CTI Submits Fourth Module to FDA In Connection With Application for Breast Imaging System
LAYTON, Utah, Sept. 5 /PRNewswire/ -- Computerized Thermal Imaging, Inc. (CTI) (OTCBB: COII - news) announced today that it has submitted its fourth module to the U.S. Food and Drug Administration (FDA) in connection with the company's application for Pre-Market Approval for its thermal breast imaging system.
``The submission of this fourth module is another important milestone for CTI,'' said CTI President David A. Packer. ``We now have four of the five modules that comprise our Pre-Market Application delivered to the FDA with the first two accepted by them. It takes us one step closer to completing the application process.''
Module 4 contains information on non-clinical testing such as bio-compatibility testing, electrical safety, electromagnetic compatibility, environmental assessment, reliability and durability, and stress and wear. Module 5 which will contain the results of the ongoing clinical trial is in preparation by the company.
CTI is seeking FDA approval to use its breast imaging system as an adjunct to mammography and clinical examination in the detection of breast cancer. The company's patented system uses a sophisticated heat-sensitive camera to take thermal images of breast tissue, which are processed by proprietary computer algorithms. The process is quick, painless, and non-invasive.
CTI is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. More information about CTI can be found by visiting the company's website, 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.
SOURCE: Computerized Thermal Imaging, Inc. |
