Femasys Secures UK Regulatory Approval for FemBloc Permanent Birth Control.

Femasys Inc. has received UK regulatory approval for FemBloc Permanent Birth Control, a non-surgical permanent birth control option. This marks a milestone in the company's efforts to expand availability of the product in Europe. The MHRA approval signifies that FemBloc has met the required standards for safety, quality, and effectiveness in the UK.

Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator, has received a significant milestone in its European commercialization strategy. The company announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved FemBloc Permanent Birth Control for the United Kingdom market. This approval marks an important step forward for Femasys as it expands the availability of its non-surgical permanent birth control option to women in Europe.

The MHRA approval signifies that FemBloc has met the required standards for safety, quality, and effectiveness in the UK. This achievement follows the company's recent CE mark approval for Europe and reinforces its momentum toward broader international market access. Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc., stated that this regulatory approval demonstrates regulatory confidence in their technology and positions the company to move forward with securing a strategic partner to support commercialization in the UK.

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 UK’s single-payer National Health Service (NHS), innovative 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 a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women’s reproductive health. 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. With no comparable alternatives on the market, FemBloc represents a disruptive advancement with broad global potential.

Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide. The company’s broad, patent-protected portfolio includes FemaSeed® Intratubal Insemination and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over 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 of 2025. Commercialization of this highly cost-effective, convenient, and significantly safer approach 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. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing. The company's forward-looking statements include the potential ability to obtain regulatory approvals for its FemBloc product candidate, develop and advance its current FemBloc product candidate, and successfully enroll and complete the clinical trial.

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. [1] https://www.globenewswire.com/news-release/2025/08/20/3136445/0/en/Femasys-Secures-UK-Regulatory-Approval-of-FemBloc-Permanent-Birth-Control.html
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. [2] https://www.globenewswire.com/news-release/2025/08/20/3136445/0/en/Femasys-Secures-UK-Regulatory-Approval-of-FemBloc-Permanent-Birth-Control.html