Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate

• The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys’ earlier FemBloc studies -
  
• FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway -
  

ATLANTA, Sept. 27, 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 a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The FDA approved multi-center pivotal 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.

Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc in late-stage clinical development for permanent birth control and its now-United States Food and Drug Administration (FDA)-cleared product, FemaSeed for infertility treatment. The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.

“After just announcing the start of the FINALE trial in August, we are delighted to announce the first academic site is activated to enroll in FemBloc’s FINALE pivotal trial, led by a thought leader in the field of gynecology,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We appreciate the long-standing support for the FemBloc technology evidenced by the prominent investigators who are electing to participate in the FINALE trial, as we work to bring this much needed option to women."

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 trial 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.