EDAP's Ablatherm-HIFU to be Showcased at 31st World Congress of Endourology

Planet edap Inc.
Oct 22,2013

EDAP's Ablatherm-HIFU to be Showcased at 31st World Congress of Endourology

LYON, France, Oct. 22, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that its high-intensity focused ultrasound (HIFU) for the treatment of localized prostate cancer, Ablatherm-HIFU, will be featured in multiple presentations addressing minimally invasive prostate cancer therapies and the successful evaluation of EDAP's device at the 31st World Congress of Endourology (WCE). Top level technical presentations will be made from key opinion leaders in urology, including Dr. Chaussy Christian, Department of Urology, University of Regensburg, Dr. Thuroff Stefan, Department of Urology, Klinikum Munchen Harlaching, and Dr. Sebastian Crouzet, Urologist at Edouard Herriot Hospital in Lyon, France. The WCE is scheduled to take place from October 22-26, 2013, in New Orleans, LA.

John Rewcastle, Ph.D., Medical Director of EDAP-TMS, commented, "The World Congress of Endourology is a marquee event in the urologic calendar. The clinical data to be presented evidence further recognition and adoption of HIFU and is the foundation of the increased interest. The presentations from Drs. Chaussy and Thuroff show the durability of the excellent long-term outcomes they published earlier this year. Importantly, they demonstrate that cancer control was achieved with an acceptable morbidity profile."

Marc Oczachowski, Chief Executive Officer of EDAP TMS, stated, "We are excited that the World Congress of Endourology meeting this year will have a significant focus on prostate cancer, and in particular, the use of high intensity focused ultrasound as a minimally invasive treatment option. Globally, people are becoming more aware of the prevalence of prostate cancer and efforts to identify the disease at an earlier stage are increasing.

"With the notable benefits of HIFU treatment, we believe demand will continue to grow as patients seek a non-invasive curative therapy that affords quality of life and is backed by solid clinical evidence. We look forward to the poster presentations from our colleagues which will demonstrate the successes we have achieved with the use of Ablatherm-HIFU in the treatment of localized prostate cancer."

Presentations and Posters:
Prostate Cancer Research
 
Wednesday, October 23, 2013 
Plenary Session
Prostate Cancer: Options and Management for Advanced Disease
Moderator: Christian Chaussy, M.D.
Salvage Treatment Options: HIFU
Christian Chaussy, M.D.
 
MP09-04 
Classification and Endoscopic Repair of Infravesical Obstruction After HIFU
Stefan Thueroff*, Munich, Germany,
Christian Chaussy, Regensburg, Germany
 
MP09-05
High Intensity Focused Ultrasound in Incidental Prostate Cancer — a Non-Invasive Curative Therapy
Stefan Thueroff*, Derya Tilki, Munich, Germany
Christian Chaussy, Regensburg, Germany
 
MP10-14 
Complete HIFU in Localized Prostate Cancer
Christian Chaussy*, Regensburg, Germany 
Derya Tilki, Stefan Thueroff, Muenchen, Germany
 
Thursday, October 24
Panel Discussion
Minimally Invasive Prostate Cancer Therapies
Moderator: Peter A. Pinto, M.D.
Panel: Sebastien Crouzet, Ph.D.; Thomas Polascik, M.D.; and Stephen
Scionti, M.D.
 
MP13-12 
Start of Salvage Treatment for Persistent Positive Biopsies after HIFU
Rafael Sanchez-Salas*, Dominique
Prapotnich, Paris, France, Fernando
Secin, Buenos Aires, Argentina, Eric
Barret, Francois Rozet, Marc Galiano,
Annick Mombet, Nathalie Cathala, Xavier
Cathelineau, Paris, France
 
MP20-09 
Evolution of Technology: Short-Term Outcomes with Integrated Imaging Ablatherm-HIFU
Rafael Sanchez-Salas*, Dominique
Prapotnich, Paris, France, Fernando
Secin, Buenos Aires, Argentina, Eric
Barret, Francois Rozet, Marc Galiano,
Annick Mombet, Nathalie Cathala, Xavier
Cathelineau, Paris, France
 
Friday, October 25, 2013 
MP25-20 
Holmium Laser Enucleation of the Prostate (HOLEP) Before High Intensity Focused Ultrasound (HIFU) for the Prostate Cancer Treatment: Our Experience
Antonio Salvaggio*, Angelo Cafarelli,
Donato Dente, Abano Terme (Padua),
Italy, Emanuele Cappa, Chieti, Italy,
Angelo Porreca, Abano Terme (Padua),
Italy

About Ablatherm-HIFU

Ablatherm-HIFU is an ultrasound guided HIFU device for the treatment of organ-confined prostate cancer. The device consists of a treatment module, a control table with a computer and a computer screen, and a diagnostic ultrasound device connected to the treatment module. After insertion of an endorectal probe, the physician visualizes the prostate and defines the area to be treated. The computer automatically calculates the optimum treatment distribution of lesions. During the treatment, the transducer automatically moves and fires at each predefined lesion until the entire area has been treated, while controlling and imaging the treatment in real time due to its integrated imaging system. Cell destruction by HIFU is accomplished by a combination of thermal and cavitation effects caused by focused application of piezoelectric-generated high-intensity ultrasound. The procedure is performed under general or spinal anesthesia.

Ablatherm-HIFU is cleared for distribution in the European Union, South Korea, Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia. As of December 31, 2012, more than 32,000 prostate cancer treatments successfully performed clinical outside the U.S. with Ablatherm-HIFU and results have been published in 60 peer-reviewed scientific publications.

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. 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 contains forward-looking statements that involve risks and uncertainties. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the FDA PMA review process, our ability to expand our U.S. operations and execute our growth strategy and the market potential for our medical technologies, as well asrisks 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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