Core Points - Femasys Inc. has received CE mark certification for its FemBloc blended polymer component, marking the first global regulatory approval for a non-surgical permanent birth control solution [1][2] - The FemBloc System is now approved for marketing in the European Economic Area, which includes 27 EU member states and 3 EFTA countries [1] - Femasys plans to commercialize FemBloc in select European countries, starting with Spain, and is also pursuing U.S. FDA approval through ongoing clinical trials [2][4] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [4] - The FemBloc System is a non-surgical solution that places a proprietary blended polymer into the fallopian tubes, creating natural scar tissue to block them permanently [3] - Femasys also has a fertility portfolio that includes FemaSeed for infertility treatment and FemVue for fallopian tube assessment, with FemaSeed showing over twice the effectiveness of traditional IUI [4]

Core Insights - Femasys, Inc. has appointed Kelley Nicholas as Chief Commercial Officer to enhance its commercial strategy and revenue growth, particularly in the U.S. infertility market and through global partnerships [1][2] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products, including FemaSeed® and FemVue® [5] - The company is actively commercializing its products in the U.S. and international markets, with a strong emphasis on addressing unmet needs in women's health [5] Leadership Appointment - Kelley Nicholas brings over 25 years of industry experience, including significant roles in commercial strategy and revenue growth in the medical device and biotechnology sectors [2] - Her previous positions include Head of Sales at NeuroPace and Global Vice President of Marketing at Hologic, where she successfully led revenue and market expansion initiatives [2] Stock Option Grant - Femasys has granted Kelley Nicholas an option to purchase 100,000 shares of common stock, effective on her first day of employment, as an inducement for her joining the company [3][4] Product Portfolio - FemaSeed® is highlighted as a groundbreaking infertility treatment, showing over twice the effectiveness of traditional IUI for low male sperm count, with high satisfaction rates [5] - FemBloc®, a non-surgical permanent birth control method, is expected to receive full regulatory approval in Europe by mid-2025, with commercialization planned to begin in Spain [6]