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Biotech / Medical : COMPUTERIZED THERMAL IMAGING (COII)- research only -- Ignore unavailable to you. Want to Upgrade?

To: chirodoc who wrote (228)	6/27/2000 1:57:00 PM
From: chirodoc	Read Replies (1) \| Respond to of 256

FDA approves Module 2 of CTI's Pre-Market Approval Application for its Breast Cancer Detection System ô LAYTON, Utah--(BUSINESS WIRE)--June 27, 2000--Computerized Thermal Imaging, Inc. (OTCBB: COII - news) announced today that it has received approval from the U.S. Food and Drug Administration for Module 2 of its Pre-Market Approval Application. This module was submitted in February and is the second of 5 modules to be approved. ``I am delighted that we have accomplished this next important step toward receiving FDA approval for our Breast Cancer System,'' stated David Packer, president. ``Module 2 contains system design information and is the most technologically complex of all the modules. Approval of this module confirms our steady progress toward our goal of FDA approval of our revolutionary breast imaging 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 patented 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. The FDA has approved CTI's use of the new modular approach to submitting an application for Pre-Market Approval (PMA). Under this approach, CTI's 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. Module 1 was approved in December 1999. CTI is continuing to work closely with the FDA as they review Module 3 data, which was submitted in early May. The remaining 2 modules are in preparation and will be submitted as each is completed