Femasys Announces First-Patient-In for Pivotal Clinical Trial Evaluating its FemBloc Permanent Birth Control

ATLANTA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including two lead revolutionary late-clinical stage product candidates and FDA-cleared, innovative diagnostic products, today announced the achievement of First-Patient-In for its pivotal clinical trial evaluating FemBloc, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control for women. The landmark pivotal clinical trial (the “FINALE” trial) is currently enrolling patients and additional clinical sites are planned to support the further expansion of the trial.

“We are very encouraged to have the first-patient-in for the FINALE pivotal trial of FemBloc. Accessible birth control options are critical for women, and FemBloc could provide a first-of-its-kind option to those considering surgical tubal sterilization or women using temporary or long-term birth control methods that often require exposure to implants or hormones,” stated Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “In addition to creating accessible options for women for permanent birth control, we continue to advance our other lead product candidate, FemaSeed, that also has the potential for long-term impact by replacing decades old technology for infertility.”

About the FINALE Pivotal Clinical Trial

Femasys ‘FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] trial (NCT05977751) is designed as a prospective, multi-center, open-label, single-arm study to evaluate the safety and efficacy of FemBloc, a novel, non-surgical female permanent birth control approach. The primary endpoint is pregnancy rate, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. The study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for one year. Follow-up will continue annually for five years post-market. For more information, visit www.FemBloc.com.