EDAP TMS S.A. Adds to Clinical Depth
EDAP TMS S.A. Adds to Clinical Depth
"These studies further demonstrate Ablatherm-HIFU specifically offers patients the ability to secure effective treatment for localized prostate cancer with a low risk of side effects as compared to other therapies, and do so without precluding other therapies if they should require more aggressive intervention strategies at a later time," said Raphael Varona, Medical Director of EDAP. "EDAP has consistently positioned itself as an excellent choice for patients not willing to undergo surgery, or not able to endure the rigors or surgery, and these studies provide even greater clarity that Ablatherm offers a highly predictable outcome across centers around the world through the careful refinement and parameters built to ensure the most appropriate application of HIFU to the patient case. These studies clearly reference the growing consensus for HIFU as a primary therapy in Europe as more doctors and patients are drawn to its unique benefit profile."
In a publication accepted in April 2006 by European Urology, the European Association of Urology professional journal, Laura Poissonier et al detailed a study of 227 patients treated at Edouard Herriot Hospital in Lyon, France from April 1994 to July 2003. Patients were treated by original prototype and the market launched Ablatherm-HIFU unit and showed a progression of success as the unit parameters were refined. Most patients were clinical stage T1C or T2, which corresponds to low risk cancers. Post-HIFU biopsies were negative in 86% of the patients across the entire study spectrum and 84% of patients reached a nadir PSA of less than 0.5 ng/ml. The study also demonstrated the elective combination of a TURP procedure prior to HIFU greatly reduced catheter time. Potency data measured from a subset of patients who volunteered to provide data demonstrated good potency preservation.
The study notes that a similar study population in Germany achieved a 93.4% success rate and median nadir PSA of 0.07 ng/ml by treating 146% of the prostate volume by overlapping treated areas without observing higher side effects than those reported in the Lyon study. The study notes the high success rate identifies HIFU as a competitive therapy against mainline choices with HIFU's rapid results obtained post treatment and no therapeutic impasse being significant advantages in considering treatment options.
A study accepted by Prostate Cancer and Prostatic Diseases in June 2006 details the experience of Samsung Medical Center at the Sungkyunkwan University Medical Center in Seoul, South Korea from its initial Ablatherm-HIFU treatment launch. The study observes these newly trained users obtained in a single treatment population of 58 patients stage T1 and T2 and unwilling or unable to undergo surgical care. The outcomes showed an 85% success rate in low risk cases after a single treatment, consistent with results obtained in larger clinical studies of 288 and 146 patients each at experienced Ablatherm-HIFU research sites. The median nadir PSA was 0.2 ng/ml reached within a mean of eight weeks post treatment. Patients who did not achieve success in a single treatment session were able to elect for an additional HIFU session, or choose from watchful waiting, hormone or radiation courses.
A third study accepted May 2006 by the World journal of Urology assesses the repeatability of HIFU therapy by comparing side effect risks between primary treatment and follow-up treatment cases. The study compares the occurrence of urinary tract infections, chronic pelvic pain, obstruction, incontinence and impotence for both populations. Of importance is the unique dedicated parameter designed for Ablatherm-HIFU retreatment cases to adjust for the unique heat diffusion properties of tissues previously treated in order to limit side effects. Of the 223 patients, 39% were not eligible for surgery and 61% electively opted out of surgery due to high side effect risks. 174 patients were successfully treated with a single session while another 49 patients underwent the initial plus a second HIFU session. The study demonstrates additional HIFU treatments in case of primary treatment failure for patients with localized prostate cancer are associated with only a minor increase in side effects. The objective is clearly to lower the rate of patients with residual cancer after initial HIFU treatment by refining patient selection and treatment modalities.
For more information on these articles and additional clinical data, please visit http://www.edap-hifu.com/ .and select "Physicians," then "HIFU-Ablatherm," then "Published Abstracts & Articles."
"These studies and others confirm our position as a new but important part of the prostate cancer treatment choices for patients in Europe today," said Hughes de Bantel, EDAP CEO. "EDAP continues to add to its marketing and education programs in key markets to help develop more centers offering Ablatherm-HIFU care and increase the number of patients seeking HIFU treatment. We are seeing early signs for success in these programs, which have just begun. We believe our continued expansion of the marketing efforts coupled with excellent clinical results such as those documented in these and other studies will continue to increase treatments in the coming months based on patient and urologist desire for an effective treatment with rapid recovery and low side effects."
About EDAP TMS S.A.
EDAP TMS S.A. 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. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
For more information on the Company, contact Halliburton Investor Relations at (972) 458-8000, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at http://www.edap-tms.com and http://www.hifu-planet.com.
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 yet FDA approved or marketed in the United States.