Femasys (NASDAQ:FEMY) initiated enrollment in a prospective multi-center pivotal trial to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc.
The 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.
“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 [pivotal] FINALE trial data are positive, for our PMA submission to the FDA for market approval,” Kathy Lee-Sepsick, founder, president and CEO of Femasys, said in a statement.
She said the company also continues to advance FemaSeed, its 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.
