FORT LAUDERDALE, Fla., Aug. 5 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS)
Dear IDSI Shareholders,
As many of you know, I returned to the company three months ago to assume the position of Interim CEO and Chairman of the Board; we have received many phone calls from our shareholders asking essential questions about the Company's direction and future. As my first priority, I have recently secured a tiered debenture for up to 2 million dollars to aid in the clinical collection of the PMA data and the submission of the PMA application.
Over the past two years, the Company had installed upgraded CTLM(R) systems, a new study protocol utilizing a new intended use at 10 various clinical sites throughout the United States. These sites are currently gathering cancer cases and non-cancer cases required to support the intended use hypothesis for the PMA application. Once the data required has been obtained it will be tested by independent radiologists, analyzed by our bio-statisticians and formalized into the PMA application for submission to the Food and Drug Administration (FDA). Developing an innovative medical imaging technology is a complicated and time-consuming process. The CTLM(R) is a revolutionary diagnostic imaging device designed to detect breast cancer without radiation or compression. Since the development of the first CTLM(R) prototype, our engineering team has incorporated many improvements based on both new and evolving technologies in lasers, computer processors, image display, surface-mount electronics, and software. We believe we are on schedule to complete the data collection and submit the PMA application to the FDA in its entirety by the end of this year.
We have been fortunate enough to have a large number of longtime
shareholders. They have experienced volumes of Company history and have
been anticipating IDSI's technologic achievements and sales breakthrough.
|SOURCE Imaging Diagnostic Systems, Inc.|
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