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(BSNS WIRE) CTI Moves Closer to FDA Approval with Submission of Third Modul
CTI Moves Closer to FDA Approval with Submission of Third Module
Business Editors
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.
--30--ajk/cgo*
CONTACT: Computerized Thermal Imaging Inc.
Dee Rose, 801/776-4700
KEYWORD: UTAH CALIFORNIA
INDUSTRY KEYWORD: COMPUTERS/ELECTRONICS MEDICAL DEVICES
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