EDAP Receives U.S. FDA Administrative Acceptance Review Notification for
Ablatherm(R)-HIFU Pre-Market Approval Application
PMA for Treatment of Low Risk, Localized Prostate Cancer
LYON, France, March 7, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today that the U.S. Food
and Drug Administration (FDA) has provided a positive administrative
acceptance review notification for the Company's Pre-Market Approval (PMA)
application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused
Ultrasound) device for treatment of low risk, localized prostate cancer. The
FDA conducted an administrative acceptance review of EDAP's PMA application
and found it to contain all of the necessary elements and information needed
to proceed with filing review.Based on the FDA PMA Review Process, the
administrative acceptance review is the first step in the multi-step process
and the next step is the filing review. Both of these reviews access the
completeness of the application and not the clinical outcomes of the study,
which begins after a positive filing review.
Marc Oczachowski, Chief Executive Officer of EDAP-TMS, remarked, "We are
pleased to continue to move through the PMA Review Process for the application
submitted for Ablatherm Integrated Imaging HIFU PMA.We look forward to
keeping investors informed as we continue to advance through the FDA process."
Ablatherm-HIFU is an ultrasound guided HIFU device for the treatment of
organ-confined prostate cancer. The device consists of a treatment module, a
control table with a computer and a computer screen, and a diagnostic
ultrasound device connected to the treatment module. After insertion of an
endorectal probe, the physician visualizes the prostate and defines the area
to be treated. The computer automatically calculates the optimum treatment
distribution of lesions. During the treatment, the transducer automatically
moves and fires at each predefined lesion until the entire area has been
treated, while controlling and imaging the treatment in real time due to its
integrated imaging system. Cell destruction by HIFU is accomplished by a
combination of thermal and cavitation effects caused by focused application of
piezoelectric-generated high-intensity ultrasound. The procedure is performed
under general or spinal anesthesia.
Ablatherm-HIFU is cleared for distribution in the European Union, South Korea,
Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico,
Argentina, Brazil and Russia. As of December 31, 2012, more than 32,000
prostate cancer treatments successfully performed clinical outside the U.S.
with Ablatherm-HIFU and results have been published in 60 peer-reviewed
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm(R), 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(R) 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.
In addition to historical information, this press release may contain
forward-looking statements that involve risks and uncertainties. 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
The Ruth Group
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