EDAP Reports First US Cohort Study Results of Focal HIFU Prostate Ablation Shows Promising Outcomes
Clinical Results Presented at the Southeastern Section of the American Urological Association
Confirms HIFU's Safety, Efficacy and Benefits for Patients' Quality Of Life
LYON, FRANCE, AUSTIN, TX -- APRIL 3, 2018 - EDAP TMS (Nasdaq: EDAP) today announced that preliminary results of the first U.S. clinical cohort study of focal therapy, using the company's Ablatherm Robotic HIFU system for partial-gland ablation demonstrated promising outcomes for prostate cancer patients. Patients participating in the study, conducted by the University of Miami Miller School of Medicine, experienced fewer side effects of incontinence and impotence commonly associated with prostate cancer treatments such as surgery and radiation therapy.
In a presentation at the Southeastern Section of the American Urological Association (SESAUA) on March 22, 2018, lead investigators Bruno Nahar, MD and Dipen Parekh, MD showed the initial results of 50 patients enrolled in the study. All patients had been diagnosed with localized prostate cancer and were eligible for focal HIFU therapy, which involves ablating only the diseased part of the prostate, thus preserving healthy prostate tissue and minimizing common side effects.
The University of Miami was among the first medical institutions to acquire Ablatherm Robotic HIFU at the end of 2015 following FDA clearance of the device for prostate tissue ablation. Doctors initiated the clinical study to evaluate focal therapy using HIFU after European studies yielded encouraging short-term results.
"These men showed significantly fewer side effects, such as urinary incontinence and erectile dysfunction, compared to traditional whole-gland treatment like surgery and radiation," said Dr. Nahar. "Most importantly, focal HIFU ablation of the prostate showed promising oncological short-term outcomes, even in clinically-significant prostate cancer."