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]

--New CCO to Lead U.S. Commercialization of Fertility Products, Including FemaSeed®, and Expand Strategic Global Partnerships Across Full Portfolio-- ATLANTA, June 17, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc. (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, today announced the appointment of Kelley Nicholas as Chief Commercial Officer (CCO). Ms. Nichola ...

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 ...