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ATLANTA - Femasys Inc. (NASDAQ:FEMY), a $31.5 million market cap medical device company whose stock has surged nearly 17% in the past week, announced Wednesday it has received its first European commercial order for its FemBloc Permanent Birth Control system, valued at approximately $400,000 USD from distribution partners in Spain.
The order marks the company’s first commercial entry into Europe following FemBloc’s full regulatory approval in the region in June 2025. Spain becomes the first country globally to offer access to this non-surgical permanent contraceptive option. According to InvestingPro data, analysts project significant sales growth for Femasys this year, with revenue expected to increase by 225%.
Femasys has partnered with Spanish distributors Comercial Medico Quirúrgica and Durgalab to introduce FemBloc to the market. Both companies previously commercialized Essure, a now-discontinued permanent contraceptive device.
"We are focused on scaling production to meet anticipated demand as interest builds across Europe," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys.
FemBloc provides a non-surgical alternative to traditional sterilization procedures. The system uses a patented delivery method to place a proprietary blended polymer into the fallopian tubes, which degrades and forms natural scar tissue for permanent occlusion.
According to the company, the procedure eliminates risks associated with surgical sterilization, including anesthesia complications, infection, and recovery downtime.
Femasys is currently conducting the FINALE pivotal trial in the United States to seek FDA approval for FemBloc.
The information in this article is based on a company press release. While Femasys maintains a healthy gross profit margin of 66%, InvestingPro analysis indicates the company is currently burning through cash with an EBITDA of -$19.47M. For deeper insights into Femasys’s financial health and growth prospects, including 8 additional ProTips and detailed metrics, consider subscribing to InvestingPro.
In other recent news, Femasys Inc. announced that its FemBloc System received CE Mark certification under the European Union Medical Device Regulation, marking its first global regulatory approval for a non-surgical permanent birth control option. This development follows previous approval for the delivery system, expanding Femasys’ footprint in women’s reproductive health solutions. The company also set the pricing for a public stock offering and concurrent private placement, with shares priced at $0.85 and $1.02, respectively, expected to raise approximately $4.5 million in gross proceeds. These funds are intended to bolster commercial efforts, advance product development, and cover general corporate expenses. Additionally, Femasys appointed Kelley Nicholas as Chief Commercial Officer to lead commercial strategy and drive revenue growth, particularly in the U.S. infertility market. Meanwhile, the company received a notification from The Nasdaq Stock Market about noncompliance with the minimum bid price rule, granting Femasys a 180-day grace period to address the issue. The notification does not immediately affect the trading of Femasys’ stock on the Nasdaq Capital Market. Lastly, the company announced plans for a public stock offering and private placement, emphasizing that the transactions are subject to market conditions.
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