EDAP TMS Achieves Record-Breaking Quarter with 39% Revenue Growth in Core HIFU Business
EDAP TMS, a leading medical device company, has reported record-breaking results for its fourth quarter and full year 2025 financial and operating performance. The company's Chief Executive Officer, Ryan Rhodes, highlighted the transformative year the company had, with a 39% revenue growth in its core HIFU business.
The quarter was marked by significant commercial success for Focal One, EDAP TMS's flagship product, with record system placements and strong procedure growth. The company achieved a record 15 Focal One placements worldwide, including 14 cash sales, representing the strongest quarter to date in both placements and cash sales.
The U.S. market played a crucial role in driving this success, delivering 10 cash sales, its highest quarterly total on record. EDAP TMS's customer base continues to expand, with leading academic centers and major community hospitals adopting Focal One technology. The company achieved four new Focal One placements in the state of Pennsylvania during the quarter, further solidifying its presence in this region.
The University of Pennsylvania, a member of the National Comprehensive Cancer Network and a National Cancer Institute-designated comprehensive cancer center, converted their existing HIFU program to Focal One. This marked an important milestone for EDAP TMS, as Focal One has now been adopted by 55% of NCCN member institutions.
The company's penetration in the prestigious Society of Urologic Oncology-approved fellowship program reached 63%, with the addition of two additional Cleveland Clinic hospitals in the U.S. during the fourth quarter, bringing the total number of Focal One systems within the global Cleveland Clinic hospital network to five. EDAP TMS also continues to see existing competitive HIFU programs converting to Focal One technology.
In a notable development, three major focal therapy programs converted from legacy HIFU technology to Focal One during the quarter, including Penn State Health and Lakewood Ranch Medical Center in Florida. Dr. Stephen Scionti, a high-volume focal therapy expert, has transitioned to the Focal One Eye platform at Lakewood Ranch Medical Center.
EDAP TMS's Chief Executive Officer, Ryan Rhodes, emphasized that much of this growth was driven by accelerated adoption in the U.S., where the company delivered record system placements and strong procedure growth. The installed base continues to expand, resulting in increased utilization across hospitals and a positive recurring revenue opportunity created by each Focal One system placement.
The company's financial performance was also highlighted, with a 34% increase in HIFU revenue over the same period last year. EDAP TMS reported record commercial performance for Focal One, driven by capital sales and treatment-driven revenues. The company has outlined its strategic priorities for 2026, which will focus on further expanding its presence in the U.S. market and driving growth through increased utilization of its products.
EDAP TMS's commitment to innovation and customer satisfaction has enabled it to achieve these impressive results, solidifying its position as a leader in the medical device industry. As the company looks to 2026, it is poised for continued success, driven by its strong product portfolio, expanding customer base, and strategic priorities.
