EDAP TMS

EDAP TMS SA is a holding company, which, through its subsidiary, engages in the development, production, and marketing of minimally invasive medical devices for urological diseases. It operates through the High Intensity Focused Ultrasound (HIFU) and Urology Devices and Services (UDS) segments. The HIFU segment develops, manufactures, and markets devices for the minimally invasive ablation of certain types of localized tumors using HIFU technology. The UDS segment focuses on the development, marketing, manufacturing, and servicing of medical devices for the minimally invasive diagnosis or treatment of urological disorders, mainly urinary stones, and other clinical indications. The company was founded on December 3, 1979 and is headquartered in Vaulx-en-Velin, France.

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EDAP TMS reports Q1 revenue growth and FDA breakthrough designation

EDAP TMS reported solid revenue growth in Q1 2024, driven by strong international placements and advancements in Focal One technology. While facing financial challenges, the company is strategically positioned to benefit from the expanding HIFU market and upcoming regulatory milestones. Opportunities lie in market expansion, new study data releases, and continued engagement with regulatory bodies.

EDAP TMS reports strong Q2 earnings, poised for market expansion

EDAP TMS delivered robust performance in Q2 2024, driven by revenue growth and advancements in key medical programs.
While facing challenges in profitability and expenses, the company is strategically positioned to capitalize on market opportunities.
Investments in research, management, and clinical trials signal a proactive approach towards sustainable growth and innovation.

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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 Treatment-free Survival (STFS) after High Intensity Focused Ultrasounds (HIFU) compared to Radical Prostatectomy (RP) at 30 months Study shows that patients receiving HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving RP LYON, France, December 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the publication of the full results from the HIFI study in the prestigious, peer-reviewed journal, European Urology, which has the highest impact factor amongst scientific journals focused in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first line treatment of localized prostate cancer.

Landmark HIFI Study Publication Demonstrates Positive Outcomes with Focal One® Robotic HIFU Versus Surgery in the Management of Prostate Cancer

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 2024 AAGL Global Congress, which took place from November 16-19, 2024, in New Orleans, LA. The presentation was entitled, "Evaluation of rectal endometriosis treatment with high-intensity focused ultrasound versus surgery: a retrospective multicenter study", and was delivered by Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse University Hospital, Lyon, France, and Principal Investigator.

EDAP Announces Scientific Presentation at 2024 AAGL Global Congress Comparing Focal One HIFU Versus Surgery for the Treatment of Deep Infiltrating Endometriosis

EDAP TMS S.A. (NASDAQ:EDAP ) Q3 2024 Earnings Conference Call November 7, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Conference Call Participants Michael Sarcone - Jefferies Sean Lee - H.C.

EDAP TMS S.A. (EDAP) Q3 2024 Earnings Call Transcript

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 7th, 2024. 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.

EDAP to Announce Third Quarter 2024 Financial Results on November 7, 2024

When combined with EDAP's Focal One platform, Avenda's Unfold AI enables more accurate and patient-specific treatment options.

EDAP's Avenda Deal for AI-Assisted Cancer Care Likely to Drive Stock

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 September 19-21, 2024 LYON, France, September 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, and Avenda Health (“Avenda”), a leading AI healthcare company, today announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda's groundbreaking AI technology, Unfold AI, to launch the world's first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures. Avenda Health's Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care.

EDAP and Avenda Health Launch World's First AI-Assisted Focal One® Robotic HIFU Procedures

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 26th Annual Global Investment Conference, which is being held September 9-11, 2024, in New York City.

EDAP to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

EDAP TMS S.A. (NASDAQ:EDAP ) Q2 2024 Results Conference Call August 28, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Francois Dietsch - Chief Accounting Officer Conference Call Participants Michael Sarcone - Jefferies Joseph Downing - Piper Sandler RK Ramakanth - H.C.

EDAP TMS S.A. (EDAP) Q2 2024 Earnings Call Transcript

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 SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the second quarter of 2024.

EDAP Reports Second Quarter 2024 Financial Results

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 28th, 2024. 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.

EDAP to Announce Second Quarter 2024 Financial Results on August 28, 2024

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 measures (endometriosis and digestive symptoms) across the entire study population at three months The Phase 3 study continues as planned per protocol, with patients from the Sham treatment arm electing HIFU therapy LYON, France, July 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60-patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels.

EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU for the Treatment of Deep Infiltrating Endometriosis

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 further strengthen the Company's European and Middle Eastern commercial leadership. Mr. Desmedt has been appointed Vice President of Sales for Europe, Middle East, Africa, and India (EMEAI), and Mr.

EDAP Appoints New Executive Leaders to Strengthen Europe and Middle East Commercial Operations

EDAP TMS (NASDAQ:EDAP ) Q1 2024 Earnings Call Transcript May 16, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Conference Call Participants Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Jason Bednar - Piper Sandler Swayampakula Ramakanth - HC Wainwright Operator Greetings and welcome to the EDAP TMS First Quarter 2024 Earnings Conference Call. At this time.

EDAP TMS (EDAP) Q1 2024 Earnings Call Transcript

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 session of the AUA focused on paradigm-shifting and practice-changing clinical trials in urology HIFI Study is the largest clinical study ever conducted evaluating treatment outcomes with Focal One robotic HIFU, enrolling a total of 3,328 prospective patients, including 1,967 consecutive HIFU patients and 1,361 RP patients across 46 centers LYON, France, May 6, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced a recent presentation highlighting the positive, final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One® high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 119th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, “Paradigm-shifting, Practice-changing Clinical Trials in Urology”.

EDAP Announces Positive Final Results from the HIFI Study Comparing Outcomes of Focal One® HIFU Versus Radical Prostatectomy During Plenary Session at the 119th American Urological Association (AUA) Annual Meeting

Company to host conference call and webcast on Thursday, May 16 th at 8:30am EDT LYON, France, May 2, 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 first quarter ended March 31, 2024, before the markets open on Thursday, May 16th, 2024. 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.

EDAP to Announce First Quarter 2024 Financial Results on May 16, 2024

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 Association Annual Meeting (AUA 2024), which is taking place from May 3-6, 2024, in San Antonio, Texas, USA.

EDAP Announces Final Results from HIFI Study Comparing Outcomes of Focal One® HIFU Versus Radical Prostatectomy to be Presented During Plenary Session at the Upcoming 119th American Urological Association (AUA) Annual Meeting

EDAP TMS (EDAP) Q4 2023 Earnings Call Transcript

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 27th, 2024. 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.

EDAP to Announce Fourth Quarter and Full-Year 2023 Financial Results on March 27, 2024

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 34th Annual Healthcare MedTech & Services Conference, which is being held virtually from March 12-13, 2024.

EDAP to Present at the Oppenheimer 34th Annual Healthcare MedTech & Services Conference

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 cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue.

EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis

LYON, France, February 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, today announced preliminary unaudited fourth quarter and full-year 2023 revenues.

EDAP Announces Record Preliminary Fourth Quarter and Full-Year 2023 Revenues

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 Focal One systems, inclusive of ten capital sales.

EDAP Announces Preliminary Fourth Quarter Record Focal One® System Sales and Placements

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.

EDAP Appoints Ken Mobeck, Global Chief Financial Officer, and Francois Dietsch, Global Chief Accounting Officer

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 positive opinion from HAS is an important milestone along the regulatory pathway of securing final reimbursement in France.

EDAP Announces Positive Opinion for Reimbursement from the French National Authority for Health (HAS) for HIFU treatment of Prostate Cancer

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.

News for EDAP TMS Stock (EDAP)