Femasys gets FDA OK for final FemBloc trial, secures $12M financing, stock surges

Femasys (FEMY) on Monday said that the FDA  approved continuation of the final phase of its FemBloc pivotal trial, sending shares 25% higher in premarket trading. This milestone follows the 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 to issue an aggregate of $12 million principal amount of senior secured convertible notes and accompanying warrants to purchase shares 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, Femasys (FEMY) said.

“This FDA IDE approval represents a critical milestone in advancing FemBloc toward U.S. approval, bringing women a long overdue, non-surgical option for permanent birth control, as women in Europe and other select countries are now beginning to benefit from this important innovation,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc.

“This milestone gives us a clear pathway to potentially achieving U.S. FDA approval and the opportunity to finally make this transformative option available to women in the United States."