CTI submits final module to FDA in connection with breast imaging system application
Computerized Thermal Imaging Inc. (CTI) recently announced that it has submitted the final module of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Breast Cancer System 2100, a system that uses thermal imaging to help doctors differentiate between benign and malignant breast lesions. CTI is seeking FDA approval for its breast imaging system to be used as an adjunct to mammography and clinical examination to help physicians in the fight against breast cancer. The fifth module contains data from CTI's clinical studies to demonstrate the value of the additional information provided by CTI's breast imaging system.
"Being involved with the clinical trials from the beginning, I am very encouraged about the results I have seen," said Dr. Yuri Parisky, Chief of Breast Imaging Services at USC/Norris Comprehensive Cancer Center and a principal investigator. "We are starting to see a real need among radiologists to look at adjunctive tests and I believe computerized thermal imaging technology holds great promise."
With guidance provided by the FDA, CTI established a research protocol to demonstrate that CTI's breast imaging system could have adjunctive value for physicians when used with mammography and clinical examination in the detection of breast cancer. The study looked at women who were recommended for biopsy either because a clinical breast examination or a mammogram had identified a suspicious lesion.
"I am quite pleased with our submission package," said John Brenna, CTI President and COO. "The study data show promising results in several areas, particularly with our ability to predict benign conditions as well as the system's overall adjunctive value when used with mammography. CTI's breast imaging system provides a unique computerized thermal analysis of physiological and metabolic activity that complements the diagnostic qualities of mammography's X-ray anatomical imaging. Our goal is to provide radiologists additional information to assist them in accurately determining the need for surgical biopsy." Ultimately, the FDA must review the results of the clinical trials before any final conclusions can be made.
CTI initiated pre-clinical and clinical trials at six prestigious hospitals including USC/Norris Comprehensive Cancer Center, Los Angeles; Providence Hospital, Washington, D.C.; Howard University, Washington, D.C.; Mt. Sinai Medical Center, Miami Beach, Florida; St. Agnes Hospital, Baltimore; and the Lahey Center, Boston.
During a typical diagnostic session with CTI's breast imaging system, a patient lies face down on a customized scanning table. CTI's breast imaging system is non-invasive and requires no radiation, breast compression or electric current. The procedure takes less than 10 minutes. It is painless and the radiologist can read the results immediately. CTI's breast imaging system captures 103 dynamic images of each breast and analyzes over 8.3 million temperature values to measure minute changes in physiological and metabolic activity. This data, when combined with diagnostic qualities of mammograms, provides radiologists additional information that can be useful in determining more precisely when a surgical biopsy is needed.
"The submission of Module 5 marks a milestone for the Company and concludes more than four years of studies conducted at six prestigious medical institutions," stated Richard Secord, CTI Chairman and CEO. "It further demonstrates our commitment to move beyond research and development."
CTI is using the FDA's modular approach, which divides the traditional PMA application into five modules. Each module contains a portion of the total data required and is reviewed and accepted by the FDA individually. The FDA has already accepted four of the five modules for CTI's breast imaging system.
The Breast Cancer System 2100 is presently available in the U.S. only as an investigational device and is not available for sale until approved by the FDA.
Computerized Thermal Imaging Inc. is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. Information about CTI can be found on the Internet at www.cti-net.com or by calling CTI Public Affairs at (801) 926-1113.
Source: Computerized Thermal Imaging Inc.
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