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EDAP TMS SA, the global leader in therapeutic ultrasound, reported today successful completion of the first phase of the clinical protocol aimed at evaluating High Intensity Focused Ultrasound (HIFU) technology in patients with metastatic liver cancer.

HIFU has the potential to destroy liver tumors through ablation and to reduce bleeding during surgery.

In an initial preliminary protocol phase, six patients were successfully treated using a newly-developed HIFU tool delivering focused ultrasound to cancerous liver tumors. Clinical results observed fully conformed with those obtained in pre-clinical studies and validated HIFU as being an additional potential option to address liver cancer. More studies need to be implemented and EDAP, together with the clinical team from Lyon-based Centre Leon Berard and INSERM U556, will enter into a second clinical phase that will include a larger number of patients. This study is designed to further validate the performance of this new High Intensity Focused Ultrasound (HIFU) instrument in the treatment of liver cancer.

Pr. Michel Rivoire, Head of Digestive Cancer Surgery Department at Centre Leon Berard, Lyon, commented, "The initial phase of this clinical trial allowed us to confirm safety and efficacy of this new powerful device. All our clinical hypotheses have been confirmed and we were pleased to make these preliminary assessments in less than six months. After validation of these results by an external independent committee, we will begin the second phase of this trial that will be designed to demonstrate the ability and precision of this new tool to fully destroy liver tumors without inducing damage to normal surrounding liver parenchyma."

Marc Oczachowski, EDAP Chief Executive Officer, added, "We are very pleased with the performance of our HIFU technology in this early stage study addressing liver cancer. Our expertise in focused ultrasound, together with the close and long term relationship we have with INSERM in developing High Intensity Focused Ultrasound (HIFU) technology, should help in advancing future therapies. In the meantime, we remain fully focused on expanding the Ablatherm-HIFU activity for patients with localized prostate cancer."

The HIFU device was jointly developed by EDAP, Centre Leon Berard and INSERM Unit 556 with the financial support from the French organizations CLARA and OSEO that are dedicated to supporting innovative cancer treatment initiatives and technological innovation.

Source: EDAP TMS SA

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