Ablatherm-HIFU Adoption Growing Across Europe<BR>LYON, France,
May 17 /PRNewswire-FirstCall/ -- EDAP TMS S.A.
(Nasdaq: EDAP), the global leader in High Intensity Focused Ultrasound (HIFU)
treatment of prostate cancer, updates shareholders on continued success of its
marketing rollout across major European markets where EDAP is the top provider
of HIFU for localized prostate cancer.
"EDAP's strong efforts as the HIFU market leader in Europe are paying off
in center and treatment growth, especially in our Revenue Per Procedure
business where we reported strong growth in our recent first quarter results
per our commitment to regular updates on our progress," said Marc Oczachowski,
CEO of EDAP. "Ablatherm-HIFU is well positioned and accepted by the medical
community in major European markets. As the only HIFU provider with broad
market access at more than 150 centers and more than 12,500 treatments
performed to date showing the high repeatability of our outcomes, EDAP is
creating a new standard of care in localized prostate cancer with the
Ablatherm-HIFU."
EDAP operates across Europe and other markets where Ablatherm-HIFU is
approved. It is currently in the midst of a major marketing and education
program directed to the largest European medical markets on a local and
regional level. Ablatherm-HIFU uses focused ultrasound to destroy prostate
tissue without radiation or incision. The therapy generally requires one
session of an average of two 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. Ablatherm-HIFU is
currently in clinical trials in the US for future FDA approval.
Germany
EDAP is the clear leading provider of HIFU therapy in Germany, the largest
and most advanced HIFU market in Europe. EDAP is driving marketing and
education programs for both doctors and patients in Germany including
attendance at urology congresses, organization of specific Ablatherm-HIFU
symposiums and the company's first of its kind HIFU-Tour. Patient inquiries on
EDAP's HIFU-Planet.com web site doubled in the last two months and treatments
at existing sites are rising in response to these outreach programs.
In addition to ongoing strong launches of new mobile Revenue Per Procedure
(RPP) centers, EDAP also launched its newest fixed RPP center at Krankenhaus
Nordwest in Frankfurt. The center initially started services on a mobile RPP
basis in January 2004. Due to growing patient loads and consistent outcomes
the center advanced to a fixed RPP installation with a multiyear contract
providing guaranteed baseline levels of utilization.
Professor Becht of Nordwest stated: "After three years of positive
experience with Ablatherm-HIFU on a mobile basis for scheduling and
organization we are very comfortable with the method. Krankenhaus Nordwest has
now decided to install an Ablatherm on a fixed RPP basis. The reasons are very
good experiences using strict inclusion criteria of over age 65, PSA less than
10, and Gleason 6 or less among those with localized prostate cancer, risk
concerns for complications, or those where surgery is not applicable. The
fixed Ablatherm equipment opens up the opportunity to offer HIFU to our
patients without waiting time and makes our daily operating organization more
efficient to increase patient satisfaction."
France
EDAP's new centers in France during the first quarter include one of the
largest Urology departments in France, at Hospital Foch, Paris. Pr. Botto,
from Hospital Foch, commented: "I am very pleased to add Ablatherm-HIFU to our
portfolio of therapies offered to our patients with localized prostate cancer
who seek the best standards of care available to preserve their quality of
life. Ablatherm-HIFU reports the top outcomes available on HIFU in peer
reviewed literature, including multi-center studies, and the lowest occurrence
of side effects."
EDAP also opened its first fixed RPP site in France for private clinics at
Clinique du Parc Rambot, Aix-en-Provence, and at Clinique de la Chataigneraie,
at Clermont Ferrand.
Pierre Reboul, Director for France, commented, "We're clearly moving into
the private sector as we see a growing interest in response to patients
demanding therapy, a major step forward for EDAP. With no reimbursement in
France yet, the outstanding results and recognized benefits compelled private
clinics to add the Ablatherm to their treatment offering. As of today, we have
39 trained Ablatherm user sites, among which more than 26 are offering
treatment on a shared or mobile basis. Today in France, half of prostate
treatments are performed in private clinics. We are now seeing patients are
ready to pay to preserve their quality of life after they learn of the
tremendous outcomes available with Ablatherm-HIFU."
United Kingdom
EDAP is pursuing expansion in the United Kingdom through its growing
relationships with top UK centers, patient groups and the urology community.
The company engaged a specialized medical public relations agency to
vigorously build awareness of Ablatherm-HIFU in the UK among patients,
urologists and general practitioners. EDAP is organizing a Users' Group
Meeting for UK Ablatherm Users and a HIFU Tour in the second part of the year.
Already the company has 16 up-and-running Ablatherm-HIFU centers with multiple
trained staff in all sites across the UK, including 12 centers using services
on a mobile basis. With EDAP's strong efforts, now four private insurers are
reimbursing the HIFU procedure in the UK at strong values ranging from £10,500
and £12,000 per treatment package. Centers now include EDAP's first fixed RPP
center in the UK, the Capio Springfield Hospital in Chelmsford (Essex).
Mark Perry, UK Sales Manager, said: "We are very pleased with the progress
in the UK where EDAP has a strong start and significant accomplishments are
already paving the way toward our future successes. We still need to maintain
strong focus on the education of patients and doctors, which we will do with
the support of our agency. The dual offering of both lithotripsy and Ablatherm
creates excellent opportunities to visit urologists on quality platforms,
opening more doors for EDAP based on an established history of success and
innovative new standards of care."
Italy
EDAP concluded its first Italian HIFU Tour in major cities May 15
presenting Ablatherm-HIFU in Aviano, Milano, Genoa, Firenze, Rome and other
centers. As with the company's ongoing marketing programs, there is strong
interest in Ablatherm-HIFU from its long-term clinical base, consistent proven
methodologies and stable outcomes for both high efficacy and low side effects.
The company is following this initial interest through the conversion process
of awareness, education, commitment from the center, training and site launch.
As in Germany, in the UK and in France, EDAP will engage a local PR resource
to greatly increase awareness of Ablatherm-HIFU. The conversion process
generally takes several months, from which the center launches initial
service, then increases utilization toward higher levels.
EDAP also participated in the International Urology Meeting held in Sicily
with strong attendance at the Ablatherm-HIFU presentations by Dr. Thuroff. The
company's Italian business is growing strongly in line with expectations, and
continued growth in the RPP lines is anticipated as the company's marketing
efforts launch new centers. A number of centers are already training or
scheduled for training in advance of opening new fixed and mobile RPP centers
in Italy in the months ahead.
Europe
In other progress from around Europe, the company continues to advance in
launching Ablatherm-HIFU at centers in other countries. Aker Hospital in
Norway upgraded from an RPP unit to a purchased unit due to strong demand and
good outcomes. The center had established Ablatherm-HIFU over the course of
about 12 months, and is the largest prostate cancer center in Scandinavia.
EDAP has successfully launched services in Turkey, a new market for the
company with several procedures now completed at Turkish centers. The company
also continues training new doctors from Spain where the company recently
established services on the RPP basis.
"We are pleased with the progress from our dedicated marketing programs
and the early signs of success ahead from our continued hard work. These
results show it was clearly a good decision to implement the RPP strategy and
our marketing growth programs. Growth in treatments, especially RPP sessions,
is now the main metric to evaluate the success of EDAP. The per procedure
business emphasis builds a higher recurring revenue base for steady growth and
results as EDAP moves to profitability by the end of 2008. We will continue to
launch new centers and train more users to fuel Ablatherm-HIFU's clear march
toward standard of care that will, as anticipated, convert into performed
treatments. EDAP's position as the HIFU leader for prostate cancer in Europe,
with more than 96% of the European market being controlled by EDAP, is more
than ever reinforced."
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. 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. The company is also developing this technology for the potential
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 Magnolia Investor Relations
at (972) 801-4900, the Corporate Investor Relations Dept at
+33 (0)4 78 26 40 46 or see the Company's Web sites at http://www.edap-tms.com
and http://www.hifu-planet.com.
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In addition to historical information, this press release contains
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 these 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 in clinical trials but not yet FDA approved or
marketed in the United States.
CONTACT: EDAP TMS S.A. Magnolia Investor Relations
Blandine Confort Matt Kreps
+33 4 78 26 40 46 972 801 4900
SOURCE EDAP TMS S.A.