CTI Receives Medical Device License to Market Breast Cancer Thermal Imaging System (BCS2100) in Canada.

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CTI Receives Medical Device License to Market Breast Cancer Thermal Imaging System (BCS2100) in Canada. OGDEN, Utah, April 27 /PRNewswire-FirstCall/ -- Computerized Thermal Imaging Inc. (CTI) (BULLETIN BOARD: COIB) announced that it has received a Medical Device License from Health Canada to market its Breast Cancer Imaging System (BCS2100) in Canada. The BCS2100 uses infrared thermal imaging (IR) as an adjunct device to assist doctors in the early detection and discrimination of breast cancer. The process is designed to be quick, painless, non-invasive, and requires no patient exposure to radiation, breast compression, or electrical current. Dr. J.R. Keyserlingk, Medical Directors of VilleMarie Breast and Oncology Center in Montreal stated that, "Integrating IR imaging into the first-line strategy for the detection of breast cancer can increase the sensitivity at this crucial stage by providing an early warning of an abnormality that in some cases is not evident in other components. Combining IR imaging and mammography in an IR-assisted mammography strategy is particularly appealing in the current era of increased emphasis on screening by imaging and less reliance on palpation as tumor size further decreases." "I am pleased that CTI has received a Medical Device License to market the BCS 2100 in Canada," said Richard Secord, CTI Chairman and CEO. "CTI is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. Our goal is to provide radiologists additional information to assist them in better determining the need for surgical biopsy." As part of the Medical Device License, CTI was required to be certified to the international quality system requirements for medical devices, ISO 13485, and be audited by a recognized registrar for compliance with the Canadian Medical Devices Conformity Assessment System (CMDCAS) which was completed in October of 2003. CTI's Thermal Image Processor (TIP) is the core imaging device within the BCS 2100. CTI has placed or sold over 120 TIP systems worldwide. The TIP system is designed for use in thermal screening for cancer as well as other physiological ailments. Three of theses TIP systems are being used by the Canadian Government in airports measuring elevated skin temperatures in connection with SARS screening. The TIP System and the Photonic Stimulator, another product of CTI, have also received a Medical Device License from Health Canada, as well as 510(k) clearance by FDA in the USA. CTI believes its three Canadian distributors are looking forward to adding the BCS 2100 to the leasing program recently provided by the $500 million commitment from Associated International Leasing Corp. CTI believes the new leasing program will allow doctors and other practitioners to lease the BCS 2100 on a monthly payment program, which may be more affordable than an outright purchase. At this time the BCS 2100 is not available for sale in the USA. CTI continues to seek FDA pre-market approval to market and sell the BCS2100 as an adjunct to mammography and clinical examination in the detection of breast cancer. About CTI CTI designs, manufactures and markets thermal imaging and infrared devices and services used for clinical diagnosis, pain management and non-destructive testing of industrial products and materials. CTI has developed six significant proprietary technologies, four of which relate to its breast imaging system, BCS 2100. These include a climate-controlled examination unit to provide patient comfort and facilitate reproducible tests for the BCS 2100; an imaging protocol designed to produce consistent results for the BCS 2100; a statistical model that detects physiological irregularities for the BCS 2100, and infrared imaging and analysis hardware, including a proprietary heat-sensing camera. CTI also markets the Thermal Image Processor and Photonic Stimulator, two cleared pain management devices used for diagnostic imaging and therapeutic treatment. THIS PRESS RELEASE CONTAINS "FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. THESE FORWARD-LOOKING STATEMENTS ARE SUBJECT TO CERTAIN RISKS, TRENDS AND UNCERTAINTIES THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE PROJECTED. AMONG THOSE RISKS, TRENDS AND UNCERTAINTIES ARE CTI'S PENDING APPLICATION BEFORE THE FDA SEEKING PRE-MARKET APPROVAL OF CTI'S BCS 2100 BREAST IMAGING SYSTEM, CTI'S ABILITY TO RAISE ADDITIONAL CAPITAL TO FUND CASH REQUIREMENTS FOR FUTURE OPERATIONS AND CTI'S ABILITY TO CONTINUE AS A GOING CONCERN. IN PARTICULAR, CAREFUL CONSIDERATION SHOULD BE GIVEN TO CAUTIONARY STATEMENTS MADE IN THE VARIOUS REPORTS CTI HAS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. CTI UNDERTAKES NO DUTY TO UPDATE OR REVISE THESE FORWARD-LOOKING STATEMENTS. DATASOURCE: Computerized Thermal Imaging Inc. CONTACT: BJ Mendenhall of Computerized Thermal Imaging Inc., +1-801-776-4700, ext. 31 Web site: http://www.cti-net.com/

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