While the Company believes that it will be able to secure the additional funding necessary on commercially reasonable terms and follow the PMA timetable, there can be no assurance that the Company will be able to do so.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM(R) system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM(R)) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
The FDA has determined that the Company's clinical study is a non- significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The company is currently conducting clinical studies to collect the data necessary to support the FDA PMA application. The CTLM system is limited by United States Federal Law to investigational use only in the United States.
For more information, visit our website: http://www.imds.com
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|SOURCE Imaging Diagnostic Systems, Inc.|
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