Femasys Inc., a biomedical innovator focused on advancing women’s reproductive health, has achieved a key milestone in its FemBloc FINALE pivotal trial, marking significant progress toward potential U.S. Pre-Market Approval (PMA) for FemBloc, its groundbreaking nonsurgical permanent birth control solution. Designed as a safe, accessible, and office-based alternative to surgical sterilization, FemBloc represents a paradigm shift in permanent contraception. Alongside this clinical advancement, Femasys recently secured $12 million in financing, with potential proceeds of up to $58 million, to support commercialization and market readiness efforts globally.

In this exclusive interview with MedTech Spectrum, Kathy Lee-Sepsick, CEO of Femasys, discusses the clinical and strategic importance of this milestone, the innovation behind FemBloc’s technology, and how the company is expanding its broader portfolio to redefine accessibility and affordability in women’s reproductive healthcare.