Femasys Inc. has earned Medicines and Healthcare products Regulatory Agency (MHRA) approval for its FemBloc Permanent Birth Control in the United Kingdom.

“The U.K.’s regulatory approval for FemBloc permanent birth control is another milestone in our global expansion strategy,” Femasys Founder/CEO Kathy Lee-Sepsick stated. “This follows our recent CE mark for Europe and reinforces our momentum toward broader international market access. This achievement demonstrates regulatory confidence in our technology and positions us to move forward with securing a strategic partner to support commercialization in the U.K.”

The United Kingdom represents one of the largest and most influential healthcare markets in Europe, with a strong emphasis on advancing women’s health solutions. With the U.K.’s single-payer National Health Service (NHS), technologies that improve access, reduce costs, and enhance outcomes have a clear pathway to broad adoption. Securing MHRA approval not only validates FemBloc’s safety and effectiveness but also enables Femasys to serve a diverse patient population in this critical market.

FemBloc is touted as a first-of-its-kind, non-surgical solution for permanent birth control. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. 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 focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its patent-protected portfolio of 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-step infertility treatment and FemVue, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates 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 is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June. Commercialization will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec diagnostic product provides an ultrasound-based test to confirm procedural 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.