FORT LAUDERDALE, Fla., Nov. 20 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., a pioneer in laser optical breast cancer imaging systems, announced that the Company will feature breast cancer cases imaged with optical computed tomography technologies at RSNA 2007, in Chicago, Illinois from November 25 - 28. A CT Laser Mammography (CTLM(R)) system and clinical results will be exhibited in the North Building, Hall B, in booth #6600.
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The Company will again be included in RSNA’s Molecular Imaging Zone, a designation that highlights products, services and research in the emerging field of molecular imaging. CTLM is considered by many to be a cutting-edge modality in this revolutionary field; IMDS is currently conducting a US clinical trial on the use of CTLM as an adjunct to mammography in patients with dense breasts. The clinical trial is part of the Company’s effort to seek FDA Premarket Approval (PMA) of the system.
Among the cases that will be presented are several work-in-progress applications including optical fluorescence imaging, assessing the status of presurgical breast cancer chemotherapy treatment compared to MRI, and the potential of using laser optical techniques to aid in categorizing types of ductal carcinoma in situ (DCIS).
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.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an 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 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 CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
For more information, visit our website: www.imds.com.
As contemplated by the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995, this news release may contain forward-looking statements pertaining to future, anticipated, or projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates or predictions of future results or events and there can be no assurance that actual results or events will not materially differ from expectations. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filings with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
lcgroup@mindspring.comwilliams@imds.com
CONTACT: Media, Elizabeth Williams of Imaging Diagnostic Systems, Inc.,
+1-954-581-9800, williams@imds.com, or Investors, Rick Lutz for Imaging
Diagnostic Systems, Inc., +1-404-261-1196, lcgroup@mindspring.com
Web site: http://www.imds.com/
