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Femasys Announces UK Regulatory Approvals for FemaSeed® for Female Infertility Treatment and Two Diagnostic Devices
UK regulatory approval follows FemaSeed, FemVue and FemCerv clearance/ approvals in the U.S., Europe, Canada and Israel ATLANTA, Feb. 11, 2025 (GLOBE
About this update from Femasys Inc.
[{"type":"text","content":"UK regulatory approval follows FemaSeed, FemVue and FemCerv clearance/ approvals in the U.S., Europe, Canada and Israel\nATLANTA, Feb. 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 the receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection. “This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” stated Kathy Lee-Sepsick, Femasys’ CEO. “We remain committed to advancing much-needed options that are safe, effective and cutting-edge for patients globally.” About FemaSeedFemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.1 It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at www.femaseed.com. About FemVueFemVue® is the first FDA-cleared product that creates natural saline and air contrast for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound. When combined with a uterine cavity assessment, it provides a comprehensive exam in the comfort of the gynecologist’s office. Since FemaSeed infertility treatment requires at least one open fallopian tube, FemVue is an essential companion diagnostic. Learn more at www.femvue.com. About FemCervFemCerv® is the first and only FDA-cleared product purposefully designed to collect a comprehensive and uncontaminated sample in a pain-free office procedure for the detection of cervical cancer. Lea...