EDAP Receives South Korean FDA Approval for Sonolith i-move Lithotripter
December 13 2010 - 9:54AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, reported today the approval of its new lithotripter
Sonolith i-move by South-Korean Food and Drug Administration
(KFDA).
South Korea is the second largest market in Asia for lithotripsy
devices after Japan. This approval marks another milestone in
EDAP's strategy to aggressively gain market share and reinforces
the Company's 24-year presence in the South Korean
market. Through the 24 years, the Company has
maintained its leading position as provider of high-end
lithotripter devices. EDAP has one of the largest lithotripter
installed base in South Korea, with more than 50 fully installed
devices.
Mr. Y.H. Park, Managing Director of EDAP's direct and wholly
owned representative office in Seoul, South-Korea, commented,
"EDAP's new Sonolith i-move, with its revolutionary infrared
stereo-vision system for stone localization and its modular
configurations, really positions the equipment to fully answer
current Korean hospital needs. Its innovative features will clearly
facilitate the renewal of our strong Sonolith Praktis installed
base. Sonolith i-move's superiority is definitively a huge and
unique advantage that will allow EDAP to take more market share
from the competition, hence strengthening our prominent position in
South Korea."
Marc Oczachowski, Chief Executive Officer, added, "The approval
of our new Sonolith i-move by the Korean FDA is another step
forward in introducing our innovative Sonolith i-move technology in
major markets worldwide. It also confirms our capacity to navigate
approval processes in various countries to further maintain our
leading position in major lithotripsy markets. As we successfully
advance in our regulatory milestones, we continue to make progress
in view of approval of our Sonolith i-move device by Japanese
authorities and US FDA."
The innovative Sonolith i-move is a compact and modular
lithotripter with a revolutionary infrared stereo-vision system for
real-time, three-dimensional ultrasound free line localization of
urinary stones. With its various and flexible configurations, the
Sonolith i-move offers a wide range of treatment procedures for
clinical sites and hospitals. Its patented and unique
electro-conductive technology has proved successful and
demonstrated the highest efficiency rates, thus definitely bringing
significant benefits to patients and users.
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 ENLIGHT U.S. clinical study. 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: EDAP TMS SA
Blandine Confort
Investor Relations/Legal Affairs
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
Stephanie Carrington
646-536-7017
scarrington@theruthgroup.com
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