September 15, 1999 11:23....CTI Files First FDA Module
OGDEN, Utah, Sept. 15 /PRNewswire/ -- Computerized Thermal Imaging Inc. (OTC Bulletin Board: COII) announced today that it has submitted its first data package to the FDA as part of its application for Pre Market Approval (PMA) of its breast cancer detection system.
"This is an exciting announcement," said David A. Packer, CTI's president. "The submission of data to the FDA is a very important milestone. Although we have worked with the FDA for some time,
this begins the official review process. Under the Modular approach, each module is individually reviewed and approved by the FDA. We will be working closely with the FDA as they review this data. Successful completion of this process will allow the CTI System to be introduced to the market and accepted more readily. We are pushing forward as quickly as good science permits"
In April, 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 modules, each containing a portion of the data needed for FDA review. The preparation of Module 2 is already well underway with the remaining modules to be submitted in a timely fashion. Further announcements are planned as the various modules are completed and filed.
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.
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