Femasys Inc. announced the approval of an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial (the "FINALE" trial). FemBloc is intended to be a safer option for women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable option for permanent birth control.

FemBloc along with FemaSeed(R) localized directional insemination for infertility represent the two lead product candidates of the Company and if approved will provide therapeutic solutions to compliment the Company's existing marketed diagnostic products, FemVue(R) for fallopian tube assessment by ultrasound which can be used in conjunction with FemCath(R), an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv(R), an endocervical sampler for cervical cancer diagnosis that is the first product of the technology platform for tissue sampling. FemaSeed, FemCerv, and FemCath have received product approval in Canada.