LYON, France, June 18, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it received CE Mark (European regulatory approval) for Focal.One ® , its new and innovative robotic HIFU device fully dedicated to focal therapy of prostate cancer. Focal.One was showcased as world premiere at the European Urology Association Congress in Milan, Italy on March 15-19, 2013.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "This is a significant regulatory achievement and a key milestone as we received EU market clearance for the first robotic HIFU device dedicated to a focal targeted treatment approach. This CE mark positions Focal.One for full commercialization in Europe and in many other countries. It confirms EDAP's expertise in managing R&D and regulatory programs successfully. I wish to deeply congratulate the EDAP team for their extraordinary efforts in bringing Focal.One to market in a timely manner."
Mr. Oczachowski continued, "Utilizing a focal therapy approach to target the cancer cells within the prostate gland for the treatment of prostate cancer is gaining wider acceptance across the international urological community. Combining into one unique HIFU device the latest imaging modalities, such as MRI localization and contrast-enhanced ultrasound control, with the ultimate dynamic focusing HIFU technology, Focal.One will offer an optimal focal therapy of prostate cancer while preserving patient quality of life."Focal.One is the first device fully 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. EDAP's unique and exclusive range of HIFU products, including Ablatherm Integrated Imaging and Focal.One, has now the capacity to offer a wide array of treatment options to patients with prostate cancer.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV