EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company's proprietary Focal One robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH).

"We've been offering targeted HIFU ablation to prostate cancer patients for more than 15 years," said Harry Toledano, MD, Head of the Urology Department of Martigues Hospital in Martigues, France. "Based on this large experience and the follow-up of hundreds of prostate cancer patients with their functional outcomes, we believe that the HIFU energy precisely delivered by Focal One has the potential to improve BPH symptoms with minimal side effects allowing a quick return to normal activities for a significant number of patients. We are enthusiastic to co-lead the first phase of this important clinical trial with our colleagues from Edouard Herriot Hospital – Lyon University and are looking forward to offering a new option to our BPH patients."

"We are excited to initiate this important clinical study evaluating Focal One robotic HIFU for the treatment of BPH, a condition which impacts millions of men each year," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. We believe Focal One is ideally positioned to deliver this type of treatment solution, and this clinical approach in addressing BPH represents a logical next step in expanding our technology beyond the application in prostate cancer. We also believe this study will serve as a foundation for initiating a BPH clinical study in the United States next year."

The Phase I/II study is a company-sponsored, prospective, multicenter clinical trial designed as a two-part study. Part 1 of the Phase I/II study will take place at two leading academic prostate treatment centers in France with a recognized expertise in the treatment of BPH as well as in the use of Focal One HIFU technology. Part 1 is designed to define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. Part 2 of the study will expand patient enrollment across a larger number of treatment centers in order to validate the safety and efficacy of the parameters as defined in Part 1 of the study.