A leading biomedical innovator in women's health, Femasys Inc., announced two significant advancements: successfully securing U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to proceed with the final phase (Part B) of the FINALE pivotal trial for FemBloc, and a major financing agreement.

The FDA approval to continue enrollment follows the successful completion of Part A of the multi-stage trial and is a critical milestone toward potential U.S. Pre-Market Approval (PMA) for FemBloc, which is described as the only non-surgical, in-office solution for permanent birth control. FemBloc works by placing a proprietary blended polymer into both fallopian tubes, which safely degrades to form natural scar tissue for permanent occlusion, offering a significantly safer, more convenient alternative to surgical sterilization that avoids the need for anesthesia, incisions, and recovery time; the product has already received full regulatory approval in Europe, the UK, and New Zealand.

Alongside this clinical progress, Femasys entered into a definitive agreement for a private placement, led by existing investor Jorey Chernett, to issue $12 million in senior secured convertible notes and accompanying warrants, with the potential to raise a total of $58 million if all warrants are exercised for cash. This capital, which will be used to refinance existing debt and accelerate the commercialization of Femasys’ permanent birth control and fertility portfolio—which also includes the FemaSeed® Intratubal Insemination product—reflects strong investor confidence in the company's mission to redefine women's reproductive care. CEO Kathy Lee-Sepsick stated the FDA milestone offers a clear pathway to bringing this long-overdue option to U.S. women, while lead investor Jorey Chernett highlighted his belief that FemBloc and FemaSeed are transformative innovations that will redefine the standard of care in a multi-billion-dollar market.