Leverages Growing U.S. Awareness and Demand for Minimally
Invasive Prostate Cancer Treatment to Drive Off-Shore
Market Potential
LYON, France, Jan. 30, 2012 (GLOBE NEWSWIRE) -- EDAP TMS SA
(Nasdaq:EDAP), a global leader in therapeutic ultrasound,
announced today that it has regained the distribution
rights for its Ablatherm®-HIFU treatment in Canada and the
Caribbean. In 2005, EDAP entered the North American market
with an exclusive sales agreement with Maple Leaf HIFU,
which has expired. The Company plans to leverage its
growing presence among U.S. urologists to expand the
off-shore potential of this non-invasive attractive HIFU
treatment option for prostate cancer patients that is not
yet available in the U.S.
EDAP will now, effective immediately, be in direct control
of leveraging the strong market potential across North
America as the demand for minimally invasive treatment of
prostate cancer and the preservation of patients'
quality of life continues to grow. American urologists and
patients will now benefit from direct access to our HIFU
technology through EDAP's surging U.S. presence. This
is a timely development as the Company receives more and
more requests for this treatment, which is not yet
available in the U.S.
EDAP has an increasing presence among U.S. urologists
through its sales and marketing network developed to
promote its FDA approved Sonolith range of lithotripters.
Based on these relationships, EDAP has become aware of the
opportunity to leverage these relationships to offer
treatment options to urologists and patients.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented, "We are most excited to leverage this
opportunity to provide patients in the U.S. with access to
our Ablatherm-HIFU technology through convenient offshore
locations. We now have a well-organized and active US based
EDAP Technomed subsidiary in charge of sales and marketing
geographically close to North American markets allowing us
to seize all opportunities and requests for
Ablatherm-HIFU."
Marc Oczachowski continued, "We are at the end of our
follow-up phase in our FDA approval process for the
Ablatherm-HIFU. We plan to submit our file to the FDA by
the end of 2012 and expect a response from the agency in
the early days of 2013. Retrieving the rights to all of
North America is a huge opportunity for EDAP to start
building the US market in both answering patients and
urologists needs with an off-shore solution and in
establishing its network of partners, users and customers
in the US. We are laying the foundation in advance of the
anticipated approval for our Ablatherm-HIFU."
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm®, the most
advanced and clinically proven choice 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.
Approved in Europe as a treatment for prostate cancer,
Ablatherm-HIFU (High Intensity Focused Ultrasound) is
currently undergoing evaluation in a multi-center U.S.
Phase II/III clinical trial under an Investigational Device
Exemption (IDE) granted by the FDA, the ENLIGHT U.S.
clinical study. The Company also is developing this
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.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington
The Ruth Group
646-536-7017
scarrington@theruthgroup.com
Source: EDAP TMS SA
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