Mar 15 2013
EDAP TMS SA, the global leader in therapeutic ultrasound, announced today the launch of Focal.One®, its new and innovative robotic HIFU device fully dedicated to focal therapy of prostate cancer.
Focal.One® will be showcased for the first time at the European Association of Urology (EAU) 28th Annual Congress to be held in Milan, Italy on March 15-19, 2013 (booth # D41).
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "We are very excited to present to the urological community our latest HIFU technology bringing together many of the latest innovations to fulfill the focal strategy for the treatment of prostate cancer. Focal.One is the first and only device specifically designed to fully answer the need from urologists for a non-invasive, robotic device that fully addresses the quality of life preservation concerns of prostate cancer patients who are increasingly better informed about treatment options."
Focal.One is the first device dedicated to the focal approach for prostate cancer therapy. It combines the three essential components to efficiently perform a focal treatment: (i) state-of-the-art imaging to localize tumors with the use of magnetic resonance imaging (MRI) combined with real-time ultrasound, (ii) utmost precision of HIFU treatment focused on identified targeted cancer areas only and (iii) immediate feedback on treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging.
As the prostate cancer patient profile has evolved over recent years with earlier diagnosis and life expectancy significantly increasing, men with prostate cancer want to preserve their quality of life more than ever. Until today, those patients are mainly offered two options to address their prostate cancer: either a radical treatment approach with the surgical removal or irradiation of the entire prostatic gland, usually associated with high risk of side effects such as incontinence and impotence, or a "watchful waiting" approach with the monitoring of disease evolution through regular PSA testing and biopsies, usually associated with a high degree patient stress and anxiety ultimately resulting in the necessity for a radical treatment. Between "over-aggressive treatment" and "no treatment," there is definitely a need for a non-invasive therapeutic alternative that offers a control over the disease while focally treating the cancer tumors only.
Hugo Embert, Marketing Director of EDAP TMS, added, "We strongly believe that, in the upcoming years, the focal approach will become more and more prominent in the management of prostate cancer as it is already the case for other organs. This is the reason why we combined the latest imaging modalities with cutting-edge proprietary HIFU technology into one unique device, Focal.One. Thanks to the latest improvements of MR-Imaging in the diagnostic of prostate cancer, HIFU precision combined with a highly performing ultrasound tool to validate treatment efficiency, Focal.One is the first device that meets the need for an optimal focal therapy of prostate cancer while preserving patient quality of life."
Mr. Embert concluded, "By adding Focal.One to our well-established Ablatherm® device, we expanded our range of HIFU devices for localized prostate cancer and have now the capacity to answer a wide array of treatment options and to address every population of urologists by bringing them the right solution for their prostate cancer practice. This is unique to EDAP TMS and the result of many years of R&D expertise and HIFU clinical experience."
EDAP expects to file for CE mark for Focal.One in the second quarter of 2013 and to pursue commercial distribution in Europe thereafter. A global regulatory program will be implemented to pursue requisite approvals across key global markets.
Source: http://www.edap-tms.com/