FORT LAUDERDALE, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., , a pioneer in laser optical breast imaging systems, announced that hospitals in the Beijing, China area may now charge patients for CT Laser Mammography (CTLM(R)) breast imaging procedures.
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According to the Beijing Municipal Commission of Development & Reform and the Beijing Municipal Health Bureau, CTLM procedures may be priced up to RMB300 ($38 at the current exchange rate) per breast as listed on the "Interim Procedures for Beijing Medical Service Price" schedule. Imaging Diagnostic Systems had previously registered their CTLM system with the State Food and Drug Administration of the People's Republic of China (SFDA); the equivalent of the US Food and Drug Administration.
"We have been anticipating this price schedule listing following our SFDA registration and the successful introduction of CT Laser Mammography at Beijing Friendship Hospital," stated Tim Hansen, IDSI Chief Executive Officer. "Now that this first approval to charge patients has issued we expect other institutions to add our new laser imaging capabilities to their breast imaging services. We are also pursing similar listings at the National level and in other regions. All of this is very good news for our global commercialization program and for the Chinese women who will now gain access to our new non- invasive procedure for detecting and evaluating breast cancer cases," he continued.
China sources report that the incidence of breast cancer in China 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 CTLM(R) system is a new continuous wave laser breast imaging system and utilizes state-of-the-art technology and patented algorithms to create 3-D images of the breast. The procedure is non-invasive, painless and does not expose the patient to radiation or require breast compression. 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.
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.
Investor Relations: Rick Lutz 404-261-1196 lcgroup@mindspring.com
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