CE Mark for Focal One Robotic HIFU
Focal One Robotic HIFU received CE Mark for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone.
HIFU Revenue Growth
HIFU revenues increased by 15% year-over-year in the fourth quarter, with a total worldwide revenue growth of 5.7% over 2023.
Record Global Sales of Focal One Systems
A record global number of 11 Focal One systems sold in the fourth quarter, including strategic sales in the US and new markets such as Turkey and Portugal.
51% Growth in Focal One Procedures
Focal One procedures grew approximately 51% in 2024 compared to 2023, indicating strong adoption among urologists.
Publication of HIFI Study
The landmark HIFI study published in European Urology demonstrated Focal One's excellent oncologic control and better functional outcomes, potentially driving further adoption.
Positive Reimbursement Developments
CMS finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025.