Core Insights - Femasys Inc. has initiated a post-market surveillance clinical study for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy under the EU Medical Device Regulation [1][2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including the FemBloc and FemaSeed [4] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes without the need for anesthesia or incisions, thus avoiding surgical risks [3][5] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and is positioned to meet the strong demand for safe and accessible permanent birth control options among women [5] Clinical Study and Compliance - The post-market surveillance study aims to monitor the safety and performance of FemBloc in real-world settings, complying with the rigorous requirements of the EU MDR [2][3] - The study has received approval from multiple Ethics Committees and adheres to ISO 14155:2020 for Good Clinical Practice [2] Market Potential - FemBloc addresses a significant unmet need in women's reproductive health, with no comparable alternatives currently available, indicating a broad global market potential [3][5] - The company aims to build a foundation for broader physician adoption and reimbursement through the generation of real-world data from the clinical study [3]