EDAP TMS announces first patients treated in Phase I/II study of Focal One

EDAP TMS 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 technology for the treatment of benign prostatic hyperplasia. 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.