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Femasys Announces FemBloc Delivery System Approval in Europe; A Significant Step Towards FemBloc Permanent Birth Control Availability as the First-Ever Non-Surgical Approach

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Femasys Inc.
Femasys Inc.

First-in-world approval of FemBloc delivery system for women seeking permanent birth control

ATLANTA, March 13, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc® delivery system for non-surgical female permanent birth control. For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, the Company has successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review, with potential approval expected mid-2025.

“European approval for the FemBloc delivery system was achieved through interactive collaboration with the Notified Body to accelerate the approval of this innovative technology in the first region of the world. This is a significant step towards a long-awaited turning point for women seeking a safer, more accessible permanent contraceptive option as an alternative to the centuries-old surgical approach, the sole option available today,” stated Kathy Lee-Sepsick, Femasys’ CEO and Founder. “As we seek to complete the CE mark process for the FemBloc blended polymer, we are preparing for potential market launch of FemBloc to select European countries and we will continue to enroll participants in our FDA IDE approved final pivotal clinical trial for U.S. approval. FemBloc is a disruptive technological advancement that addresses a major gap in women’s reproductive health and exemplifies the innovations transforming women’s health from Femasys.”

About Permanent Birth Control
In the 1800’s, surgical sterilization (tubal ligation) was first performed and evolved to be performed laparoscopically, becoming the most commonly used contraceptive method worldwide. Despite the progress made in the last century, unintended pregnancies continue to rise and present a significant personal burden for individuals, as well as a major public health issue in the United States and globally. Due to the invasive nature of surgical sterilization, women may be utilizing temporary/ reversible methods to avoid the reported risks, which include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death. Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. For over 100 years, there has been stagnant innovation for permanent contraception which has resulted in a significant unmet need for women seeking an alternative to surgical sterilization.