Femasys Inc. (FEMY), a biomedical company focused on women's health, said Thursday it has received CE mark certification under the European Union Medical Device Regulation (EU MDR) for its FemBloc delivery system, marking the first-ever regulatory approval for a non-surgical permanent birth control option for women.
The approval comes after the company completed an expedited G12 Special MDR Audit for Class III devices and successfully navigated the regulatory review process.
The FemBloc delivery system utilizes a patented delivery method to administer a synthetic tissue adhesive into the fallopian tubes, which then forms nonfunctional scar tissue, providing a permanent contraceptive solution.
Femasys is now preparing for the market launch of FemBloc in select European countries, with the blended polymer portion of the product expected to receive full approval by mid-2025.
The company is also progressing with its FDA clinical trial for U.S. approval, with its pivotal FINALE trial currently enrolling participants.
This approval is a significant milestone for FemBloc, which provides a non-surgical, more accessible alternative to traditional tubal ligation, with fewer risks and lower costs.
Currently, FEMY is trading at $1.54 up by 5.4 percent on the Nasdaq.
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