EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
22 Mayo 2014 - 7:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced that the U.S. Food and Drug
Administration (FDA) Gastroenterology and Urology Devices Panel of
the Medical Devices Advisory Committee will review the Pre-Market
Approval ("PMA") application for EDAP's Ablatherm-HIFU device for
the treatment of localized prostate cancer on July 30, 2014.
Marc Oczachowski, EDAP's Chief Executive Officer, said,
"Confirmation of this important milestone is great news for the
Company and its PMA application. The FDA provided us with a
worksheet that details the deadlines and documents to be prepared
and sent to the panel members for review ahead of the advisory
committee meeting on July 30, 2014. We are very excited to now have
a much clearer path toward FDA approval and the entire team at EDAP
is diligently preparing for this major event in the PMA application
process."
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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