Landmark HIFI Study Publication Demonstrates Positive Outcomes with Focal One® Robotic HIFU Versus Surgery in the Management of Prostate Cancer
HIFI Study Results: The HIFI study, the largest clinical trial comparing prostate cancer treatments, found that Focal One Robotic HIFU is non-inferior to radical prostatectomy in terms of Salvage Treatment-free Survival (STFS) at 30 months, with better outcomes for urinary continence and erectile function in patients treated with HIFU.
Publication Impact: The results were published in the prestigious journal European Urology, which is expected to enhance awareness and adoption of Focal One as a first-line treatment option for localized prostate cancer, highlighting its clinical benefits over traditional surgical methods.
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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.
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.
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.
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.
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.
Natural Killer Cell Treatments Drive $254B Shift in Immunotherapy Market
Advancements in Cancer Immunotherapy: MIT and Harvard scientists have engineered CAR-NK cells that evade the immune system, enhancing cancer destruction and enabling immediate off-the-shelf treatments. The global cancer immunotherapy market is projected to grow significantly, driven by innovations in cellular therapies and biomarker-driven drug development.
GT Biopharma's Clinical Progress: GT Biopharma is advancing its Phase 1 trial of GTB-3650 for treating relapsed or refractory blood cancers, showing promising early results in immune activation without significant side effects. The company plans to file for human trials of its solid tumor-targeting therapy, GTB-5550, by late 2025.
Evaxion's Personalized Cancer Vaccine: Evaxion A/S is set to present two-year data from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, demonstrating a 69% overall response rate in advanced melanoma patients. The company emphasizes the importance of personalized therapies in oncology.
RenovoRx and EDAP TMS Innovations: RenovoRx has initiated a registry study to evaluate its drug-delivery device, RenovoCath, for solid tumors, while EDAP TMS gained national attention for its non-invasive Focal One Robotic HIFU treatment for prostate cancer, highlighting advancements in minimally invasive cancer therapies.
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.
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.
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.
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.
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.
Natural Killer Cell Treatments Drive $254B Shift in Immunotherapy Market
Advancements in Cancer Immunotherapy: MIT and Harvard scientists have engineered CAR-NK cells that evade the immune system, enhancing cancer destruction and enabling immediate off-the-shelf treatments. The global cancer immunotherapy market is projected to grow significantly, driven by innovations in cellular therapies and biomarker-driven drug development.
GT Biopharma's Clinical Progress: GT Biopharma is advancing its Phase 1 trial of GTB-3650 for treating relapsed or refractory blood cancers, showing promising early results in immune activation without significant side effects. The company plans to file for human trials of its solid tumor-targeting therapy, GTB-5550, by late 2025.
Evaxion's Personalized Cancer Vaccine: Evaxion A/S is set to present two-year data from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, demonstrating a 69% overall response rate in advanced melanoma patients. The company emphasizes the importance of personalized therapies in oncology.
RenovoRx and EDAP TMS Innovations: RenovoRx has initiated a registry study to evaluate its drug-delivery device, RenovoCath, for solid tumors, while EDAP TMS gained national attention for its non-invasive Focal One Robotic HIFU treatment for prostate cancer, highlighting advancements in minimally invasive cancer therapies.
