CTI's Breast Cancer Detection System Wins FDA Pre-Market Approval for Module I.LAYTON, Utah--(BUSINESS WIRE)--Dec. 17, 1999-- Computerized Thermal Imaging, Inc. announced today that it has received approval from the U.S. Food and Drug Administration for Module 1 of its Pre-Market Approval Application. This module was submitted in September and is the first of 5 modules to be submitted. "I am delighted that we have accomplished the first step in receiving 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. approval for our Breast Cancer System," stated David Packer, president. "I would like to recognize all members of the CTI (Computer Telephone Integration) Combining data with voice systems in order to enhance telephone services. For example, automatic number identification (ANI) allows a caller's records to be retrieved from the database while the call is routed to the appropriate party. team who contributed to achieving this milestone. The fact that this first module was approved without comment or request for clarification from the FDA confirms that we have assembled the right skills necessary to successfully complete the FDA approval process. Although the remaining modules are more technical in nature and subject to detailed review, this approval confirms that we are on the right track." Earlier this year, the FDA approved CTI's use of the new modular approach to submitting an application for Pre-Market Approval (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 ). Under this approach, CTI's PMA application has been broken into five modules, each containing a portion of the data needed for FDA review. Each module is individually reviewed and approved by the FDA. The remaining modules are in various stages of preparation and will be submitted as each is completed. CTI is seeking FDA approval for the use of the Computerized Thermal Imaging System as an adjunctive diagnostic test to the mammogram mammogram /mam·mo·gram/ (mam´o-gram) a radiograph of the breast. mam·mo·gram n. An x-ray image of the breast produced by mammography. and clinical examination for the detection of breast cancer. The system uses a sophisticated heat sensitive camera to record thermal images of breast tissue, which are processed by proprietary computer algorithms. The test is simple, painless and involves no radiation, breast compression, electrodes, electrical current or skin contact. It should significantly reduce the number of breast biopsies that turn out to be benign each year. The company currently has FDA trials underway at Providence Hospital Providence Hospital is a 247 bed acute-care facility located east of downtown Columbia, South Carolina. The hospital was founded in 1938 by the Sisters of Charity of Saint Augustine as a ministry to the Catholic community, in both body in spirit. , Washington, D.C.; Mt. Sinai Cancer Center, Miami Beach Miami Beach, city (1990 pop. 92,639), Dade co., SE Fla., on an island between Biscayne Bay and the Atlantic Ocean; inc. 1915. It is connected to Miami by four causeways. , Fla.; USC/Norris Cancer Center, Los Angeles, Calif.; St. Agnes Hospital St. Agnes Hospital is a fictional mental institution created for MTV's Fear reality series. It was featured on Season 1, Episode 2. The real location was attempted to be kept under wraps since local ghost hunters would surely head to the site to do their own "investigations. , Baltimore, Md.; and Lahey Clinic, Peabody, Mass. Computerized Thermal Imaging, Inc. is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. The information about CTI can be found on the Internet at or by calling CTI Public Affairs at (801) 926-1113. Except for historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. In addition to the factors set forth above, other important factors that could cause actual results to differ materially include, but are not limited to technical risks associated with new technology development, government regulatory approvals or continued working capital. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings. Copies of these filings may be obtained by contacting the Company or the SEC. |
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