Montreal, Canada - ART Advanced Research Technologies Inc. ("ART") (TSX: ARA) has received an unconditional Health Canada Medical Device Licence to commercialize its SoftScan® optical breast imaging device, effective immediately. ART is now in a position to make SoftScan accessible to Canadian hospitals and clinics to help improve the diagnosis of breast cancer for thousands of women in Canada.

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 radiation.

According to Dr. Alfred B. Watson, Jr., M.D., M.P.H., F.A.C.R., F.A.C.P.M., Vice Chairman of the Department of Radiology and Chief of Breast Imaging at Baylor College of Medicine, Texas Medical Center, as well as acting Chairman of ART’s Clinical Advisory Board, the licensing of the SoftScan optical breast imaging system by Health Canada opens “a new era for breast imaging”. Dr. Watson further stated: “I am confident that this promising new optical technology, which has now received regulatory approval from Canada’s health authorities, will give clinicians the ability to address, over time, a number of unmet needs in the detection, diagnosis, staging and follow-up of breast conservation treatment of breast cancer”.


Dr. Nathalie Duchesne, M.D., F.R.C.P. (c), the Director of the Ville Marie Radiology and Breast MRI Centers in Montreal as well as the Scientific Director of the internationally renowned The Breast Course, who acted as a principal investigator in some of the clinical trials of SoftScan, commented: “Mammography is currently the widest front-line approach for the detection of breast cancer but there are significant instances where mammography is either ineffective or impractical to use. The approval of SoftScan means that women in this patient population will have another option available in Canada that could help in the diagnosis of breast cancer, through this innovative optical imaging technology”. Dr. Duchesne concluded: “I'm delighted that SoftScan will now be offered to breast cancer patients as a safe, non-invasive diagnostic tool to complement X-ray mammography and I hope it will ultimately help in the early detection and treatment of breast cancer”.

“We are very pleased by Health Canada’s licensing of SoftScan which constitutes a major milestone and a first step in our strategy to penetrate a global market of US$1.8 billion; it is a testimony to the fact that our product is safe, effective and of high quality – and ready for commercialization,” stated Sébastien Gignac, President and CEO of ART. “Health Canada’s green light will give Canadian hospitals, clinics and research centers, the opportunity to deliver the benefits of ART’s optical imaging technology to their patients and thus offer the prospect of better diagnosis for Canadian women affected by breast cancer and, eventually, this technology will help clinicians around the world improve breast care for women”, added Mr. Gignac.

The Medical Device Licence was issued in accordance with the Medical Devices Regulations for a Class III device and certifies that the device meets the safety and effectiveness requirements of Canada’s Medical Device Regulations, which along with the ISO 13485 quality standard certification, are among the highest in the industry.

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