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EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance

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EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenu...

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EDAP reported impressive preliminary fourth quarter and full-year 2025 HIFU revenues, led by strong system placements and increasing procedures. Guidance for 2026 indicates continued growth in HIFU revenue, driven by escalating clinical validation and adoption in prostate cancer treatment, suggesting promising returns for investors.

Sentiment Rationale

EDAP's strong HIFU revenue growth and optimistic guidance indicate solid market demand, similar spikes in stock values were observed after previous record earnings announcements in tech-focused healthcare segments.

Trading Thesis

Buy EDAP as strong revenue growth signals robust future performance in HIFU market.

Market-Moving

  • Record quarterly HIFU revenue could significantly impact EDAP's stock performance.
  • 2026 revenue guidance foreshadows continued growth, potentially driving stock prices up.
  • Increased Focal One placements indicate strong future prescription growth and recurring revenue.
  • Clinical studies supporting Focal One's efficacy could lead to broader market acceptance.

Key Facts

  • EDAP expects record fourth quarter HIFU revenue of $12.9M-$13.3M.
  • 2025 annual HIFU revenue forecasted at $36.7M-$37.2M, all-time high.
  • Focal One systems placements rose 69% YoY in 2025.
  • 2026 guidance projects HIFU revenue of $50M-$54M with strong demand.
  • Clinical validation enhances Focal One adoption, especially in prostate cancer management.

Companies Mentioned

  • EDAP TMS SA (EDAP): Strong growth and optimistic revenue guidance positively impact EDAP's market position.

Corporate Developments

This news falls under 'Corporate Developments' due to the significant updates in revenue and guidance prospects, which directly indicate the company's operational success and future outlook. Such developments are critical for potential investors gauging the growth trajectory of EDAP's HIFU technology.

EDAP Reports Record Fourth Quarter and Full Year 2025 HIFU Revenue with 2026 Guidance

AUSTIN, Texas, January 12, 2026 -- EDAP TMS SA (Nasdaq: EDAP) has announced impressive preliminary unaudited financial results for its fourth quarter and full year 2025, showcasing record High Intensity Focused Ultrasound (HIFU) revenue. This growth is attributed to the surge in Focal One® system sales and an increase in procedures performed in the U.S. The company also provided initial revenue guidance for 2026.

Fourth Quarter Highlights

For the fourth quarter ending December 31, 2025, EDAP's HIFU revenue is projected to be between $12.9 million and $13.3 million (approximately €11.2 million to €11.6 million). This marks the highest quarterly HIFU revenue in the company's history, reflecting a year-on-year growth of approximately 36% to 38%.

Additionally, the annual HIFU revenue for 2025 is expected to reach between $36.7 million and $37.2 million (about €32.5 million to €32.9 million), setting another record. Key contributors to this remarkable performance include:

  • 15 Focal One System Placements in Q4, indicating robust demand from healthcare facilities.
  • 28% Growth Year-On-Year in the number of Focal One HIFU procedures in the United States.
  • 69% Annual Growth in Focal One system placements.

CEO Ryan Rhodes Comments on Growth

Ryan Rhodes, Chief Executive Officer of EDAP, stated, “Our preliminary results reflect a strong finish to 2025 and accelerating demand for Focal One across global markets.” He highlighted that for the first time, HIFU revenue growth represents over half of the company's total expected revenue, affirming the effectiveness of their business strategy.

Rhodes emphasized, “Increasing clinical validation, including results from significant trials such as the landmark HIFI study, is driving broader adoption of focal therapy for prostate cancer.” He noted that major hospital networks are increasingly viewing Focal One as an essential investment in comprehensive prostate cancer management.

2026 Financial Guidance and Future Outlook

Looking ahead, EDAP has issued its initial financial guidance for 2026, predicting core HIFU business revenue to be between $50.0 million and $54.0 million (approximately €43.0 million to €46.0 million). The company anticipates combined non-core revenue (including Distribution and ESWL) to range from $22.0 million to $26.0 million (about €19.0 million to €22.0 million).

Rhodes concluded, “Our global pipeline is expanding and customer engagement remains robust, which gives us confidence in our ability to drive revenue growth and shareholder value in 2026.”

Important Considerations

The financial information disclosed is preliminary and is subject to final quarter-end reporting processes. EDAP warns investors to exercise caution in their reliance on these preliminary results. The company is expected to release its complete 2025 annual financial results in March 2026.

About EDAP TMS SA

EDAP TMS SA is a pioneering force in robotic energy-based therapies, dedicated to developing minimally invasive medical devices worldwide. The company leverages cutting-edge technologies in imaging and robotics to offer the Focal One®, the leading prostate focal therapy solution, with potential applications beyond prostate cancer.

For further information, visit focalone.com.

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