Femasys Inc. receives MHRA approval for FemBloc in the UK.

Femasys Inc. has received MHRA approval for its FemBloc Permanent Birth Control in the UK, marking a significant milestone in the company's European expansion strategy. This approval signifies that the product has met safety, quality, and effectiveness standards. The company had recently received CE mark approval for Europe and is now poised to expand availability of its non-surgical permanent birth control option to women in the UK and other European countries.

Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator, has achieved a significant milestone in its European expansion strategy by securing approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its FemBloc Permanent Birth Control in the UK. This regulatory approval signifies that the product has met stringent standards for safety, quality, and effectiveness, paving the way for broader availability in the UK and other European countries.

The UK's regulatory approval follows Femasys' recent CE mark approval for Europe and reinforces the company's momentum towards broader international market access. Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc., stated, "The UK’s regulatory approval for FemBloc permanent birth control is another milestone in our global expansion strategy. 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 UK."

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. Unlike traditional surgical sterilization, FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective [1].

The UK represents one of the largest and most influential healthcare markets in Europe, with a strong emphasis on advancing women’s health solutions. The UK’s single-payer National Health Service (NHS) provides a clear pathway for innovative technologies that improve access, reduce costs, and enhance outcomes. 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.

Femasys is committed to making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide. With its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys' fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment, and FemVue®, a companion diagnostic for fallopian tube assessment [2].

Femasys Inc. is now poised to expand the availability of its FemBloc Permanent Birth Control in the UK and other European countries, further solidifying its position as a leading biomedical innovator in the global healthcare market.

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