EDAP Confirms Robotic Ablatherm(R)-HIFU Position as 'Must Have' Complement to Prostate Cancer Surgery at Two Major Scientific Conferences

Planet edap Inc.
Dec 08,2011

EDAP Confirms Robotic Ablatherm(R)-HIFU Position as 'Must Have' Complement to Prostate Cancer Surgery at Two Major Scientific Conferences

Ablatherm-HIFU Featured in Eight Presentations at World Congress of Endourology (WCE)

Ablatherm-HIFU Focal Treatment Advantages Showcased at First Montreal Conference on Focal Therapy

LYON, France, Dec. 8, 2011 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced that its best-in-class Ablatherm®-HIFU device and renewed lithotripsy product line were showcased at two recent international conferences. Eight presentations that support Ablatherm-HIFU's efficacy for the treatment of localized prostate cancer were featured at the 29th World Congress of Endourology and SWL (WCE), held November 30December 3 in Kyoto, Japan. At its booth at the First Montreal Conference on Focal Therapy for Prostate Cancer held December 2 — 3 in Montreal, Canada, EDAP presented the new positioning for robotic Ablatherm-HIFU as the 'must have' complement to prostate cancer surgery with its exclusive Canadian distribution partner Maple Leaf HIFU.

Marc Oczachowski, EDAP's Chief Executive Officer, commented, "At the WCE, we clearly saw a shift from the international urological community in the management of prostate cancer. A focal and customized treatment approach preserving patient potency and continence is preferable, versus a radical surgical removal of the whole prostate gland. Our Ablatherm-HIFU device is being viewed as the required tool for the focal therapy treatment approach. Our device was featured in eight presentations that garnered strong interest from the attending opinion leaders. The WCE also provided a forum for EDAP to conduct demonstrations at our booth for our innovative lithotripsy devices Sonolith i-sys and i-move, which were well received in Japan, the largest worldwide market for lithotripsy devices."

Mr. Oczachowski continued, "Considering the growing trend for focal therapy, the First Montreal Conference on Focal Therapy for Prostate Cancer was an opportune forum for EDAP. We saw strong and confirmed interest from international urologists in providing a new strategy for the management of localized prostate cancer that is more adapted to new younger patient profile. This focal treatment strategy will provide patients with accurate control of their disease and good preservation of their quality of life. Promising presentations on new and innovative imaging modalities to better target prostate cancer were delivered, as well as discussions regarding potential therapies to focally treat prostate cancer were conducted. We were pleased to confirm that HIFU is considered to be the best positioned technology for focal therapy given its technological precision and real world expertise, and more specifically Ablatherm-HIFU based on its unique experience and long term proven clinical data on focal therapy. This is a significant competitive advantage for us as it will likely take other therapies many years to garner a similar position to capitalize on that new trend."

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 (IDE) 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 (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 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, expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device and the market potential for the Sonolith i-move 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
Source: EDAP TMS SA

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