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NEWS & PRESS RELEASE ARCHIVES
Wednesday, March 18, 2009 :: CT LASER MAMMOGRAPHY DISTRIBUTOR SELECTED FOR OMAN Wednesday, March 11, 2009 :: Imaging Diagnostic Systems Redefines Its Global Marketing Strategy and Retains New Distributors for the International Market Wednesday, March 11, 2009 :: Imaging Diagnostic Systems Redefines Its Global Marketing Strategy and Retains New Distributors for the International Market Tuesday, March 10, 2009 :: CT Laser Mammography Clinical Results Improves Mammography Sensitivity Highlighted at European Congress of Radiology (ECR) Tuesday, March 10, 2009 :: CT Laser Mammography Clinical Results Improves Mammography Sensitivity Highlighted at European Congress of Radiology (ECR)
Fort Lauderdale, Florida, March 18, 2009—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced today that Shihab Muscat United (SMU) L.L.C. has been appointed as the exclusive distributor for the country of Oman. The company will market, and service the CT Laser Mammography (CTLM®) system to the private and public sector of Oman.
IDSI exhibited at the Arab Health 2009 medical conference during which they met with many officials interested in marketing the CTLM system throughout different countries. In particular, IDSI discussed the marketing potential for the CTLM system for the country of Oman with a prominent company by the name of Shihab Muscat United L.L.C., which markets and services medical and dental products throughout Oman.
“One of the highlights of the CTLM system at the Arab Health conference was the discrete manner in which a woman is examined which is desirable in the Middle East due to the cultural customs. We hope to produce a long lasting relationship with SMU and introduce the CTLM system to the women of Oman,” stated Deborah O’Brien/Senior Vice President of Imaging Diagnostic Systems, Inc.
The quality of healthcare in Oman is generally high and equal to that in Western Europe. In addition, Oman recently announced plans to develop a healthcare city near Muscat with an investment of 300-400 million Rilas (Iranian currency). Managing Director Arvind Gaikwad of Shihab Muscat United L.L.C. will present the CT Laser Mammography system to the Ministry of Health officials of Oman and to the private imaging centers.
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 patented new breast imaging system that utilizes continuous wave laser 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 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 corporate 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
Imaging Diagnostic Systems, Inc., IMDS a pioneer in laser optical breast imaging, has redefined its marketing strategy and launched a new campaign focusing on the international market. While attending the Arab Health Exhibition and Congress in Dubai, United Arab Emirates from January 26-29, 2009, IDSI company management secured new distributors for the United Arab Emirates and hired a Managing Director to market the CT Laser Mammography System (CTLM®) in the UAE and parts of the Middle East.
“This is one of the many international conferences we will be attending in hopes to retain new distributors to market our CTLM system. We are disappointed with the performance of our previous distributors, which inspired this new direction for our international marketing efforts,” stated Deborah O’Brien, Senior Vice President of Imaging Diagnostic Systems. “Arab Health was very beneficial to us as it enabled us to meet with dignitaries and distributors from around the Middle East who are interested in the CTLM system, but are difficult to speak with directly. The system’s innovative approach to detecting breast cancer and the discreet method in which the patient is examined was well received. I am confident that this is only the beginning of several distributors we will sign on and gain more sales as a result.”
The Company is in negotiations with distributors representing Oman, Egypt, Saudi Arabia, India, Yemen, Belgrade and Syria.
The Arab Health Exhibition and Congress is the premier event for the Middle East, bringing healthcare manufacturers, wholesalers, and distributors together with some of the most important and influential decision-makers in the Arab world. As the second largest exhibition of its kind in the world, with over 3,000 exhibitors from over 65 countries and more than 60,000 medical professionals, it is recognized as an imperative global event for companies to showcase their products in one of the fastest growing and most lucrative healthcare markets in the world.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Mammography (CTLM®) system to be used as an adjunct to mammography. The Company's PMA application will be submitted in its entirety at the completion of the data collection and review process. 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. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003certification and FDA export certification for its CT Laser Mammography system.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information.
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (OTCBB:IMDS - News) a pioneer in laser optical breast imaging, has redefined its marketing strategy and launched a new campaign focusing on the international market. While attending the Arab Health Exhibition and Congress in Dubai, United Arab Emirates from January 26-29, 2009, IDSI company management secured new distributors for the United Arab Emirates and hired a Managing Director to market the CT Laser Mammography System (CTLM®) in the UAE and parts of the Middle East.
“This is one of the many international conferences we will be attending in hopes to retain new distributors to market our CTLM system. We are disappointed with the performance of our previous distributors, which inspired this new direction for our international marketing efforts,” stated Deborah O’Brien, Senior Vice President of Imaging Diagnostic Systems. “Arab Health was very beneficial to us as it enabled us to meet with dignitaries and distributors from around the Middle East who are interested in the CTLM system, but are difficult to speak with directly. The system’s innovative approach to detecting breast cancer and the discreet method in which the patient is examined was well received. I am confident that this is only the beginning of several distributors we will sign on and gain more sales as a result.”
The Company is in negotiations with distributors representing Oman, Egypt, Saudi Arabia, India, Yemen, Belgrade and Syria.
The Arab Health Exhibition and Congress is the premier event for the Middle East, bringing healthcare manufacturers, wholesalers, and distributors together with some of the most important and influential decision-makers in the Arab world. As the second largest exhibition of its kind in the world, with over 3,000 exhibitors from over 65 countries and more than 60,000 medical professionals, it is recognized as an imperative global event for companies to showcase their products in one of the fastest growing and most lucrative healthcare markets in the world.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Mammography (CTLM®) system to be used as an adjunct to mammography. The Company's PMA application will be submitted in its entirety at the completion of the data collection and review process. 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. 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.
Please visit Imaging Diagnostic Systems’ website at: www.imds.com for additional information..
In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
Imaging Diagnostic Systems, Inc. IMDS, a pioneer in laser optical breast imaging systems, exhibited CT Laser Mammography (CTLM®) clinical results at the annual European Congress of Radiology (ECR 2009), March 6-10, in Vienna, Austria. IDSI is located at Expo 574.
The clinical study accepted as one of the conferences’ presentations was from the Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. The study demonstrated that: “when the CTLM system was used as an adjunct to mammography in heterogeneously and extremely dense breasts, the sensitivity (detecting cancer) increased significantly.” See company website for details of the published clinical report.
One of the largest medical meetings in Europe and the second-largest radiology meeting in the world, ECR 2009 is expected to attract an estimated 18,000 participants 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. 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 company is currently undergoing the clinical studies required for the Premarket approval application. 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.
Study Results Compared CTLM to Mammography When Used Adjunctively for Detecting Angiogenesis in Women with Dense Breasts
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc. (OTCBB:IMDS - News), a pioneer in laser optical breast imaging systems, exhibited CT Laser Mammography (CTLM®) clinical results at the annual European Congress of Radiology (ECR 2009), March 6-10, in Vienna, Austria. IDSI is located at Expo 574.
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The clinical study accepted as one of the conferences’ presentations was from the Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. The study demonstrated that: “when the CTLM system was used as an adjunct to mammography in heterogeneously and extremely dense breasts, the sensitivity (detecting cancer) increased significantly.” See company website for details of the published clinical report.
One of the largest medical meetings in Europe and the second-largest radiology meeting in the world, ECR 2009 is expected to attract an estimated 18,000 participants 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. 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 company is currently undergoing the clinical studies required for the Premarket approval application. 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.
