EDAP Receives European Approval for New Sonolith i-move Lithotripsy Device
2010年4月12日 - 10:00PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today the European approval of its new
lithotripter, the Sonolith i-move. The EDAP sales team and
distributors will begin marketing Sonolith i-move immediately and
will officially introduce the product to distributors, partners and
visiting urologists at the European Association Urology (EAU)
congress, Booth #14, from April 17-19, 2010 in Barcelona, Spain.
Leveraging EDAP's patented electroconductive technology,
Sonolith i-move is a compact, stand alone 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 targets the
largest lithotripsy market segment, offering a wide range of
treatment procedures for mid-size clinical sites and hospitals.
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
locatization systems.
In addition to the official launch in Europe, EDAP is actively
working towards filing for regulatory approval of Sonolith i-move
in the U.S. and in Japan.
Hugo Embert, EDAP's ESWL Product Manager, commented, "With the
addition of Sonolith i-move, EDAP is the only company in the
extracorporeal shock wave lithotripsy market covering all market
segments, offering the widest range of lithotripters, from standard
compact devices to high-end, fully integrated lithotripters. We
look forward to the official introduction of Sonolith i-move during
next week's EAU congress. This is the optimal forum for our sales
team and distribution partners to promote and market our latest
lithotripter. We encourage members of the urology community to stop
by our booth and experience Sonolith i-move first hand."
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "The
launch of Sonolith i-move validates EDAP as a leader in the
development and innovation of high-end technology. Importantly, the
European approval highlights our ability to successfully navigate
regulatory processes and obtain approvals for multiple devices in
major global markets. We will continue to focus on providing the
most state-of-the-art, minimally invasive technologies for patients
and physicians."
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 and http://www.pcaresearch.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. 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. Ablatherm-HIFU treatment is
in clinical trials, but not FDA-approved or marketed in the United
States.
CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com
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