EDAP Outlines U.S. ENLIGHT Clinical Strategy
2010年4月26日 - 8:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced its strategy for the ongoing U.S.
ENLIGHT Ablatherm-HIFU clinical trial. Following the FDA
Gastroenterology and Urology Devices Panel in December 2009 and the
Company's January 2010 meeting with the FDA concerning its
recommendations for the trial protocol, the Company has thoroughly
evaluated all options aiming at an IDE submission in a feasible
timeframe and with acceptable economics. Based on input from its
clinical and regulatory advisors and with concurrence of the Board
of Directors, EDAP said it will discontinue enrollment in the
Ablatherm-HIFU study in the coming weeks and complete the required
2-year follow-up of all patients treated to that date. The
resulting data set, which will include outcomes from more than 100
patients, will form the foundation of a submission to the FDA,
which the Company expects to occur in 2012. The Company believes
that the submission of data from the patients treated in the U.S.
ENLIGHT trial, combined with the strong long-term data in Europe
where more than 22,000 Ablatherm-HIFU treatments have been
performed to date, and compared with the retrospective clinical
data on other therapies from existing registries, will provide a
strong clinical profile for FDA evaluation.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "As a
Company, we believe there is merit in this strategy as the most
practical option to move forward with our U.S. ENLIGHT clinical
trial, allowing us to complete the HIFU study in the timeliest
possible manner. We believe the data collected from the number of
patients that will have been treated in the U.S. with
Ablatherm-HIFU represents a valuable asset and, combined with our
abundant 10-year data on European patients, should form a strong
clinical background for our IDE submission."
Mr. Oczachowski continued, "Our U.S. clinical strategy not only
positions us to seek FDA approval in a timely and efficient manner,
but also optimizes the Company's financial resources. We will
continue to focus our efforts on bringing the Company to
profitability through strong global operating efficiencies and
business development initiatives. To date, more than 22,000
prostate cancer treatments have been performed with Ablatherm-HIFU
and we intend to further expand HIFU adoption through our RPP
model. Separately, we also continue our growth initiatives in
lithotripsy with our high-range Sonolith I-Sys device
which was recently approved in the key markets of Japan and the
U.S., as well as our new Sonolith i-move device that
was launched in Europe last week. "
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, the conclusiveness of the results of
and success of its Ablatherm-HIFU clinical trials and expectations
regarding the IDE submission to and approval by the FDA of the
Ablatherm-HIFU 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: 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
EDAP TMS (NASDAQ:EDAP)
過去 株価チャート
から 8 2024 まで 9 2024
EDAP TMS (NASDAQ:EDAP)
過去 株価チャート
から 9 2023 まで 9 2024