Femasys has initiated the enrolment of subjects at Stanford Medicine in Palo Alto, California, US, for FemBloc, a non-implant, non-surgical in-office solution for permanent birth control.
The FemBloc Intratubal Occlusion for Transcervical Permanent Birth Control (FINALE) trial is intended to assess the efficacy and safety of the investigational candidate.
Claimed to be the first-of-its-kind product, FemBloc is designed to provide a safer alternative for women, with a significantly lower estimated cost compared to the traditional surgical option.
This is achieved by eliminating the requirements for anaesthesia, incisions, and permanent implants.
Approved by the US Food and Drug Administration (FDA), the multi-centre study focuses on addressing the significant gap in options for women seeking a permanent birth control solution, as elective surgery is currently the only available choice.
In June 2023, the company received an investigational device exemption (IDE) approval from the FDA to commence the trial of the permanent birth control solution.
The pregnancy rate is the primary endpoint, which will be analysed after 401 women use FemBloc for a year as a method of permanent birth control.
The study is designed as a roll-in and will begin with the enrolment of 50 women for a clinical readout of initial safety data before enrolling the rest of the participants.
Femasys founder, president and CEO Kathy Lee-Sepsick said: “We are thrilled to include Stanford amongst the clinical trial sites participating in this initial phase of the FINALE trial, as we have partnered with Drs Blumenthal and Cahill in earlier FemBloc studies.
“Dr Blumenthal, a leader in the field of gynaecology, has dedicated his career to advancing research and bringing women’s health technologies to those in need around the globe.
“We greatly appreciate his long-standing support of FemBloc and the selection of Dr Cahill as the principal investigator in the FINALE trial, as we continue to work together to progress this much-needed non-surgical permanent birth control option for women.”
The company also offers FemaSeed, approved in the US and Canada, for infertility treatment.
It also provides additional diagnostic products such as FemVue, FemCath, and FemCerv. These products were created in-house and received regulatory approvals in the US, Canada, and other ex-US territories.
