EDAP TMS SA Reports Record Q4 Focal One Sales

TL;DR

EDAP TMS SA crushed Q4 sales with 11 Focal One systems sold globally, record US procedures!

AI Summary

EDAP TMS SA announced preliminary record fourth quarter sales for its Focal One system, selling 11 units worldwide and achieving a record number of U.S. procedures. The company, headquartered in Vaulx-en-Velin, France, filed this report on January 13, 2025, with Ken Mobeck, CFO, signing off.

Why It Matters

This indicates strong market adoption and potential revenue growth for EDAP's key medical device, suggesting positive momentum for the company.

Risk Assessment

Risk Level: low — This is a routine 6-K filing providing preliminary sales data, not a significant event that inherently increases risk.

Key Numbers

• 11 — Focal One Systems (Preliminary record fourth quarter worldwide sales)

Key Players & Entities

• EDAP TMS SA (company) — Registrant
• Focal One® (product) — System sold
• Ken Mobeck (person) — Chief Financial Officer
• January 13, 2025 (date) — Filing date

FAQ

Filing Documents

• f6k_011325.htm (6-K) — 14KB
• 0001171843-25-000192.txt ( ) — 15KB

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: January 13, 2025 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER EDAP Announces Preliminary Record Fourth Quarter Focal One ® System Sales and Record U.S. Procedures Company Reports Preliminary Worldwide Record Fourth Quarter Sales of 11 Focal One Systems Record U.S. Fourth Quarter Focal One System Sales Record Number of U.S. Focal One Procedures, with Year-Over-Year Growth of 30% AUSTIN, Texas, January 13, 2025 -- EDAP TMS SA (Nasdaq: EDAP) ("the Company" or "EDAP"), the global leader in robotic energy-based therapies, today announced preliminary record Focal One Ò System sales for the fourth quarter of calendar year 2024. The Company experienced robust demand for its Focal One Robotic HIFU technology, reporting preliminary record fourth quarter of 11 Focal One Systems. "Our strong fourth quarter performance reflects the growing adoption of our industry-leading Focal One Robotic HIFU technology platform, which is fundamentally transforming how urologists manage prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP. "The number of Focal One procedures also continues to grow rapidly, underscoring the practice changing dynamics taking place as Focal One Robotic HIFU becomes a mainstream treatment option for patients with prostate cancer. As Focal One continues to grow, we also expect the recent publication of the groundbreaking HIFI study in the prestigious scientific journal, European Urology, will further drive awareness and adoption." "Entering 2025, our Focal One pipeline remains robust and strong, and we continue to expect a growing number of urology practices to adopt Focal One for men diagnosed with prostate cancer." The above information is preliminary and subject to completion of quarter-end financial reportin

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

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