Global therapeutic ultrasound leader EDAP TMS SA today announced the launch of its new robotic HIFU device, Focal.One, which is fully dedicated to the focal therapy of prostate cancer. For the first time, Focal.One will be showcased at the European Association of Urology (EAU) 28 Annual Congress, taking place March 15-19 in Milan, Italy.
“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,” said EDAP TMS CEO Marc Oczachowski. “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.”
The first device to be dedicated to the focal approach for prostate cancer therapy, Focal.One combines the three components that are essential to efficiently perform a focal treatment: state-of-the-art imaging to localize tumors, using magnetic resonance imaging (MRI) combined with real-time ultrasound; maximum precision of HIFU treatment, focused on identified targeted cancer areas only; and immediate feedback on treatment efficacy, utilizing Contrast-Enhanced Ultrasound Imaging.
As the profile for prostate cancer sufferers has evolved in recent years due to earlier diagnosis and considerable increase of life expectancy, men diagnosed with prostate cancer are even more keenly desirous to preserve their quality of life. Until now, prostate cancer patients were primarily offered two options to address their disease: a radical treatment approach involving surgical removal or irradiation of the entire prostatic gland – usually associated with high risk of side effects like incontinence or impotence; or a “watchful waiting” approach involving disease monitoring through regular PSA testing and biopsies – usually associated with a high degree of patient stress and anxiety, ultimately resulting in the need for radical treatment. Between “over-aggressive treatment” and “no treatment,” a need has existed for a noninvasive therapeutic alternative that offers control over the disease while focally treating the cancer tumors only.
“We strongly believe that, in the upcoming years, the focal approach will become more and more prominent in the management of prostate cancer, as is already the case for other organs,” said EDAP TMS Marketing Director Hugo Embert. “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.”
By adding Focal.One to its well-established Ablatherm device, EDAP has expanded its range of HIFU devices for localized prostate cancer and now has the capacity to answer a wide variety of treatment options and address every population of urologists by providing the right solution for their prostate cancer practices. Unique to EDAP TMS, this has been the result of many years of R&D expertise and HIFU clinical experience.
The company plans to file for CE Mark approval for Focal.One sometime in the second quarter of 2013. Following that, the company intends to pursue commercial distribution in Europe. A worldwide regulatory program will be implemented to pursue needed approvals across key global markets.
For more information, visit www.edap-tms.com or www.hifu-planet.com
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