EDAP's HIFU Technology Highlighted at 12th International Symposium on Therapeutic Ultrasound

Planet edap Inc.
Jun 20,2012

EDAP's HIFU Technology Highlighted at 12th International Symposium on Therapeutic Ultrasound

LYON, France, June 20, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that its developments in High Intensity Focused Ultrasound (HIFU) were highlighted at the 12th International Symposium on Therapeutic Ultrasound (ISTU 2012), which took place from June 10-13, 2012, in Heidelberg, Germany. At ISTU 2012, EDAP's experts in HIFU technology presented their recent advances in the development of therapeutic focused ultrasound.

Top level technical presentations from EDAP's partner INSERM, a French public research laboratory, addressed the successful evaluation of HIFU technology in targeting liver cancer. One of these presentations, done in collaboration with Centre Leon Berard, a Lyon-based hospital dedicated to cancer treatment and research, discussed the evaluation of an ongoing clinical trial of HIFU in the treatment of liver metastasis.

Other data presented at the conference examined HIFU as a therapy for prostate cancer. One such poster examined data from large cohorts of prostate cancer patients treated with Ablatherm-HIFU over more than ten years, computed from a comprehensive clinical registry. The long term results confirm EDAP as the most advanced player in the use of HIFU to address prostate cancer.

Emmanuel Blanc, Chief Technology Officer of EDAP, commented, "We are pleased by the recognition at ISTU 2012 of EDAP's expertise in therapeutic ultrasound. We clearly noted a dynamic and positive trend in the number of HIFU developments presented at the Symposium, with a larger range of pathologies addressed than in previous years."

Marc Oczachowski, Chief Executive Officer of EDAP TMS, added, "ISTU 2012 confirmed the growing importance of HIFU and therapeutic ultrasound across the international medical community. Major advances in focused ultrasound, as highlighted by many scientific experts at ISTU 2012, are proving the urgent need to further develop these HIFU technologies for the benefit of cancer patients worldwide."

Presentations and Posters:

Prostate Cancer Research
 
- Presentation A-192: Locally recurrent prostate cancer after initial radiation therapy: results of a multicenter European study (418 patients)
A. Gelet(1), J.Y. Chapelon(2)
(1) Hospices Civils de Lyon, Urology and transplantation surgery, lyon, France, (2) INSERM unit 1032, laboratory of therapeutic applications of ultrasound, LYON, France
 
- Presentation A-305: Robotic transrectal high intensity focused ultrasound at 3 MHz in localized prostate cancer: Efficacy in 704 patients after 10 years
S. Thuroff(1), C. Chaussy(1)
(1) Harlachinger Krebshilfe e.V, HIFU Projekt, Munchen, Germany
 
- Poster A-149: Focused Ultrasound ablation of Localized Prostate cancer. Teen Years oncological outcomes and morbidity in 1078 consecutive patients
A. Gelet(1), J.Y. Chapelon(2)
(1) Hospices Civils de Lyon, Urology and transplantation surgery, (2) INSERM unit 1032, laboratory of therapeutic applications of ultrasound
 
- Poster A-207: Robotic High-Intensity Focused Ultrasound (rHIFU) for the Prostate Cancer Treatment
V. Solovov(1), M. Vozdvishenskiy(1), L. Shaplygin(1)
(1) Samara Oncology Center
 
- Poster A-377: Interest of Reference-less MR Thermometry for Monitoring Trans-rectal Prostate HIFU Sonication with Interleaved Electronic and Mechanical Displacement of the Focal Point
L. Petrusca(1), J. Ngo(2), M. Viallon(1), L. Brasset(3), E. Blanc(3), A. Murillo(2), V. Auboiroux(1), F. Cotton(4), J.-Y. Chapelon(2), R. Salomir(1)
(1) Geneva University Hospital, Radiology Department, (2)Inserm, U1032, (3)EDAP-TMS, (4)Department of Radiology, RMN Unit
 
Liver Cancer Research
 
- Presentation A-147: Clinical evaluation of a toroidal High Intensity Focused Ultrasound transducer used intra-operatively for the treatment of liver metastases
D. Melodelima(1), J. Vincenot(1), Y. Chen(2), A. Dupre(2), A. Gandini(2), J.-Y. Chapelon(1), M. Rivoire(2)
(1) INSERM, LabTAU - U1032, LYON, France, (2) Centre Leon Berard, Department of Surgery, LYON, France
 
- Presentation A-210: Toroidal Transducer With Two Large Focal Zones For Increasing The Coagulated Volume
J. Vincenot(1), D. Melodelima(1), A. Vignot(1), F. Chavrier(1), J.-Y. Chapelon(1)
(1) Inserm, U1032 ; Université de Lyon, Lyon, F-69003, France
 
- Presentation A-353: Effect of respiratory motion on intra-operative liver thermal therapy performed with a toroidal-shaped HIFU transducer
W.A. N'Djin(1), D. Melodelima(1), J.-Y. Chapelon(1), N. Miller(2), J. Bamber(2)
(1) LabTAU, INSERM U1032, Laboratory of Therapeutic Applications of Ultrasound, University of Lyon, Lyon Cedex 03, France, (2) Royal Marsden NHS trust and Institute of Cancer Research, Sutton, United Kingdom

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.

About ISTU

The International Society for Therapeutic Ultrasound (ISTU) is a non-profit organization founded in 2001 to increase and diffuse knowledge of therapeutic ultrasound to the scientific and medical community, and to facilitate the translation of therapeutic ultrasound techniques into the clinical arena for the benefit of patients worldwide.

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 CarringtonThe Ruth Group

         646-536-7017

         scarrington@theruthgroup.com
Source: EDAP TMS SA

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