Healthcare Industry News: MDD
News Release - February 7, 2007
ART Advanced Research Technologies Receives CE Marking for SoftScan Device
SoftScan's Optical Breast Imaging Device certified for sale in all countries of the European marketMONTREAL--(Healthcare Sales & Marketing Network)--Feb 7, 2007 -- ART Advanced Research Technologies Inc. ("ART")(Toronto:ARA.TO ), a Canadian medical device company and a leader in optical molecular imaging products for the healthcare and pharmaceutical industries, today announced that it has received the CE certificate which entitles it to affix the CE marking on its SoftScan® optical breast imaging device, making the device approved for sale throughout the European market.
Obtaining the CE marking enables ART to sell its SoftScan device in all 25 member states of the European Union (EU), as well as in Norway, Iceland, Liechtenstein and Turkey, without having to undergo country specific certifications. To acquire the CE marking, ART had to submit comprehensive technical documentation, including evidence of clinical performance, to a European Notified Body for review, demonstrating that its SoftScan system complies with the safety and effectiveness requirements of the European Medical Devices Directive (MDD).
SoftScan is a non-invasive and painless optical imaging technology, which enables the characterization of breast tumours by clinicians as benign or malignant, without exposing the patients to ionizing radiation.
"Obtaining the CE marking represents an important commercial milestone for ART and opens up an important market for our SoftScan device, further confirming the strength of our time domain optical imaging platform and our ability to function effectively in the global regulatory arena," said Sebastien Gignac, President and CEO of ART. "We are now one critical step closer to commercialization of SoftScan in Europe."
Joseph Kozikowski, M.D., ART's Chief Medical Officer, added: "SoftScan has been received with great interest in Europe, especially in the area of treatment monitoring. I expect this CE marking to help doctors and hospitals across Europe to improve patient care with SoftScan breast imaging."
About SoftScan
The SoftScan optical breast imaging system has been designed first as a complementary diagnostic tool to mammography, with ultimate uses in the detection and treatment monitoring of breast cancer. Its non-invasive, painless approach uses time-domain optical imaging technology, which may allow better characterization of breast tumors as benign or malignant and could provide faster assessment of therapeutic effectiveness. The device was created and developed by ART Advanced Research Technologies Inc.
About ART
ART Advanced Research Technologies Inc. is a leader in molecular imaging products for the healthcare and pharmaceutical industries. ART has developed products in medical imaging, medical diagnostics, disease research, and drug discovery with the goal of bringing new and better treatments to patients faster. eXplore Optix(TM), an optical molecular imaging device designed for monitoring physiological changes in living systems at the preclinical study phases of new drugs, is distributed by GE Healthcare and is used by industry and academic leaders worldwide. SoftScan®, an optical medical imaging device, is designed to improve the diagnosis and treatment of breast cancer. ART is commercializing these products in a global strategic alliance with GE Healthcare, a world leader in mammography and imaging. Finally, the Fenestra(TM) line of molecular imaging contrast products provide image enhancement for a wide range of preclinical Micro CT applications allowing scientists to see greater detail in their imaging studies, with potential extension into other major imaging modalities. ART's shares are listed on the TSX under the ticker symbol ARA. For more information on ART, visit our website at www.art.ca .
This press release may contain forward-looking statements subject to risks and uncertainties that would cause actual events to differ materially from expectations. These risks and uncertainties are described in the Management Proxy Circular of ART dated October 24, 2006, available on SEDAR (www.sedar.com) under the profile of "ART Advanced Research Technologies Inc. (old)" (ART's predecessor issuer).
Source: Advanced Research Technologies
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