Femasys Inc. has announced groundbreaking results from multiple clinical trials of FemBloc®, their innovative non-surgical permanent birth control solution, demonstrating both superior effectiveness and sustained safety over a five-year period. The findings, published in the Journal of Gynecology & Reproductive Medicine, mark a significant advancement in women's reproductive healthcare.
Breakthrough Efficacy Results
The clinical trials, involving carefully selected participants, achieved a remarkable 0% pregnancy rate among subjects who demonstrated bilateral occlusion at the three-month confirmation test (95% UCB: 0.057; n=0/51). This outcome significantly surpassed the established performance benchmark of 6% based on traditional surgical sterilization methods (one-sided p-value=0.0426).
Revolutionary Non-Surgical Approach
FemBloc represents a paradigm shift in permanent contraception, utilizing a proprietary synthetic tissue adhesive to occlude the fallopian tubes. The procedure's mechanism of action involves the adhesive's complete degradation, which leads to the formation of non-functional scar tissue, effectively preventing pregnancy without the need for surgical intervention.
Comprehensive Safety Profile
Safety data from 229 participants demonstrated remarkable results:
- No serious adverse events reported throughout the study period
- Side effects limited to those typically associated with standard intrauterine transcervical procedures
- Consistent safety profile maintained through five years of follow-up
Patient and Practitioner Experience
The trials revealed overwhelming positive feedback from both patients and healthcare providers. The majority of participants indicated they would "probably or definitely" recommend FemBloc to others, while investigators reported similarly high satisfaction levels with the procedure's implementation and outcomes.
Clinical Implementation and Accessibility
As a non-surgical, in-office procedure, FemBloc offers several advantages over traditional surgical sterilization:
- Reduced procedural risks
- Fewer contraindications
- Significantly lower costs
- Enhanced accessibility through office-based delivery
Ongoing Development
The FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants for U.S. regulatory approval. This study builds upon the successful initial trials and aims to further validate FemBloc's potential as a transformative option in permanent contraception.
"This peer-reviewed publication brings Femasys closer to achieving our goal of providing a safer, more accessible in-office alternative to longstanding surgical sterilization for permanent contraception, without compromising effectiveness," stated Kathy Lee-Sepsick, CEO of Femasys.
