Core Insights - EDAP TMS SA reported strong financial results for Q4 and full-year 2024, highlighting significant growth in its Focal One Robotic HIFU business, particularly in the prostate cancer treatment market [1][5][20]. Business Performance - Full-year 2024 HIFU revenue reached USD 25.7 million, a 15.3% increase from 2023 [5]. - Q4 2024 HIFU revenue was USD 9.3 million, reflecting a 15.0% increase compared to Q4 2023 [5]. - The number of Focal One HIFU procedures in the U.S. grew by 51% year-over-year in 2024 [5]. Clinical Developments - The Focal One system received CE Mark certification for treating deep infiltrating endometriosis [5][6]. - The landmark HIFI study published in European Urology demonstrated positive outcomes for Focal One Robotic HIFU compared to surgery for prostate cancer management [2][7]. - The first patients were treated in a Phase I/II study evaluating Focal One Robotic HIFU for Benign Prostatic Hyperplasia (BPH) [5][10]. Financial Overview - Total worldwide revenue for Q4 2024 was EUR 20.3 million (USD 21.5 million), a 3.6% increase from Q4 2023 [13]. - Gross profit for Q4 2024 was EUR 9.1 million (USD 9.6 million), with a gross profit margin of 44.8% [17]. - The net loss for Q4 2024 was EUR 1.9 million (USD 2.1 million), an improvement from a net loss of EUR 5.0 million (USD 5.5 million) in Q4 2023 [19]. Strategic Focus - The company aims to expand its core Focal One business while reducing investments in non-core products, targeting high-growth opportunities in therapeutic HIFU [3]. - EDAP TMS is positioned to create significant value for patients and shareholders as it advances clinical development programs in various conditions beyond prostate cancer [3]. Upcoming Events - EDAP TMS will have a significant presence at the American Urology Association (AUA) Meeting from April 26-29, 2025, in Las Vegas, Nevada [11].
EDAP Reports Record HIFU Fourth Quarter and Full-Year 2024 Results