Femasys Inc. has earned Conformité Européene (CE) mark certification for FemBloc’s blended polymer component, marking the world’s first regulatory approval of the FemBloc System for non-surgical female permanent birth control.

After European Medicines Agency (EMA) review, the Notified Body granted CE mark certification. The regulatory approval for the blended polymer joins the approval announced earlier this year for FemBloc’s delivery system component. The FemBloc System can now be marketed in the European Economic Area, which includes the European Union’s 27 member states and the three European Free Trade Association countries.

“European approval of the entire FemBloc System represents a major milestone for Femasys and the field of women’s health. It marks the first global regulatory endorsement of our non-surgical permanent birth control solution, following a rigorous scientific evaluation of the technology. This achievement reflects years of dedication and underscores our commitment to bringing safe, accessible alternatives to traditional surgical options,” Femasys Founder/CEO Kathy Lee-Sepsick stated. “Femasys is preparing to make FemBloc commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain through our existing partners and will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval.”

FemBloc is a first-of-its-kind non-surgical solution for permanent birth control, addressing a large unmet need in women’s reproductive health. Delivered in-office through a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue to permanently block them. In contrast to surgical sterilization, FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective.

Femasys is a biomedical innovator addressing critical unmet needs in women’s health with a patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the United States and key international markets. Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination, a first-line infertility treatment and FemVue, a companion diagnostic for fallopian tube assessment. Published clinical trial data show FemaSeed is more than twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.¹

FemBloc permanent birth control, the first and only non-surgical, in-office alternative to centuries-old surgical sterilization, has received regulatory approval in Europe. Commercialization will begin in Spain through engaged partnerships followed by select European countries. Alongside FemBloc, the FemChec is a diagnostic product that enables an ultrasound-based test to confirm procedure success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.² For U.S. Food and Drug Administration approval, enrollment in the FINALE pivotal trial is ongoing.

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. doi: 10.33140/JGRM.08.02.08.
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. doi: 10.33140/JGRM.09.01.05.