EDAP Announces Launch Of New Focal One i Robotic HIFU System At Upcoming 120th American Urological Association Annual Meeting April 26-29 In Las Vegas, Nevada

• Focal One i expands HIFUsion® patient-specific imaging compatibility to include PSMA PET, ExactVu™ Micro-Ultrasound, along with AI-driven and intelligent algorithms including Unfold AI™ and OnQ™ Prostate
• Focal One i extends HIFUsion capabilities to integrate Koelis® 3D biopsy maps and DynaCAD Urology datasets
• Focal One i system will enable future capabilities including treatment streaming and recording, remote collaborative procedures and expanded clinical indications
  
  
   EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced the launch of the new Focal One i system at the upcoming 120th American Urological Association (AUA) Annual Meeting being held in Las Vegas, Nevada from April 26-29, 2025.

The Focal One i system incorporates important new features and enhanced capabilities including:

• Expanded HIFUsion compatibility including Prostate-Specific Membrane Antigen (PSMA) PET scans, ExactVu Micro-Ultrasound, Unfold AI® and OnQ Prostate®, as well as extended capabilities for Koelis 3D biopsy maps and DynaCAD Urology datasets
• Streamlined HIFUsion and treatment workflows with guided, step-by-step procedures designed to improve efficiency
• Onboard Video Libraries to facilitate sharing standard techniques and clinical best practices
• Integrated ability to stream and record Focal One i treatments as well as enabling remote proctoring and remote collaborative procedures

"The new features and design of the Focal One i system are based directly on the feedback from our customers, as well as anticipating the future needs of surgeons performing focal therapy. Voice of Customer feedback is clear that Focal One surgeons want to incorporate the latest diagnostic imaging modalities like PSMA PET and emerging AI- driven and intelligent algorithms to further personalize Focal One Robotic HIFU procedures," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "In addition, we believe Focal One's digital interface and fully robotic HIFU energy delivery design is uniquely suited to enable remote proctoring and remote collaborative procedures. Cleveland Clinic's successful achievement of the world's first remote transatlantic Focal One Robotic HIFU treatment from Ohio to Abu Dhabi serves as the first step in continued innovations that will allow Focal One surgeon experts to connect remotely and share their expertise. We also believe the Focal One i will allow more efficient and effective training and mentoring of surgeons while further broadening patient access to expert care."