LYON, France, Feb. 11, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq: EDAP ), the global leader in therapeutic ultrasound, announced today the installation of its Focal One device at the ESKULAP Private Hospital in Bydgoszcz, Poland. Focal One is the first robotic HIFU device dedicated to the focal approach for prostate cancer therapy. It combines the three essential components to efficiently perform a focal treatment: state-of-the-art imaging to localized tumors with the use of magnetic resonance imaging (MRI) combined with real-time ultrasound, utmost precision of robotic HIFU treatment focused only on identified targeted cancer areas, and immediate feedback on treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging.
EKSULAP has over 20 years of experience providing healthcare services in Poland. In 2012 it established its own hospital to provide minimally invasive procedures in various pathologies. With the acquisition of its first Focal One device, the Hospital is equipped to address localized prostate cancer with a focused therapeutic approach that will minimize patient side effects.
Prof. Stanislaw Molski, Director of ESKULAP, commented, "We are very excited about the integration of this Focal One HIFU device within our therapeutic arsenal, as it will provide our patients with an alternative to traditional therapies and will help to preserve the quality of their lives. With the recent acquisition of an MRI device in our hospital, we will be able to combine a highly efficient localization of patient cancer with this Focal One innovative ultrasound identification of tumors. The Focal One HIFU device is a unique treatment option for the management of localized prostate cancer and we look forward to utilizing this as part of our arsenal of innovative diagnostic and treatment options."
Marc Oczachowski, EDAP TMS Chief Executive Officer added, "Following the introduction of Focal One to the market last year, we are expanding our strategy with an additional placement in Europe. There is strong interest for such a focal therapeutic approach to treating prostate cancer. Our exclusive HIFU technology combined with MRI images and our dynamic fusion capability for an effective and precise ultrasound guidance of the robotic probe gives Focal One the unique capability to destroy cancerous cells while leaving the healthy part of the prostate untouched. There is indeed a clear need for less radical options in treating localized prostate cancer and we believe Focal One is the safe and unique solution that fits this need for both urologists and patients."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm ® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment, Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In February 2013, the Company introduced a new innovative HIFU device, the Focal One ® dedicated to focal therapy of prostate cancer. Focal One ® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith ® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com , and http://www.hifu-planet.com .
Forward-Looking Statements
In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others the uncertainties of the U.S. FDA approval process, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
ESKULAP hospital web page: www.szpitaleskulap.pl
Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 Investors: Stephanie Carrington /David Burke The Ruth Group 646-536-7017/7009
