Femasys Inc. 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 (FDA) in September 2023 and an approval from Health Canda in April 2023.

FemaSeed is creating accessible innovative options for women, as exemplified with FemaSeed, now an FDA-cleared fertility 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. FemaSeed is an innovative infertility treatment designed to deliver sperm locally and directly to the fallopian tube where creation occurs.

The FemaSeed procedure works synergistically with FemVue, Femasys' FDA-cleared diagnostic device that enables an in-office ultrasound assessment of the fallopian tubes and serves to provide an infertility diagnosis prior to treatment with FemaSeed. FemaSeed has completed enrollment in a pivotal clinical trial specific for male factor infertility. Fema Seed has achieved U.S. FDA clearance and regulatory approval in Canada.

The FemaSeed LOCAL clinical trial is a prospective multi-center, unblinded study (NCT04968847) requiring evaluation of up to 214 women undergoing 214 FemaSeed cycles due the male factor infertility.