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Femasys Initiates Enrollment in Pivotal Trial of its Permanent Birth Control Candidate FemBloc
- First of its kind, non-surgical, permanent birth control option begins enrollment in landmark trial - ATLANTA, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Femasys
About this update from Femasys Inc.
[{"type":"text","content":"- First of its kind, non-surgical, permanent birth control option begins enrollment in landmark trial -\nATLANTA, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health, announced the initiation of enrollment in a prospective multi-center pivotal trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the “FINALE” trial), to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc®. The robust 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 options for women that have the potential for long-term impact by replacing decades old technology with our two lead product candidates for permanent birth control (FemBloc®) and infertility (FemaSeed®). The Company is commercializing novel complimentary diagnostic products, internally developed with regulatory approvals in the U.S., Canada and other countries outside the U.S. through in-house manufacturing capabilities. “We are very pleased to have quickly initiated the pivotal clinical trial phase for FemBloc, which is an important milestone for Femasys,” stated Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “The FINALE trial, along with data from earlier FemBloc clinical studies that evaluated 228 subjects and demonstrated the safety and tolerability profile of FemBloc, will form the basis, assuming the FINALE trial data are positive, for our PMA submission to the FDA for market approval. Femasys is striving to provide a safe and accessible permanent birth control alternative for women who today must choose between elective surgery and its associated risks or remain on temporary contraception, which can carry the risk of implants or hormones.” Ms. Lee-Sepsick continued, “As this landmark pivotal trial progresses, we look forward to providing enrollment updates and preliminary data results. In addition, we continue to advance FemaSeed, our other highly compelling product candidate that could provide women with a first-line t...