FEMY

-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices -- ATLANTA, May 08, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update. Corporate Highlights from 1Q 2026 to date Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care. Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office. Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities. Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight. Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control. FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care. “During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clin...

-- Enrollment underway in FDA-authorized FINALE pivotal trial demonstrating execution toward FemBloc® U.S. approval -- ATLANTA, March 31, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the year ended December 31, 2025 and provides a corporate update. Corporate Highlights from 4Q 2025 to date Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, strengthening leadership and strategic oversight. FemBloc permanent birth control system achieved certification under the Medical Device Single Audit Program (MDSAP), supporting global regulatory readiness. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed® intratubal insemination (ITI), supporting future reimbursement pathway. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed and other products within the portfolio in Switzerland. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment in community-based care. Secured FDA 510(k) clearance for the FemVue® Controlled device, supporting commercialization of an innovative solution for evaluating fallopian tube status. Completed $12 million financing, strengthening balance sheet to support ongoing clinical and commercial execution. Initiated European post-market surveillance study for FemBloc, advancing real-world evidence generation and commercialization efforts. “During the fourth quarter of 2025 and into the first quarter of 2026 we achieved significant clinical, regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination product solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are actively expanding FemaSeed commercialization in the U.S. with the introduction of the FemSperm® product family, which enables gynecologists to perform in-office sperm preparation and analysis for use with our first-step infertility treatment. Concurrently, we are advancing FemBloc with the in...

– FDA Approval to Advance Final FemBloc® Trial with Clear Pathway to Potentially Achieve U.S. FDA Approval – – $12 Million Financing Strengthens Balance Sheet and Extends Cash Runway – ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the third quarter of 2025. Corporate Highlights from 3Q 2025 Announced second partner order for FemBloc in Europe Announced FDA IDE approval to continue enrollment in final phase of the FINALE pivotal trial for FemBloc Announced a definitive agreement for the issuance of $12 million in secured convertible notes and accompanying warrants for total potential funding of $58 million, if all warrants are exercised for cash Announced the initiation of post-market surveillance study for FemBloc in Europe Announced partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc in France and the Benelux region (the Netherlands, Belgium and Luxembourg) Announced partnership with Medical Electronic Systems LLC to provide FemSperm™ Analysis Kit for use with FemaSeed® Announced FemSperm Setup and Preparation Kits, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination Announced New Zealand regulatory approval of FemBloc Announced underwritten public offering with gross proceeds of $8 million Announced United Kingdom regulatory approval of FemBloc “Our third quarter marked several pivotal milestones for Femasys as we advanced on multiple fronts, securing key regulatory approvals, strengthening our balance sheet through new financing, and expanding global partnerships for FemBloc, all reinforcing our commitment to delivering innovative solutions for women’s health,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “Regulatory approvals of the complete FemBloc System in the U.K. and New Zealand significantly expand access to this revolutionary, non-surgical permanent birth control option across Europe and the Asia-Pacific region. With initial commercial orders received from our distribution partners in Spain and France, we are building early momentum as we pursue additional country approvals. At the same time, we continue to advance toward U.S...

Explore Femasys's Fair Values from the Community and select yours Revenue: US$409.3k (up 85% from 2Q 2024). Net loss: US$4.59m (loss narrowed by 2.1% from 2Q 2024). US$0.16 loss per share (improved from US$0.21 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 65%. Earnings per share (EPS) exceeded analyst estimates by 1.5%. Looking ahead, revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Performance of the American Medical Equipment industry. The company's shares are up 10% from a week ago. Don't forget that there may still be risks. For instance, we've identified 5 warning signs for Femasys (2 can't be ignored) you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025. Corporate Highlights from 2Q 2025 to date Announced European Union Medical Device Regulation approval of FemBloc®, the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution Secured first European order for FemBloc from Spain distribution partners for approximately $400,000 Announced Australian and New Zealand regulatory approvals for FemaSeed® and FemVue®, a cost-effective first step in fertility Announced new Chief Commercial Officer to help drive execution and global growth Announced partnership with Carolinas Fertility Institute, one of America’s best fertility clinics, to offer FemaSeed in its eight locations Announced pricing of underwritten public offering and concurrent private placement with gross proceeds of $4.5 million “Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval. “Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this moment...

-- Company delivers on mission to transform women’s health with innovative solutions, including FemaSeed® for first-line infertility treatment and FemBloc® non-surgical permanent birth control (full system approval pending in Europe) -- ATLANTA, May 08, 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 financial results for the quarter ended March 31, 2025 and provides a corporate update. Corporate Highlights from 1Q 2025 to date Announced FemBloc permanent birth control delivery system approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced United Kingdom and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced partnership with CNY Fertility, a national conglomerate of eleven fertility centers, to offer FemaSeed Announced distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed “Securing the first regulatory approval globally for the FemBloc delivery system marks a key milestone toward full system approval and the introduction of a first-of-its-kind, non-surgical permanent birth control option for women in Europe,” said Femasys’ CEO Kathy Lee-Sepsick. “Additionally in the first quarter of 2025, we began executing our commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., an encouraging early indicator of strong market momentum and the unmet need for additional fertility treatment options. We remain dedicated to closing critical gaps in women’s reproductive health through the advancement of safe, effective, accessible and innovative solutions.” Financial Results for Quarter Ended March 31, 2025 Sales increased by $70,124, or 25.9%, to $341,264 for the three months of 2025, from $271,140 for the three months of 2024 du...

-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain -- ATLANTA, March 27, 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 financial results for the year ended December 31, 2024 and provides a corporate update. Corporate Highlights from 4Q 2024 to date Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed® Announced strategic distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial “During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products,” said Femasys’ CEO Kathy Lee-Sepsick. “We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations...