FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., , a pioneer in human laser optical imaging systems, announced that it has signed a multiyear exclusive distribution agreement with CTLM ITALIA, a new company formed to commercialize the CTLM laser breast imaging system.
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CTLM ITALIA has a unique business model to accelerate market entry. Building on the previous commercial sales and IDSI clinical research sites in Italy, CTLM ITALIA has organized 14 sales locations into a network spanning the country. The group is supported by a centralized in-country marketing group, with administration, service, and local language collaterals.
Vito DeMitri, CTLM ITALIA Managing Director, stated, “We believe the time is right to bring the CTLM functional breast imaging technology to the women of Italy. We have seen the research done at Catholic University Hospital in Rome and the European Institute of Oncology (IEO) in Milan and we see that this promising new imaging modality can provide highly valuable information to doctors specializing in breast cancer.”
The new CTLM ITALIA organization kicked off with a gala celebration on November 17, followed by a day-long seminar to teach its representatives CTLM technical and clinical basics. Giuseppe Bonfitto, Radiologic Technologist at IEO, presented early experiences with 105 CTLM cases. Marcello Montovani, who has worked with the IEO clinical team for several months, presented CTLM fundamentals. The group also reviewed clinical results from Udine University and Catholic University Hospital, among other global sites.
Tim Hansen, IDSI Chief Executive Officer, stated, “We have been developing the Italian market for some time, knowing that Italy has historically been an early adopter of new medical technologies. It is gratifying to see that early work support the new CTLM ITALIA business model. Mr. Di Mitri and his team have years of medical imaging experience; they know how to sell and, more importantly, how to provide excellent service relationships with customers. We are proud to have them represent us.”
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 of Imaging Diagnostic Systems,Inc., +1-404-261-1196, or lcgroup@mindspring.com
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