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AUSTIN, Texas May 14, 2026 EDAP TMS S.A. (Nasdaq: EDAP) today announced that it has entered into a letter of intent with Telix Pharmaceuticals Limited ("Telix") to explore joint clinical research activities and physician education focused on the combination of EDAP's Focal One Robotic HIFU and Telix's PSMA PET imaging products in the management of prostate cancer.
The initial area of investigational focus is expected to study the combination of PSMA PET diagnostic imaging scans within the Focal One HIFU treatment workflow to optimize treatment planning, deliver a precise, image-guided focal therapy treatment, and monitor responses after treatment and during subsequent patient follow-up. This collaboration will be investigated in both the primary treatment setting as well as the salvage treatment setting after radiation therapy.
Based on early clinical experience integrating PSMA PET with Focal One HIFU and with the recently published prospective HIFI-2 study showing positive patient outcomes using Focal One to treat patients with recurrence after radiation therapy, this combination with Telix holds the promise to further improve patient outcomes.
"We are uniquely designed to enable the integration of PSMA PET imaging with Focal One's real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects," said Ryan Rhodes, EDAP Chief Executive Officer. "As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix's PSMA PET imaging agents and Focal One Robotic HIFU."
"Precision medicine requires precision treatment strategies," said Kevin Richardson, Telix Precision Medicine Chief Executive Officer. "As disruptive technologies continue to transform prostate cancer care, we believe PSMA PET imaging has the potential to play an important role in helping clinicians better inform treatment decisions across a range of minimally invasive and image-guided treatment approaches. We are excited to explore a collaboration with Focal One that may further advance personalized care for patients."
The parties may also explore clinician educational programs such as webinars, symposia, and training initiatives and clinical studies involving mutual customers managing patients with Telix PSMA PET imaging products and Focal One Robotic HIFU.
The parties may enter into more definitive agreements in the future. There can be no assurance that any specific initiatives or programs will result from this initial collaboration, and the letter of intent imposes no obligation on either party to enter into any such agreement. The parties have not made any financial commitments under the letter of intent, and the collaboration is not expected to have a material impact on EDAP's financial results.
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 introduced the Focal One® in Europe and the United States as a leading prostate focal therapy platform 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.
About Telix Pharmaceuticals Limited
Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Visit www.telixpharma.com for further information about Telix.
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, risks specific to the announced collaboration with Telix Pharmaceuticals Limited, including the possibility that the parties do not enter into definitive agreements, that any contemplated clinical or educational activities are delayed, modified, or do not occur, that anticipated benefits of the collaboration are not realized, 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, 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 10-K.
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.
Investor Contact
Louisa Smith
Gilmartin Group
investor.relations@focalone.com
