EDAP Announces Reimbursement of HIFU Treatment for Prostate Cancer by France's Ministry of Health
April 21 2014 - 8:30AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today the reimbursement of prostate cancer
treatment procedures using High Intensity Focused Ultrasound
("HIFU") by the French health authorities. The French Minister of
Social Affairs and Health outlined the acceptance of HIFU treatment
for prostate cancer for reimbursement during a visit to the
Company's headquarters on April 18, 2014. Such reimbursement is
part of an innovative process to further validate breakthrough
therapies and to accelerate reimbursement process based on clinical
trials and data registries.
Pierre Reboul, EDAP's VP of France's Business Unit, commented,
"We are very pleased with the French authorities' decision to grant
reimbursement as they recognize the benefits of HIFU technology as
a treatment option for prostate cancer. HIFU treatment offers a
non-invasive approach to treating prostate cancer that minimizes
side effects such as incontinence and impotence, and therefore
allows patients to preserve their quality of life. We are grateful
for the support of the French Association of Urology ("AFU") for
initializing the reimbursement process that led to today's
recognition and reimbursement."
Marc Oczachowski, EDAP's Chief Executive Officer, said, "This
reimbursement is a major milestone for EDAP and its HIFU
technology. This recognition further validates EDAP's HIFU devices
for prostate cancer treatment and we look forward to working toward
increasing adoption of EDAP's HIFU technology in France and in
markets around the world."
Mr. Oczachowski continued, "We were extremely honored to welcome
the French Minister of Social Affairs and Health to EDAP's
headquarters last Friday. Mrs. Marisol Touraine came to see for
herself our technology and personally confirmed that she officially
signed for the reimbursement of HIFU treatment for prostate cancer
within the framework of her innovative technologies program."
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: 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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