EDAP TMS SA Announces FDA Breakthrough

TL;DR

EDAP TMS SA gets FDA nod for Focal One device, big win for prostate cancer treatment.

AI Summary

EDAP TMS S.A. announced on March 4, 2024, a significant breakthrough with the FDA for its Focal One device, marking a major step in prostate cancer treatment. This development is expected to enhance the company's market position in the electromedical apparatus sector.

Why It Matters

This FDA clearance for EDAP TMS SA's Focal One device represents a significant advancement in non-invasive prostate cancer treatment, potentially improving patient outcomes and expanding the company's therapeutic offerings.

Risk Assessment

Risk Level: low — The filing is a routine 6-K report providing an update, not indicating any immediate financial distress or significant negative events.

Key Players & Entities

• EDAP TMS S.A. (company) — Registrant
• Focal One (product) — Device for prostate cancer treatment
• FDA (organization) — Regulatory body
• March 4, 2024 (date) — Filing date
• KEN MOBECK (person) — Chief Financial Officer

FAQ

Filing Documents

• f6k_030424.htm (6-K) — 19KB
• logo.jpg (GRAPHIC) — 4KB
• 0001171843-24-001148.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: March 4, 2024 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER EDAP Announces FDA Breakthrough Device Designation for Focal One ® in the Treatment of Deep Infiltrating Rectal Endometriosis Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue. “Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches.” By definition, the FDA’s Breakthrough Device designation is granted to products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This unique program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and

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