EDAP Gains U.S. FDA 510(k) Lithotripter Clearance
August 03 2011 - 8:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced it has received marketing clearance from the
U.S. Food and Drug Administration (FDA) for its Sonolith i-move
device, a technologically advanced compact mobile lithotripter. The
U.S. FDA has cleared EDAP's Sonolith i-move device for
fragmentation of kidney stones, extracorporeal shock wave
lithotripsy procedures and endourology applications.
Marc Oczachowski, EDAP's Chief Executive Officer, commented,
"This FDA clearance is a major milestone for EDAP and its U.S.
business. The Sonolith i-move lithotripter is a technologically
advanced device with modularity and mobile capability. We believe
our Sonolith i-move is attractively positioned to take market share
in the U.S., the second largest lithotripsy market worldwide. Our
established U.S. sales and marketing organization has clearly
identified potential customers within this dynamic lithotripsy
market."
Marc Oczachowski added, "Our Sonolith platform offers both
patients and physicians innovative efficient technology to treat
urinary stones. The state-of-the-art technology and high level of
innovation brought by both the Sonolith i-move and i-sys devices
will enable us to renew our existing installed base of
lithotripters and to maximize opportunity to take market share from
the competition in the U.S."
Sonolith i-move is a compact lithotripter with a revolutionary
infrared stereo-vision system for real-time, three-dimensional
ultrasound localization of urinary stones. With its various modular
configurations, Sonolith i-move will replace Sonolith Praktis, an
earlier generation lithotripter, and complements the Company's
high-end Sonolith I-sys lithotripter, an integration of x-ray and
ultrasound localization systems. Sonolith i-move received European
(CE) approval in April 2010 and Japanese approval in June 2011.
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 multi-center U.S. Phase II/III clinical
trial under an Investigational Device Exemption (IDE) 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 (the Sonolith® range) 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, and http://www.hifu-planet.com.
Forward-Looking Statements
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, the conclusiveness of the results of
and success of its Ablatherm-HIFU clinical trials, expectations
regarding the IDE submission to and approval by the FDA of the
Ablatherm-HIFU device and the market potential for the Sonolith
i-move device. Such statements are based on management's current
expectations and are subject to a number of uncertainties,
including the uncertainties of the regulatory process, 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 and in particular, in the sections "Cautionary Statement
on Forward-Looking Information" and "Risk Factors" in the Company's
Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical
trials, but not FDA-approved or marketed in the United States.
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
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Aug 2024 to Sep 2024
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Sep 2023 to Sep 2024