EDAP TMS S.A. Reports Success, Rapidly Growing Interest at EAU Congress
April 11 2006 - 12:58PM
PR Newswire (US)
10-Year Experience Data and Salvage Therapy Studies Generate
Increased Interest LYON, France, April 11 /PRNewswire-FirstCall/ --
EDAP TMS S.A. (NASDAQ:EDAP), the global leader in high intensity
focused ultrasound treatment of localized prostate cancer,
experienced a significant upwelling of interest in
Ablatherm(R)-HIFU at the recently concluded European Association of
Urology Conference in Paris. The interest, generated from the 10
years of European experience in Ablatherm-HIFU, its recently
announced success as a leading salvage therapy option for radiation
failures and the company's fast growing presence throughout Europe
kept EDAP's booth continuously busy with large groups of urologists
inquiring about offering Ablatherm-HIFU in urology clinics around
the world. The Scientific Program of the Congress included seven
scientific posters on HIFU technology presented by several
scientists. All of the selected and approved abstracts on HIFU
related exclusively to the use of Ablatherm-HIFU, the clear global
leader. This strong interest for HIFU, and Ablatherm applied to
localized prostate cancer in particular, clearly demonstrate EDAP's
leadership and excellence in this field. Several of the scientific
posters related to the 10 years of Ablatherm- HIFU experience in
Europe. Dr. Thuroff, from Harlaching Hospital in Munich, presented
the first long-term tolerance and safety study on the use of
Ablatherm-HIFU for localized prostate cancer. The data, compiled
over a 10- year period and measuring 50 potential adverse events,
confirm the side effect profile of patients treated as first
intention therapy compared very favorably with established
treatment modalities. During the congress, success rates obtained
over the past 10 years were confirmed by different European user
sites such as Dr. Gelet, Lyon, France, Dr. Chaussy, Munich,
Germany, and Dr. Callea, Bari, Italy, with negative biopsy rates
ranging from 96% to 75% for low to intermediate risk cases. The use
of Ablatherm-HIFU over the last decade demonstrated a good balance
between high local efficacy and low therapy induced side effects,
making the Ablatherm a clear option for patients who are not
candidates for surgery or who wish to avoid related side effects.
Additionally, posters presented by two different user centers
addressed the use of Ablatherm-HIFU for patients showing a
recurrence of cancer after radiotherapy treatment. Radiotherapy
failures range from 30% to 50% of treatments. Dr. F. Murat, Lyon,
France, presented a cohort of patients who failed radiotherapy and
opted for an Ablatherm procedure as a salvage option, with success
rates ranging from 76.5% up to 84%, with limited side effects
compared to current treatment modalities. Dr. Bensadoum, Caen,
France, highlighted post-operative low side effects rates
associated with the use of Ablatherm-HIFU on patients who failed
radiotherapy. These two presentations concluded that with its
unique side effects to efficacy ratio, Ablatherm-HIFU was to become
the gold standard for external beam radiation failures. Rafael
Varona, Medical Director of EDAP commented, "Clearly there is a
fast growing consensus among urologists that Ablatherm-HIFU therapy
in particular offers significant advantages to a growing number of
patients bringing interest to previously unheard of levels.
Although there is a wide choice of treatment for localized prostate
cancer, Ablatherm-HIFU is a clearly compelling choice for patients
who are not candidates for surgery or who failed a radiotherapy
treatment. It is also an attractive option for men seeking a less
invasive therapy preserving their quality of life. Our clinical
results are not only the most extensive by a significant margin,
but also clearly show our outcomes, in terms of efficacy, to be at
levels rivaling all standard therapies." During the conference EDAP
also hosted a Symposium on Ablatherm-HIFU gathering more than 350
urologists, all existing and potential Ablatherm HIFU users. This
Symposium included presentations by significant luminaries within
the European urology community who are also experienced
practitioners using Ablatherm-HIFU. Following the Symposium all
participants together with all EDAP's worldwide agents and
distributors celebrated the 10 years of experience with
Ablatherm-HIFU. Strong proximity with early adopters of
Ablatherm-HIFU is a key to the long-term success of Ablatherm-HIFU
applied to localized prostate cancer. The European HIFU Club met on
Friday, April 7, with strong attendance reflecting the fast growing
interest for Ablatherm-HIFU. Lecture and discussion forums were
held on advances in the best-in-class Ablatherm-HIFU integrated
imaging system, preservation of continence and potency, treatment
of large-volume prostates, the comprehensive Ablatherm-HIFU
learning curve, HIFU history and patient discussions and concerns
in learning about Ablatherm- HIFU. The advanced integrated imaging
system launched by EDAP in April of 2005 is allowing users to more
completely visualize the prostate and directly apply energy to the
diseased prostate while offering the opportunity to see continuing
reduction in side effects. During the entirety of the conference,
the EDAP booth was lined with urologists seeking more information
on this treatment option, especially due to EDAP's highly flexible
per procedure model and supportive training program, which uniquely
allows urologists to quickly gain access to Ablatherm-HIFU
treatments while getting top results from the time they begin
offering the therapy. EDAP's rapidly growing per-procedure business
model reflects a clear understanding of the European clinical
setting and the Company's deep commitment to assist physicians in
offering this therapy to their patients. "Our reception at the EAU
Congress was by far the largest interest we have ever seen in this
therapy and clearly indicative of our entry to the ranks of
mainstream choices for localized prostate cancer," said Hugues de
Bantel, CEO of EDAP. "EDAP with the Ablatherm-HIFU is, without any
doubt, considered the global leader in HIFU therapy for localized
prostate cancer based on the strongest long-term clinical outcomes
available with the lowest side effects. Only the Ablatherm-HIFU can
demonstrate clear and thoroughly credible data from multiple
centers proving long-term efficacy of this treatment combined with
low side effects. The results on radiotherapy failures clearly
position Ablatherm-HIFU as the potential gold standard for
radiation failure patients. Our growing acceptance by the medical
and scientific communities across Europe and locations worldwide is
a clear acknowledgement of our focus on verifiable clinical
success, technological advancement and constant emphasis on
Ablatherm-HIFU training to give doctors the best course of HIFU
care available today." 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) 458-8000, 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., all at +33 4 78 26 40 46; or Matt
Kreps, or Geralyn DeBusk, both of Halliburton Investor Relations,
both at +1-972-458-8000 Web site: http://www.edap-tms.com/
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