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Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
GlobeNewswire News Room· 2025-06-25 13:00
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]
Femasys Names New Chief Commercial Officer to Drive Execution and Global Growth
GlobeNewswire News Room· 2025-06-17 13:00
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]
连续获批!辅助生殖医疗器械
思宇MedTech· 2025-02-07 16:18
2025年2月4日,美国生物医学公司Femasys Inc.(纳斯达克:FEMY)(2024年前三季度收入约为132万美元)宣布,其不孕症治疗产品 FemaSeed® 及两款诊断设备 FemVue® (输卵管评估)和 FemCerv® (宫颈癌检测)获得以色列卫生部医疗器械分部(AMAR)批准。这是继美国FDA(2023年9月)和欧盟CE(2024年6月) 后,Femasys全球化布局的又一关键进展。 # 产品介绍 1. FemaSeed® :输卵管内定向人工授精系统 ● 操作流程: 超声定位优势卵泡位置; ○ 安全性:非侵入性,无麻醉需求; ○ 适用人群:男性少精症(精子数<500万/毫升)、不明原因不孕夫妇。 2. FemVue® :输卵管超声评估系统 已获得以色列监管机构批准。 3. FemCerv® :无痛宫颈组织取样器 ○ 无痛操作:减少患者不适,门诊即可完成。 ● 临床价值: 用于异常宫颈涂片后的阴道镜活检,降低漏诊率。 2024年第三季度在美国和欧洲(西班牙)开始商业化;2025年2月获得以色列监管机构批准。 ● 技术原理: 通过导管将精子直接注入输卵管(自然受孕部位),提升受精率。 ○ 导管定 ...