CTI Moves Closer to FDA Approval-Submission of Third Module
LAYTON, Utah--(BUSINESS WIRE)--May 2, 2000--Computerized Thermal Imaging, Inc. (OTC BB: COII) announced today that it has submitted the third of five modules to the FDA in its application for Pre Market Approval (PMA) of its breast cancer detection system.
"This submission is another major step toward FDA approval,'' said David A. Packer, CTI's president. Under the Modular approach, each of five Modules is individually reviewed and approved by the FDA. Module one was approved by the FDA in December 1999. Module two was submitted in February and is under review. This third module addresses manufacture of the Breast Cancer System 2100, including all pertinent information regarding the manufacturing and quality control processes. As in the past, we will be working closely with the FDA as they review this data. Preparation of Module four is underway; Module five will follow and will contain the results of the ongoing clinical trial. Completing this process will lead to a successful launch and rapid acceptance of the CTI System.
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 or electrical current.
Computerized Thermal Imaging, Inc. is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. More information about CTI and the modular submissions to the FDA can be found on the Internet at www.cti-net.com 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.
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