On May 14, 2026 EDAP TMS S.A. (Nasdaq: EDAP) reported 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.
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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.
(Press release, EDAP TMS, MAY 14, 2026, View Source [SID1234665730])