Femasys, a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to continue enrollment in the final phase (Part B) of the FINALE pivotal trial for FemBloc. This milestone follows the successful completion of Part A of the multi-stage trial design and represents a critical step towards potential U.S. Pre-Market Approval (PMA). Femasys also entered into a definitive agreement with certain institutional and accredited investors (the “Investors”), led by existing investor Jorey Chernett, in which it agreed to issue an aggregate of $12 million principal amount of senior secured convertible notes and accompanying warrants (Warrants) to purchase shares of common stock for a possible total of $58 million if all warrants are exercised for cash. The proceeds will be used to refinance existing debt and advance commercialisation of Femasys’ fertility and permanent birth control portfolio, underscoring investors' continued confidence in the Company’s mission to transform women’s health.

“This FDA IDE approval represents a critical milestone in advancing FemBloc toward U.S. approval, bringing women a long overdue, non-surgical option for permanent birth control, as women in Europe and other select countries are now beginning to benefit from this important innovation,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This milestone gives us a clear pathway to potentially achieving U.S. FDA approval and the opportunity to finally make this transformative option available to women in the United States. Coupled with the continued support of our investors, this financing strengthens our capital position and provides stability to accelerate growth and create lasting value as we transform women’s health. Our investors recognize the significant opportunity to profoundly impact women’s reproductive care by potentially introducing FemBloc as a safe and effective alternative to surgical sterilization, the only permanent contraceptive option currently available in the U.S. We believe our breakthrough innovations in birth control and fertility have the potential to redefine care for millions of women worldwide and establish Femasys as a leader in women’s health innovation.”