Femasys Expanded FemBloc Clinical Trial Network
The company has doubled its active study sites to 12 as it seeks U.S. FDA approval for its non-surgical birth control device.
Updated on Oct. 14, 2026 in Women’s Health
Live Poll
Do you trust non-surgical medical procedures as much as traditional surgical options for your healthcare?
Femasys Inc. has increased the number of U.S. clinical sites for its FemBloc FINALE trial to 12. The study aims to support the company’s push for FDA approval of its non-surgical, permanent birth control device.
Why it matters
The expanded trial network helps Femasys reach its goal of gathering data on 401 participants. This study is crucial for demonstrating the efficacy of FemBloc, a device that occludes fallopian tubes using a blended polymer.
The FINALE trial requires 401 women for its primary endpoint, with an interim analysis planned once 300 participants complete one year of use. Participants will undergo a five-year follow-up period following the study.
The players
Femasys Inc.
This company is a biomedical firm headquartered in Atlanta that develops medical devices for women's reproductive health.
Baylor Research Institute
This organization is one of the clinical sites participating in the ongoing FemBloc trial.
Columbia University Medical Center
This medical institution serves as a clinical research site for the evaluation of the FemBloc device.
The details
The prospective, open-label, single-arm study protocol requires the placement of a blended polymer into both fallopian tubes. An initial roll-in cohort of 50 women has already successfully completed the safety assessment.
Timeline
FemBloc received regulatory approvals in Europe, the UK, and New Zealand in 2025.
Femasys secured financing to advance the FINALE trial in August 2026.
The expansion to twelve trial sites was announced on October 14, 2026.
The Big Picture
The trial expansion marks a strategic push to meet the clinical evidence standards required by the U.S. FDA approval process.
FemBloc offers a non-surgical alternative to permanent birth control procedures by using a polymer-based occlusion method. Patients at participating sites will be the first in the U.S. to access this technology under clinical evaluation.
The takeaway
FemBloc provides a new, non-surgical approach to permanent contraception that has already gained international regulatory clearance. Patients interested in non-invasive sterilization methods should monitor the progress of this trial for future domestic availability.
What happens next
The company plans to conduct an interim analysis once 300 women have used the device for one year, which will inform the subsequent filing for FDA approval.
Further reading
Learn more about evolving options in the Women’s Health section.
More information
For detailed trial protocols and device specifications, visit the FemBloc trial and product information.
Source note: This article includes information reported by The Manila times.
Live Poll
Do you trust non-surgical medical procedures as much as traditional surgical options for your healthcare?
