To: KAKALAK who wrote (1641 ) 9/1/1998 9:17:00 AM From: Mitch Aunger Read Replies (1) | Respond to of 4122
Imaging Diagnostic Launches Phase I Clinical Studies And Submits First Series of Findings to FDA FT. LAUDERDALE, Fla., Sept. 1 /PRNewswire/ -- Imaging Diagnostic Systems, Inc. (OTC-Bulletin Board: IMDS) announced that it has formally submitted the first series of the 20 patient in-vivo (human) images and the corresponding interpretation data to the U.S. Federal Drug Administration (FDA). The FDA has required the Company to submit 20 patient in-vivo images for review in accordance with Phase I clinical trials. Upon completion and submission of the 20 images, the Company intends to initiate Phase II clinical studies immediately, which provides for an approximate 400 case study at three prominent hospitals here in the United States, in accordance with the PMA submission. According to Richard Grable, CEO of Imaging Diagnostic, "This event marks a historic achievement for the Company; one that has been anxiously awaited by management, our team of researchers, and our loyal company supporters. We couldn't be more delighted with the quality of the images and the quantitative data which our imaging device is producing, which only serves to strengthen our resolve and commitment to bring this viable medical diagnostic tool to market as soon as reasonably possible." Anyone interested in viewing a sample of the images can do so on the Company's website imds.com beginning Wednesday, September 2, 1998. Imaging Diagnostic has developed the world's first patented laser based breast imaging device that utilizes state of the art laser technology and sophisticated computer algorithms that create contiguous cross sectional slice images of the breast. This examination, known as the CTLM, does not require breast compression or x-rays. Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties, including, without limitation, the Company's ability to successfully complete and file a PMA application; the status of competing products; and uncertainties detailed in the Company's form 10-KSB filed September 26th, 1997 with the SEC. SOURCE Imaging Diagnostic Systems, Inc. CO: Imaging Diagnostic Systems, Inc. ST: Florida