EDAP Completes FDA Q&A Session for Its Ablatherm-HIFU Pre-Market Approval Application
21 March 2014 - 12:37AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that it has completed its response to
questions from the FDA regarding the Company's Ablatherm-HIFU
Pre-Market Approval ("PMA") application, closing this step within
the U.S. Food and Drug Administration ("FDA") review process.
Marc Oczachowski, Chief Executive Officer of EDAP TMS SA,
commented, "This is another significant milestone within the FDA
approval process for our Ablatherm-HIFU device. As per the standard
FDA review timeframe, the next step is an advisory committee
meeting that we expect to be held within the next four to six
months. We do not believe there will be any further questions
related to the filing or additional requests from the FDA prior to
the panel meeting. With this step behind us, we are focusing our
efforts to be fully prepared for the upcoming panel 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 statements00 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:
Stephanie Carrington /David Burke/Aaron Estrada
The Ruth Group
646-536-7017/7009/7028
scarrington@theruthgroup.com
dburke@theruthgroup.com
aestrada@theruthgroup.com
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