EDAP Secures Market Clearance for Its Sonolith(R) Lithotripters in Major Asian Markets
June 14 2011 - 9:37AM
-- Latest and Modular Model, Sonolith®
i-move, is Now Approved in Japan --
-- Fully Integrated and Robotized Model,
Sonolith® i-sys, is Approved in Taiwan --
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today the approval of its Sonolith® i-move
lithotripter by the Japanese Health Authorities allowing for the
marketing of EDAP's innovative Sonolith i-move lithotripter in the
Japanese territory. EDAP also announced today the approval of its
Sonolith® i-sys high-end integrated lithotripter in Taiwan.
Japan lithotripsy market ranks number one worldwide with the
largest number of installed lithotripters. With Japanese
Authorities granting EDAP with marketing approval for its latest
Sonolith i-move device, EDAP will now offer a complete range of
innovative lithotripters to Japanese hospitals and clinics, going
from a compact, modular and flexible Sonolith i-move concept to a
fully integrated robotized high-end Sonolith i-sys device. EDAP's
dedicated and experienced direct sales force is fully committed to
address the Japanese market where there is a strong orientation
towards innovation and state-of-the-art technologies.
With the addition of EDAP's Sonolith i-sys approval in Taiwan,
EDAP will further expand its activities in this mature market,
which accounts for more than an estimated one hundred installed
lithotripters. Sonolith i-sys will be distributed in Taiwan by
Lotus Meditec, a well-established partner with expertise in
lithotripsy and a very successful track record in the field thanks
to their long term experience in the market. The Taiwanese Health
Authorities are currently reviewing the marketing application for
EDAP's next generation lithotripsy device, Sonolith i-move.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented, "We are very pleased to receive these approvals for both
our Sonolith i-move and Sonolith i-sys lithotripters for their
marketing in major Asian lithotripsy markets. Our renewed product
range inclusive of Sonolith i-move lithotripter is now approved in
nearly all markets offering non-invasive high-standard treatments
to patients around the globe suffering from urinary stones."
Marc Oczachowski continued, "It further validates EDAP's focused
strategy aimed at expanding our business through innovation
programs and regulatory approvals. This leads to gaining market
share for our renewed range of lithotripters in major markets
worldwide, supported by dedicated sales force and distribution
partners."
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
http://www.edap-tms.com, http://www.hifu-planet.com.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington
The Ruth Group
646-536-7017
scarrington@theruthgroup.com
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