Regulatory Momentum

Galaxy continues to advance toward key regulatory milestones across major global markets.

The Company has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), marking a significant milestone in Galaxy’s regulatory pathway and reflecting years of clinical, technical, and operational execution.

In parallel, CE Mark activities remain on track as Galaxy continues to work toward regulatory clearance in Europe.

These milestones represent important progress in Galaxy’s mission to expand access to next-generation intrasaccular technology for the treatment of intracranial aneurysms.