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Strategies & Market Trends : Stock Watcher's Thread / Pix of the Week (POW) -- Ignore unavailable to you. Want to Upgrade?

To: Stock Watcher who wrote (22013)	12/17/1999 1:57:00 PM
From: DENNIS TULLY	Read Replies (1) \| Respond to of 52051

COII....NEWS: 12/17/99 - CTI's Breast Cancer Detection System Wins FDA Pre-Market Approval for Module I -------------------------------------------------------------------------------- LAYTON, Utah, Dec 17, 1999 (BUSINESS WIRE) -- 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 approval for our Breast Cancer System," stated David Packer, president. "I would like to recognize all members of the CTI 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). 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 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, Washington, D.C.; Mt. Sinai Cancer Center, Miami Beach, Fla.; USC/Norris Cancer Center, Los Angeles, Calif.; St. Agnes Hospital, 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 provisions of the Private Securities Litigation Reform Act 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. Copyright (C) 1999 Business Wire. All rights reserved.