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Hifu Mind Warp Trivia

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Subject: HIFU mind Warp trivia
Date: 05/02/2008

For the last three days I have wrapped my mind around every bit of information I could find on HIFU for prostate cancer.  Most of the websites seem to be or state funding from the companies who make the two different machines, and the Dr's that use them.  Keeping that in mind I decided to look for the Dr's who have the most experience with how many men they treated using HIFU.  More experience = less room for error.  I also came up with a list of questions to interrogate the Dr's.  So here's what I just bounced off a Dr.  PLEASE do not quote me on my interpretation of the discussion.  I am three days into this so for those who are quite more researched please be kind.  These are my thoughts processed in my mind from my 15 conversation written in my words.  Ablertherm was the first machine used.  It's better for larger prostrates because the ultrasound "wave" hits a bigger area.  A smaller prostrate would be more difficult because it would hit outside the prostrate gland. Size matters with ablertherm.  Turp is sometimes done on men with bigger prostrates before ablertherm to shrink the prostrate because Ablertherm has size restrictions or rather specifications. Turp is done sometimes after either machine to shrink the swelling of the "shell" of the prostrate making it easier to urinate and pass the dead cells and tissues.  The ultrasound "wave" heats and destroys the whole prostrate gland and the tissues and cells all work there way out and pass with urine.  Slothing being the side effect.  A hollow shell of the gland is left.  Interesting.  Sonoblate  has been used on 10,000. men in the world since it came out.  The technology upgrades to the 500 software do not have a steep learning curve.  This Dr did 1500. procedures himself.  He said he has used the Ablertherm machine as well and an afterthought was how many times in the 1500 . did he use Ablertherm or were those men a separate number.  He was trained at University of Indiana and went to Europe for additional training.  Makes me think Urology in Indiana and HIFU certified in Europe possibly started using Ablertherm.  It seems like Ablertherm is used more in Europe.  Would the companies themselves keep up on Dr's for how many men they used their machines on?  I heard someone mention somewhere  A top 5 in HIFU urologists.  Where can you correctly find out who the top 5 are?  Top referred to as the most men personally treated.  Is the 2% risk of nerve damage a statistic from both machines or the Sonoblate itself?  Is the 2 % statistic from the updated software on the sonoblate machine (500)?  Who are the Dr's who have had the most experience on men that use one machine and the other?  Finally the “hollow” shell of the gland.  If the dead cells expel though the shell what happens inside.  Can it fill with fluids and or toxins overtime?  Its always difficult to talk with a Dr when you have little time to pull together all of your questions and thoughts.  Even when they are patient and informative there will always be the afterthought of why didn't I ask that. Any kind feedback with different thoughts or resources to get statistics on the most experienced Dr’s would be great.  I am meeting the Dr I spoke with today next week in person so I will have a whole new Mind warp Trivia…

Subject: RE: HIFU mind Warp trivia
Date: 05/02/2008
 04/10 09:03AM PRESS RELEASE: EDAP Adds World Renowned Cancer Center for Phase II/III Ablatherm-HIFU Clinical Trial
EDAP Adds World Renowned Cancer Center for Phase II/III
Ablatherm-HIFU Clinical Trial
LYON, France, April 10, 2008 (PRIME NEWSWIRE) -- EDAP TMS SA
(Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced
today that it has received Institutional Review Board (IRB) approval
for Memorial Sloan-Kettering Cancer Center in New York City to
participate in EDAP's ongoing Phase II/III clinical trial of
Ablatherm(r)-High Intensity Focused Ultrasound (HIFU). The trial
compares the outcomes of Ablatherm and Cryotherapy for the treatment of
low-risk prostate cancer. This IRB approval brings the total number of
active sites in the trial to 10 HIFU sites and 6 Cryotherapy sites.
"This clinical trial will evaluate the safety and efficacy
of HIFU for the treatment of prostate cancer," said Dr. James Eastham,
Attending Surgeon in the Urology Service at Memorial Sloan-Kettering.
"Results from Europe have been encouraging, and it is hoped that they
will be substantiated by this study and help further define the role of
the procedure both within the United States and around the world."
John Rewcastle, Ph.D., Medical Director of EDAP TMS,
commented, "Memorial Sloan-Kettering is one of the most respected and
active prostate cancer treatment sites in the world. Their
participation in the ENLIGHT study represents a significant milestone
for EDAP as accrual is expected to rapidly progress due to the large
prostate cancer patient population in Manhattan and the surrounding
boroughs."
Marc Oczachowski, EDAP's Chief Executive Officer, stated,
"We are extremely pleased to add a world premier center like Memorial
Sloan-Kettering to participate in the prospective non-inferiority trial
evaluating Ablatherm-HIFU versus Cryotherapy. As a major U.S. leader in
the treatment of prostate cancer, Memorial Sloan-Kettering further
validates the potential of our non-invasive approach to treating
localized prostate cancers and adds credibility to our technology
overall. We believe that the quality of participating sites in this
trial enhances EDAP's profile among urologists, which is supported by
the continued momentum for our patient awareness trial program to
accelerate our screening and recruitment of patients."
About the Study
The prospective non-inferiority study is designed to
evaluate the safety and efficacy of EDAP's Ablatherm-HIFU system versus
Cryotherapy for the treatment of low-risk, localized prostate cancer.
The clinical trial is currently enrolling men over age 60 diagnosed
with clinical stage T1a, b, or c or T2a localized prostate cancer. The
primary outcome measure of the trial will be a statistically
significant reduction and stability of the prostate-specific antigen
(PSA) throughout a 24-month follow-up period. Details of the study and
background on Ablatherm-HIFU can be found online at
www.ClinicalTrials.gov by searching for "Ablatherm."
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 multicenter U.S. Phase II/III clinical trial under an
Investigational Device Exemption granted by the FDA. 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 for treatment of urinary tract stones using
extra-corporeal shockwave lithotripsy (ESWL). For more information on
the company, please visit ,
or

-0-

CONTACT: EDAP TMS SA

Investor Relations / Legal Affairs:

Blandine Confort

+33 4 72 15 31 72

bconfort@edap-tms.com

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