Femasys secures FDA approval to advance final FemBloc trial phase

Femasys (FEMY) announced U.S. Food and Drug Administration, FDA, Investigational Device Exemption, IDE, approval to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc. This milestone follows successful completion of Part A of the multi-stage trial design and represents a critical step towards potential U.S. Pre-Market Approval, PMA. Femasys also entered into a definitive agreement with certain institutional and accredited investors, led by existing investor Jorey Chernett, in which it agreed to issue an aggregate of $12 million principal amount of senior secured convertible notes and accompanying warrants to purchase shares of common stock for a possible total of $58 million if all warrants are exercised for cash. The proceeds will be used to refinance existing debt and advance commercialization of Femasys’ fertility and permanent birth control portfolio, underscoring investors continued confidence in the Company’s mission to transform women’s health.