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NEWS & PRESS RELEASE ARCHIVES
Tuesday, January 29, 2008 :: Imaging Diagnostic Systems Exhibits at
Imaging Diagnostic Systems Exhibits at
Major Middle East Health Conference
CTLM Technology to be Highlighted at Molecular Imaging Conference
Fort Lauderdale, Florida, January 29, 2008—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast imaging, is exhibiting at Arab Health 2008, January 28 – 31, 2008, in Dubai, United Arab Emirates. The company is located at stand CD89.
CTLM technology was featured during the Molecular Imaging Conference, one of 17 conferences on specialized areas featured at Arab Health. Professor Eric Milne detailed the principals of imaging the breast with CTLM in his lecture, “Optical Imaging: Computed Tomographic Laser Mammography of the Breast.” Observations from one of the Company’s Luminary Partner sites were also presented. Professor Paolo Belli from Catholic University, Rome, Italy, discussed his experiences with CTLM in his talk, “Clinical Experience with Computed Tomography Laser Mammography Breast Scanning System.”
“The Molecular Imaging Conference at Arab Health 2008 illustrates dramatically how the most advanced technologies have been rapidly disseminated throughout the world. Heavy emphasis is being placed on the need to image function rather than form, which is where CT Laser Mammography excels,” explained Professor Milne. “As part of the Molecular Imaging and PET/CT conference, I presented the methodology and clinical results of CTLM, obtained from 11 of our clinical centers throughout the world. I demonstrated how laser imaging can achieve the same three-dimensional functional images as PET, but without the need for cyclotrons, radioactive injectates, or physicists at a fraction of the cost and time needed for imaging.”
More than 50,000 medical professionals are expected to attend Arab Health, the world’s largest multi-track healthcare Congress.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
The FDA has determined that the Company’s clinical study is a non-significant risk (NSR) investigational device study 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.
For more information, visit our website: www.imds.com
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.
Thursday, December 27, 2007 :: Imaging Diagnostic Systems CEO Announces Retirement
Imaging Diagnostic Systems CEO Announces Retirement
Fort Lauderdale, Florida, December 27, 2007—Imaging Diagnostic Systems, Inc., (OTCBB: IMDS) a pioneer in laser optical breast cancer imaging systems, announced that Tim Hansen will be retiring as Chief Executive Officer and Director effective January 1, 2008.
Tim Hansen was appointed IDSI Chief Executive Officer and a Director of the Company by the Board of Directors in July 2004. Mr. Hansen is a veteran medical imaging business executive. He held a number of leadership positions prior to IDSI and most notably served as President of Picker International, a global manufacturer of diagnostic imaging systems including CT and MRI scanners, nuclear medicine imagers and X-Ray systems until April 2001.
"We will miss Tim's vision, leadership, and outstanding knowledge and experience in the medical imaging field. He brought a women's health focus to our business, launched a comprehensive global commercialization program, led our advanced technology efforts and guided us through strategic matters. Clearly, we will miss his leadership but we wish him the best in his well- deserved retirement," said Jay Bendis, Co-Chairman of IDSI's Board. "Tim has agreed to a limited term consulting agreement to aid in our transition process. Allan Schwartz, our Executive VP & CFO and Deborah O'Brien, IDSI Senior VP, will form an executive committee with Co Chairman Patrick Gorman and me to further ensure a smooth transition," added Mr. Bendis.
"We are optimistic about the future, with our US PMA trials well underway and global commercialization gaining momentum. We are still a development- stage company but one with a large and growing clinical experience base in the attractive molecular breast imaging marketplace. Our recent experience at the Radiological Society of North America annual meeting in Chicago suggests growing interest in our optical breast imaging solutions to the limitations of conventional mammography, especially in the difficult dense breast cases," commented Mr. Bendis.
IDSI users have performed over 13,000 CT Laser Mammography (CTLM®) clinical cases worldwide.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CTLM is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography system to be used as an adjunct to mammography. The FDA has determined that the Company's clinical study is a non-significant risk (NSR) investigational device study 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 CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
For more information, visit our website: http://www.imds.com.
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.
Tuesday, November 27, 2007 :: IMAGING DIAGNOSTIC SYSTEMS UPDATES PMA FILING STATUS FOR THE NEW CT LASER BREAST IMAGING SYSTEM
IMAGING DIAGNOSTIC SYSTEMS UPDATES PMA FILING STATUS FOR THE NEW CT LASER BREAST IMAGING SYSTEM SECURES 10TH U.S. CLINICAL SITE
Fort Lauderdale, Florida, November 27, 2007—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast imaging, announced today that the Company has secured its 10th U.S. clinical site to participate in its CTLM® clinical trials. Under an approved protocol, the sites are collecting patient studies for the eventual submission of a Premarket Approval (PMA) application to the Food and Drug Administration. “We are very pleased to have achieved our goal of 10 clinical sites. The CT Laser Mammography (CTLM®) system promises to add significant adjunctive value to current mammography practices,” stated Deborah O’Brien, IDSI Senior Vice President. “While we have performed over 13,000 CTLM breast exams internationally, we have elected to utilize only those cases collected in the U.S. under our approved PMA clinical trials protocol. We may also include two additional U.S. clinical sites to further shorten the time needed to collect the prescribed number of confirmed cancer and non-cancer cases to be used for the statistical analysis as a major component of our PMA application.” O’Brien continued, “Upon completion of the data collection phase, we will conduct an image interpretation or ‘reading’ phase where CTLM scans and conventional mammography exams will be read adjunctively by specially trained radiologists. That data, along with confirmed biopsy results, will then be analyzed according to our primary and secondary intended uses by an outside biostatistical firm. Their results will be submitted to King and Spalding, who will assist in our preparation of the final PMA application. Unlike IDSI’s prior PMA application, the new PMA application will not be submitted in the modular form, although IDSI will use the previous work in preparing the new single PMA filing. Once the new PMA application is submitted, a 180-day clock will begin for the FDA to review the application. The FDA may also require a panel of experts to review the findings in order to make a final recommendation.” According to FDA regulations, new technologies such as the Company’s CT Laser Mammography system are subject to the PMA process. IDSI believes that it is prepared for the rigorous PMA process with well-documented, established and previously approved quality and manufacturing practices in place. The FDA has declared the current U.S. trial a non-significant risk (NSR) device study. The Company is also governed by other international regulatory agencies. The CTLM system has completed registrations including the CE Mark, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification. About Imaging Diagnostic Systems, Inc. Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with
mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth. The FDA has determined that the Company’s clinical study is a non-significant risk (NSR) investigational device study 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. For more information, visit our website: www.imds.com 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 Media Contact: Elizabeth Williams (954) 581-9800 williams@imds.com
Tuesday, November 20, 2007 :: Imaging Diagnostic Systems to Present Laser Breast Imaging Clinical Results at the 2007 Radiological Society of North America Scientific Assembly
Imaging Diagnostic Systems to Present Laser Breast Imaging Clinical Results at the 2007 Radiological Society of North America Scientific Assembly CT Laser Mammography System Included in Molecular Imaging Zone
Fort Lauderdale, Florida, November 20, 2007—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast cancer imaging systems, announced that the Company will feature breast cancer cases imaged with optical computed tomography technologies at RSNA 2007, in Chicago, Illinois from November 25 - 28. A CT Laser Mammography (CTLM®) system and clinical results will be exhibited in the North Building, Hall B, in booth #6600. The Company will again be included in RSNA’s Molecular Imaging Zone, a designation that highlights products, services and research in the emerging field of molecular imaging. CTLM is considered by many to be a cutting-edge modality in this revolutionary field; IMDS is currently conducting a US clinical trial on the use of CTLM as an adjunct to mammography in patients with dense breasts. The clinical trial is part of the Company’s effort to seek FDA Premarket Approval (PMA) of the system. Among the cases that will be presented are several work-in-progress applications including optical fluorescence imaging, assessing the status of presurgical breast cancer chemotherapy treatment compared to MRI, and the potential of using laser optical techniques to aid in categorizing types of ductal carcinoma in situ (DCIS). About Imaging Diagnostic Systems, Inc. Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth. Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an 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 study is a non-significant risk (NSR) investigational device study 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 CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification. For more information, visit our website: www.imds.com 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 Media Contact: Elizabeth Williams (954) 581-9800 williams@imds.com
Thursday, November 15, 2007 :: New Optical Breast Cancer Imaging Technology Garners Cover Story in National Radiology Magazine
New Optical Breast Cancer Imaging Technology Garners Cover Story in National Radiology Magazine Fort Lauderdale, Florida, November 15, 2007—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast cancer imaging systems, announced that its CT Laser Mammography (CTLM®) system, designed as an adjunct to x-ray systems to detect breast cancer, and its future clinical applications were featured in a cover story in the September 17, 2007 issue of RT Image magazine. This major article was contributed by Eric Milne, MD, FRCR, FRCP, IMDS Director of Clinical Research. The article, "CT Laser Mammography Functional Optical Imaging of Breast Cancer," can be viewed on the RT Image website at: www.rt-image.com. CTLM may solve some of the clinical problems associated with current breast cancer detection methods. Professor Milne explains, “The incidence of breast cancer is growing steadily throughout the world. There is an urgent need for a simple, easily installed, inexpensive – but reliable – method of detecting breast cancer at an early stage that does not employ ionizing radiation or require the injection of contrast media, and has greater sensitivity and specificity than current mammographic techniques.” The CTLM procedure is not yet FDA approved, but it was featured in RT Image as one of the newest breast imaging technologies; its possible future applications were the focus of the article. RT Image, an award-winning magazine, has been published for 20 years and is the only national, weekly magazine for radiology professionals. About Imaging Diagnostic Systems, Inc. Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth. Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an 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 study is a non-significant risk (NSR) investigational device study 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 CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification. For more information, visit our website: www.imds.com 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 Media Contact: Elizabeth Williams (954) 581-9800 williams@imds.com