EDAP Receives U.S. FDA Filing Acceptance of Pre-Market Approval Application
Ablatherm(R)-HIFU PMA Application Proceeds to Substantive Review
LYON, France, March 28, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP),
the global leader in therapeutic ultrasound, announced today that the U.S.
Food and Drug Administration has provided a positive Filing Review
Notification on the Company's Pre-Market Approval (PMA) application for its
Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device
for the treatment of low-risk, localized prostate cancer. The FDA conducted a
filing review of EDAP's PMA, and found it to contain all of the information
needed to proceed with the substantive review, in which the FDA will evaluate
the safety and effectiveness of Ablatherm Integrated Imaging HIFU device, as
well as EDAP's engineering, manufacturing and quality systems.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "Receiving
FDA filing acceptance for our PMA in less than two months is both very timely
and a major milestone. We are moving forward in the PMA Review Process as the
agency commences its substantive review. We will continue to work closely with
the FDA review team."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® 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. Ablatherm-HIFU is approved and commercialized in Europe as a
treatment for prostate cancer, and is currently under regulatory review in the
U.S. following submission of the Pre-Market Approval application in February
2013 after the completion of a multi-center U.S. Phase II/III clinical trial
conducted under an Investigational Device Exemption (IDE) granted by the FDA.
The Company also develops its HIFU 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
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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