-- Femasys leverages Kebomed’s pan-European distribution strength to drive adoption of FemBloc permanent birth control in France and Benelux, unlocking significant market access --ATLANTA, Sept. 25, 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 today a partnership with Kebomed, a leading European distributor of medical devices and equipment, to com ...

Addition strengthens FemSperm family of products and enables gynecologists to offer complete in-office sperm handling for FemaSeed Intratubal InseminationATLANTA, Sept. 22, 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 today a partnership with Medical Electronic Systems LLC (MES) to provide advanced sperm analysis technology. The FemSperm Analysis ...

Core Insights - Femasys Inc. has launched the FemSperm Insemination Prep Kit, enhancing the sperm preparation process for FemaSeed Intratubal Insemination, aimed at increasing revenue growth through gynecologist activation [1][2][3] - The introduction of this kit is a significant step in Femasys' strategy to penetrate the underserved fertility market, providing a streamlined in-office solution for gynecologists [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’s fertility portfolio includes FemaSeed, which is positioned as a first-step infertility treatment, and FemVue, a diagnostic tool for fallopian tube assessment [4] Product Details - The FemSperm Insemination Prep Kit allows gynecologists to perform sperm preparation and offer FemaSeed Intratubal Insemination directly in their practices, addressing the needs of an estimated 10 million U.S. women facing infertility [3] - FemaSeed has demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count, making it a safer and cost-effective alternative to IVF [3][4] Market Strategy - The commercialization of FemBloc, a non-surgical permanent birth control method, has received regulatory approvals in Europe, the UK, and New Zealand, with plans for strategic partnerships to enhance market presence [5] - Femasys aims to broaden patient access to fertility treatments and strengthen its long-term revenue growth strategy by positioning FemaSeed as a first-step treatment before IVF [2][3]

Core Insights - Femasys Inc. has received approval from New Zealand's MEDSAFE for its FemBloc Permanent Birth Control, marking a significant step in the company's global expansion strategy [1][2] - The approval follows recent CE Mark and UK approvals, indicating growing regulatory confidence in Femasys' technology [2] - FemBloc is a non-surgical solution for permanent birth control, utilizing a patented delivery system that creates natural scar tissue for permanent occlusion, offering a safer and more cost-effective alternative to surgical sterilization [3][5] 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 fertility portfolio includes FemaSeed Intratubal Insemination and FemVue, a companion diagnostic for fallopian tube assessment, with FemaSeed showing over twice the effectiveness of traditional IUI [4] Market Context - New Zealand is identified as a strategically important healthcare market in the Asia-Pacific region, emphasizing women's health and equitable access to innovative treatments [2] - The approval of FemBloc not only validates its safety and effectiveness but also positions Femasys to provide women in New Zealand with access to a groundbreaking non-surgical permanent birth control option [2]

Core Insights - Femasys Inc. has successfully closed $8 million in financing to enhance its commercialization efforts and address unmet needs in women's reproductive health [1][2] - The company focuses on making fertility treatments and non-surgical permanent birth control more accessible and cost-effective for women globally [3] Company Overview - Femasys is a biomedical innovator with a patent-protected portfolio of therapeutic and diagnostic products aimed at women's health [3] - The company's lead products include FemaSeed, an intratubal insemination treatment, and FemBloc, a non-surgical permanent birth control option [3][4] Recent Milestones - Regulatory approvals for FemBloc were obtained in Europe on June 25, 2025, and in the United Kingdom on August 20, 2025 [6] - FemaSeed received regulatory approval in Australia and New Zealand on July 1, 2025 [6] - The company made its first commercial entry into Europe with a $400,000 order for FemBloc in Spain on August 6, 2025 [6] - A partnership was established with Carolinas Fertility Institute to offer FemaSeed across eight locations [6] Leadership Commentary - CEO Kathy Lee-Sepsick emphasized the importance of the new financing in executing the company's strategy and achieving revenue growth [2] - Jorey Chernett, a major shareholder, highlighted the critical need addressed by FemBloc and expressed confidence in Femasys' mission and products [2]

Group 1 - The core point of the article is that Femasys (FEMY.US) experienced a significant stock price drop of 37%, reaching a new low for the year at $0.32 [1] - The company announced a public offering to raise $8 million, which will be used to support its business expansion and product development plans [1]

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 Inc. has launched the FemSperm Setup Kit, the first product in a new line aimed at enabling gynecologists to offer FemaSeed Intratubal Insemination, thereby expanding access to fertility treatments and driving revenue growth [1][2] - The FemSperm Setup Kit includes a pre-configured centrifuge for optimal sperm preparation, facilitating a streamlined in-office solution for gynecologists [1][2] - FemaSeed is positioned as a first-step fertility treatment that enhances natural fertilization by delivering sperm directly to the fallopian tube, showing more than double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [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 [3] - The company is actively commercializing its lead product innovations, including FemaSeed and FemVue, in the U.S. and key international markets [3] - Femasys' FemBloc product, a non-surgical permanent birth control solution, received regulatory approval in Europe and the UK in mid-2025, with commercialization planned through strategic partnerships [4]

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]

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]