ATLANTA, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY) (“Femasys” or the “Company”), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, today announced that on January 13, 2026, it received notification from The Nasdaq Stock Market LLC ("Nasdaq") that Nasdaq approved the Company's request for an additional 180-calendar day extension to regain compliance with the minimum closing bid price requirement ...

Core Insights - Femasys Inc. has announced a partnership with Refuah Health Center to enhance the adoption of FemaSeed, a fertility treatment, within community-based healthcare settings [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company’s lead product, FemaSeed, is a next-generation artificial insemination solution that has shown over double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [3][4] Product Details - FemaSeed is designed to deliver sperm directly to the fallopian tube, providing a safe, accessible, and cost-effective first-line treatment option before in vitro fertilization (IVF) [3] - The product is authorized for use in multiple regions, including the U.S., Europe, UK, Canada, and Israel [3] Partnership Impact - The collaboration with Refuah Health Center aims to expand patient access to FemaSeed, thereby increasing its utilization as a first-line approach in infertility treatment [1][2] - Refuah Health Center, a Federally Qualified Community Health Center, emphasizes providing evidence-based options to streamline the fertility journey for patients [7]

Core Insights - Femasys Inc. has achieved significant regulatory milestones, including FDA IDE approval for the final pivotal trial of FemBloc, which positions the company for potential U.S. FDA approval [3][5][19] - The company secured $12 million in financing, enhancing its balance sheet and extending its cash runway, with total potential funding of $58 million if all warrants are exercised [5][7] - Sales for the third quarter of 2025 increased by 31.4% to $729,394, driven primarily by FemBloc sales, while R&D expenses decreased significantly [6][12] Regulatory Approvals - Femasys received regulatory approvals for the complete FemBloc System in the U.K. and New Zealand, expanding access to this non-surgical permanent birth control option [3][5][19] - Initial commercial orders have been received from distribution partners in Spain and France, indicating early momentum in the European market [3][5] Financial Performance - For the third quarter of 2025, sales increased by $174,486 to $729,394 compared to the same period in 2024, primarily due to FemBloc [6] - R&D expenses decreased by 40.0% to $1,382,022, reflecting a shift towards commercialization and reduced costs [6] - The net loss for the third quarter was $4,194,821, or ($0.10) per share, an improvement from a net loss of $5,408,860, or ($0.24) per share, in the prior year [6] Cash Position - As of September 30, 2025, Femasys had approximately $4.6 million in cash and cash equivalents, with an accumulated deficit of approximately $141.9 million [7] - The company expects its current cash position, bolstered by recent financing, to fund operations into September 2026 [7] Strategic Partnerships - Femasys announced a partnership with Kebomed to commercialize FemBloc in France and the Benelux region, enhancing its distribution capabilities [5] - A partnership with Medical Electronic Systems LLC was established to provide the FemSperm™ Analysis Kit, further expanding the company's product offerings [5]

Core Insights - Femasys Inc. has announced a significant initial order valued at approximately $500,000 for the commercial launch of FemBloc in France and the Benelux region, marking continued expansion in key European markets [1][2] - FemBloc is a non-surgical permanent contraceptive solution that addresses a significant unmet need in women's reproductive health, utilizing a patented delivery system to occlude fallopian tubes without the risks associated with surgical procedures [2][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a broad patent-protected portfolio of products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including FemSeed and FemVue, which have shown high effectiveness and patient satisfaction [3] Product Details - FemBloc is the first and only non-surgical, in-office alternative to surgical sterilization, receiving full regulatory approval in Europe, the UK, and New Zealand in 2025 [4] - The product is designed to be cost-effective, convenient, and significantly safer than traditional surgical options, with no anesthesia, incisions, or recovery time required [2][4] Strategic Partnerships - Femasys has partnered with Kebomed, a leading distributor in Europe, to facilitate the introduction of FemBloc in France and the Benelux region, reflecting a strategic approach to market access and women's healthcare advancement [2][6] - Kebomed has a strong presence across Europe and has been focused on women's health, enhancing its portfolio through partnerships with innovators in minimally invasive gynecology [6][7]

Core Insights - Femasys Inc. has received FDA Investigational Device Exemption (IDE) approval to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc, a non-surgical permanent birth control solution, marking a significant step towards potential U.S. Pre-Market Approval (PMA) [1][2] - The company has secured $12 million in senior secured convertible notes, with total potential proceeds of $58 million if all warrants are exercised, indicating strong investor confidence in Femasys' mission to enhance women's health [1][2] Company Developments - The successful completion of Part A of the FINALE trial allows Femasys to advance to Part B, which is crucial for obtaining U.S. FDA approval for FemBloc [1][2] - The financing from institutional and accredited investors will be utilized to refinance existing debt and support the commercialization of Femasys' fertility and permanent birth control portfolio [1][2] Product Information - FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control that uses a patented delivery system to create natural scar tissue in the fallopian tubes, providing a safer and more convenient alternative to surgical sterilization [2][8] - The product has already received regulatory approval in Europe, the UK, and New Zealand, with commercialization efforts underway in select European countries [8] Financial Details - The convertible notes bear an interest rate of 8.5% per annum and have a 10-year maturity, convertible into approximately 16.38 million shares of common stock at a conversion price of $0.73 per share, which is a 15% premium to the stock's closing price prior to the agreement [3][4] - The accompanying warrants include multiple classes with exercise prices ranging from $0.81 to $1.10 per share, potentially generating additional proceeds of up to $46 million if exercised for cash [3][4] Market Position - Femasys aims to redefine women's reproductive care with FemBloc, addressing a significant unmet need in the market for permanent birth control options, which currently only includes surgical sterilization in the U.S. [2][8] - The company is positioned to create long-term value for shareholders in a multi-billion-dollar market by introducing innovative solutions in women's health [2][8]

Core Insights - Femasys Inc. has initiated a post-market surveillance clinical study for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy under the EU Medical Device Regulation [1][2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including the FemBloc and FemaSeed [4] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes without the need for anesthesia or incisions, thus avoiding surgical risks [3][5] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and is positioned to meet the strong demand for safe and accessible permanent birth control options among women [5] Clinical Study and Compliance - The post-market surveillance study aims to monitor the safety and performance of FemBloc in real-world settings, complying with the rigorous requirements of the EU MDR [2][3] - The study has received approval from multiple Ethics Committees and adheres to ISO 14155:2020 for Good Clinical Practice [2] Market Potential - FemBloc addresses a significant unmet need in women's reproductive health, with no comparable alternatives currently available, indicating a broad global market potential [3][5] - The company aims to build a foundation for broader physician adoption and reimbursement through the generation of real-world data from the clinical study [3]

Core Insights - Femasys Inc. will showcase its innovative fertility solutions at the ASRM 2025 Scientific Congress & Expo in San Antonio, Texas from October 25-29 [1][4] - The company is highlighting its next-generation artificial insemination solution, FemaSeed, which has demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count [2][5] - Femasys has expanded its FemaSeed portfolio to include various kits that enable gynecologists to perform sperm preparation and offer FemaSeed directly in their practices [3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally [5] - The company has a patent-protected portfolio of therapeutic and diagnostic products, including FemaSeed and FemVue, aimed at improving reproductive health [5] - Femasys has received regulatory approvals for its products in multiple regions, including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand [2][6] Product Highlights - FemaSeed is positioned as a safe, accessible, and cost-effective alternative to IUI, particularly for patients with low male sperm count [2] - The FemBloc product, a non-surgical permanent birth control solution, received full regulatory approval in Europe, the UK, and New Zealand in 2025 [6] - The FemChec diagnostic product provides an ultrasound-based test to confirm procedural success for FemBloc [6]

Core Insights - Femasys Inc. has partnered with Kebomed to commercialize FemBloc Permanent Birth Control in France and the Benelux region, significantly enhancing market access for this innovative product [1][2] - The collaboration is a key part of Femasys' European growth strategy following the recent CE mark approval for FemBloc, which is the only non-surgical permanent birth control option available [1][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of products [3] - The company's lead product innovations include FemBloc and FemaSeed, with clinical data showing FemaSeed is over twice as effective as traditional IUI [3] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes, offering a safer and more cost-effective alternative to surgical sterilization [2][4] - The product has received full regulatory approval in Europe, the UK, and New Zealand, with ongoing efforts for U.S. FDA approval through the FINALE pivotal trial [4] Strategic Partnership - Kebomed, a leading independent distributor of medical devices in Europe, will leverage its established infrastructure and expertise in women's health to drive the adoption of FemBloc [2][6] - The partnership aims to unlock significant growth potential in key European markets, particularly in France, which represents the largest market opportunity for FemBloc [2][6]

Core Viewpoint - Femasys Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $8.0 million to support its commercial expansion and product development efforts [2][4]. Group 1: Offering Details - The public offering consists of 10,434,586 shares of common stock and pre-funded warrants to purchase up to 11,750,000 shares, with a combined offering price of $0.36 per share and accompanying common warrant [1][2]. - The offering is expected to close on or about August 27, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - Femasys plans to utilize the net proceeds from the offering for the expansion of commercial efforts, product development, general corporate purposes, capital expenditures, and working capital [2]. Group 3: Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [6]. - The company’s fertility portfolio includes FemaSeed, which is over twice as effective as traditional IUI, and FemVue, a diagnostic tool for fallopian tube assessment [6]. - FemBloc, a non-surgical permanent birth control method, received regulatory approval in Europe and the UK in 2025, with commercialization planned through strategic partnerships [7].

Core Insights - Femasys reported strong revenue growth of 84.8% year-over-year, reaching $0.41 million in Q2 2025, driven by sales of FemaSeed and FemVue products [1][5] - The company achieved a GAAP net loss of $4.59 million, a slight improvement from the previous year's loss of $4.68 million [1][8] - Femasys has a cash balance of $3.22 million as of June 30, 2025, indicating a need for additional funding to sustain operations [1][10] Financial Performance - Revenue (GAAP) for Q2 2025 was $0.41 million, significantly above analyst estimates of $1.02 million [2] - Diluted earnings per share (GAAP) improved to $(0.16), better than the previous year's $(0.21) [2] - Research and Development expenses decreased by 28.6% to $1.41 million compared to $1.98 million in Q2 2024 [2][8] Product and Market Development - Femasys focuses on non-surgical products for women's reproductive health, including the FemBloc system for permanent birth control and fertility solutions like FemaSeed and FemVue [3][4] - The company made significant regulatory progress, receiving its first European approval for FemBloc and gaining approvals for FemaSeed and FemVue in Australia and New Zealand [6][7] - A notable order from Spain indicates a pivotal step in Femasys's international expansion efforts [5] Strategic Partnerships and Intellectual Property - Femasys formed a partnership with the Carolinas Fertility Institute to expand the reach of FemaSeed [7] - The company is actively working on protecting its intellectual property, with new patents expected to be granted in Europe and the U.S. for FemBloc and FemaSeed [7] Future Outlook - Management did not provide specific revenue or earnings targets for the upcoming quarters but emphasized the importance of translating recent approvals into commercial adoption [9] - The company expects its current cash position to fund operations into early Q4 2025, highlighting the need for monitoring its international expansion and product pipeline [10]