EDAP's HIFU and Lithotripsy Devices Highlighted at 29th Annual EAU Congress
April 10 2014 - 8:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced its participation at the European Association
of Urology (EAU) 2014 Annual Congress that will be held in
Stockholm on April 11-15, 2014. EDAP's HIFU and lithotripsy device
portfolio will be featured in multiple poster sessions.
John Rewcastle, Ph.D., Medical Director of EDAP TMS, commented,
"The EAU is one of the leading global events in the field of
urology. Clinical data that will be presented provides further
recognition and validation of HIFU for the treatment of prostate
cancer. Noteworthy is the interest generated among leading
clinicians for our Focal One® device. The presentations to be made
on Focal One showcase important milestones in the progression of
this device that received the CE mark in June of last year."
The scientific program will include seven poster abstracts
pertaining to clinical research by clinicians and scientists
utilizing Ablatherm HIFU and Focal One. EDAP's devices will be
highlighted in three continuing education courses pertaining to
prostate imaging, focal treatment of prostate cancer and an update
on stone disease. The Company will host live demonstrations at its
booth of both the Focal One and the Sonolith i-move devices. A
meeting of the @-Registry users will be held to provide data and
publication updates. The @-Registry is an approved global registry
of HIFU data from patients with HIFU. This meeting will include
discussions by significant luminaries within the European urology
community who are also experienced practitioners of
Ablatherm-HIFU.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "We are
proud that posters highlighting our Ablatherm-HIFU and Focal One
devices have been accepted for presentation at the upcoming EAU
Annual Congress. This is clear academic recognition of HIFU as
a valuable technology for treating prostate cancer and reflects
positively on the high level of research supporting Ablatherm-HIFU.
This is a key differentiator for EDAP, and reinforces our
established leadership in HIFU for the treatment of prostate cancer
both from a technological and a clinical standpoint."
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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