Atlanta, United States – March 10, 2026
Femasys Inc. has announced the initiation of patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, a first-of-its-kind non-surgical permanent birth control technology designed to provide a safer and more accessible alternative to traditional surgical sterilization procedures. The milestone follows U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval, allowing the company to advance the study toward potential regulatory submission in the United States. The trial represents a major step in the development of FemBloc®, an innovative reproductive health technology aimed at expanding contraceptive options while reducing the risks, costs, and recovery time associated with surgical procedures.
Pivotal FINALE Trial to Evaluate Safety and Effectiveness
The FINALE (FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control) clinical trial is a prospective, multi-center, open-label pivotal study designed to assess the safety and effectiveness of FemBloc in women seeking permanent birth control. The study follows encouraging results from earlier clinical investigations and is expected to serve as the final clinical step required to support future U.S. regulatory approval.
The pivotal trial will evaluate the device’s ability to prevent pregnancy while maintaining a strong safety profile. The primary endpoint will measure the pregnancy rate after one year of FemBloc use, with researchers analyzing outcomes once 401 women have completed one year following the procedure. An interim analysis is planned after 300 participants reach the one-year milestone, providing early insights into the performance of the technology.
The pivotal trial will evaluate the device’s ability to prevent pregnancy while maintaining a strong safety profile. The primary endpoint will measure the pregnancy rate after one year of FemBloc use, with researchers analyzing outcomes once 401 women have completed one year following the procedure. An interim analysis is planned after 300 participants reach the one-year milestone, providing early insights into the performance of the technology.
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Non-Surgical Birth Control Technology Addresses Unmet Need
Permanent birth control is among the most widely used contraceptive methods worldwide, yet current options typically require surgical procedures involving anesthesia, abdominal incisions, and recovery periods. These procedures can introduce risks such as infection, surgical complications, and increased healthcare costs.
FemBloc® is designed to provide a minimally invasive alternative to these traditional surgical sterilization techniques. The system uses a patented delivery device that places a proprietary biodegradable polymer into the fallopian tubes, where it safely breaks down and triggers the formation of natural scar tissue. This biological response creates a permanent occlusion of the fallopian tubes, preventing fertilization and achieving long-term contraception.
Because the procedure can be performed in a non-surgical, in-office setting, FemBloc has the potential to expand access to permanent contraception while reducing hospital resources and procedural risks. This approach may offer significant benefits for both patients and healthcare providers by simplifying the procedure and improving patient experience.
Globally, millions of women undergo surgical sterilization procedures every year, highlighting the demand for safer and more convenient alternatives. By eliminating the need for surgery, anesthesia, and extensive recovery time, FemBloc could transform how permanent contraception is delivered in modern healthcare systems.
Global Regulatory Progress and Commercialization Strategy
FemBloc has already demonstrated significant regulatory progress internationally. The technology has received full regulatory approval in Europe, the United Kingdom, and New Zealand, where it is currently being introduced as a non-surgical alternative to traditional sterilization procedures. These approvals reflect growing recognition of the technology’s potential to improve women’s reproductive healthcare.
Femasys plans to commercialize FemBloc through strategic partnerships across select international markets, while simultaneously advancing the pivotal trial required for approval in the United States. The company believes the technology could become a cost-effective and scalable contraceptive solution that reduces procedural complexity while improving patient access to long-term birth control.
Beyond FemBloc, Femasys is developing a broader portfolio of innovative fertility and reproductive health technologies, including diagnostic and therapeutic solutions aimed at improving treatment outcomes and accessibility for women worldwide. The company’s mission focuses on delivering modern, office-based medical technologies that simplify complex reproductive healthcare procedures.
With the launch of the FINALE pivotal trial, Femasys has entered a critical stage in the development of FemBloc. If the study confirms the strong safety and effectiveness results seen in earlier trials, the technology could become the first widely available non-surgical permanent birth control option in the United States, addressing a longstanding gap in women’s healthcare innovation.
The advancement of FemBloc therefore represents a major milestone in reproductive medicine and medical device innovation, potentially reshaping how permanent contraception is delivered while expanding safe and accessible options for millions of women worldwide.
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Source: Femasys Inc. press release
