EDAP Highlights Recent UK NICE Positive Guidance for Focal Therapy Using HIFU to Treat Localized Prostate Cancer
07 June 2012 - 10:00PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced that the National Institute for Health and
Clinical Excellence (NICE), an independent organization that
advises the National Health Service (NHS) of the United Kingdom on
treatment and care, recently published guidance regarding focal
therapy using High Intensity Focused Ultrasound (HIFU) to treat
localized prostate cancer.
In its International Procedure Guidance 424 on focal HIFU, the
NICE guidance highlights the "potential for focal HIFU to avoid
many of the complications of more radical treatment procedures" for
localized prostate cancer in properly selected patients.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, said,
"NICE is a highly respected institution, and the positive guidance
they issued on the use of focal HIFU is a clear indicator of the
growing official recognition of HIFU in treating localized prostate
cancer. We are very pleased to see that NICE highlighted the strong
ability for focal treatment using HIFU to preserve patient quality
of life. This guidance further demonstrates the strong future of
the technology in the modern environment of prostate cancer
management."
Ablatherm-HIFU data has been presented at the 5th International
Symposium on Focal Therapy and Imaging in Prostate and Kidney
Cancer, held from June 6 to June 8, 2012 in Durham, North
Carolina.
Marc Oczachowski concluded, "Focal HIFU has been a major topic
of discussion at the Focal Therapy and Imaging Symposium this week.
Dr. E. Baco, from Oslo University Hospital, Norway, presented data
regarding successful outcomes as a result of treatment with
Ablatherm-HIFU for patients who failed radiotherapy. The study,
'Hemi salvage HIFU in patients with radiorecurrent prostate cancer'
demonstrated focal HIFU efficiency with a very good preservation of
patient quality of life, and further confirms targeted HIFU as a
satisfactory, non-invasive therapeutic approach in the treatment of
localized prostate cancer."
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.
Forward-Looking Statements
In addition to historical information, this press release
contains forward-looking statements that involve risks and
uncertainties. These include statements regarding the
Company's growth and expansion plans, the conclusiveness of the
results of and success of its Ablatherm-HIFU clinical trials and
expectations regarding the IDE submission to and approval by the
FDA of the Ablatherm-HIFU device. Such statements are based on
management's current expectations and are subject to a number of
uncertainties, including the uncertainties of the regulatory
process, and risks that could cause actual results to differ
materially from those described in these forward-looking
statements. Factors that may cause such a difference 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:
Stephanie Carrington
The Ruth Group
646-536-7017
scarrington@theruthgroup.com
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