EDAP TMS SA (Nasdaq: EDAP) has announced the treatment of the first patients in its Phase I/II clinical trial evaluating the Focal One® robotic high-intensity focused ultrasound (HIFU) technology for treating benign prostatic hyperplasia (BPH). The company, a global leader in robotic energy-based therapies, is sponsoring the multicenter, prospective study.
The Phase I/II study is structured in two parts. The first part will take place at two academic prostate treatment centers in France, both recognized for their expertise in BPH treatment and Focal One HIFU technology. This initial phase aims to define the optimal treatment parameters to effectively treat BPH and its related symptoms while minimizing side effects. The second part of the study will broaden patient enrollment across more treatment centers to validate the safety and efficacy of the parameters established in the first part.
Potential Benefits of Focal One HIFU
Harry Toledano, MD, Head of the Urology Department of Martigues Hospital in France, emphasized the potential of HIFU in BPH treatment. "We've been offering targeted HIFU ablation to prostate cancer patients for more than 15 years," he stated. "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."
Addressing Unmet Needs in BPH Treatment
Ryan Rhodes, Chief Executive Officer of EDAP TMS, highlighted the need for less invasive BPH treatments. "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," said Rhodes. He added that EDAP TMS believes Focal One is well-suited to deliver such a solution and that this clinical approach represents a logical step in expanding the technology beyond prostate cancer applications. The company also anticipates that this study will lay the groundwork for initiating a BPH clinical study in the United States next year.
About Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia (BPH), a condition affecting millions of men, involves the enlargement of the prostate gland, leading to lower urinary tract symptoms. Current treatments range from medication to surgery, but less invasive options that preserve the integrity of the urethra are highly desirable.
