Confirmation of HIFU Position in Expanding Focal Therapy Trend in Prostate Cancer
Strong Recognition of EDAP's Expertise in Lithotripsy Innovation
LYON, France, March 25, 2011 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, reported today positive feedback from participation in the 26th Annual European Association of Urology (EAU) Conference, held in Vienna, Austria from March 18-21, 2011.
The EAU conference is the world's premier urology event with more than 14,000 urologists in attendance. All urinary pathologies and related existing and new innovative therapies were addressed and discussed.
A major topic at this year's meeting was the move to a focal approach in the treatment of prostate cancer. The change in prostate cancer patient profile to younger patients with a life expectancy of more than 15 years after diagnosis is irrevocably changing the treatment strategy and approach. This new generation of patients is not appropriate for radical surgery or other invasive alternatives, and not willing to accept a no treatment strategy. These patient trends are pushing the urology community to design a way of controlling the disease with a repeatable, multimodal and flexible technology. Ablatherm-HIFU meets these criteria and provides the most complete and adapted answer to the establishment of focal therapy.
The conference also provided EDAP with the opportunity to showcase its latest successful innovation, the Sonolith i-move lithotripter. Urologists have shown strong interest for this equipment, particularly its revolutionary infrared stereo-vision system to localize urinary stones in real-time. Live demonstrations of all innovative features of our Sonolith i-move were performed continuously at the EDAP booth during the three days of the exhibition. The EDAP booth was the most active and probably the most visited booth in the exhibition area. In addition to the strong attendance and visits of our existing customers and partners, the Company recorded more than 100 lead sheets from new contacts and projects.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "The reception EDAP received at this major medical event confirms our superiority and expertise in developing and offering new innovative medical devices. Our newly introduced range of lithotripters, Sonolith i-move and i-sys, benefited from the highest recognition from urologists as an innovator meeting their patient needs and expectations. We are confident that our unique innovation capability among lithotripsy players will support our continued growth as the market leaders and increase our market share."
"In HIFU, long experienced urologists and opinion leaders clearly addressed the issue of preservation of quality of life for patients with prostate cancer. Existing therapies, requiring total gland removal, result in major side effects, unacceptable to patients. HIFU is today regarded as the potential solution to focally treat the tumor only, while preserving patient's quality of life with an effective control of the disease."
Marc Oczachowski concluded, "We are encouraged by the strong and positive feedback received during this major medical event on our recent investments to consistently introduce new and innovative concepts, products and technologies to the urology community. This conference was very well attended and EDAP was very successful in attracting a significant number of delegates to see and discuss its technologies."
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, the ENLIGHT U.S. clinical study. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit , and.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans, the conclusiveness of the results of and success of its Ablatherm-HIFU clinical trials and expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference 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.
CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 bconfort@edap-tms.com Investors: Stephanie Carrington The Ruth Group 646-536-7017 scarrington@theruthgroup.com
