EDAP TMS Focal One HIFU Shows Promise vs. Surgery

TL;DR

EDAP TMS's Focal One HIFU beats surgery in massive prostate cancer study.

AI Summary

EDAP TMS S.A. announced on December 4, 2024, that the Landmark HIFI Study, the largest prospective, comparative, multi-center clinical study ever conducted with 3,328 participants, demonstrated positive outcomes for its Focal One® Robotic HIFU treatment compared to surgery for prostate cancer management.

Why It Matters

This study's findings could influence treatment decisions for prostate cancer, potentially favoring less invasive robotic HIFU procedures over traditional surgery.

Risk Assessment

Risk Level: medium — The filing is a routine report of a clinical study publication, but the success of the technology impacts future revenue and market share.

Key Numbers

• 3,328 — HIFI Study Participants (Largest prospective, comparative, multi-center clinical study for prostate cancer treatment.)

Key Players & Entities

• EDAP TMS S.A. (company) — Registrant and developer of Focal One®
• Focal One® (company) — Robotic HIFU treatment system
• KEN MOBECK (person) — Chief Financial Officer
• 3,328 (dollar_amount) — Number of participants in the HIFI Study

FAQ

Filing Documents

• f6k_120424.htm (6-K) — 15KB
• 0001171843-24-006717.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: December 4, 2024 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER Landmark HIFI Study Publication Demonstrates Positive Outcomes with Focal One Robotic HIFU Versus Surgery in the Management of Prostate Cancer 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. The paper is entitled "Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial" and is authored by Dr. Guillaume Ploussard from Department of Urology, UROSUD, Clinique La Croix du Sud, France. A link to the publication can be found here. "The publication of the HIFI study in European Urology will importantly serve to increa

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 demand for our devices and services. Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forwar

View Full Filing

View this 6-K filing on SEC EDGAR