Femasys Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemaSeed® for Female Infertility Treatment

Patent and Intellectual Property - The resulting patent for FemaSeed is expected to expire in 2044 at the earliest, providing long-term protection for the product [1] - The company plans to continue prosecuting additional patent applications to enhance its existing portfolio, which includes FemaSeed, FemBloc, and other diagnostic products [1] - The USPTO issued a Notice of Allowance for U.S. Patent Application 18/443,798, strengthening the company's intellectual property position for FemaSeed Intratubal Insemination [3] - The company's global patent portfolio consists of over 180 patents, demonstrating a strong commitment to protecting innovation and commercial opportunities [7] Product Portfolio and Development - FemaSeed is an FDA-cleared infertility treatment designed to deliver sperm directly to the fallopian tube, offering a safe, accessible, and cost-effective alternative to IVF [8] - FemBloc is a late-stage product candidate for permanent birth control, intended to be a non-surgical, in-office option that is safer and less costly than surgical alternatives [4] - The company has developed complementary diagnostic products, including FemVue, FemCath, and FemCerv, which have received regulatory approvals in the U.S., Canada, Europe, and other territories [4] - FemaSeed has received regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024), following its U.S. FDA clearance in September 2023 [8] Clinical Trials and Market Potential - A prospective, multi-center, pivotal clinical trial (NCT0468847) for FemaSeed concluded at the end of 2023, demonstrating its safety and efficacy as a treatment option for couples with male-factor or unexplained infertility [8] - Positive data from the clinical trial showed significantly higher efficacy for FemaSeed compared to historic intrauterine insemination for couples with low male sperm count [8] - The company's products are designed to address significant unmet needs of women worldwide, offering innovative and accessible therapeutic and diagnostic solutions [4] Strategic Vision and Commercialization - The company aims to expand its patent portfolio to protect its suite of products, including FemaSeed, FemBloc, and diagnostic solutions, ensuring better, lower-cost, and more accessible options for women [7] - Femasys has in-house manufacturing capabilities, making its diagnostic products commercial-ready and enabling the company to establish, maintain, and grow sales and revenues [4] - The company's business model focuses on advancing current product candidates, completing clinical trials, and successfully commercializing its products, including FemaSeed [9]