Femasys Initiates Patient Enrollment in FINALE Clinical Trial
Femasys announced the initiation of patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc. This milestone follows U.S. Food and Drug Administration, FDA, Investigational Device Exemption, IDE, approval to advance the study based on positive clinical data generated in its earlier phase. FemBloc has already received regulatory approvals and is being commercialized in Europe and other select countries outside the United States as a non-surgical alternative to the surgical procedures currently used for permanent birth control. Completion of the FINALE study is expected to support a future U.S. regulatory submission.