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Medical Forum / Diseases and Disorders / Prostate Cancer / April 2006

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HiFu -  10-Year Experience Shows Excellent First Indication    Outcomes

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c palmer - 21 Apr 2006 22:34 GMT
10-Year Experience for Treatment of Localized Prostate Cancer Presented
at EUA
Experience Shows Excellent First Indication Outcomes; Post Radiation
Salvage Therapy Demonstrates Preferable Outcomes Over Standard Options

LYON, FRANCE -- April 7, 2006 -- EDAP TMS S.A. 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.

The treatment is performed transrectally, generally under spinal
anesthesia. A probe is placed in the rectum. This probe emits a beam of
high intensity convergent ultrasound. In the point where the ultrasounds
are focused (focal point) the sudden and intense absorption of the
ultrasound beam creates a sudden elevation of the temperature (from 85
to 100°C) which destroys the cells located in the targeted zone.
The targeted zone destroyed by each shot is oval-shaped and measures
about 22 mm in height by 2 mm in diameter. Repeating the shots, and
moving the focal point between each shot, it is possible to destroy a
volume that includes the whole tumor.

The Ablatherm is approved for the EU, Canada, Russia and South Korea.
The Ablatherm is not available in the US where a clinical trial is
ongoing.

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."

SOURCE: EDAP TMS S.A.    

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
Leonard Evens - 22 Apr 2006 20:03 GMT
> 10-Year Experience for Treatment of Localized Prostate Cancer Presented
> at EUA
> Experience Shows Excellent First Indication Outcomes; Post Radiation
> Salvage Therapy Demonstrates Preferable Outcomes Over Standard Options

Unless I missed it, they don't seem to say anything about PSA recurrence
over time following this treatment.  Without knowing that, it is hard to
judge if this is a viable method of treatment.

> LYON, FRANCE -- April 7, 2006 -- EDAP TMS S.A. presented the 10-year
> Ablatherm(R)-HIFU European experiences and a review of results of
[quoted text clipped - 108 lines]
> invariably fatal. Prostate cancer is only sometimes so."
> http://community.webtv.net/PALMER_ENT/doc
c palmer - 22 Apr 2006 21:49 GMT
From: len@math.northwestern.edu (Leonard Evens)
c palmer wrote:

10-Year Experience for Treatment of Localized Prostate Cancer Presented
at EUA
Experience Shows Excellent First Indication Outcomes; Post Radiation
Salvage Therapy Demonstrates Preferable Outcomes Over Standard Options

Unless I missed it, they don't seem to say anything about PSA recurrence
over time following this treatment. Without knowing that, it is hard to
judge if this is a viable method of treatment.

========
hi leonard - you didn't miss it.  i didn't see it either.   they were
reporting the findings and of course, they are going to put a positive
spin on it.

~ curtis

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
 
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