Femasys Announces FDA Approval of Modular PMA Submission Approach for FemBloc®

ATLANTA, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announced today that the U.S. Food and Drug Administration has approved the Company’s modular premarket approval application (PMA) pathway for FemBloc, its investigational non-surgical permanent birth control technology in the United States. FemBloc is approved for marketing in Europe and other select international markets.

“FDA approval of the modular PMA pathway provides a clear and efficient framework for advancing FemBloc toward U.S. approval, allowing key components of the submission to be reviewed by FDA in advance of the final clinical data,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “This approach enables us to make meaningful regulatory progress as the clinical program advances. In parallel, we are building a U.S. commercial team as we broaden commercialization of our fertility portfolio beyond infertility specialists to OB/GYNs, helping bring fertility care earlier in the patient journey. This same team is intended to ultimately support FemBloc, creating an efficient commercial foundation for expanding access to transformative reproductive health technologies through the OB/GYN setting.”