product closer to market in the United States. Femasys’ fertility portfolio also includes FemaSeed Intratubal Insemination and diagnostic and sperm preparation products, which are being commercialized in the U.S. and select international markets.
FemBloc has already received regulatory approvals for marketing in Europe, the UK, and New Zealand in 2025. The company is building a U.S. commercial team to expand the commercialization of its fertility portfolio beyond infertility specialists to OB/GYNs.
