EDAP Announces European Association of Urology Recommends HIFU for Treatment of Localized Prostate Cancer
April 24 2014 - 8:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced that HIFU for the primary treatment and
salvage therapy of localized prostate cancer are recommended by the
European Urology Association in its 2014 Guidelines released in
April at the EAU's Annual Congress held in Stockholm.
In the EAU Guidelines 2014 edition, HIFU is recommended for the
primary treatment of localized prostate cancer and received a "C"
recommendation grade. HIFU was not previously recommended nor
graded by the EAU. HIFU as a salvage therapy following failed
radiation therapy was recommended in the 2014 edition with a "B"
recommendation grade. In the 2013 edition, HIFU as salvage therapy
was recommended as an experimental treatment option without a
grade.
The EAU Guidelines aim to help improve clinical practice and are
based on a formal review of all of the evidence obtained from peer
reviewed publications. Based on the EAU's methodology, each
treatment is assigned a recommendation grade, which is not a scale
but rather reflects the types of studies used to evaluate the
treatment and make the recommendation.
John Rewcastle, Ph.D., EDAP's Medical Director, commented, "The
EAU Guidelines on Prostate Cancer are the primary reference for
urologists in Europe and many other countries and the primary
resource used to establish standards of care for the treatment of
prostate cancer. Inclusion in the treatment guidelines as a
recommended therapeutic option, which is based on clinical
evidence, further validates HIFU technology and the procedure as an
accepted clinical practice among health authorities and
urologists."
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "The
EAU's recommendation for HIFU both as a primary treatment and
salvage therapy clearly establishes HIFU as a standard of care for
prostate cancer. This is another substantial positive
recognition following the recently received reimbursement in
France."
Mr. Oczachowski concluded, "EDAP garnered strong visibility at
this year's EAU Annual Congress. Focal therapy was a
significant topic at the meeting having been featured prominently
in both the scientific sessions and the continuing education
courses. Our Focal One device is the key facilitator of this
targeted treatment approach. The live demonstrations of the
Focal One and Sonolith i-move devices in our booth yielded record
attendance."
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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