Femasys has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the clinical trial of a permanent birth control solution, FemBloc.

The Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for Transcervical Permanent Birth Control (FINALE) pivotal study is expected to begin in the third quarter of this year.

It will assess the safety and efficacy of the non-implant, non-surgical and in-office solution for permanent birth control.

FemBloc aims to provide women with a safer alternative by eliminating the requirement for incisions, anaesthesia and permanent implants.

The pregnancy rate is the primary endpoint of the single-arm, open-label study.

The analysis will be conducted once 401 women have used FemBloc for a duration of one year for permanent birth control.

Furthermore, the FINALE trial is designed as a roll-in beginning with the recruitment of 50 women for a clinical readout primarily of initial safety data before enrolling the rest of the subjects.

Once 300 women have used the solution over the course of a year, an interim analysis of clinical data endpoints will be carried out.

Follow-up will be conducted on an annual basis for a period of five years post-market.

Femasys founder, president and CEO Kathy Lee-Sepsick said: “FemBloc has been designed to be a solution that provides an alternative to surgical tubal ligation (or tying a woman’s tubes), thus reducing the unnecessary risks and substantial cost associated with surgery.

“In addition, FemBloc could provide an option to women using temporary birth control methods long term that may require implants or hormones.”