Xillix Receives Final FDA Approval.RICHMOND, British Columbia--(BUSINESS WIRE)--Sept. 20, 1996--XILLIX TECHNOLOGIES (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :XLX) Xillix is pleased to announce that they have received final approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the Xillix(R) LIFE-Lung Fluorescence Endoscopy endoscopy Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the System(TM). "The FDA approval is a monumental achievement for Xillix as we can now aggressively pursue our corporate objectives and, more importantly, it is a significant breakthrough for those in the medical community working in the area of lung cancer detection and treatment", said Mr. Pierre Leduc, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Xillix. "Our goal is to make fluorescence endoscopy the industry standard." The global market potential for Xillix LIFE-Lung Fluorescence Endoscopy System is estimated to be US$750 million of which 35 percent is estimated to come from the U.S. market. Xillix has teamed up with Olympus Optical Co. Ltd. (Olympus) of Tokyo, Japan, to handle worldwide marketing and distribution of the Xillix LIFE-Lung Fluorescence Endoscopy System. Olympus currently enjoys over 70 percent of the global market for endoscopic equipment and accessories. Olympus and Xillix are preparing a worldwide product launch of the Xillix LIFE-Lung Fluorescence Endoscopy System in the first quarter of 1997. "Our PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy process, from the initial submission to the final approval, was completed in less than nine months compared to the industry average of 22 months. This is a significant accomplishment for Xillix and it shows the level of concern the U.S. FDA has for lung cancer and the importance of expediting devices, such as ours, to control the disease", said Mr. Barry Allen, Director of Regulatory Affairs. "Clinical tests conducted in major cancer centers in North America, indicated that the Xillix LIFE-Lung Fluorescence Endoscopy System is 171 percent more sensitive in identifying and locating abnormal tissue than conventional white light bronchoscopy Bronchoscopy Definition Bronchoscopy is a procedure in which a cylindrical fiberoptic scope is inserted into the airways. This scope contains a viewing device that allows the visual examination of the lower airways. alone. Using our technology, abnormal lesions that may not be visible under white light can be readily spotted and it is this early diagnosis that will provide the physician with a better chance to control and cure the disease." Lung cancer is a leading cause of cancer deaths in the world. Statistics from the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, show that each year approximately 185,000 new lung cancer patients are diagnosed in the U.S. alone and fewer than 15 percent survive more than 5 years. The World Health Organization estimates that this year more than 590,000 deaths from lung cancer are expected in the industrial world. Early diagnosis provides physicians with a better chance to control and cure the disease. The Xillix LIFE-Lung Fluorescence Endoscopy System uses a blue light source to activate the natural fluorescence of the lung tissue, employing the principle that healthy tissue fluoresces differently than cancerous or precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. tissues. No drugs are used to achieve this effect. The system detects and enhances these differences, displaying them on a video screen in real time, revealing the location and extent of the suspicious tissue for biopsy and further study by the physician. Xillix Technologies Corp. is a medical devices company engaged in the research, development and commercialization of imaging products which aid in the early detection of cancer. The Company is listed on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the trading symbol "XLX". CONTACT: Xillix Technologies Corp. Laurie McMichael, 604/278-5000 604/278-3356 (Fax) INTERNET: http://www.xillix.com E-MAIL e-mail: see electronic mail. in full electronic mail Messages and other data exchanged between individuals using computers in a network. : lmcm@xillix.com |
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