FemVue

Search documents
Femasys Achieves Australian and New Zealand Regulatory Approvals for FemaSeed® for First-Line Infertility Treatment and FemVue Diagnostic
Globenewswire· 2025-07-01 13:00
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 ...
Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
GlobeNewswire News Room· 2025-06-25 13:00
ATLANTA, June 25, 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, announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR 2017/745) of the Class III FemBloc blended polymer component, marking the first regulatory approval in the world for the FemBloc® System ...
Femasys Names New Chief Commercial Officer to Drive Execution and Global Growth
GlobeNewswire News Room· 2025-06-17 13:00
--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 ...
Femasys Announces Partnership with Carolinas Fertility Institute, One of America’s Best Fertility Clinics, to Offer FemaSeed® in its More than 8 Locations
Globenewswire· 2025-06-11 13:00
-- Femasys continues to expand access and market share for its first-line infertility treatment option, FemaSeed® -- ATLANTA, June 11, 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 announces a partnership with Carolinas Fertility Institute (CFI), one of America’s best fertility clinics. Carolinas Fertility Ins ...
Femasys Announces Pricing of Underwritten Public Offering and Concurrent Private Placement with Gross Proceeds of $4.5 Million
Globenewswire· 2025-05-30 12:00
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 ...
Femasys Announces Proposed Public Offering of Common Stock and Concurrent Private Placement
Globenewswire· 2025-05-29 20:23
ATLANTA, May 29, 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 that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Femasys expects to grant the underwriters a 30-day option to purchase up to an additional 15% ...
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 ...