Company Reports Preliminary Worldwide Record Fourth Quarter Sales of 11 Focal One Systems Record U.S. Fourth Quarter Focal One System Sales Record Number of U.S. Focal One Procedures, with Year-Over-Year Growth of 30% AUSTIN, Texas, January 13, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced preliminary record Focal One System sales for the... Read More

AUSTIN, Texas, January 10, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced the appointment of Joshua H. Levine to its Board of Directors. “We are pleased to welcome Josh Levine to our Board of Directors," said Dr. Lance Willsey, Interim Chairman of the Board of EDAP TMS. “Josh brings a wealth of executive experience and a track record of... Read More

AUSTIN, Texas, January 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors. “The initiation of the PULS Trial represents a major milestone in... Read More

HIFI Study is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments Positive study results are expected to drive further adoption of Focal One as a first line treatment option for the management of localized prostate cancer Study shows Focal One Robotic HIFU is non-inferior to surgery, meeting primary endpoint of non-inferiority for Salvage... Read More

LYON, France, November 27, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that Ryan Rhodes, Chief Executive Officer of EDAP TMS, is scheduled to participate in a fireside discussion and host 1x1 investor meetings at the upcoming Piper Sandler 36 th Annual Healthcare Conference, which is taking place from December 3-5, 2024, in New York City. Presentation Details: Piper... Read More

Early feasibility work demonstrates Focal One system’s ability to generate histotripsy lesions ex vivo LYON, France, November 22, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced a scientific presentation which demonstrated the technical feasibility of performing non-thermal histotripsy energy delivery and generating histotripsy lesions in biological tissues ex vivo... Read More

Treatment with robotic HIFU showed reduction in moderate and severe post-operative complications and reduced hospital stay compared to surgery LYON, France, November 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced a moderated scientific presentation of clinical data comparing Focal One HIFU versus surgery for the treatment of deep infiltrating endometriosis at the... Read More

Reported Q3 worldwide revenue of EUR 13.1 million (USD 14.4 million), increasing 11.6% over Q3 2023 Reported Q3 worldwide HIFU revenue of EUR 4.5 million (USD 4.9 million), increasing 48.2% over Q3 2023 34% year-over-year growth in U.S. Focal One HIFU procedures CMS increases Medicare Hospital Outpatient Focal One HIFU procedure payment by 5.4% for 2025 Announced AI collaboration with Avenda Health for Focal One Robotic HIFU... Read More

LYON, France, November 6, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that Ryan Rhodes, Chief Executive Officer, is scheduled to present and host 1x1 investor meetings at the Jefferies London Healthcare Conference, which is being held November 19-21, 2024. Date: Tuesday, November 19 Time: 8:30-8:55 AM GMT Location: The Waldorf Hilton London Webcast: LINK The live and... Read More

Company to host conference call and webcast on Thursday, November 7 th at 8:30am EDT LYON, France, October 24, 2024 -- 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, 2024, before the markets open on Thursday, November 7 th , 2024. An accompanying conference call and webcast... Read More

LYON, France, October 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company’s proprietary Focal One ® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH). “We’ve been offering targeted HIFU ablation to prostate cancer... Read More

First Unfold AI ® -Assisted Focal One procedures successfully performed at the UCLA School of Medicine FDA-cleared Unfold AI enables urologists to provide tailored, patient-specific Robotic HIFU ablation for prostate cancer patients EDAP and Avenda Health to present Unfold AI-Assisted Focal One simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC... Read More

LYON, France, August 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, 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 26 th Annual Global Investment Conference, which is being held September 9-11, 2024, in New York City. Date: Tuesday, September 10 th Time: 3:00-3:30 PM ET... Read More

Record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million) increased 10.6% over Q2 2023 Record first half 2024 total worldwide revenue of EUR 30.7 million (USD 33.1 million) increased 5.6% over first half 2023 Strong Q2 2024 U.S. Focal One ® HIFU procedure growth of +63% year-over-year Company to host conference call and webcast today, August 28th, at 8:30 a.m. EDT LYON, France, August 28, 2024 - EDAP TMS... Read More

Company to host conference call and webcast on Wednesday, August 28 th at 8:30am EDT LYON, France, August 7, 2024 -- 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, 2024, before the markets open on Wednesday, August 28 th , 2024. An accompanying conference call and webcast will be... Read More

Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis At three months post procedure, the study’s primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met Significant improvements were observed across primary and secondary outcome... Read More

LYON, France, July 8, 2024 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced the appointment of Fran Schulz to its Board of Directors. “We are pleased to welcome Fran Schulz to our Board of Directors," said Marc Oczachowski, Chairman of the Board of EDAP TMS. “Fran brings a wealth of executive experience in the healthcare industry, and her expertise... Read More

New appointments bring significant commercial experience with a focus on growing key strategic markets Expands executive leadership in growing disruptive, robotics-based capital equipment in both Urology and Gynecology therapeutic applications LYON, France, June 3, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the appointments of Damien Desmedt and Alexander Fromm to... Read More

LYON, France, May 22, 2024 -- 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 5-6, 2024, in New York City. Presentation details: Date: Wednesday, June 5 th Time: 7:30 AM ET... Read More

Strong Q1 2024 U.S. Focal One ® HIFU procedure growth of +92% year-over-year Q1 2024 HIFU revenue of EUR 5.8 million ($6.3 million USD), an increase of 10.2% over Q1 2023 Q1 2024 total revenue of EUR 14.9 million ($16.1 million USD) increased 0.8% over Q1 2023 Company to host conference call and webcast today, May 16th, at 8:30 a.m. EDT LYON, France, May 16, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic... Read More

Final results demonstrate a significantly higher salvage treatment free survival rate (STFS) at 30 months of 89.6% in the HIFU-treated arm versus 86.2% in patients who underwent radical prostatectomy (RP) Functional evaluation criteria show better results with respect to urinary continence and erectile function in patients receiving HIFU therapy versus patients receiving RP Final study results were presented during a plenary... Read More

LYON, France, April 23, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that final results from the HIFI Study, the largest clinical trial ever conducted comparing EDAP’s Focal One robotic high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for the treatment of prostate cancer, will be presented during a plenary session at the 119th American Urological... Read More

Record Q4 2023 total revenue of EUR 19.6 million ($21.3 million USD) increased 24.8% over Q4 2022 Record Q4 2023 HIFU revenue of EUR 7.5 million ($8.1 million USD), an increase of 38.8% over Q4 2022 Record full-year 2023 total revenue of EUR 60.4 million ($65.4 million USD) increased 9.6% over full-year 2022 Record full-year 2023 HIFU revenue of EUR 20.6 million ($22.3 million USD), an increase of 31.7% over full-year 2022... Read More

Company to host conference call and webcast on Wednesday, March 27 th at 8:30am EDT LYON, France, March 13, 2024 -- 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 fourth quarter and full-year ended December 31, 2023, before the markets open on Wednesday, March 27 th , 2024. An accompanying conference call and... Read More

LYON, France, March 6, 2024 -- 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 virtual presentation and host 1x1 investor meetings at the Oppenheimer 34 th Annual Healthcare MedTech & Services Conference, which is being held virtually from March 12-13, 2024. Presentation details: Date:... Read More

Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA... Read More

Record full-year 2023 preliminary unaudited revenue of EUR 60.4 million ($65.4 million USD), an increase of 9.6% over full-year 2022, driven by 31.7% HIFU growth Record Q4 2023 preliminary unaudited revenue of EUR 19.6 million ($21.3 million USD), an increase of 24.8% over for Q4 2022, driven by 38.8% HIFU growth Strong Q4 2023 U.S. Focal One ® HIFU procedure growth of 136% year-over-year LYON, France, February 29, 2024 -... Read More

60 Patients Completed Enrollment in Under 9 Months Study Results Expected in the Second Half of 2024 LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal... Read More

Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales LYON, France, January 8, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, announced today preliminary Focal One placement results for the fourth quarter of calendar year 2023. The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve... Read More

LYON, France, January 2, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that the Company has appointed Ken Mobeck as its Chief Financial Officer of EDAP worldwide, and Francois Dietsch as Global Chief Accounting Officer. Both appointments are effective as of January 1, 2024. “Over the past year, we have continued to align our organization in support of our... Read More

Represents Key Milestone Toward Universal Coverage for Focal One HIFU in France LYON, France, December 12, 2023 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that the French National Authority for Health (“HAS”) released a favorable recommendation for the reimbursement of high-intensity focused ultrasound (HIFU) therapy in the treatment of prostate cancer. The... Read More

LYON, France, December 6, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced the appointment of Lance Willsey, M.S., M.D. to its Board of Directors. Dr. Willsey replaces Dr. Argil Wheelock who has resigned as director of the Company. “I appreciate the opportunity to join the board of EDAP, where the company’s Focal One Robotic HIFU platform is... Read More

LYON, France, November 30, 2023 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, today announced that is has received the Industry Category Award from the French National Institute for Intellectual Property (INPI) based on the Company’s innovative therapeutic ultrasound technology. On November 23, 2023, the jury for the 2023 edition of the INPI Trophies honored five companies at an... Read More

LYON, France, November 20, 2023 -- 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 Piper Sandler 35 th Annual Healthcare Conference, which is being held November 28-30, 2023, in New York, New York. Presentation details: Date: Wednesday,... Read More

Strong Q3 2023 U.S. Focal One ® HIFU procedure growth of +150% year-over-year Record nine months HIFU revenues reflecting growing demand Two additional Focal One systems already placed in the fourth quarter Announces immunotherapy clinical research collaboration with Mount Sinai, Department of Urology Company to host conference call and webcast today, Thursday, November 9 th at 8:30 am EDT LYON, France, November 9, 2023 -... Read More

LYON, France, November 6, 2023 -- 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 London Healthcare Conference, which is being held November 14-16, 2023, in London. Presentation details: Date: Tuesday, November 14 Time: 9:00 – 9:25... Read More

Company to host conference call and webcast on Thursday, November 9 th at 8:30am EDT LYON, France, October 26, 2023 -- 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 th , 2023, before the markets open on Thursday, November 9 th , 2023. An accompanying conference call and... Read More

LYON, France, September 6, 2023 -- 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 upcoming Morgan Stanley 21 st Annual Global Healthcare Conference and the H.C. Wainwright 25 th Annual Global Investment Conference, both being held September... Read More

Record second quarter and first half revenues of EUR 14.3 million (USD 15.5 million) and EUR 29.1 million (USD 31.5 million), respectively Total HIFU Q2 2023 year-over-year revenue growth of 63.6% Strong Q2 2023 year-over-year U.S. Focal One ® HIFU procedure growth of 85% Received reimbursement approval in Switzerland for use of HIFU in the treatment of prostate cancer More than half of patients now enrolled in Phase 3 study... Read More

Company to host conference call and webcast on Thursday, August 24 th at 8:30 am EDT LYON, France, August 10, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the second quarter ended June 30 th , 2023, before the markets open on Thursday, August 24 th , 2023. An accompanying conference call and webcast will be hosted by... Read More

LYON, France, July 26, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it has received reimbursement approval in Switzerland for the use of High-Intensity Focused Ultrasound (HIFU) in the treatment of prostate cancer. This reimbursement took effect on July 1, 2023. "Receipt of appropriate reimbursement from the Swiss healthcare authorities is... Read More

LYON, France, May 24, 2023 -- 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 Healthcare Conference, which is being held June 7-9, 2023, in New York City. Presentation details: Date: Wednesday, June 7 Time: 1:30-1:55 PM ET in Track 2... Read More

Record first quarter revenue Positive results from two studies reconfirm safety and efficacy of Focal One Company to host conference call and webcast today, Wednesday, May 17 th at 8:30 am EDT LYON, France, May 17, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today unaudited financial results for the first quarter ended March 31, 2023. “After achieving record results in... Read More

Company to host conference call and webcast on Wednesday, May 17 th at 8:30 am EDT LYON, France, May 3, 2023 - 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 st , 2023 before the markets open on Wednesday, May 17 th , 2023. An accompanying conference call and webcast will be hosted... Read More

Meeting to Showcase EDAP’s Focal One ® Robotic High Intensity Focused Ultrasound (HIFU) Platform for the Management of Prostate Cancer LYON, France, April 21, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that the Company will be showcasing its Focal One ® Robotic High Intensity Focused Ultrasound (HIFU) platform at the upcoming Annual Meeting of the... Read More

Leading Center Demonstrates Focal HIFU as a Tool in The Management of Prostate Cancer Webcast scheduled for Tuesday, April 18 th at 12:00 p.m. PDT (3:00 p.m. EDT) LYON, France, April 10, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today announced that the Company will host a webcast that will feature a live procedure broadcast of its Focal One HIFU as a potential... Read More

Allows for market launch of the only micro-ultrasound platform for precision prostate biopsies LYON, France, April 6, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today provided a regulatory and clinical update. The Company has received approval from the Pharmaceutical and Medical Devices Agency (“PMDA”) for the commercialization of the ExactVu™ micro-ultrasound... Read More

Record full-year 2022 total revenue of EUR 55.1 million ($58.0 million) increased 25.1% over full-year 2021 Full-year HIFU revenue was EUR 15.6 million (USD 16.4 million), an increase of 57.7% as compared to EUR 9.9 million (USD 11.7 million) for the full-year 2021 Record Q4 2022 total revenue of EUR 15.7 million ($16.2 million) versus EUR 14.0 million ($15.9 million) for Q4 2021 Ended the year with a strong cash position of... Read More

Results demonstrate salvage treatment free survival rate (STFS) at 30 months of 90.1% in the HIFU-treated arm versus 86.8% in patients who underwent radical prostatectomy (RP) The HIFU treated arm showed significant benefits across multiple side effect and quality-of-life measures LYON, France, March 21, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today announced a... Read More

LYON, France, March 9, 2023 -- 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 fourth quarter and full-year ended December 31, 2022, before the markets open on Thursday, March 30 th , 2023. An accompanying conference call and webcast will be hosted by Marc Oczachowski, Chairman of the Board and Chief Executive... Read More

Record full-year 2022 total preliminary unaudited revenue of €55.1 million ($58.0 million) represents an increase of 25.1% over full-year 2021, driven by 58.1% HIFU growth Record Q4 2022 total preliminary unaudited revenue of €15.8 million ($16.2 million) versus €14.0 million ($15.9 million) for Q4 2021 Maintains strong balance sheet with cash and cash equivalents of €63.1 million ($67.5 million) as of December 31, 2022... Read More

Focal One® HIFU treatment resulted in significant improvements in endometriosis symptoms and quality of life (QoL) Positive safety profile with 96.7% of patients with no or non-significant adverse events Data was presented at the Paris Santé Femmes Major Gynecology French Congress on Friday, January 27 Company intends to initiate randomized, double-blind, SHAM-controlled study in 2Q 2023 LYON, France, January 31, 2022 --... Read More

Company preliminarily reports nine Focal One Placements in the U.S., including seven sales LYON, France, January 5, 2023 -- EDAP TMS SA (NASDAQ: EDAP) (the “Company”), the global leader in robotic energy-based therapies, announced today that the Company experienced robust demand for its Focal One HIFU technology in the fourth quarter of 2022, placing nine Focal One machines in the U.S. The breadth of new placements also... Read More

Study to begin enrolling patients in Q2 2023 Endometriosis represents significant expansion opportunity for Focal One LYON, France, November 30, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic therapeutic ultrasound, today announced that the Company has received approval from French authorities to initiate a Phase 3 randomized, controlled clinical trial evaluating Focal One high intensity... Read More