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NEWS & PRESS RELEASE ARCHIVES
Tuesday, January 23, 2007 :: Imaging Diagnostic Systems to Exhibit Laser Breast Imaging Device at Major Middle East Health Conference
Imaging Diagnostic Systems to Exhibit Laser Breast Imaging Device at Major Middle East Health Conference
Fort Lauderdale, Florida, January 23, 2007—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) will highlight its patented CT Laser Mammography (CTLM®) system at Arab Health 2007, January 29-February 1 in Dubai, United Arab Emirates. IDSI will be located in the U.S. Pavilion.
The CTLM system is an innovative continuous wave laser breast imaging system that utilizes state-of-the-art technology and patented algorithms to create 3-D images of the breast. There are two operating clinical CTLM® systems in Dubai; over 8,000 breast studies have been performed globally using the system. The procedure is non-invasive, painless, and does not expose the patient to radiation or require breast compression.
Arab Health is the largest healthcare exhibition in the Middle East and one of the largest healthcare events in the world. Over 33,000 visitors are expected to attend the exhibition and its multi-track series of conferences.
In the United States, Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for the 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 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
Monday, January 22, 2007 :: Imaging Diagnostic Systems Renews CEO’s Three-Year Contract
Imaging Diagnostic Systems Renews CEO’s Three-Year Contract
Fort Lauderdale, Florida, January 22, 2007—Imaging Diagnostic Systems, Inc., (OTCBB: IMDS) announced that it has renewed the employment contract of its CEO, Tim Hansen, through January 2010.
“Our board is very pleased with Tim’s vision, leadership and execution,” stated Jay Bendis, Co-Chairman of IDSI. “We have great confidence in our CT Laser Mammography technology and our strategic initiatives. This new three-year agreement is an important step toward meeting the Company’s objectives.”
Hansen commented, “CTLM offers real solutions to serious breast cancer detection and treatment problems. We are well on the way not only to bring CTLM to the global market but also to take advantage of the family of clinical solutions made possible by this technology. We have an excellent leadership team, full command of laser breast imaging technologies, and the motivation to serve customers. I am pleased to extend my commitment to build shareholder value by helping us move from a development stage company to full commercialization.”
Hansen was appointed CEO of Imaging Diagnostic Systems in July 2004.
The CTLM 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®) 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
Monday, December 11, 2006 :: Hospitals Now Permitted To Charge For CT Laser Breast Imaging Exams
Imaging Diagnostic Systems Announces CTLM Procedure Payment Approval In Beijing China
Hospitals Now Permitted To Charge For CT Laser Breast Imaging Exams
Fort Lauderdale, Florida, December 11, 2006 -Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), 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®) breast imaging procedures.
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 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®) 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 statement
Friday, December 8, 2006 :: CT Laser Breast Imaging Attracts Attention at
CT Laser Breast Imaging Attracts Attention at
Radiological Society of North America Annual Meeting
CTLM Application for Following Chemotherapy Draws Interest
Fort Lauderdale, Florida, December 8, 2006 -Imaging Diagnostic Systems, Inc., (OTCBB: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.
Investor Relations:
Rick Lutz
404-261-1196
Monday, November 27, 2006 :: Imaging Diagnostic Systems Launches a Dedicated CT Laser Mammography Company in Italy
Imaging Diagnostic Systems Launches a Dedicated CT Laser Mammography Company in Italy
Monday November 27, 10:06 am ET
FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS - News), 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.
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®) 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.
Investor Relations
Rick Lutz
404-261-1196
lcgroup@mindspring.com