Femasys receives UK regulatory approval for non-surgical birth control

ATLANTA - Femasys Inc. (NASDAQ:FEMY), a medical device company with a market capitalization of $21.7 million, announced Wednesday it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its FemBloc Permanent Birth Control system.

The approval follows the company’s CE mark certification in Europe obtained in June 2025 and represents a significant step in Femasys’ European commercialization strategy for its non-surgical permanent birth control option. According to InvestingPro data, analysts anticipate significant sales growth for the company this year, with revenue projected to more than double.

FemBloc offers an alternative to surgical sterilization by using a patented delivery system that places a proprietary blended polymer into the fallopian tubes, which degrades and forms natural scar tissue for permanent occlusion.

"The UK’s regulatory approval for FemBloc permanent birth control is another milestone in our global expansion strategy," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. "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."

The United Kingdom, with its National Health Service (NHS), represents one of the largest healthcare markets in Europe. Femasys aims to leverage this approval to expand availability of its technology, which eliminates risks associated with surgical sterilization such as anesthesia, infection, and recovery downtime. While the company’s current financial health score is classified as weak by InvestingPro, with rapid cash burn being a concern, analysts maintain optimistic price targets ranging from $3 to $8 per share.

Femasys is also pursuing FDA approval in the United States, where enrollment in the FINALE pivotal trial is ongoing.

The company’s product portfolio includes additional fertility solutions such as FemaSeed Intratubal Insemination and FemVue, a diagnostic for fallopian tube assessment. Despite reporting a gross profit margin of 65%, the company remains in its growth phase and is currently trading near its 52-week low. Unlock 12 additional valuable insights about Femasys with InvestingPro.

The information in this article is based on a press release statement from Femasys Inc.

In other recent news, Femasys Inc. has made significant strides with its FemBloc Permanent Birth Control system, receiving its first European commercial order from Spain, valued at approximately $400,000. This follows the system’s full regulatory approval in Europe in June 2025, marking Spain as the first country to offer this non-surgical contraceptive option. Additionally, Femasys announced the pricing for its latest public stock offering and private placement, expecting combined gross proceeds of around $4.5 million, which will be used for commercial expansion and product development.

The company also received a notification from Nasdaq regarding noncompliance with the minimum bid price requirement, as its stock has traded below $1.00 per share for 30 consecutive days. Femasys has until January 12, 2026, to regain compliance by maintaining a closing bid price of at least $1.00 per share for ten consecutive business days. In another development, Femasys appointed Kelley Nicholas as Chief Commercial Officer to lead its commercial strategy and drive revenue growth.

Furthermore, the FemBloc System achieved full CE Mark certification under European Union Medical Device Regulation, marking its first global regulatory approval for permanent birth control. This certification includes the Class III blended polymer component, following earlier approval for its delivery system. These developments reflect Femasys’ ongoing efforts to expand its market presence and enhance its product offerings.

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