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EDAP TMS SA reports developments in robotic energy-based therapies and minimally invasive ultrasound medical devices. The company develops, manufactures, promotes, and distributes systems that combine imaging, robotics, and focused ultrasound, with news frequently centered on the Focal One robotic HIFU platform for prostate focal therapy.
Recurring EDAP updates include HIFU revenue, Focal One system placements, U.S. procedure volumes, clinical evidence for prostate cancer applications, FDA clearances, and product enhancements. News also covers the company’s non-core ESWL lithotripsy and Distribution activities, investor presentations, financial guidance, and board or committee changes affecting the France-based issuer’s Nasdaq-listed American depositary shares.
EDAP (Nasdaq: EDAP) signed a non-binding letter of intent with Telix Pharmaceuticals to explore joint clinical research and physician education in prostate cancer. The collaboration centers on integrating Focal One Robotic HIFU with Telix’s PSMA PET imaging to enhance diagnosis, treatment planning, and follow-up.
The parties may develop clinical studies and training for mutual customers in primary and salvage treatment settings. There are no financial commitments, no binding obligations to proceed, and the collaboration is not expected to materially impact EDAP’s financial results.
EDAP (Nasdaq: EDAP) will host an Investor Day on June 1, 2026, from 8:00–10:00 am ET. The event will feature the executive leadership team and a urologic surgeon specializing in focal therapy and Focal One HIFU.
Topics include growth strategy, long-term financial targets, expanding therapeutic indications, and innovation in focal therapy. Investors can register online and access a replay and slides on the Focal One investor relations website.
EDAP (Nasdaq: EDAP) reported first quarter 2026 results with record HIFU revenue of $11.6 million, up 78% year over year. The company sold 11 Focal One systems (+83% YoY) and U.S. procedures rose 53% YoY. Total revenue was $17.8 million.
Gross margin improved to 45.7%, operating loss was $7.4 million, and net loss was $9.1 million or ($0.24) per share. 2026 HIFU revenue guidance remains $50.0M–$54.0M.
EDAP TMS (Nasdaq: EDAP) published the HIFI-2 prospective multicenter study on salvage Focal One Robotic HIFU for prostate cancer recurrence after radiotherapy.
The dataset includes 531 patients across >30 centers, reporting 71% androgen deprivation therapy–free survival (ADT-FS) at 30 months, up to 84% ADT-FS in favorable subgroups, low severe complication rates, and preserved quality of life at 12 months.
EDAP (Nasdaq: EDAP) will release first quarter 2026 financial results before market open on May 7, 2026. A conference call and webcast with CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch is scheduled for 8:30 a.m. EDT the same day.
Investors can join via domestic and international dial-in numbers using passcode EDAP, or access the live webcast through the provided registration link.
EDAP (Nasdaq: EDAP) reported record fourth-quarter and full-year 2025 HIFU revenue, driven by higher Focal One system sales and U.S. procedure growth.
Full-year HIFU revenue rose 39% YoY; the company reiterated 2026 revenue guidance of $72.0M–$80.0M, with core HIFU revenue expected to grow 34%–45% YoY.
EDAP (Nasdaq: EDAP) will present at the Oppenheimer 36th Annual Healthcare MedTech & Services Conference on Wednesday, March 18, 2026. CEO Ryan Rhodes will deliver a virtual presentation and, with CFO Ken Mobeck, host one-on-one investor meetings from 12:00–12:30 PM ET. A live and archived webcast is available.
EDAP (Nasdaq: EDAP) will release fourth quarter and full year 2025 financial results before market open on Wednesday, March 25, 2026.
The company will host a conference call and webcast on March 25 at 8:30 a.m. EDT featuring CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch. Dial-in and webcast registration details are provided.
EDAP (Nasdaq: EDAP) announced the appointment of David Horn to its Board of Directors, effective February 11, 2026, and the departure of Glen French, effective February 10, 2026.
Mr. Horn will join the Audit Committee and Nominations Committee, bringing capital markets and medical device experience from roles at Seer, Morgan Stanley, RITA Medical Systems, and Chemdex.
EDAP (Nasdaq: EDAP) reported preliminary unaudited results showing record fourth-quarter and full-year 2025 HIFU revenue driven by increased Focal One system sales and growing U.S. procedure volume. Q4 2025 HIFU revenue is expected to be $12.9M–$13.3M and full-year 2025 HIFU revenue $36.7M–$37.2M, both company records. Q4 included a record 15 Focal One system placements and ~28% YoY growth in U.S. Focal One procedures. EDAP issued 2026 guidance of $50.0M–$54.0M HIFU revenue (36%–38% YoY growth) and combined non-core revenue of $22.0M–$26.0M. Results are preliminary and unaudited; final 2025 results expected in March 2026.