EDAP Looking to Accelerate US Study Enrollment With the Upcoming Addition of McMaster University Hospital
EDAP Looking to Accelerate US Study Enrollment With the Upcoming Addition of McMaster University Hospital
"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
"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,"
"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 http://www.clinicaltrials.gov 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).
For more information on the Company, contact Magnolia Investor Relations at (972) 801-4900, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at http://www.edap-tms.com and http://www.hifu-planet.com.
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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
CONTACT: EDAP TMS S.A. Magnolia Investor Relations
Blandine Confort Matt Kreps +33 4 78 26 40 46 972 801 4900
SOURCE EDAP TMS S.A.