Home
October 2008 November 2008 December 2008
Su Mo Tu We Th Fr Sa
Week 44 1
Week 45 2 3 4 5 6 7 8
Week 46 9 10 11 12 13 14 15
Week 47 16 17 18 19 20 21 22
Week 48 23 24 25 26 27 28 29
Week 49 30

EDAP Ablatherm-HIFU Presents at American Urology Association Accelerates US Study Enrollment Show Comments PDF Print E-mail
  
Tuesday, 29 May 2007

LYON, FRANCE (Press Release) - EDAP TMS S.A. (Nasdaq: EDAP), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, reports the continuing advancement of its clinical trial and education programs at the American Urology Association Congress in Anaheim May 19-22, 2007. EDAP's booth was well attended with inquiries about its Ablatherm-HIFU line for localized prostate cancer, currently in US clinical trials, and its well established lithotripsy business which unveiled the next generation lithotripter intended for European and USA sales.

"We received very strong interest from the urology community in both our newly unveiled Sonolith I-sys and the Ablatherm-HIFU's continuing strong clinical results," said Marc Oczachowski, CEO of EDAP. "The S.I-sys received high marks for its features and ease of use. With more than 25 years in the urology market, EDAP is a well known name. The S.I-sys will begin European delivery in September of this year. This device is designed to address the high demand needs of lithotripsy centers and support broader awareness of EDAP."

As announced previously, EDAP will accelerate its ongoing US clinical trial of the Ablatherm-HIFU device with strong awareness and outreach under its direction with full ownership of the study. Based on strong results recently released in Europe showing sustainable outcomes at 8 years and growing US interest in the clinical program by urologists, EDAP is currently fielding several inquiries from centers wishing to join the study and deploying greater resources to the clinical program. EDAP hosted its first investigator meeting since assuming full control of the study with strong support and commitment from the centers.

EDAP's participation in the AUA event included poster presentations on:

  • EDAP's ongoing long term clinical success including a video presentation of outcomes from the first 10 years of Ablatherm-HIFU therapy in Germany, attended by more than 300 urologists,
  • a cost comparison concluding Ablatherm-HIFU can be lower in cost than six common therapies such as robotic surgery, external radiation or brachytherapy, and
  • preliminary outcomes in a study of Ablatherm combined with hormone and radiation therapies for metastatic cancers and use of Ablatherm-HIFU as a documented salvage therapy option of proven success.

"EDAP continues the advancement of HIFU therapy in localized prostate cancer," said Oczachowski. "With the strong enthusiasm of our US clinical centers to conduct the Ablatherm US study more rapidly, we have every expectation of success in bringing Ablatherm-HIFU to American patients seeking high quality of life as well as effective treatment. Many of the best centers in the US have contacted EDAP with interest in joining the study as additional sites, and we are presently discussing options with them as well as securing the necessary approvals. In the interim, we continue to educate urologists on our study as well as the ideal indications making Ablatherm an established consideration for patients with localized prostate cancer."

The Ablatherm-HIFU Phases II/III clinical study is currently enrolling men diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer. HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue. Details of the study and background on Ablatherm-HIFU can be found online at www.clinicaltrials.gov by searching for "Ablatherm." The therapy generally requires one session of two to three hours and a minimum of recuperative time. Ablatherm-HIFU is proven effective comparable to other standard nonsurgical treatments of localized prostate cancer, but often with lower side effects. The highly robotized procedure offers clear statistically predictive outcomes without any impasse to future care if it should be required. Ablatherm is also the HIFU system with proven dedicated protocols for treatment of recurrent prostate cancer following failed radiation therapy.

(PRESS RELEASE)

Reader Comments

Please log-in or register in order to submit comments.

Powered by AkoComment!

 
User Rating: / 0
PoorBest


 
< Prev   Next >

Member's Section

Login

Sign Up

FAQ

Quick Search