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. The 510(k) clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i launched earlier this year.

GlobeNewsWire • Nov 20, 2025

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 2 nd , 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 City. Date:                     Tuesday, December 2nd Time:                  10:30-10:55 am ET (fireside discussion) Format:                Fireside discussion and 1x1 investor meetings Location:               The Lotte New York Palace  Webcast:              https://event.webcasts.com/starthere.jsp?ei=1743759&tp_key=aa01607b94 The live and archived webcast of the presentation can be accessed in the Investors section of the Company's website here.

GlobeNewsWire • Nov 18, 2025

EDAP TMS S.A. (EDAP) Q3 2025 Earnings Call Transcript

EDAP TMS S.A. ( EDAP ) Q3 2025 Earnings Call November 6, 2025 8:30 AM EST Company Participants Ryan Rhodes - CEO & Director Ken Mobeck - Chief Financial Officer Conference Call Participants John Fraunces - Lifesci Advisors, LLC Charles Wallace - H.C.

Seeking Alpha • Nov 6, 2025

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 Volumes 167% YoY Growth in Focal One System Placements 15% YoY Growth in U.S. Focal One HIFU Procedures Company 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.

GlobeNewsWire • Nov 6, 2025

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 18 th , 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. Date:                             Tuesday, November 18th Presentation Time:         4:30-4:55 pm GMT Format:                        Presentation and 1x1 investor meetings Location:                       Waldorf – Aldwych, Entresol Level Webcast:                      https://wsw.com/webcast/jeff332/edap/1817998  The live and archived webcast of the presentation can be accessed in the Investors section of the Company's website here.

GlobeNewsWire • Nov 4, 2025

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 10 th , 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. Date:                    Monday, November 10th Format:               1x1 investor meetings Location:               PGA National Resort Hotel, Palm Beach Gardens, Florida Registration:         Click here to register for the conference (for UBS clients only), or please contact your UBS sales representative.

GlobeNewsWire • Oct 27, 2025

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 6 th 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 Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer.

GlobeNewsWire • Oct 23, 2025

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 used to support the continued global expansion of the Company's Focal One Robotic High-Intensity Focused Ultrasound (HIFU) platform.

GlobeNewsWire • Oct 20, 2025

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 viewers nationwide. The segment, which included an interview with a patient treated with Focal One, aired during an episode of Health Uncensored with Dr. Drew on the Lifetime Network, as part of the company's Prostate Cancer Awareness Month campaign.

GlobeNewsWire • Sep 30, 2025

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.

GlobeNewsWire • Sep 16, 2025