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 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 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 Insights - Femasys Inc. has received MHRA approval for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy [1][2] - The approval follows the CE mark received earlier and positions Femasys to secure strategic partnerships for commercialization in the UK [2] - FemBloc is a non-surgical solution for permanent birth control, utilizing a patented delivery system to create natural scar tissue for occlusion, thus avoiding the risks associated with surgical sterilization [3][5] Company Overview - Femasys is focused on making fertility and non-surgical permanent birth control more accessible and cost-effective through a patent-protected portfolio of products [4] - The company is actively commercializing its innovations in the U.S. and key international markets, with a fertility portfolio that includes FemaSeed and FemVue [4] - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, with plans for commercialization through strategic partnerships in select European countries [5] Market Context - The UK is one of the largest healthcare markets in Europe, emphasizing women's health solutions, which provides a favorable environment for innovative technologies like FemBloc [2] - The single-payer NHS system in the UK facilitates the adoption of technologies that improve access and reduce costs [2] - FemBloc's approval validates its safety and effectiveness, allowing Femasys to cater to a diverse patient population in this critical market [2]