FemBloc Delivery System Approved by European Regulators

Femasys Inc. has earned world-first CE mark certification for its non-surgical female permanent birth control solution, the FemBloc delivery system.

The company has completed an expedited G12 Special MDR Audit for Class III devices for the FemBloc blended polymer, an integral part of the FemBloc permanent birth control system. A 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,” Femasys Founder/CEO Kathy Lee-Sepsick said. “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.”

Related: Femasys Issued New U.S. Patent for FemBloc 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 co-morbidities. 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.

FemBloc permanent birth control is a first-of-its-kind non-surgical approach that involves minimally-invasive placement of a patented delivery system for precise delivery of Femasys’ proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously. Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes. In contrast to historic surgical sterilization, the FemBloc approach has the potential to offer a non-surgical, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost.

Femasys is a biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of accessible, in-office therapeutic and diagnostic products. The U.S. manufacturer has received regulatory approvals for its product portfolio worldwide, and it is currently being commercialized in the United States and key international markets. FemaSeed Intratubal Insemination, a first-line infertility treatment, is cleared by the U.S. Food and Drug Administration (FDA) and approved in Europe, the United Kingdom, Canada, and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.¹ FemVue, a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, the United Kingdom, Canada, Japan, and Israel. FemCerv, a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, the United Kingdom, Canada, and Israel.

FemBloc permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. For FDA approval, the FINALE pivotal clinical trial is currently enrolling participants. Peer-reviewed publication of positive data from FemBloc’s initial clinical trials have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.² FemCath and FemChec, diagnostic products for FemBloc’s ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada.

References
¹ Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12.

² Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12.