EDAP TMS S.A. Presents 10-Year Experience for Treatment of Localized Prostate Cancer
April 07 2006 - 9:59AM
PR Newswire (US)
10-Year Experience Shows Excellent First Indication Outcomes; Post
Radiation Salvage Therapy Demonstrates Preferable Outcomes Over
Standard Options LYON, France, April 7 /PRNewswire-FirstCall/ --
EDAP TMS S.A. (NASDAQ:EDAP), the global leader in high intensity
focused ultrasound treatment of localized prostate cancer,
presented the 10-year Ablatherm(R)- HIFU European experiences and a
review of results of treatments dating as far back as 1995 on
patients who failed prior radiation therapy at a special dedicated
symposium during the European Association of Urology in Paris.
Conference response from the urological community has already been
exceptionally strong clearly supporting Ablatherm-HIFU as a therapy
of great interest for mainstream use on patients with localized
prostate cancer. The company will issue a complete report of the
EAU Congress events following the conference conclusion. Dr.
Francois-Joseph Murat of Edouard Herriot University Hospital, Lyon,
presented details of Ablatherm-HIFU results when used as salvage
therapy following external beam radiation therapy failure on more
than 150 patients between 1995 and 2006. Patients fail radiotherapy
treatment of localized prostate cancer at rates up to 50% and have
few current treatment choices, all with significant side effects.
Almost all patients are offered palliative care options -- designed
to reduce symptoms and slowing disease progression but not stopping
the cancer -- rather than curative solutions as surgery or
cryotherapy, which are difficult to use in these cases and present
substantial complications making them often undesirable. Dr.
Murat's study demonstrated Ablatherm-HIFU provided a 76.5 percent
negative biopsy rate and PSA back to normal in local tumor control
with low levels of side effects, especially as compared to
alternate therapy side effect rates. Control of the cancer was
highly correlated to the pre-radiation cancer risk level with those
patients at earlier stages showing the best outcomes. The results
also demonstrated that specific post-radiation failure protocols
introduced for Ablatherm-HIFU in 2002 reduced the occurrence of
fistulas to zero and lowered the occurrence of incontinence to
below surgery and cryotherapy incidence rates. This confirms
Ablatherm-HIFU as a preferable choice for both limiting side
effects and treating the cancer itself as compared to other options
with lower success rates and higher side effect occurrences. Dr.
Stefan Thuroff presented a discussion on efficacy, results and
safety covering 10 years of experience based on treatments at
University Hospital of Munich, Harlaching, Germany. The 10-year
experience with Ablatherm-HIFU in Europe clearly demonstrates the
clinical, technical and safety strength compared to other
treatments. In 2006 Ablatherm-HIFU is now fully accepted as a
treatment for localized prostate cancer, offering a minimally
invasive solution for patients with localized prostate cancer who
cannot undergo surgery or fail radiotherapy. Over the past 10
years, EDAP has been fully dedicated to enhancing the
Ablatherm-HIFU bringing average treatment times now to 95 minutes
following the introduction of the advanced imaging head. Also, the
company introduced nerve sparing applications that can preserve
potency in up to 85 percent of patients electing this option. A
review of the first indication patient data including patients
treated in 1996 shows incontinence in less than 2 percent of
patients and preservation of potency in 45 percent of patients
electing complete prostate treatment rather than nerve sparing
choices, comparing very well or better against traditional care
options. Dr. Thuroff's presentation reiterated negative biopsy
rates from 79.4 percent in locally advanced prostate cancer to 93.7
percent in localized low to medium risk prostate cancer cases. Dr.
Gail ter Haar of the Institute for Cancer Research at the Royal
Marsden NHSF Trust, Surrey, U.K., and a principal investigator of
HIFU technology on a global scale, presented an outstanding review
of HIFU principles and applications to date as well as a summation
of HIFU technology marketed today among which the Ablatherm is a
leading choice. Specifically, the Ablatherm-HIFU addresses the
localized prostate cancer market with its best-in-class integrated
imaging, industry-leading safety features and efficient treatment.
Dr. ter Haar's presentation concluded that HIFU is becoming a
choice in future therapies based on significant benefits including
its minimally invasive profile, repeatability, flexibility and
efficacy. "These results confirm Ablatherm-HIFU is the most
clinically advanced HIFU choice in treating localized prostate
cancer with excellent success, lower side effects and better
preservation of the patient's quality of life. The studies also
show Ablatherm-HIFU is fully capable of providing a curative
treatment choice for even patients in some of the most clinically
difficult situations of recurrence post radiation, where medical
professionals are often at an impasse of curative therapy," said
Hugues de Bantel, CEO of EDAP. "Our dedicated symposium event was
very well attended by urologists from around the world who are
attracted to EDAP based on our ability to provide clinical results,
complete training support and unparalleled clinical outcomes. EDAP
is the only HIFU provider to have 10-year experience in localized
prostate cancer treatment. Our outcomes compare well against all
established therapies. Urologists and oncologists are increasingly
inquiring about the option of offering Ablatherm-HIFU in their
clinic after seeing these demonstrated results, something no other
company can offer or represent. Our new marketing and education
programs continue to grow ever more interest and demand for
Ablatherm-HIFU." 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. The company is also developing this technology for the
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) 458-800, the Corporate Investor
Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web
site at: http://www.edap-tms.com/ . This press release contains, in
addition to historical information, 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 the 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 not
yet FDA approved or marketed in the United States. CONTACT: EDAP
TMS S.A. Hugues de Bantel - Philippe Chauveau Blandine Confort +33
4 78 26 40 46 Halliburton Investor Relations Matt Kreps - Geralyn
DeBusk 972 458 8000 DATASOURCE: EDAP TMS S.A. CONTACT: Hugues de
Bantel, Philippe Chauveau, or Blandine Confort, all of EDAP TMS
S.A., +33-4-78-26-40-46; or Matt Kreps or Geralyn DeBusk, both of
Halliburton Investor Relations, +1-972-458-8000, for EDAP TMS S.A.
Web site: http://www.edap-tms.com/
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