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Yahoo
11-02-2025
- Business
- Yahoo
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 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 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 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. Learn more at About FemasysFemasys, an Atlanta-based leading biomedical innovator, develops and commercializes a portfolio of patent-protected, minimally invasive women's health solutions, all manufactured in the U.S. Our innovative therapeutic and diagnostic products have received global regulatory approvals and are being commercialized in the U.S. and select countries. FemaSeed® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, UK, Canada and Israel. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, UK, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel. FemBloc® permanent birth control, the Company's late-stage product candidate, is the first and only non-surgical, in-office, method offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The pivotal clinical trial (NCT05977751) is now enrolling participants for U.S. approval. FemCath® and FemChec®, companion diagnostic products for FemBloc's ultrasound-based confirmation test, are U.S. FDA-cleared and approved in Europe and Canada. Learn more at or follow us on X, Facebook and LinkedIn. Reference1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. Forward-Looking StatementsThis press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'pending,' 'intend,' 'believe,' 'suggests,' 'potential,' 'hope,' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts:Investors:IR@ Media Contact:Media@ in to access your portfolio
Yahoo
05-02-2025
- Business
- Yahoo
Femasys gains approvals for infertility and diagnostic products in Israel
Femasys has gained approval for its FemaSeed Intratubal Insemination product and two diagnostic devices from the Ministry of Health's (AMAR) Israeli medical device division. The diagnostic devices, FemCerv and FemVue, are designed to identify cervical cancer and tubal assessment, respectively. Intended to improve fertilisation by delivering sperm directly into the fallopian tube, FemaSeed claims to provide a safe and cost-effective alternative for women, men, and couples struggling with infertility who are ready to conceive through the insemination process. A pivotal trial demonstrated the 'effectiveness' of FemaSeed, particularly for cases of low male sperm count, offering a lower-risk alternative before considering in vitro fertilisation (IVF). FemCerv, the first Food and Drug Administration (FDA)-cleared product specifically tailored for collecting a comprehensive and uncontaminated sample, facilitates a pain-free office procedure for cervical cancer identification. It has also gained approvals in Israel, Canada, and Europe. FemVue, another diagnostic device for assessing fallopian tubes via ultrasound, has been cleared by the US regulator and approved in Canada, Israel, Europe and Japan. Headquartered in Atlanta, Femasys develops and commercialises minimally invasive women's health solutions. Companion diagnostic products FemCath and FemChec, used for FemBloc's ultrasound-based confirmation test, have also been cleared by the FDA and gained approval in Canada and Europe. Femasys CEO Kathy Lee-Sepsick said: 'We remain committed to our mission of delivering critically important technological advancements to women globally, with Israel now added to our expanding reach. 'FemaSeed, along with our entire suite of products, has been developed to provide women with better, lower-cost, and more accessible options. We remain focused on commercial execution in the US and select other countries as we continue to expand the availability of our much-needed product solutions.' In August 2024, the company secured CE mark certification and Health Canada approval for FemVue MINI, a compact solution for assessing fallopian tubes. "Femasys gains approvals for infertility and diagnostic products in Israel" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
