Strong Revenue Growth
Total worldwide revenue for Q3 2024 was EUR 13.1 million, marking an 11.6% increase from EUR 11.7 million in Q3 2023. This was a record for third-quarter revenue performance.
Significant Growth in Focal One HIFU Business
The Focal One HIFU business experienced a 48.2% year-over-year revenue increase, with three system placements all being cash sales.
Positive Clinical Outcomes and Strategic Collaborations
The first AI-assisted Focal One robotic HIFU procedures were conducted in collaboration with Avenda Health, receiving positive feedback.
Increase in U.S. HIFU Procedures
U.S. HIFU procedures grew by 34% year-over-year, indicating strong adoption by urologists.
Favorable Reimbursement Rates
CMS finalized a Medicare hospital payment rate of $9,247 for HIFU procedures, a 5.4% increase over 2024 rates.
Endometriosis Program Progress
85% of patients from the Sham arm of the endometriosis study elected to cross over into the HIFU arm after experiencing a return to high baseline pain levels.