Core Insights - EDAP TMS SA reported strong growth in the adoption of its Focal One robotic HIFU system, achieving a record nine system placements in Q1 2025, the highest in the company's history [2][5] - The company launched the new Focal One i Robotic HIFU System, which includes enhanced features aimed at improving treatment efficiency and expanding its market leadership in focal therapy [2][6] - Positive clinical data from the FARP randomized controlled trial supports the use of HIFU for early-stage prostate cancer, indicating non-inferiority compared to traditional robotic radical prostatectomy [3][6] Business Update - The company achieved a record number of Focal One system placements and received CE Mark designation for the treatment of deep infiltrating endometriosis [5][7] - The FARP trial results were presented at the AUA 2025 meeting, marking a significant milestone in clinical evidence for ultrasound-based focal ablation therapy [6][5] - The Focal One i system features new capabilities, including compatibility with advanced imaging technologies and improved treatment workflows [6][5] Financial Performance - Total HIFU revenue for Q1 2025 was EUR 6.2 million (USD 6.5 million), a 6.8% increase from EUR 5.8 million (USD 6.3 million) in Q1 2024, driven by increased system sales [10] - Total revenue for the non-core business declined to EUR 7.4 million (USD 7.8 million) from EUR 9.1 million (USD 9.9 million) in the previous year, reflecting the company's strategic focus on high-growth opportunities in focal therapy [11] - The company's total worldwide revenue for Q1 2025 was EUR 13.6 million (USD 14.3 million), down 9.1% from EUR 14.9 million (USD 16.1 million) in Q1 2024 [13] Operating Metrics - Gross profit for Q1 2025 was EUR 5.7 million (USD 6.0 million), with a gross profit margin of 42.0%, slightly down from 42.8% in Q1 2024 [14] - Operating expenses increased to EUR 11.7 million (USD 12.3 million) from EUR 11.2 million (USD 12.1 million) in the same period last year, primarily due to investments in the HIFU business [15] - The net loss for Q1 2025 was EUR 7.1 million (USD 7.5 million), compared to a net loss of EUR 4.5 million (USD 4.9 million) in Q1 2024 [16] Cash Position - As of March 31, 2025, the company held cash and cash equivalents of EUR 22.8 million (USD 24.6 million), down from EUR 29.8 million (USD 30.9 million) at the end of 2024 [16]