FORT LAUDERDALE, Fla., April 11 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., a pioneer in laser optical breast imaging systems, announced that it has modified its China distribution arrangements to accelerate market penetration of the new CT Laser Mammography system (CTLM(R)).
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IDSI terminated its exclusive agreement with China Far East International Trading Corp. (CFET) to permit IDSI to appoint non-exclusive distributors and representatives in the country. Tim Hansen, IDSI Chief Executive Officer, recently met with CFET representatives in Beijing to work out the details. He also visited breast imaging specialists in Beijing, Tianjin, Guangzhou, Hong Kong, and Macau to discuss how CTLM might improve their practices.
Hansen explained the change in distribution: “We had a nice start with CFET some time ago. We earned the Chinese government’s SFDA approval for the CTLM, sold several systems, and installed a CTLM at the Beijing Friendship Hospital to qualify for procedure payments under the Beijing health care system. We subsequently were approved for procedure payments.
“In July 2006, with the encouragement of CFET and BAC, the company we hired to manage our Asian distributors, IDSI opened a representative office in Beijing and added marketing, administrative, and service support personnel. We wanted to show that we were taking the market opportunity seriously and providing the very best customer service and support. Despite these moves, sales have not met our expectations. In fact, the lack of sales in China has been a huge disappointment and we believe one of the causes may have been lack of market coverage and CTLM clinical awareness. Our new approach will allow us to appoint distributors in multiple areas and work directly with luminaries and health care organizations. With our office and staff now in place, we believe we are positioned to support CFET customers as well as new distributors.
“The good news is that the breast cancer detection and treatment market in China is enormous,” continued Hansen, “and our technology can play a vital role in delivering better and more effective breast cancer management tools to patients and clinicians. We must seize this opportunity.”
The CTLM(R) system is a new continuous wave laser breast imaging system that 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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CONTACT: Investor Relations, Rick Lutz of Imaging Diagnostic Systems,Inc., +1-404-261-1196, lcgroup@mindspring.com
Web site: http://www.imds.com/
