EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance
Rhea-AI Summary
EDAP (Nasdaq: EDAP) reported preliminary unaudited results showing record fourth-quarter and full-year 2025 HIFU revenue driven by increased Focal One system sales and growing U.S. procedure volume. Q4 2025 HIFU revenue is expected to be $12.9M–$13.3M and full-year 2025 HIFU revenue $36.7M–$37.2M, both company records. Q4 included a record 15 Focal One system placements and ~28% YoY growth in U.S. Focal One procedures. EDAP issued 2026 guidance of $50.0M–$54.0M HIFU revenue (36%–38% YoY growth) and combined non-core revenue of $22.0M–$26.0M. Results are preliminary and unaudited; final 2025 results expected in March 2026.
Positive
- HIFU revenue set preliminary record at $36.7M–$37.2M for 2025
- Record 15 Focal One system placements in Q4 2025
- U.S. Focal One procedures grew ~28% YoY in Q4 2025
- 2026 HIFU revenue guidance of $50.0M–$54.0M (36%–38% YoY)
Negative
- Financials are preliminary and unaudited; subject to material adjustments before March 2026
- Independent auditors have not reviewed or provided assurance on these preliminary results
News Market Reaction
On the day this news was published, EDAP gained 11.41%, reflecting a significant positive market reaction. Argus tracked a peak move of +3.7% during that session. Argus tracked a trough of -5.4% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $15M to the company's valuation, bringing the market cap to $146M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Pre-announcement, EDAP was down 2.9% while peers were mixed: QIPT -0.28%, YI +13.65%, ZYXI -37.34%, COSM +5.75%, OMI +2.19%. With no peers in the momentum scanner, moves appear stock-specific rather than a unified sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 20 | Regulatory clearance | Positive | +5.8% | FDA 510(k) clearance for upgraded Focal One imaging and workflow features. |
| Nov 18 | Investor conference | Neutral | +3.4% | Participation in Piper Sandler healthcare conference with CEO presentation and meetings. |
| Nov 06 | Earnings update | Neutral | -4.3% | Q3 2025 results with strong HIFU growth but continued net loss and flat total revenue. |
| Nov 04 | Investor conference | Neutral | +1.5% | Jefferies Global Healthcare Conference presentation and investor meetings in London. |
| Oct 27 | Investor conference | Neutral | -1.8% | UBS Global Healthcare Conference participation with 1x1 investor meetings scheduled. |
Recent news has generally seen aligned reactions, with positive technical/regulatory updates and conference appearances followed by modest gains, but a mixed reaction to earnings where shares declined despite HIFU growth.
Over the last several months, EDAP highlighted HIFU momentum and capital structure steps. On Nov 6, Q3 2025 results showed stronger HIFU growth but a 24h share decline of 4.33%. Subsequent conferences on Oct 27, Nov 4, and Nov 18 featured investor outreach with small positive or negative moves. The Nov 20 FDA 510(k) clearance for enhanced Focal One imaging coincided with a 5.83% gain, reinforcing that clear product milestones have drawn more favorable reactions than financial updates.
Market Pulse Summary
The stock surged +11.4% in the session following this news. A strong positive reaction aligns with the article’s emphasis on record HIFU performance and robust 2026 guidance, with HIFU revenue expected at $36.7–$37.2M for 2025 and $50–$54M for 2026. Historically, clear product or regulatory milestones, such as the Nov 20 FDA clearance that saw a 5.83% move, have attracted buying interest. Investors would still need to weigh ongoing net losses and execution on procedure growth when assessing sustainability.
Key Terms
hifu medical
randomized controlled trial medical
focal therapy medical
AI-generated analysis. Not financial advice.
EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance
AUSTIN, Texas, January 12, 2026 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced select preliminary unaudited financial and operational results highlighting record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and accelerating procedure growth. The Company also issued initial worldwide revenue guidance for 2026.
For the fourth quarter ended December 31, 2025, the Company’s worldwide HIFU revenue is expected to range between
EDAP’s non-core (Distribution and ESWL) preliminary unaudited fourth quarter revenue is expected to range between
“Our preliminary results reflect a strong finish to 2025 and accelerating demand for Focal One across global markets,” said Ryan Rhodes, Chief Executive Officer. “System placements reached a quarterly record, and procedure growth in the U.S. continues to scale, which we believe reinforces the strength and durability of our recurring revenue model. For the first time in the Company’s history, the expected growth in HIFU revenue represents more than half of our expected annual revenue, validating our execution strategy.”
Mr. Rhodes added, “We believe increasing clinical validation, including data from key trials such as the landmark HIFI study and FARP Randomized Controlled Trial, is driving broader clinical adoption of focal therapy for prostate cancer. As a result, more large hospital networks are recognizing Focal One as both a strategic and necessary investment in a comprehensive prostate cancer management program.”
“Entering 2026, our global pipeline is expanding, customer engagement remains strong, and procedure utilization continues to grow. Based on this momentum, we are confident in our ability to deliver continued revenue growth and shareholder value creation in the year ahead.”
2026 Financial Guidance
The Company is issuing its initial 2026 financial guidance. In 2026, the Company’s core HIFU business revenue is expected to be in the range of
The above information is preliminary and subject to completion of quarter-end financial reporting processes and reviews. The preliminary financial and operational results and 2026 financial guidance included in this press release have been prepared by, and are the responsibility of, our management. During the course of the preparation of our financial statements and related notes as of for the fiscal year ended December 31, 2025, we may identify items that would require us to make material adjustments to the preliminary financial and operational results presented herein. As a result, investors should exercise caution in relying on this information and should not draw any inferences from this information. Our independent registered public accounting firm has not audited, reviewed, examined, compiled, or performed any procedures with respect to these preliminary unaudited financial and operational results and 2026 financial guidance, nor has our independent registered public accounting firm expressed any opinion or any other form of assurance on these preliminary unaudited financial and operational results and 2026 financial guidance. This preliminary financial and operational information should not be viewed as a substitute for full financial statements prepared in accordance with U.S. GAAP and reviewed by our independent registered public accounting firm. EDAP expects to release completed 2025 annual financial results in March 2026.
Currency Translation
Euro-denominated amounts have been translated into U.S. dollars for convenience using an average exchange rate of
About EDAP TMS SA
A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com/.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements include those related to the demand and growing adoption of our products, the drivers thereof, and our future financial results. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services. Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Investor Contacts
Investor Relations
EDAP TMS SA
investor.relations@focalone.com
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
FAQ
What were EDAP's preliminary Q4 2025 HIFU revenue and full-year 2025 HIFU revenue?
How many Focal One systems did EDAP place in Q4 2025 (EDAP)?
What is EDAP's 2026 HIFU revenue guidance and implied growth (EDAP)?
What U.S. procedure growth did EDAP report for Q4 2025 (EDAP)?
Are EDAP's 2025 results audited and final (EDAP)?
