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Barbara Kram, Editor | October 24, 2005
ART Advanced Research
Technologies' SoftScan
Montreal, October 24, 2005 - ART Advanced Research Technologies Inc., in collaboration with the Cedars Breast Clinic of the McGill University Health Centre (MUHC), has launched a pivotal clinical study, North American in scope, the final stage prior to commercializing SoftScan, an optical breast imaging system designed to improve the diagnosis and treatment of breast cancer.
ART intends to present results of the study in its submission to Health Canada and the U.S. Food and Drug Administration (FDA) to support its pre-market approval application for SoftScan. "It is with great pride and the hope of improving the quality of life for a great many women that we are launching today this SoftScan clinical study that will eventually become North American in scope," explains Micheline Bouchard, president and CEO of ART Advanced Research Technologies Inc. "For the past ten years, we have been the only company in Quebec and Canada to have invested time and major resources to perfect this promising optical imaging technology for the diagnosis of breast cancer."
Developed in Quebec, SoftScan has been designed first as a complementary diagnostic tool to mammography, to be used ultimately for the detection and treatment monitoring of breast cancer. Its non-invasive and pain-free approach uses time-domain optical imaging technology, capable of precision characterization of benign and malignant breast tumors, while maintaining the patient's well-being. A suspicious mammogram is typically followed by a biopsy, even though 80 percent of cases prove to be negative. Ultimately, SoftScan has the potential to significantly reduce the anxiety, pain and suffering experienced by patients.

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"The SoftScan will be complementary to the mammogram," explains Dr. David Fleiszer, principal investigator and co-director of the Cedars Breast Clinic of the MUHC. "It will allow us to differentiate between benign and malignant structures in the breasts and thus prevent patients from having to go through unnecessary and unpleasant biopsies."
"Early detection using mammography allows for the reduction of the mortality rate attributed to breast cancer, but this is not a perfect diagnostic tool. Optical imaging is presenting itself as a complementary tool that could contribute to a reduction in the number of deaths from breast cancer. We hope to establish that SoftScan will improve our capacity to diagnose breast cancers and are keen on beginning pivotal trials with our patients," added Dr. Raymond Taillefer, research director, nuclear medicine, and co-principal investigator for the study with Dr. Isabelle Trop, at the CHUM.
The study will extend through 2006 and examine 600 to 950 women aged 25 to 60 and older. It will be able to determine the clinical safety of the device and its effectiveness under real conditions of use. This study will be conducted at the Cedars Breast Clinic of the McGill University Health Centre (MUHC) as well as in additional major centers in North America in the next few months.
For more information, go to
www.art.ca/.