Femasys advances FDA review path for FemBloc

• Femasys received FDA approval for a modular PMA submission approach for its FemBloc permanent birth control technology.
• The approach allows FDA review of key submission components before final clinical data are available.
• FemBloc is already approved for marketing in Europe and select international markets, while Femasys expands its U.S. commercial team.

Femasys (NASDAQ:FEMY) announced that the U.S. FDA approved its modular premarket approval submission approach for FemBloc, the company’s investigational non-surgical permanent birth control technology.

The modular PMA process allows FDA to review key parts of the FemBloc application before final clinical data are available, creating a regulatory pathway toward potential U.S. approval.

Femasys said FemBloc uses a patented delivery system and polymer placed into both fallopian tubes, which is designed to degrade and promote natural scar tissue formation for permanent occlusion without anesthesia, incisions or recovery time.

Femasys continues preparing for potential U.S. commercialization by building a commercial team and expanding distribution of its fertility portfolio from infertility specialists to OB/GYNs.

FemBloc is approved for marketing in Europe and select international markets, while the company continues regulatory activities in the United States.

Femasys said the commercial team supporting its fertility products is expected to also support FemBloc if the technology receives U.S. approval.