EDAP TMS S.A. (Nasdaq:
EDAP), the global leader in High Intensity Focused Ultrasound (HIFU)
treatment of prostate cancer, reports further intentions to accelerate its
clinical trial study enrollment with the upcoming addition of the McMaster
University Hospital near Toronto, Ontario, to the participating sites.
William L. Orovan, M.D., FRCSC, FACS, Professor and Chair Department of
Surgery McMaster University, Ontario, Canada has been treating Ablatherm
patients from North America at a private center since 2005.
"Ablatherm-HIFU is by far the best HIFU technology available with
excellent cancer control. It has proven to be the superior HIFU device from
the perspectives of precision, imaging capacity and safety," stated Dr.
Orovan. "The technique is simple, highly effective and clearly offers
tremendous advantages. In our experience over several hundred treatments,
we are extremely pleased with the outcomes, which match the clinical data
already widely reported in leading journals. Our patients have been very
satisfied with Ablatherm therapy, and most are able to resume normal
activity within 24 hours of treatment since Ablatherm is less invasive with
fewer side-effects."
"Ablatherm offers top safety protocols active throughout the robotic
treatment so the device stops application instantly if any parameter
becomes a concern, as compared to other devices requiring manual
intervention, which may not provide as rapid of a response for patient
safety," Dr. Orovan continued. "Considering that Ablatherm-HIFU is proven
repeatable and has no therapeutic impasse, this gives patients the most
complete ability to preserve quality of life and all medical options in
treating localized prostate cancer."
"This is another step in our stated plans to accelerate our US trials,"
said Marc Oczachowski, CEO of EDAP. "During the recent AUA Congress EDAP
was approached by numerous centers, including the top US institutions in
cancer care, about joining our study based on the strong clinical evidence
already documented from the approved use of Ablatherm-HIFU outside the US
where it shows more than 10 years of clear success on more than 12,000
treatments. We will meet those requests in the coming months. This will
help EDAP fully enroll the study with centers of unmatched prestige in the
US. We are also excited to now include international centers already using
Ablatherm to create a positive treatment experience for patients demanding
better options."
The Ablatherm-HIFU Phases II/III clinical study is currently enrolling
men diagnosed with clinical stage T1a, b or c or T2a localized prostate
cancer. HIFU is a noninvasive therapy using highly focused ultrasound
energy to ablate the prostate tissue. Details of the study and background
on Ablatherm-HIFU can be found online at clinicaltrials by
searching for "Ablatherm." Ablatherm-HIFU is proven effective comparable to
other standard nonsurgical treatments of localized prostate cancer, but
often offers fewer side effects.
About EDAP TMS S.A.
EDAP TMS S.A. 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. The company is also developing this technology for
the potential treatment of certain other types of tumors. EDAP TMS S.A.
also produces and commercializes medical equipment for treatment of urinary
tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).
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. Such
statements are based on management's current expectations and are subject
to a number of uncertainties 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. Ablatherm- HIFU treatment is in clinical trials but not yet FDA
approved or marketed in the United States.
EDAP TMS S.A.
edap-tms