EDAP TMS SA: Robotic HIFU Shows Safety in Endometriosis Study

TL;DR

EDAP's robotic HIFU therapy is looking safe in its Phase 3 endometriosis trial, good news for patients.

AI Summary

EDAP TMS SA announced interim results from a Phase 3 study on July 19, 2024, evaluating its Robotic HIFU therapy for deep infiltrating endometriosis. The therapy demonstrated an excellent safety profile, consistent with previous Phase 1 and 2 studies.

Why It Matters

This study's positive safety data could pave the way for a new, less invasive treatment option for women suffering from deep infiltrating endometriosis.

Risk Assessment

Risk Level: low — The filing is an interim update on a clinical trial, providing routine information without significant financial or operational changes.

Key Players & Entities

• EDAP TMS SA (company) — Registrant
• KEN MOBECK (person) — Chief Financial Officer
• July 19, 2024 (date) — Filing Date

FAQ

Filing Documents

• f6k_071924.htm (6-K) — 23KB
• logo.jpg (GRAPHIC) — 2KB
• 0001171843-24-004035.txt ( ) — 27KB

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: July 19, 2024 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU for the Treatment of Deep Infiltrating Endometriosis - 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. All patients were initially followed for three months after either the HIFU treatment or the Sham treatment. Interim results : · Robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis, confirming results from earlier Phase 1 and Phase 2 studies · While both arms of the study showed significant reduction in pelvic pain scores at three months from baseline as measured by Visual Analog Scale (VAS), the primar

Forward-Looking Statements

Forward-Looking Statements In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities 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 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 d

Forward-looking statements speak only as of the

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 statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe 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