• First Focal One^® procedure utilizing Cortechs.ai’s advanced MRI-imaging technology, OnQ Prostate, successfully performed at the University of California, San Francisco Prostate Cancer Center
• OnQ Prostate’s Restriction Spectrum Imaging (RSI) technology improves lesion localization and targeting for urologists performing Focal One Robotic High Intensity Focused Ultrasound (HIFU) ablation
• Reflects EDAP’s continued commitment to innovation and further validates Focal One as the leading focal therapy platform controlled by urologists  
  
  

San Diego, CA and Austin, Texas, February 6, 2025 - Cortechs.ai, an emerging leader in novel imaging solutions for prostate cancer care, and EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the successful completion of the world’s first OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the University of California, San Francisco (UCSF) Prostate Center. This milestone marks the first clinical application of OnQ Prostate’s patented RSI technology to guide focal therapy, demonstrating how advanced MR-imaging can improve lesion localization and targeting for urologists performing focal therapy.

As the only FDA-cleared solution for RSI-MRI, OnQ Prostate uniquely provides more detailed information about the tissue microstructure that can help urologists more confidently identify which patients are the best candidates for focal therapy and which lesions should be targeted. Additionally, OnQ Prostate integrates seamlessly into these focal therapy systems, allowing for real-time precision targeting during the procedure to maximize likelihood of successfully ablating the desired area.

“OnQ Prostate very clearly delineated the tumor anatomy in this case, and helped us map out a relatively complex treatment plan for our focal therapy patient” said Dr. Matthew R. Cooperberg, M.D., M.P.H, Professor of Urology at the University of California, San Francisco, who performed the Focal One procedure on Tuesday, January 28th, 2025. “I am quite optimistic that this technology will help improve and standardize prostate MRI interpretation in multiple contexts across the prostate cancer journey.”

“This milestone at UCSF underscores the critical role our advanced imaging plays in empowering urologists to deliver more precise, personalized treatment,” said Kyle Frye, CEO of Cortechs.ai. “We are committed to driving meaningful advancements in prostate cancer care, ensuring that both physicians and patients benefit from enhanced precision at every stage of the treatment journey.”

“We are pleased to be partnering with the Cortechs.ai team in the integration of OnQ Prostate with Focal One Robotic HIFU,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This new clinical offering further demonstrates our ongoing commitment to expand the capabilities of Focal One to assist urologists in the delivery of a precise, patient-specific treatment to their prostate cancer patients.”

Focal therapy for prostate cancer is an emerging approach that aims to ablate clinically significant disease while preserving healthy tissue, reducing the side effects associated with whole-gland treatments. For urologists performing focal therapy, the ability to precisely localize lesions is critical to achieving successful oncologic control while minimizing damage to surrounding healthy tissue. OnQ Prostate enhances this process by enhancing lesion conspicuity, allowing for more informed patient-selection and treatment planning.

As focal therapy becomes increasingly integrated into prostate cancer care, Cortechs.ai remains at the forefront of developing solutions that support urologists in delivering more effective, evidence-based, and minimally invasive treatment strategies.

About Cortechs.ai

Cortechs.ai is a leader in AI applications in radiology, leveraging advanced technologies in medical imaging to enhance disease screening and early detection, empowering healthcare providers to deliver better outcomes for patients. The company develops and markets innovative medical device software that quantifies and tracks neurodegeneration and prostate cancer, helping clinicians detect and monitor clinically significant cases. Cortechs.ai’s industry-leading imaging solutions offer radiologists, oncologists, and urologists a streamlined, cost-effective way to assess prostate health, including detection and monitoring of cancer. The company also has FDA-cleared products for use in assessing neurological disorders such as Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, tumors, and other brain abnormalities. For more information, please visit www.cortechs.ai and follow us on Twitter, LinkedIn, and Facebook.

About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One^® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.

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 Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

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.

Coretechs.ai contact:
Michi Sassa, Chief Financial Officer
msassa@cortechs.ai
+1 858 459 9700

EDAP TMS Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

EDAP TMS Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com