EDAP Appoints Top U.S. Urologist to Lead FDA HIFU Clinical Trial

Planet edap Inc.
Nov 16,2009

EDAP Appoints Top U.S. Urologist to Lead FDA HIFU Clinical Trial

LYON, France, Nov 16, 2009 (GlobeNewswire via COMTEX News Network) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that Dr. Inderbir S. Gill, professor and chairman of the Department of Urology at the Keck School of Medicine of the University of Southern California and founding director of the USC Institute of Urology will oversee the high-intensity focused ultrasound (HIFU) clinical trial being conducted at investigational sites in the United States. Dr. Gill, who began consulting with EDAP on March 15, 2009, will lead the current team of expert investigators and urologists participating in the trial.

"For the carefully selected patient with low-risk organ-confined prostate cancer, the concept of reliable, non-invasive ablation is powerful. HIFU presents such a possibility, i.e., delivering ablative energy in a controlled, reproducible manner to the prostate," said Dr. Gill. "In Europe, nearly 20,000 patients have already undergone HIFU treatment over the past nine years. This trial represents the first serious effort to evaluate the results of HIFU within the United States. As such, I look forward to this scientifically responsible and rigorous evaluation of HIFU in the U.S."

Dr. Gill is the previous chairman of the Department of Urology at the Cleveland Clinic. He is a renowned innovator in the field of minimally invasive urologic surgery and the most experienced laparoscopic/robotic surgeon in the U.S., with his team's experience now approximating 4,000 U.S. cases to date. Dr. Gill was also awarded the St. Paul's Medal by the British Urological Association (BAUS), the highest honor bestowed by the organization.

In addition to his clinical expertise, Dr. Gill is a distinguished researcher in novel robotic devices and image-guidance systems, augmented reality imaging, and innovative focal ablation therapies for prostate and kidney cancer. His team is developing and refining natural orifice and single-port laparoscopic surgery in urology, both innovative concepts towards scar-free surgery.

A prolific scholar, Dr. Gill has authored or co-authored more than 380 peer-reviewed scientific papers, 50 book chapters, and eight textbooks. He is on the editorial board of nine urologic journals and has been a visiting professor at more than 250 institutions and societies worldwide. He has performed live surgery demonstrations at more than 55 centers and was elected to the prestigious American Association of Genito-Urinary Surgeons in 2003.

Marc Oczachowski, Chief Executive Officer of EDAP TMS, added, "We are extremely pleased and excited Dr. Inderbir Gill has joined our U.S. clinical trial team to lead the team of investigators and support them actively in the current patient recruitment phase. His leadership and highly respected clinical reputation is key in the success of the enrollment program and therefore in finalizing, in the targeted timeframe, our HIFU clinical trial, heading to the Ablatherm HIFU FDA approval."

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 is currently undergoing evaluation in a multicenter 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 http://www.edap-tms.com, http://www.hifu-planet.com and http://www.pcaresearch.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. Such statements are based on management's current expectations and are subject to a number of uncertainties 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. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: EDAP TMS SA

CONTACT:  EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com
Nick Laudico
646-536-7030
nlaudico@theruthgroup.com

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