About FemaSeed FemaSeed is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Offering a safe, accessible, and cost-effective first- line treatment, FemaSeed provides a more effective alternative to intrauterine insemination (IUI). In the pivotal clinical trial (NCT0468847), it achieved over double the pregnancy rates of IUI in cases of low male sperm count. FemaSeed is an affordable, less invasi ...

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 ...

Core Insights - Femasys, Inc. has partnered with Carolinas Fertility Institute to offer its FemaSeed intratubal insemination product as a treatment option for infertility in North Carolina [1][2] - The partnership aims to provide a less invasive and cost-effective fertility solution before IVF, enhancing treatment options for patients [2] - FemaSeed is a next-generation artificial insemination solution that significantly improves fertilization rates, achieving over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count [3][4] Company Overview - Femasys is a biomedical innovator focused on women's health, with a portfolio of patent-protected therapeutic and diagnostic products [4] - The company is actively commercializing its products in the U.S. and international markets, including FemaSeed and FemVue, a diagnostic for fallopian tube assessment [4] - Femasys' FemBloc product, a non-surgical permanent birth control method, is expected to receive full regulatory approval in Europe by mid-2025 [5] Product Details - FemaSeed enhances fertilization by delivering sperm directly to the fallopian tube, offering a safe and cost-effective first-line treatment option [3] - The product is authorized for use in multiple regions, including the U.S., Europe, UK, Canada, and Israel [3] - FemBloc is positioned as a highly cost-effective and safer alternative to traditional surgical sterilization, with commercialization plans in Spain and other European countries [5] Partner Overview - Carolinas Fertility Institute is a leading fertility center in North Carolina, providing a range of reproductive care services [6] - The institute focuses on making fertility care more accessible and effective, aligning with Femasys' mission to offer innovative treatment options [2][6]

ATLANTA, May 30, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY) (the “Company” or “Femasys”), 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 pricing of an underwritten public offering of 3,600,000 shares of its common stock at a public offering price of $0.85 per share and a separate concurrent private placement of 1,686,275 shares of its ...

Core Viewpoint - Femasys Inc. plans to conduct an underwritten public offering of its common stock, with an additional 30-day option for underwriters to purchase up to 15% more shares, alongside a concurrent private placement involving existing institutional stockholders and certain directors and officers [1][2]. Group 1: Offering Details - The public offering and private placement are subject to market conditions, with no assurance on completion timing or terms [2]. - Jones is the sole book-running manager for the public offering and placement agent for the private placement [3]. - The net proceeds from the offerings will be used for commercial expansion, product development, general corporate purposes, capital expenditures, and working capital [3]. Group 2: Regulatory Information - The securities are being offered under a Registration Statement on Form S-3, previously filed and declared effective by the SEC [4]. - The private placement will rely on an exemption from registration under the Securities Act, meaning the securities may not be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - Femasys Inc. focuses on women's health, developing minimally invasive, in-office technologies for reproductive health, including products like FemBloc for permanent birth control and FemaSeed for infertility [6]. - Current marketed products include FemVue for fallopian tube assessment and FemCath, an intrauterine catheter for selective evaluation [6].

Core Insights - Femasys Inc. is focused on transforming women's health with innovative solutions, including FemaSeed for infertility treatment and FemBloc for non-surgical permanent birth control, with full system approval pending in Europe [1][3] Corporate Highlights - The company secured the first global regulatory approval for the FemBloc delivery system, marking a significant milestone for introducing a non-surgical permanent birth control option in Europe [3][7] - In Q1 2025, Femasys executed its commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., indicating strong market momentum [3] - Femasys announced partnerships with CNY Fertility and distribution partnerships for FemBloc in Spain, enhancing its market presence [7] Financial Results - For the quarter ended March 31, 2025, sales increased by $70,124, or 25.9%, to $341,264 compared to $271,140 in the same period of 2024, primarily driven by FemaSeed sales [8][12] - Research and development expenses rose by $1,197,741, or 67.6%, to $2,968,472 due to increased regulatory, material, and development costs [8][12] - The net loss for the quarter was $5,896,839, or ($0.23) per share, compared to a net loss of $3,599,510, or ($0.17) per share in Q1 2024 [8][12] Balance Sheet Overview - As of March 31, 2025, total assets were approximately $13.3 million, up from $12.4 million at the end of 2024 [10][11] - Current liabilities increased to $9,841,126 from $8,582,869, reflecting higher accounts payable and convertible notes payable [10] - The company had cash and cash equivalents of approximately $3.8 million and an accumulated deficit of about $133.1 million [8][10]

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 ...