EDAP Secures HIFU Reimbursement for Prostate Cancer Treatment in France
Reimbursement Announcement: The French Ministry of Health has approved reimbursement for the Focal One Robotic HIFU procedure, allowing eligible patients to access this non-invasive treatment for localized prostate cancer as of September 1, 2025.
Impact on Patient Access: This reimbursement milestone is expected to significantly increase patient access to effective prostate cancer treatments and may accelerate similar reimbursements in other European countries, driven by positive clinical evidence from studies like HIFI and FARP.
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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 Secures HIFU Reimbursement for Prostate Cancer Treatment in France
Reimbursement Announcement: The French Ministry of Health has approved reimbursement for the Focal One Robotic HIFU procedure, allowing eligible patients to access this non-invasive treatment for localized prostate cancer as of September 1, 2025.
Impact on Patient Access: This reimbursement milestone is expected to significantly increase patient access to effective prostate cancer treatments and may accelerate similar reimbursements in other European countries, driven by positive clinical evidence from studies like HIFI and FARP.
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 Secures HIFU Reimbursement for Prostate Cancer Treatment in France
Reimbursement Announcement: The French Ministry of Health has approved reimbursement for the Focal One Robotic HIFU procedure, allowing eligible patients to access this non-invasive treatment for localized prostate cancer as of September 1, 2025.
Impact on Patient Access: This reimbursement milestone is expected to significantly increase patient access to effective prostate cancer treatments and may accelerate similar reimbursements in other European countries, driven by positive clinical evidence from studies like HIFI and FARP.
