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Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at Stanford Medicine
- Stanford Medicine, a center with a long tradition of leadership in pioneering gynecological research and innovation, is the second academic center to
About this update from Femasys Inc.
[{"type":"text","content":"- Stanford Medicine, a center with a long tradition of leadership in pioneering gynecological research and innovation, is the second academic center to participate in the FemBloc pivotal trial since enrollment began last quarter - - Faculty of the Stanford Medicine Obstetrics and Gynecology (OB/GYN) Department, Paul Blumenthal, M.D. and Erica Cahill, M.D., participated in Femasys’ earlier FemBloc studies - - FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clearly defined U.S. regulatory pathway - ATLANTA, Dec. 15, 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 therapeutic and diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc® trial at Stanford Medicine (“Stanford”) in Palo Alto, California. 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 trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently 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 United States Food and Drug Administration (FDA)-cleared product, FemaSeed®, for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue®, FemCath® and FemCerv®, all of which 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. “We are thrilled to include Stanford amongst the clinical trial sites participating in this initial phase of the FINALE trial, as we have partnered with Doctors Blumenthal and Cahill in earlier FemBloc studies,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Dr. Blumenthal, a leader in the field of gyne...