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Femasys Inc. (NASDAQ:FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced the commencement of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent Birth Control. This study is being conducted in accordance with the European Union Medical Device Regulation (EU MDR 2017/745) and numerous thought leaders throughout the region.
This PMS study is a key component of Femasys' long-term commitment to monitor the safety and performance of its products in real-world settings while complying with the rigorous post-market requirements introduced under the MDR framework (Annex XIV Part B). The study has received approval from multiple Ethics Committees and is being carried out in compliance with ISO 14155:2020 for Good Clinical Practice and applicable national regulations.
"Launching this post-market study is a significant milestone in advancing our European commercialization strategy for FemBloc," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. "By generating real-world data, we are not only meeting stringent MDR requirements but also building the foundation for broader physician adoption and reimbursement. With strong demand among women in Europe for safe, accessible permanent birth control, FemBloc is uniquely positioned to address this unmet need and drive meaningful growth as we expand access to women worldwide."
FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women's reproductive health. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. Unlike surgical sterilization, FemBloc requires no anesthesia, no incisions, and no recovery time, avoiding the risks of infection and other surgical complications while providing women a safer, more convenient, and affordable option. With no comparable alternatives on the market, FemBloc represents a disruptive advancement with broad global potential. Learn more at www.FemBloc.com.
Posted In: FEMY
