Femasys Begins Enrollment of 401 Women in FDA-Approved FemBloc Pivotal Trial
Femasys began enrolling participants in its FDA-approved FINALE trial, targeting 401 women to evaluate one-year pregnancy rates for FemBloc non-surgical permanent birth control. The device has secured approvals in Europe, the UK and New Zealand and uses a biodegradable polymer to occlude fallopian tubes.
1. Pivotal Trial Enrollment
Femasys has commenced patient enrollment in the FINALE pivotal clinical trial under an FDA Investigational Device Exemption. The single-arm study will assess pregnancy rates in up to 401 women over a one-year period, following a completed 50-patient safety roll-in phase.
2. FemBloc Technology and Mechanism
FemBloc is a first-of-its-kind non-surgical permanent birth control that delivers a proprietary biodegradable polymer into both fallopian tubes. The material degrades to form natural scar tissue, achieving permanent occlusion without surgery or anesthesia.
3. Regulatory Approvals and Commercialization
FemBloc obtained full regulatory approvals in Europe (June 2025), the UK (August 2025) and New Zealand (September 2025) and is being commercialized through strategic partnerships. These milestones validate its safety profile and support global adoption ahead of U.S. entry.
4. Next Steps and Timelines
The FINALE trial will include an interim analysis after 300 participants complete one year of use, with full data expected upon completing 401 patients. Results will underpin a future U.S. regulatory submission and potential market launch.