FORT LAUDERDALE, Fla., April 10 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., , a pioneer in laser optical breast imaging systems, announced the publication of a significant medical study, "Role of CTLM in Early Detection of Vascular Breast Lesions." The paper, by Mohammed Emad E. Eid, M.D., Ph.D., et al., was published in The Egyptian Journal of Radiology and Nuclear Medicine, Vol. 37, No. 1, (March): 633-643, 2006.
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The study highlighted the importance of imaging the presence and extent of angiogenesis in breasts as a means to improve breast cancer detection and management methods. Angiogenesis is the formation of new blood vessels. In the breast, such new vessels are associated with cancer growth.
According to Tim Hansen, IDSI Chief Executive Officer, "Dr. Emad's work, conducted on 450 breasts, cites the problems with conventional breast imaging techniques and emphasizes the important role our new CT Laser Mammography system (CTLM(R)) can play in improving detection and management. The only other technique to image neovascularization is MRI; CTLM is less invasive, less expensive, and may have sensitivity advantages."
The CTLM procedures were performed by Dr. Emad in the Department of Radiology, SAQR Hospital, RAK, United Arab Emirates.
In the United States, Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography (CTLM(R)) system to be used as an adjunct to mammography. The FDA has determined that the Company's clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The Imaging Diagnostic Systems CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
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Investor Relations: Rick Lutz 404-261-1196 lcgroup@mindspring.com
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