Femasys Secures UK Approval for FemBloc Birth Control: A Milestone in European Commercialization Strategy.

Femasys received UK regulatory approval for FemBloc Permanent Birth Control, a non-surgical solution for permanent birth control. This approval validates FemBloc's safety and effectiveness and positions Femasys to secure a strategic partner for commercialization in the UK. Femasys Inc. is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide.

Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator, has secured regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its FemBloc Permanent Birth Control in the United Kingdom. This approval, which signifies the product has met the required standards for safety, quality, and effectiveness, marks a significant milestone in Femasys' global expansion strategy.

The UK's regulatory approval for FemBloc follows the company's recent CE mark for Europe and reinforces its momentum towards broader international market access. This achievement demonstrates regulatory confidence in Femasys' 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. The 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.

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 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 Inc. is focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. The company's fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment, and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed's effectiveness and high patient and practitioner satisfaction.

References:
[1] https://www.morningstar.com/news/globe-newswire/9515243/femasys-secures-uk-regulatory-approval-of-fembloc-permanent-birth-control
[2] https://www.globenewswire.com/news-release/2025/08/20/3136445/0/en/Femasys-Secures-UK-Regulatory-Approval-of-FemBloc-Permanent-Birth-Control.html