EDAP TMS SA Secures French Reimbursement for Prostate Cancer HIFU

TL;DR

EDAP TMS SA just got French reimbursement for its prostate cancer HIFU treatment - big win for patient access!

AI Summary

EDAP TMS S.A. announced on September 8, 2025, that its Focal One Robotic HIFU procedure for prostate cancer has received reimbursement under France's national universal health system. This significant milestone is expected to increase patient access to the Focal One treatment.

Why It Matters

This reimbursement allows more patients in France to access EDAP's Focal One HIFU technology, potentially boosting sales and patient outcomes for prostate cancer treatment.

Risk Assessment

Risk Level: low — The filing is a routine announcement of a positive regulatory development and does not present immediate financial risks.

Key Players & Entities

• EDAP TMS S.A. (company) — The company making the announcement.
• Focal One Robotic HIFU (product) — The specific medical technology for prostate cancer treatment.
• France (location) — The country where reimbursement was granted.
• September 8, 2025 (date) — The date of the announcement.
• KEN MOBECK (person) — Chief Financial Officer who signed the report.

FAQ

Filing Documents

• f6k_090825.htm (6-K) — 15KB
• 0001171843-25-005765.txt ( ) — 16KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Date: September 8, 2025 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER EDAP Receives HIFU Reimbursement for Prostate Cancer in France · Focal One Robotic HIFU procedure now covered under France's national universal health system · Reimbursement 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 Focal One Robotic HIFU procedure for eligible patients as a primary treatment of localized prostate cancer as well as a salvage treatment option following radiotherapy. "Securing reimbursement for Focal One in France represents an important commercial milestone for our company, allowing a significant number of prostate cancer patients access to an effective, non-invasive, treatment for managing their prostate cancer. Importantly, the positive results from the groundbreaking HIFI Study provided the critical scientific evidence to help secure reimbursement for Focal One," said Ryan Rhodes, Chief Executive Officer. "As one of the largest healthcare markets in Europe, we also believe that securing reimbursement in France is likely to accelerate reimbursement for Focal One Robotic HIFU in additional European countries. Over time, we anticipate additional emerging clinical evidence supporting the use of focal therapy in the management of prostate cancer will drive further adoption of Focal One. In addition to the HIFI study, we believe the Level 1 evidence from the FARP Study, which was

Forward-Looking Statements

Forward-Looking Statements In addition to historical information, this press release contains forward-looking Act") or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as "believe," "can," "contemplate," "could," "plan," "intend," "is designed to," "may," "might," "potential," "objective," "target," "project," "predict," "forecast," "ambition," "guideline," "should," "will," "estimate," "expect" and "anticipate," or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements include our expectations to enter into a credit facility with EIB, the size thereof, the timing thereof and the use of proceeds from such credit facility. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services. Other factors that may cause such a difference may also include, but

Forward-looking statements speak only as of the date they are made. Other

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking such information forms a reasonable basis for such statements, such information may be limited or incomplete. Company Contact Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 50 bconfort@edap-tms.com Investor Contact John Fraunces LifeSci Advisors, LLC (917) 355-2395 jfraunces@lifesciadvisors.com

View Full Filing

View this 6-K filing on SEC EDGAR