ATLANTA—Femasys, a biomedical company specializing in women’s reproductive health, has secured an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), allowing it to begin conducting a clinical trial for its new FemBlock permanent birth control product.
According to FemTechInsider.com, FemBloc is designed to provide a safer, more accessible option for permanent birth control, without the need for anesthesia, incisions or permanent implants. The solution features Femasys’ proprietary delivery platform, which places balloon technology close to the opening of both fallopian tubes. This in-office approach is designed to eliminate the risks of incisions, anesthesia and hormones. As a nonsurgical procedure that is implant free, FemBloc delivers a biopolymer that would expel within three months. To watch a YouTube video explaining how FemBlock works, click here.
FemBloc and FemaSeed, a localized directional insemination solution for infertility, are the company’s two lead product candidates. Once approved, the two unique solutions will supplement Femasys’ existing diagnostic products.
“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,” said Kathy Lee-Sepsick, founder, president and CEO of Femasys. “FemBloc has been designed to be a solution that provides an alternative to surgical tubal ligation, reducing unnecessary risks and substantial cost associated with surgery. In addition, FemBloc could provide an option for women who have been using temporary birth control methods long term that may require implants or hormones."
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