EDAP Completes FDA Inspection of Manufacturing Site
27 Juni 2014 - 2:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced that the U.S. Food and
Drug Administration (FDA) concluded its routine inspection of
EDAP's manufacturing site with no findings nor issuance of Form 483
observations.
Marc Oczachowski, EDAP's Chief Executive Officer, commented,
"This is another important step in the FDA PMA process for our
Ablatherm-HIFU technology. It confirms and validates EDAP's ability
to comply with high engineering, manufacturing and quality
standards. In parallel, our team remains fully focused on preparing
for the July 30, 2014 advisory committee meeting."
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
under an Investigational Device Exemption (IDE) granted by the FDA.
In February 2013, the Company introduced a new innovative HIFU
device, the Focal One® dedicated to focal therapy of prostate
cancer. Focal One® is CE marked but is not FDA approved. 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
http://www.hifu-planet.com.
Forward-Looking Statements
In addition to historical information, this press release may
contain forward-looking statements. Such statements are based on
management's current expectations and are subject to a number of
risks and uncertainties, including matters not yet known to us or
not currently considered material by us, and there can be no
assurance that anticipated events will occur or that the objectives
set out will actually be achieved. Important factors that could
cause actual results to differ materially from the results
anticipated in the forward-looking statements include, among others
the uncertainties of the U.S. FDA approval process, the clinical
status and market acceptance of our HIFU devices and the continued
market potential for our lithotripsy device. Factors that may cause
such a difference also may 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/Media:
David Burke/Aaron Estrada
The Ruth Group
646-536-7009/7028
dburke@theruthgroup.com
aestrada@theruthgroup.com
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