Femasys initiates enrollment in trial of its FemBloc

Femasys announced the initiation of enrollment in a prospective multi-center pivotal trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control, to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The robust trial is designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option. “We are very pleased to have quickly initiated the pivotal clinical trial phase for FemBloc, which is an important milestone for Femasys,” stated Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “The FINALE trial, along with data from earlier FemBloc clinical studies that evaluated 228 subjects and demonstrated the safety and tolerability profile of FemBloc, will form the basis, assuming the FINALE trial data are positive, for our PMA submission to the FDA for market approval. Femasys is striving to provide a safe and accessible permanent birth control alternative for women who today must choose between elective surgery and its associated risks or remain on temporary contraception, which can carry the risk of implants or hormones.” Lee-Sepsick continued, “As this landmark pivotal trial progresses, we look forward to providing enrollment updates and preliminary data results. In addition, we continue to advance FemaSeed, our other highly compelling product candidate that could provide women with a first-line treatment option for infertility with trial enrollment due to be completed by year-end.”