reports
EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One R...
EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer. ...
EDAP to Present at Piper Sandler 37th Annual Healthcare Conference
EDAP to Present at Piper Sandler 37th Annual Healthcare Conference EDAP to Present at Piper Sandler 37th Annual Healthcare Conference Company to Present and Host 1x1 Investor Meetings on Tuesday, December 2nd, 2025 AUSTIN, Texas, November 18, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Chief Executive Officer Ryan Rhodes is scheduled to present and, together with Chief Financial Officer Ken Mobeck, will host 1x1 investor meetings at the upcoming Piper Sandler 37th Annual Healthcare Conference in New York Cit...
EDAP Reports Third Quarter 2025 Financial Results
EDAP Reports Third Quarter 2025 Financial Results EDAP Reports Third Quarter 2025 Financial Results 49% YoY HIFU Revenue Growth, Driven by Increased Focal One® Sales and U.S. Procedure Volumes167% YoY Growth in Focal One System Placements15% YoY Growth in U.S. Focal One HIFU ProceduresCompany to Host Conference Call and Webcast on November 6 at 8:30 a.m. ET AUSTIN, Texas, November 6, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the third quarter of 2025. “Our record-breaking third-quart...
EDAP to Present at Jefferies Global Healthcare Conference in London
EDAP to Present at Jefferies Global Healthcare Conference in London EDAP to Present at Jefferies Global Healthcare Conference in London Company to Present and Host 1x1 Investor Meetings on Tuesday, November 18th, 2025 AUSTIN, Texas, November 4, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Ryan Rhodes, Chief Executive Officer, is scheduled to present and host 1x1 investor meetings at the upcoming Jefferies Global Healthcare Conference, which is being held November 18-20, 2025, in London, United Kingdom. D...
EDAP to Participate in the UBS Global Healthcare Conference
EDAP to Participate in the UBS Global Healthcare Conference EDAP to Participate in the UBS Global Healthcare Conference Company to Host 1x1 Investor Meetings on Monday, November 10th, 2025 AUSTIN, Texas, October 27, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Ryan Rhodes, Chief Executive Officer, and Ken Mobeck, Chief Financial Officer, are scheduled to host 1x1 investor meetings at the upcoming UBS Global Healthcare Conference, which is being held November 10-13, 2025, in Palm Beach Gardens, Florida. Dat...
EDAP to Announce Third Quarter 2025 Financial Results on November 6, 2...
EDAP to Announce Third Quarter 2025 Financial Results on November 6, 2025 EDAP to Announce Third Quarter 2025 Financial Results on November 6, 2025 Company to host conference call and webcast on Thursday, November 6th at 8:30am EST AUSTIN, Texas, October 23, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the third quarter ended September 30, 2025, before the markets open on Thursday, November 6th, 2025. An accompanying conference call and webcast will be conducted by ...
EDAP Secures €36 Million Credit Facility from European Investment Bank...
EDAP Secures €36 Million Credit Facility from European Investment Bank to Accelerate Growth of Focal One® Robotic HIFU EDAP Secures €36 Million Credit Facility from European Investment Bank to Accelerate Growth of Focal One® Robotic HIFU Lyon, France – October 20, 2025 – EDAP TMS SA (Nasdaq: EDAP) (“EDAP” or the “Company”), a global leader in robotic, energy-based therapeutic technologies, today announced that it has entered into a €36 million multi-tranche credit facility (the “Credit Facility”) with the European Investment Bank (the “EIB”). Proceeds from the financing will be...
Focal One® Prostate Cancer Awareness Month Campaign Shines Spotlight o...
Focal One® Prostate Cancer Awareness Month Campaign Shines Spotlight on Robotic HIFU Treatment Option Focal One® Prostate Cancer Awareness Month Campaign Shines Spotlight on Robotic HIFU Treatment Option Focal One Robotic HIFU Patient Story Featured on Health Uncensored with Dr. Drew on Lifetime Network AUSTIN, Texas – September 30, 2025 – EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, announced that its non-invasive, nonsurgical treatment option, Focal One Robotic HIFU, was featured on national television on Friday, September 26, reaching millions of view...
Focal One® HIFU Receives Prestigious Innovation Award
Focal One® HIFU Receives Prestigious Innovation Award Focal One® HIFU Receives Prestigious Innovation Award AUSTIN, Texas, September 16, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the company has been honored with the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society in recognition of its groundbreaking work with the Focal One High-Intensity Focused Ultrasound (HIFU) platform. Focal One is the first Focal Therapy technology to receive this distinguished award. The...
EDAP Receives HIFU Reimbursement for Prostate Cancer in France
EDAP Receives HIFU Reimbursement for Prostate Cancer in France Focal One Robotic HIFU procedure now covered under France’s national universal health systemReimbursement milestone allows increased patient access to Focal One Robotic HIFU AUSTIN, Texas, September 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the French Ministry of Health has awarded reimbursement for High Intensity Focused Ultrasound (HIFU) procedure for the treatment of prostate cancer in France. Reimbursement in France will specifically cover use of the Foca...
EDAP Reports Strong Second Quarter 2025 HIFU Results
EDAP Reports Strong Second Quarter 2025 HIFU Results +140% Focal One® Net Placement Growth Year over Year+76.8% HIFU Revenue Growth Year over Year 36 million Euro Credit Facility Letter of Intent Executed with European Investment Bank (EIB) to further accelerate HIFU Growth and Strategic Expansion Company raises 2025 HIFU Year over Year Revenue Growth Guidance range to 26% to 34%, up from the prior range of 16% to 25% Company to Host Conference Call and Webcast Today, August 28th, at 8:30 a.m. EDT AUSTIN, Texas, August 28, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic ...
EDAP Announces Letter of Intent for 36 Million Euro Credit Facility to...
EDAP Announces Letter of Intent for 36 Million Euro Credit Facility to Accelerate Growth and Strategic Expansion Funding to Support Continued Growth of Focal One® Robotic HIFU AUSTIN, Texas, August 26, 2025 - EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced execution of a letter of intent for EUR 36 million credit facility with the European Investment Bank (EIB). Proceeds from this financing will support the continued expansion of Focal One® Robotic HIFU in Focal Therapy, the fastest-growing treatment category for ea...
EDAP to Participate in the H.C. Wainwright 27th Annual Global Investme...
EDAP to Participate in the H.C. Wainwright 27th Annual Global Investment Conference AUSTIN, Texas, August 25, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Ryan Rhodes, Chief Executive Officer, is scheduled to participate in a fireside chat and host 1x1 investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference, which is being held September 8-10, 2025, in New York City. Date: Tuesday, September 9th Time: 8:30-9:00 AM ET Location: Lotte New York Palace Hote...
EDAP to Announce Second Quarter 2025 Financial Results on August 28, 2...
EDAP to Announce Second Quarter 2025 Financial Results on August 28, 2025 Company to host conference call and webcast on Thursday, August 28th at 8:30am EDT AUSTIN, Texas, August 7, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the second quarter ended June 30, 2025, before the markets open on Thursday, August 28th, 2025. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and Fran...
EDAP Announces Transition from Foreign Private Issuer to U.S. Domestic...
EDAP Announces Transition from Foreign Private Issuer to U.S. Domestic Filer Status Transition to U.S. reporting status to take effect on January 1, 2026 AUSTIN, Texas, July 1, 2025 - EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, announced a change in its U.S. reporting status. EDAP TMS S.A. (the “Company”) currently qualifies as a foreign private issuer under applicable U.S. Securities and Exchange Commission (“SEC”) rules and regulations. Effective January 1, 2026, the Company will no longer qualify for foreign private issuer s...
EDAP to Present at the Jefferies Global Healthcare Conference
EDAP to Present at the Jefferies Global Healthcare Conference AUSTIN, Texas, May 27, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that Ryan Rhodes, Chief Executive Officer, is scheduled to deliver a presentation and host 1x1 investor meetings at the Jefferies Global Healthcare Conference, which is being held June 3-5, 2025, in New York City. Presentation details: Date:Thursday, June 5th Time:4:20-4:50 PM ET Webcast: The live and archived webcast of the presentation can be accessed in the Investors section of th...
EDAP Reports First Quarter 2025 Financial Results
EDAP Reports First Quarter 2025 Financial Results Achieved a Record Number of Focal One® Robotic HIFU System Placements for a First Quarter Period Received CE Mark Designation for Focal One for the Treatment of Deep Infiltrating Endometriosis Positive Final Results of FARP Randomized Controlled Trial Presented at American Urology Association Annual Meeting (AUA 2025)Launched the New Focal One i Robotic HIFU System Performed World’s First Remote Transcontinental Focal One Robotic HIFU Procedure Successfully AUSTIN, Texas, May 15, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global lea...
EDAP to Announce First Quarter 2025 Financial Results on May 15, 2025
EDAP to Announce First Quarter 2025 Financial Results on May 15, 2025 Company to host conference call and webcast on Thursday, May 15th at 8:30am EDT LYON, France, May 1, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the first quarter ended March 31, 2025, before the markets open on Thursday, May 15th, 2025. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, ...
EDAP Announces Positive Results from the FARP Randomized Controlled Tr...
EDAP Announces Positive Results from the FARP Randomized Controlled Trial Presented at the American Urological Association (AUA) Annual Meeting Final 3-year outcome of Focal Ablation versus Radical Prostatectomy (FARP) Randomized Controlled Trial (RCT) presented at 120th AUA Annual Meeting on Sunday, April 27, 2025. Study achieved its primary endpoint and demonstrated that the rate of treatment failure in the Focal Ablation (FA) group is non-inferior to that in the Radical Prostatectomy (RP) group at the final 36-month follow-up. AUSTIN, Texas, April 29, 2025 - EDAP TMS SA (Nasdaq: EDAP), ...
EDAP To Launch New Focal One® i Robotic HIFU system at the Upcoming 12...
EDAP To Launch New Focal One® i Robotic HIFU system at the Upcoming 120th American Urological Association (AUA) Annual Meeting Focal One i expands HIFUsion® patient-specific imaging compatibility to include PSMA PET, ExactVu™ Micro-Ultrasound, along with AI-driven and intelligent algorithms including Unfold AI™ and OnQ™ ProstateFocal One i extends HIFUsion capabilities to integrate Koelis® 3D biopsy maps and DynaCAD Urology datasetsFocal One i system will enable future capabilities including treatment streaming and recording, remote collaborative procedures and expanded clinical indications...
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