New Collaboration Brings World’s First AI-Assisted Focal One Robotic HIFU Procedures

EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, and Avenda Health (“Avenda”), a leading AI healthcare company, today announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda’s groundbreaking AI technology, Unfold AI, to launch the world’s first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures.

Avenda Health’s Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care. Unfold AI builds 3D patient-specific cancer maps that reveal invisible tumor extent and enables physicians to avoid leaving cancerous tissue behind while sparing healthy surrounding tissue. By leveraging Unfold AI’s planning with the Focal One robotic HIFU platform, EDAP and Avenda believe that urologists can provide a more tailored, patient-specific HIFU ablation procedure for their prostate cancer patients.

“Incorporating AI technology into the diagnostics and treatment planning for patients with prostate cancer enables urologists to more accurately pinpoint the presence of tumor cells,” said Wayne G. Brisbane, M.D., Assistant Professor of Urology at The University of California Los Angeles David Geffen School of Medicine. “Having performed the first Focal One procedures utilizing data from Unfold AI, the seamless integration of these two technologies can precisely guide the ablation for optimized oncologic control without damaging healthy surrounding structures, hence minimizing the risk of side effects.”

We are pleased to enter into this collaboration with the Focal One team” said Shyam Natarajan, Ph.D., Chief Executive Officer of Avenda Health. “Unfold AI is a highly complementary technology that when combined with Focal One robotic HIFU, will enable urologists to map cancer effectively so that the entire tumor can be confidently eradicated. This exciting collaboration with Focal One represents a unique opportunity for Avenda to introduce our groundbreaking AI-technology to a broad community of leaders in the field of prostate cancer to further improve outcomes.”

We are excited to announce this unique and important collaboration with the highly talented team at Avenda Health during Prostate Cancer Awareness Month and congratulate Dr. Brisbane on successfully completing the first Unfold-AI assisted Focal One procedures,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “The combination of Avenda’s Unfold AI patient-specific cancer map with Focal One’s proprietary HIFUsion® software significantly augments a surgeon’s ability to combine existing diagnostic information and deep-learning algorithms to assist the urologist in creating a personalized precise treatment plan. AI-assisted procedures therefore represent an important and strategic next step in the evolution of the Focal One platform that will help us remain at the forefront of delivering the most advanced treatment solutions for patients with prostate cancer.”

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