Imaging Diagnostic Systems Installs CTLM(R) in Tianjin, China
FORT LAUDERDALE, Fla., Sept. 5 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast cancer imaging systems, has installed a CT Laser Mammography (CTLM(R)) system at the Tianjin Medical University's Cancer Institute and Hospital, the largest breast disease center in China.
Research at the Cancer Institute will be led by Professor Bao Runxian, Director of Radiology. Data will be collected under three research protocols designed to improve current methods of addressing breast cancer imaging and treatment follow-up. Professor E. Milne, MD, IMDS Director of Clinical Research will train the University doctors on CTLM adjunctive image interpretation and protocol methodologies.
The Tianjin system is the second research system installed in China. The first, at Beijing's Friendship Hospital, enabled CTLM clinical procedures to become listed on the Regional schedule for patient payments. IMDS plans to install several more research CTLM systems in China to accelerate market adoption of the new laser breast imaging technique.
Both the incidence and the number of deaths from breast cancer has tripled in Chinese women, making it the second most common cause of death from cancer for Chinese women. Early detection may provide women with better treatment options. Sources in China report that the incidence of breast cancer in has increased by at least 27% over the past decade and 40% of the Chinese women diagnosed with breast cancer die within five years because the cancer is already very advanced when it is diagnosed.
The Cancer Institute and Hospital is planning the 4th Congress of the World Society for Breast Health, in Tianjin, October 18th through October 21st. The Congress is sponsored by the World Society for Breast Health, the China Oncology Society and the Chinese Medical Association. IDSI Beijing will present CTLM clinical findings at the meeting.
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: http://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.
|SOURCE Imaging Diagnostic Systems, Inc.|
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