Healthcare Industry News: digital mammography
News Release - December 8, 2006
CT Laser Breast Imaging Attracts Attention at Radiological Society of North America Annual MeetingCTLM Application for Following Chemotherapy Draws Interest
FORT LAUDERDALE, Fla., Dec. 8 (HSMN NewsFeed) -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS ), a pioneer in human laser optical imaging systems, announced heightened interest in its proprietary, patented CT Laser Mammography (CTLM®) system at the 92nd annual RSNA meeting, November 26 - December 1, in Chicago, Illinois.
Attendees reviewed CTLM clinical results from numerous international research sites featuring comparisons to conventional film mammography, digital mammography, breast ultrasound, and breast MRI studies.
CTLM is a revolutionary molecular imaging approach that visualizes new blood vessel growth, or angiogenesis, usually associated with the development of breast cancer. The technique adds essential functional information when used with conventional mammography, particularly in difficult dense breast cases.
Angiogenesis is now a topic of world-wide interest. It is an important indicator of cancer behavior and in particular, of response or lack of response to treatment. Diagnosticians are imaging the process with conventional and MRI angiography and nuclear medicine, all of which are interventional procedures, and now with CTLM, which is non-interventional. Work-in-progress findings were shown in which CTLM was used to assess the results of chemotherapy treatment compared to the results in the same cases imaged with MRI. Three cases were shown in which MRI became negative after treatment, suggesting complete success, but CTLM remained positive. Biopsy confirmed that cancer was still present, indicating that CTLM may be more sensitive than MRI for treatment monitoring. The cases were contributed by Carmen Malaspina, M.D., Paulo Belli, M.D., and Lorenzo Bonomo, M.D., of the Department of Bioimaging and Radiological Science, Catholic University, Rome, Italy, one of the Company's luminary sites.
"We had a very successful showing," stated Deborah O'Brien, IDSI Senior Vice President. "CTLM's stature as an emerging, credible modality is growing based upon many years of clinical and technical developments. Visitors were attracted to our booth to learn about the new laser breast imaging modality and its ability to help them solve breast imaging problems. The clinical results from global luminary sites drew heightened interest from international prospects and researchers. The special focus of this year's RSNA meeting on diagnosis, treatment, and case management of breast disease also helped to attract interest in CTLM." Continued O'Brien, "We were gratified to experience, at the largest medical imaging meeting in the world, great enthusiasm for CT laser breast imaging technology. Our years of pioneering work with continuous wave optical CT methods to image angiogenesis and to provide adjunctive functional information was well demonstrated. Our users have the experience of over 8,000 cases. There is little doubt that imaging dense breasts with x-ray is imperfect and our CTLM technique may improve results. Also, the CTLM studies following neoadjuvant treatment progress were particularly exciting and appeared to have higher sensitivity than the MRI method for 'seeing' residual angiogenesis."
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser Mammography (CTLM®) 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 the first patented breast imaging system that utilizes state-of-the-art laser technology and patented algorithms to create 3-D images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is limited by United States Federal Law to investigational use only in the United States. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 certification and FDA export certification for its CT Laser Mammography system.
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
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