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 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. Learn more at www.femcerv.com.
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 www.femasys.com, 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@femasys.com
Media Contact:Media@femasys.comSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNN
43 minutes ago
- CNN
Salmonella outbreak linked to eggs sickens dozens of people across 7 states
More than 70 people across seven states have been sickened due to a salmonella outbreak linked to eggs recalled by a California-based egg distributor, according to the US Centers for Disease Control and Prevention. On Friday, the August Egg Company recalled 1.7 million dozen brown cage-free and brown certified organic eggs, sold under multiple brand names, that have the 'potential to be contaminated,' according to a recall notice from the US Food and Drug Administration. Of the 79 people sickened, 21 people have been hospitalized and no deaths have been reported, the CDC said. The eggs were sold to restaurants and retailers in Arizona, California, Illinois, Indiana, Nebraska, New Mexico, Nevada, Washington and Wyoming, according to the CDC. They were distributed at retail locations including Walmart, Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less and Ralphs. Salmonella can 'cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems,' according to the FDA. Salmonella can also cause fever, diarrhea, nausea, vomiting and abdominal pain in healthy people who get infected. 'August Egg Company is not selling fresh shell eggs at this time. Our firm has voluntarily been diverting eggs to an egg-breaking plant for over 30 days, which pasteurizes the eggs and kills any potential foodborne pathogens,' the company said in a statement provided to the FDA. 'It is important to know that when our processing plant identified this concern, we immediately began diverting all eggs from the plant to an egg-breaking facility, which pasteurizes the eggs and kills any pathogens.' The company also said its internal food safety team is 'conducting its own stringent review' to identify future preventative measures. 'We are committed to addressing this matter fully and to implementing all necessary corrective actions to ensure this does not happen again,' the company said. The CDC recommends that anyone who has the recalled eggs in their home or business throw them out or return them to the store where they were purchased.
Yahoo
an hour ago
- Yahoo
At Least 1.7 Million Eggs Have Been Recalled Across the U.S. — Here Are the States Affected
At least 1.7 million eggs have been recalled in the U.S. over potential salmonella contamination, according to the U.S. Food and Drug Administration (FDA) The recall impacts shoppers in California, Washington, Nevada, Arizona, Wyoming, New Mexico, Nebraska, Indiana and Illinois The FDA said 79 cases have been reported so far, and 21 people have since been hospitalizedThe U.S. Food and Drug Administration (FDA) has issued a recall of at least 1.7 million eggs. According to a news release from the organization, "brown cage-free and brown certified organic eggs" from the August Egg Company had the "potential to be contaminated" with salmonella, which can cause weakened immune systems and sometimes fatal infections in young or elderly people. The affected eggs were distributed to Walmart locations in nine states — California, Washington, Nevada, Arizona, Wyoming, New Mexico, Nebraska, Indiana and Illinois — between Feb. 3 and May 6 and featured sell-by dates ranging from March 4 to June 19, the FDA said. The eggs were also distributed to locations such as Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less and Ralphs in California and Nevada between Feb. 3 and May 15 with sell-by dates ranging from March 4 to June 4, the organization added. The FDA has shared a full list of the over-20 egg products that are being recalled, including Clover, Sunnyside and Raley's eggs. The foot items were sold in fiber or plastic cartons with codes P-6562 or CA5330 printed on one side, the organization said. The Centers for Disease Control and Prevention (CDC) is currently investigating what it's calling the "multi-state outbreak of salmonella infections" connected to the eggs. A total of 79 cases have been reported in seven states, while 21 people have been hospitalized, per the FDA. "We believe it is appropriate out of an abundance of caution to conduct this voluntary recall, as consumers may still have these eggs in their homes," the August Egg Company said in a statement shared with the FDA. 'It is important to know that when our processing plant identified this concern, we immediately began diverting all eggs from the plant to an egg-breaking facility, which pasteurizes the eggs and kills any pathogens." On top of the CDC investigation, the August Egg Company added that its internal food safety team is also "conducting its own stringent review" to identify ways to prevent such outbreaks from happening again. "We are committed to addressing this matter fully and to implementing all necessary corrective actions to ensure this does not happen again," the August Egg Company said. Customers are now being encouraged to return their eggs for a full refund or throw them away. The CDC said consumers should not eat the eggs, should wash surfaces they may have touched and should contact a healthcare provider if they experience symptoms such as diarrhea, high fever and dehydration. Per the FDA, the August Egg Company is currently not selling fresh eggs and has been "diverting eggs to an egg-breaking plant for over 30 days" to kill potential foodborne pathogens. Read the original article on People
Yahoo
an hour ago
- Yahoo
Viatris (VTRS) Faces Securities Fraud Class Action Over FDA Inspection Fallout
On May 31, 2025, Viatris Inc. (NASDAQ:VTRS) became the subject of a securities fraud class action lawsuit filed in the U.S. District Court for the Western District of Pennsylvania. The suit alleges that between August 8, 2024, and February 26, 2025, the company and certain executives made materially false or misleading statements regarding the operational status of its Indore, India manufacturing facility. Ralf Kleemann/ The complaint centers on Viatris' public assurances that its facilities were in "good operating condition" and committed to "the highest quality manufacturing standards." However, following a failed inspection, the U.S. Food and Drug Administration issued a Warning Letter and Import Alert in December 2024 that affected 11 products, including the cancer drug Lenalidomide. On February 27, 2025, Viatris (NASDAQ:VTRS) disclosed that the inspection issues would negatively impact 2025 revenue by roughly $500 million and earnings from operations by about $385 million. This revelation led to a 15% drop in Viatris' stock price, from $11.24 to $9.53 per share. Investors who purchased Viatris securities during the specified period have until June 3, 2025, to seek appointment as lead plaintiff in the lawsuit. While we acknowledge the potential of VTRS as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
