FORT LAUDERDALE, Fla., Sept. 26 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., , a pioneer in laser optical breast imaging, has signed three exclusive distributors and added five countries to its global distribution network. These additions will increase market awareness of the new CT Laser Mammography (CTLM(R)) technology for women in the regions.
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Able Global, an experienced multimodality imaging distributor, will address the growing need in Malaysia for improved breast cancer detection as IDSI’s exclusive distributor. According to the Malaysian National Cancer Registry, breast cancer is the most common cancer in Malaysian women and the number of breast cancer cases is on the rise. Since the October 2005 passing of Malaysia’s First Lady from breast cancer, there has been an increased emphasis on breast cancer detection and treatment throughout Malaysia.
IDSI’s Latin and South American distributor network will expand into Mexico as Mayerick, S.A. de C.V., one of the first radiological distributors in Mexico, begins exclusive CTLM distribution in Mexico. According to the Mexican Histopathological Registry of Neoplasias, breast cancer is the second most common type of cancer in women and the rates of new cases and deaths are increasing.
HAWA Imaging AB, an experienced medical imaging equipment distributor in Sweden, will become part of IDSI’s European Region and have exclusive coverage in Sweden, Denmark, and Norway. According to the European Network of Cancer Registries, Northern European countries, particularly Denmark and Sweden, have some of the highest incidence rates of breast cancer in Europe.
“We are pleased to announce additions to three of our global regions. Asia-Pacific, Latin and South America, and greater Europe each hold tremendous opportunities for commercialization of CTLM. Our latest distributors are experienced in the diagnostic imaging capital equipment business and have excellent customer relationships,” stated Tim Hansen, IDSI Chief Executive Officer. “Malaysia and Mexico add substantially to our global geographic coverage. Historically, there have been many scientific and clinical breast imaging developments from Scandinavia, so we anticipate an excellent reception to our new laser breast imaging technology there.”
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its 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(R) 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.
Investor Relations: Rick Lutz 404-261-1196 lcgroup@mindspring.com
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CONTACT: Investor Relations, Rick Lutz, +1-404-261-1196, orlcgroup@mindspring.com, for Imaging Diagnostic Systems, Inc.
Web site: http://www.imds.com/