Femasys completes enrollment of FemaSeed pivotal trial

Femasys announced completion of enrollment in the LOCAL FemaSeed pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility. FemaSeed, an intratubal insemination approach that delivers sperm to the fallopian tube where conception occurs is now readying for commercialization. This pivotal trial was ongoing at the time of receiving both a 510K clearance from the Food and Drug Administration in September 2023 and an approval from Health Canada in April 2023. Femasys is creating accessible innovative options for women, as exemplified with FemaSeed, now an FDA-cleared infertility treatment and its lead product candidate FemBloc in late-stage clinical development for permanent birth control. The Company is commercializing complementary diagnostic products that were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.