EDAP's Focal One HIFU Device Approved by Health Canada
09 Enero 2015 - 7:40AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced that its Focal One HIFU device has been
approved by Health Canada. With this approval, the Company is able
to market the Focal One device for the treatment of prostate cancer
in Canada.
Marc Oczachowski, EDAP's Chief Executive Officer, commented,
"Health Canada approval of Focal One, our revolutionary tool for
the focal treatment of prostate cancer, represents an important
milestone for EDAP. Moreover, this is the first regulatory approval
for our Focal One device in the Americas, and a key step forward in
our overall regulatory strategy as we work to expand Focal One's
global footprint and bring our innovative cancer therapies to a
growing number of patients worldwide."
Oczachowski continued: "In the 18 months since we received EU
marketing approval, the enthusiastic response from the European
urology community has validated our belief in the potential of
focal therapy for prostate cancer and, more specifically, our Focal
One system. In a relatively short time, the technology has been
adopted by some of Europe's leading prostate cancer Hospitals. We
look forward to a similar reception as we establish our North
American presence via the Canadian market."
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
March 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:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
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