FemBloc Permanent Contraceptive System
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Fallopian Tube
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Intended Duration:
- Permanent
- Development Stage: Phase III
- Developer(s)/researcher(s): Femasys Inc
Details
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Mechanism of Action:
- Tubal Occlusion
- Inactive Materials: Biopolymer
- Regimen: Single Placement
- MPT: Not Potential MPT
- Promising Attributes: Intended to provide permanent contraception without surgery
Product Status
Active Clinical Research
History
2017: Femasys initiates pilot trial for female permanent contraception system, NCT03067272
2018: Femasys initiates pivotal Phase 1 trial for product now named FemBloc, NCT03433911
2020: Femasys initiates confirmation feasibility trial, NCT04273594
2023: Femasys initiates Phase 3 multi-center trial FINALE, NCT05977751
2024: Femasys receives US Patent for FemBloc technology and processes
2025: FemBloc received CE mark certification for FemBloc's blended polymer. The CE mark functions as the first regulatory approval for the contraceptive system and allows for product marketing across the European Economic Area. Femasys announces intent to distribute FemBloc beginning in Spain.
2025: US FDA grants IDE approval for FemBloc, which allows for patient enrollment in the final stage of the FINALE trial