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ATLANTA - Femasys Inc. (NASDAQ:FEMY), a biomedical company specializing in women’s health with a market capitalization of $33.43 million, has received the Conformité Européenne (CE) mark certification for its FemBloc® delivery system, marking the first regulatory approval worldwide for this non-surgical permanent birth control method. According to InvestingPro data, the company has demonstrated strong revenue growth of 15.33% in the last twelve months, suggesting growing market acceptance of its innovative solutions. The certification, a critical regulatory milestone under the European Union Medical Device Regulation (EU MDR), is for the delivery system component of FemBloc.
The FemBloc system offers a minimally invasive alternative to traditional surgical sterilization, which has been the primary method of permanent birth control since the 1800s. The new technology involves a patented delivery system to administer a synthetic tissue adhesive into the fallopian tubes, which eventually forms nonfunctional scar tissue, blocking the tubes permanently.
This development is considered a significant advancement for women seeking safer and more accessible options for permanent contraception. The FemBloc blended polymer, an essential part of the system, has completed an expedited G12 Special MDR Audit for Class III devices. The Notified Body has recommended it for CE mark approval, which is expected by mid-2025 following the final stages of the European Medical Agency review.
Femasys CEO and Founder Kathy Lee-Sepsick highlighted the importance of this innovation, stating it represents a long-awaited shift from the surgical approach that has been the sole option for permanent birth control.
In preparation for the market launch of FemBloc in select European countries, Femasys is also progressing with its FDA IDE approved final pivotal clinical trial in the United States.
The company, known for addressing unmet needs in women’s health, has a portfolio of FDA-cleared and internationally approved products, including FemaSeed® for infertility treatment, FemVue® for fallopian tube assessment, FemCerv® for cervical cancer diagnosis, and diagnostic products FemCath® and FemChec®. Financial analysis from InvestingPro reveals a healthy gross profit margin of 65.83% and a strong current ratio of 3.94, indicating efficient operations and solid short-term liquidity. Investors can access 12 additional exclusive ProTips and comprehensive financial metrics with an InvestingPro subscription.
The initial clinical trials for FemBloc have shown promising effectiveness and safety over a five-year period, with high patient and practitioner satisfaction. These findings have been published in peer-reviewed medical journals. With the company’s next earnings report scheduled for March 27, 2025, InvestingPro subscribers can access detailed financial forecasts and analyst recommendations to make informed investment decisions.
This news is based on a press release statement from Femasys Inc. and does not include any promotional content. The company’s forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those projected. Femasys has not provided any updates beyond the information contained in the press release.
In other recent news, Femasys Inc. has received UK regulatory approval for three of its women’s health products: the FemaSeed Intratubal Insemination device, FemVue for tubal evaluation, and FemCerv for cervical cancer detection. These devices, which have already been approved in the US, Europe, Canada, and Israel, are now set to expand their reach in the UK market. The approval was granted by the Medicines & Healthcare products Regulatory Agency (MHRA). FemaSeed offers a novel approach to artificial insemination by delivering sperm directly to the fallopian tube, presenting a cost-effective alternative to traditional methods. FemVue is notable for being the first FDA-cleared product for real-time fallopian tube evaluation using ultrasound. Meanwhile, FemCerv provides a pain-free method for collecting cervical cancer detection samples. These developments underscore Femasys’ commitment to providing innovative and minimally invasive women’s health solutions.
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