FDA Accepts Module 3 of CTI's Pre-Market Approval Application For Its Breast Cancer Detection System
Third of Five CTI Modules Accepted by FDA
LAYTON, Utah, Sept. 22 /PRNewswire/ -- Computerized Thermal Imaging, Inc. (OTC Bulletin Board: COII - news) announced today that it has received a letter of acceptance from the U.S. Food and Drug Administration for Module 3 of its Pre-Market Approval Application. This module was submitted in May and is the third of CTI's five modules to be accepted.
``I am pleased to have this module now completed,'' stated David Packer, president, Computerized Thermal Imaging, Inc. ``Module 3 contains information about the manufacturing of our breast cancer system. It was reviewed not only by the Office of Device Evaluation but also the Office of Compliance to determine if we and our contract manufacturers have the capability to manufacture the device according to our design and the medical device good manufacturing practice (GMP) regulation. Acceptance of this module paves the way for a GMP inspection and is another step in our steady progress toward our goal of FDA approval of our breast imaging system.''
CTI is using a 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 accepted by the FDA. Module 1 was accepted late last year and Module 2 was accepted in June of this year. As each module is accepted, it is considered closed by the FDA. Although the FDA reserves the right to reopen a module, there must be strong scientific rationale and concurrence of the division director and the office director for doing so. CTI recently submitted Module 4 to the FDA and is now focused on completing Module 5, the only remaining module, and the one that will contain the results of ongoing clinical trials.
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.
CTI's general use thermal imager is also currently being used to help in the treatment of U.S. Track and Field athletes during the Olympics in Sydney. It is being used in conjunction with the company's Photonic Stimulator. The Photonic Stimulator emits infrared energy that penetrates the skin to stimulate increased blood flow, thereby providing safe, temporary relief of aches and pains. |
