Focal One CEO: Strong Finish to 2025, HIFU Revenue Exceeds Half of Annual Revenue
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
0mins
Should l Buy EDAP?
"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."
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Analyst Views on EDAP
Wall Street analysts forecast EDAP stock price to rise
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 4.100
Low
2.50
Averages
8.25
High
14.00
Current: 4.100
Low
2.50
Averages
8.25
High
14.00
About EDAP
Edap Tms SA is a France-based company that develops, manufactures, promotes and distributes minimally invasive medical devices for urology based upon ultrasound technology. The Company's activity is organized in two divisions: HIFU (High Intensity Focused Ultrasound) and ESWL (Extracorporeal ShockWave Lithotripsy) that invests in research and development, partnering with INSERM French public laboratory and international medical research institutions. It specialises in HIFU technology, a non-invasive treatment of prostate conditions with a range of Robotic HIFU devices, Ablatherm Fusion and Focal One, ESWL and Stone Laser that offers a range of minimally invasive solutions covering the full scope of urinary tract stone indications. It also operates worldwide via a network of corporate offices, subsidiaries and distribution partners
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
EDAP to Announce 2025 Financial Results on March 25, 2026
- Earnings Announcement: EDAP TMS SA will release its financial results for Q4 and full year 2025 before market open on March 25, 2026, indicating the company's ongoing growth in the medical device sector.
- Conference Call Details: The company will host a conference call at 8:30 AM EDT on the same day, led by CEO Ryan Rhodes and other executives, aimed at providing investors with insights into financial performance and future outlook.
- Technological Leadership: EDAP TMS maintains a global leadership position in robotic energy-based therapies, developing and distributing minimally invasive medical devices for various conditions, reflecting its commitment to innovation in medical technology.
- Focal One® Product Overview: The Focal One® device, introduced by EDAP, is widely used for prostate focal therapy in Europe and the U.S., with potential expansion into other indications, further solidifying its market position.
See More
EDAP Appoints David Horn to Board of Directors
- New Board Member: EDAP TMS S.A. appointed David Horn to its Board of Directors effective February 11, 2026, enhancing the board's expertise in strategic growth and transformation, which is expected to drive the company's future development.
- Audit and Nominations Committees: Horn will serve on the Company's Audit Committee and Nominations Committee, and his extensive background in the medical device industry will provide crucial support in capital markets and operational leadership.
- Rich Industry Experience: Horn has been President and CFO of Seer, Inc. since 2023 and previously spent over 20 years at Morgan Stanley, where he led healthcare investment banking, bringing valuable capital markets transaction and strategic planning experience.
- Support for Company Strategy: Horn expressed his honor in joining the board at this critical stage of the company's evolution, and his addition is expected to aid EDAP in its focus on innovation in focal therapy technology and market expansion, further enhancing shareholder value.
See More
EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 global HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected 2025 annual HIFU revenue ranges from $36.7 million to $37.2 million, representing the highest annual revenue in the company's history, indicating increasing market acceptance of the Focal One system.
- U.S. Procedure Growth: The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, enhancing the company's competitive position in the U.S. market and demonstrating the effectiveness and trust in the new systems.
- 2026 Financial Guidance: The company expects core HIFU business revenue in 2026 to range from $50.0 million to $54.0 million, with combined non-core revenue projected between $22.0 million and $26.0 million, showcasing confidence in future growth and market potential.
See More
EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 worldwide HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected annual HIFU revenue for 2025 is projected to be between $36.7 million and $37.2 million, demonstrating the company's sustained growth and leadership in the medical device sector.
- Innovative System Deployments: The company achieved 15 Focal One system placements in Q4, a 69% year-over-year increase, which not only meets the demand from hospitals and urology centers but also strengthens EDAP's competitive position in prostate cancer treatment.
- 2026 Financial Guidance: EDAP projects its core HIFU business revenue for 2026 to be between $50 million and $54 million, with combined non-core revenue expected to range from $22 million to $26 million, showcasing the company's confidence and strategic planning for future growth.
See More
EDAP Receives FDA 510(k) Clearance for Enhanced Focal One HIFU System
- FDA Clearance: EDAP TMS SA announced that its Focal One High Intensity Focused Ultrasound (HIFU) system has received FDA 510(k) clearance, further solidifying the company's market leadership in robotic focal therapy for prostate cancer. This clearance introduces advanced ultrasound imaging and an optimized user interface, enhancing treatment planning efficiency.
- Technological Innovation: The next-generation ultrasound imaging engine provides real-time visualization and supports the development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. This technological advancement not only improves treatment outcomes but may also expand the indications for Focal One.
- Market Outlook: CEO Ryan Rhodes stated that this FDA clearance represents an important technical milestone in Focal One's product roadmap, demonstrating the company's ongoing commitment to innovation. This will help the company further strengthen its leadership position in the global market, particularly in prostate cancer treatment.
- Company Background: EDAP TMS is a recognized leader in robotic energy-based therapies, focusing on the development and distribution of minimally invasive medical devices for various conditions. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP aims to meet the growing market demand.
See More
GNTA, BBIO, AMRN Surge in After-Hours Trading: Major Biotech Factors Fueling Stock Increases
Genenta Science S.p.A. Update: After a significant drop in regular trading due to a $15 million capital raise announcement, Genenta's shares saw a modest recovery in after-hours trading, indicating potential stabilization as investors assess the long-term impact of the company's strategic collaborations.
EDAP TMS S.A. Recovery: Despite a sharp decline during the day, EDAP's stock rebounded in after-hours trading, reflecting renewed speculative interest, particularly ahead of upcoming investor meetings at the UBS Global Healthcare Conference.
BridgeBio Pharma Inc. Anticipation: BridgeBio's shares rose significantly after hours, driven by investor optimism regarding the upcoming Phase 3 trial results for ADH1, with topline data expected to be released soon.
OrthoPediatrics Corp. Financial Performance: Following the release of its Q3 financial results, OrthoPediatrics experienced a surge in after-hours trading, buoyed by revenue growth and FDA approvals, leading to an optimistic revision of its full-year revenue guidance.
See More
EDAP to Announce 2025 Financial Results on March 25, 2026
- Earnings Announcement: EDAP TMS SA will release its financial results for Q4 and full year 2025 before market open on March 25, 2026, indicating the company's ongoing growth in the medical device sector.
- Conference Call Details: The company will host a conference call at 8:30 AM EDT on the same day, led by CEO Ryan Rhodes and other executives, aimed at providing investors with insights into financial performance and future outlook.
- Technological Leadership: EDAP TMS maintains a global leadership position in robotic energy-based therapies, developing and distributing minimally invasive medical devices for various conditions, reflecting its commitment to innovation in medical technology.
- Focal One® Product Overview: The Focal One® device, introduced by EDAP, is widely used for prostate focal therapy in Europe and the U.S., with potential expansion into other indications, further solidifying its market position.
See More
EDAP Appoints David Horn to Board of Directors
- New Board Member: EDAP TMS S.A. appointed David Horn to its Board of Directors effective February 11, 2026, enhancing the board's expertise in strategic growth and transformation, which is expected to drive the company's future development.
- Audit and Nominations Committees: Horn will serve on the Company's Audit Committee and Nominations Committee, and his extensive background in the medical device industry will provide crucial support in capital markets and operational leadership.
- Rich Industry Experience: Horn has been President and CFO of Seer, Inc. since 2023 and previously spent over 20 years at Morgan Stanley, where he led healthcare investment banking, bringing valuable capital markets transaction and strategic planning experience.
- Support for Company Strategy: Horn expressed his honor in joining the board at this critical stage of the company's evolution, and his addition is expected to aid EDAP in its focus on innovation in focal therapy technology and market expansion, further enhancing shareholder value.
See More
EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 global HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected 2025 annual HIFU revenue ranges from $36.7 million to $37.2 million, representing the highest annual revenue in the company's history, indicating increasing market acceptance of the Focal One system.
- U.S. Procedure Growth: The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, enhancing the company's competitive position in the U.S. market and demonstrating the effectiveness and trust in the new systems.
- 2026 Financial Guidance: The company expects core HIFU business revenue in 2026 to range from $50.0 million to $54.0 million, with combined non-core revenue projected between $22.0 million and $26.0 million, showcasing confidence in future growth and market potential.
See More
EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 worldwide HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected annual HIFU revenue for 2025 is projected to be between $36.7 million and $37.2 million, demonstrating the company's sustained growth and leadership in the medical device sector.
- Innovative System Deployments: The company achieved 15 Focal One system placements in Q4, a 69% year-over-year increase, which not only meets the demand from hospitals and urology centers but also strengthens EDAP's competitive position in prostate cancer treatment.
- 2026 Financial Guidance: EDAP projects its core HIFU business revenue for 2026 to be between $50 million and $54 million, with combined non-core revenue expected to range from $22 million to $26 million, showcasing the company's confidence and strategic planning for future growth.
See More
EDAP Receives FDA 510(k) Clearance for Enhanced Focal One HIFU System
- FDA Clearance: EDAP TMS SA announced that its Focal One High Intensity Focused Ultrasound (HIFU) system has received FDA 510(k) clearance, further solidifying the company's market leadership in robotic focal therapy for prostate cancer. This clearance introduces advanced ultrasound imaging and an optimized user interface, enhancing treatment planning efficiency.
- Technological Innovation: The next-generation ultrasound imaging engine provides real-time visualization and supports the development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. This technological advancement not only improves treatment outcomes but may also expand the indications for Focal One.
- Market Outlook: CEO Ryan Rhodes stated that this FDA clearance represents an important technical milestone in Focal One's product roadmap, demonstrating the company's ongoing commitment to innovation. This will help the company further strengthen its leadership position in the global market, particularly in prostate cancer treatment.
- Company Background: EDAP TMS is a recognized leader in robotic energy-based therapies, focusing on the development and distribution of minimally invasive medical devices for various conditions. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP aims to meet the growing market demand.
See More
GNTA, BBIO, AMRN Surge in After-Hours Trading: Major Biotech Factors Fueling Stock Increases
Genenta Science S.p.A. Update: After a significant drop in regular trading due to a $15 million capital raise announcement, Genenta's shares saw a modest recovery in after-hours trading, indicating potential stabilization as investors assess the long-term impact of the company's strategic collaborations.
EDAP TMS S.A. Recovery: Despite a sharp decline during the day, EDAP's stock rebounded in after-hours trading, reflecting renewed speculative interest, particularly ahead of upcoming investor meetings at the UBS Global Healthcare Conference.
BridgeBio Pharma Inc. Anticipation: BridgeBio's shares rose significantly after hours, driven by investor optimism regarding the upcoming Phase 3 trial results for ADH1, with topline data expected to be released soon.
OrthoPediatrics Corp. Financial Performance: Following the release of its Q3 financial results, OrthoPediatrics experienced a surge in after-hours trading, buoyed by revenue growth and FDA approvals, leading to an optimistic revision of its full-year revenue guidance.
See More
