EDAP TMS shares surge on record 2025 HIFU revenue growth
French medical device company posts 36-38% annual revenue increase, guides to 34-45% growth in 2026
EDAP TMS SA reported record fourth-quarter and full-year 2025 revenue on Wednesday, driven by accelerating adoption of its FocalOne robotic ultrasound platform for prostate cancer treatment, as the French medical device company projected continued strong growth through 2026.
The company's worldwide high-intensity focused ultrasound (HIFU) revenue reached between $12.9 million and $13.3 million in the fourth quarter of 2025, marking the highest quarterly performance in its history, according to preliminary results released before market open. Full-year HIFU revenue for 2025 totaled between $36.7 million and $37.2 million, representing annual growth of 36% to 38% year-over-year.
The strong performance reflects what management described as accelerating momentum in the urological device market, particularly for minimally invasive prostate cancer treatments. During the fourth quarter, EDAP achieved a record 15 FocalOne system placements, representing a 69% increase in system placements compared with the prior year. In the United States specifically, FocalOne HIFU procedures grew approximately 28% year-over-year during the quarter, driven by growing clinical adoption and favorable reimbursement.
Looking ahead, EDAP issued initial full-year 2026 revenue guidance, projecting core HIFU business revenue of $50.0 million to $54.0 million, representing growth of 34% to 45% compared with 2025 levels. The company also expects combined non-core revenue from distribution and ESWL businesses to reach between $22.0 million and $26.0 million, for total company revenue of $72.0 million to $80.0 million.
The strong results come as EDAP benefits from favorable tailwinds in the urology medical device market, which was valued at $17.62 billion in 2025 and is projected to reach $18.98 billion in 2026, according to market research from Towards Healthcare. The HIFU therapy market specifically was valued at approximately $1.44 billion in 2025, with an expected compound annual growth rate of 7.26% through 2034.
EDAP's FocalOne platform competes in the prostate focal therapy devices market, which reached $682.4 million in 2024 and is projected to grow at 8.2% annually through 2033, driven by increasing prostate cancer incidence and patient preference for minimally invasive treatments. The company faces competition from established players including Boston Scientific, Olympus Corporation, Cook Medical, Medtronic, and Intuitive Surgical in the broader urology device market, as well as HIFU-specific competitors such as Insightec and Profound Medical.
Despite the strong fundamentals, EDAP shares, which trade on NASDAQ under the ticker EDAP, closed at $3.91 on Tuesday, up 4.8% but still well below the company's 52-week high of $5.05. The stock has traded in a range between $1.21 and $5.05 over the past year, giving the company a market capitalization of approximately $139 million.
Analysts maintain a "Hold" consensus rating on the stock with an average price target of $8.50, suggesting potential upside of more than 117% from current levels, according to data from MarketBeat. The company's institutional ownership stands at approximately 62.7%, indicating significant institutional interest despite the stock's volatility.
Management highlighted several strategic initiatives driving growth, including the April 2025 launch of the FocalOne i system, designed to streamline HIFU procedures and enhance clinical capabilities. The company also cited growing clinical evidence supporting its technology, including the HIFI study involving 3,328 patients and the FARP study, which EDAP says demonstrate cancer control comparable to surgery with superior functional outcomes for HIFU procedures.
The company reported 87 FocalOne systems installed globally as of December 31, 2025, and noted favorable U.S. Medicare reimbursement coverage for HIFU procedures, which should support continued adoption in the world's largest healthcare market. EDAP TMS SA is headquartered in Lyon, France, and develops, produces, markets, distributes, and maintains a portfolio of minimally invasive medical devices for the treatment of urological diseases across Asia, Europe, the United States, and internationally.