Femasys Gets FDA IDE Nod for FemBloc Birth Control Trial

Femasys has gained U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) for the FINALE clinical trial of FemBloc, a non-surgical, non-implant, in-office solution for permanent birth control.
 
FemBloc removes the need for anesthesia, incisions, and permanent implants. It could present women a convenient, reliable option for permanent birth control.
 
Fembloc along with FemaSeed localized directional insemination for infertility are Femasys’ two lead product candidates, and if the therapeutic solutions are approved, they will complement the company’s existing diagnostic products. FemVue is used for fallopian tube assessment by ultrasound, used in conjunction with the FemCath intrauterine catheter to evaluate the fallopian tubes and FemCerv endocervical sampler for cervical cancer diagnosis.
 
“We are excited to be one step closer to making FemBloc, an extremely important and novel non-surgical, permanent birth control approach a reality for women seeking a better option,” Kathy Lee-Sepsick, founder, president, and CEO of Femasys told the press. “On this one-year anniversary of the overturn of Roe v. Wade, the need for more accessible birth control options for women has never been more important. 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. FemBloc is one of several candidates in Femasys’ portfolio of products that showcases our dedication to developing safer and more accessible reproductive health options for women.”
 
Femasys intends to begin the FINALE (FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control) pivotal trial in Q3 2023. The study design includes pregnancy rate as the primary endpoint, which will be assessed after 401 women use FemBloc for a year as permanent birth control.
 
Further, the study is designed as a “roll-in,” starting with enrollment of 50 women for clinical readout of mainly preliminary safety data before enrolling the rest of the subjects. Interim analysis of data endpoints in planned once 300 women have used FemBlock for permanent birth control for a year. Follow-up will continue every year for five years post-market.

Check out an episode of editor-in-chief Sean Fenske’s “Medtech Matters” podcast with Femasys founder and CEO Kathy Lee-Sepsick here!