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NEWS & PRESS RELEASE ARCHIVES
Wednesday, November 25, 2009 :: Second Malaysia sale
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (OTCBB:IMDS - News) a pioneer in laser optical breast imaging systems, announced today that it has received a deposit for its second CTLM® system for Malaysia and a purchase order for a system to be installed in Indonesia. The systems will be delivered in January 2010; installation and training will commence immediately upon delivery.
The orders were placed through Jainsons PTY LTD., a distribution company based in Perth, Australia that serves as IDSI’s distributor for the CTLM system in Australia and Southeast Asia. Established in 1996 to distribute medical equipment in Southeast Asia, Jainsons represents U.S.-based medical companies that have developed innovative medical products and laser technologies.
“With a second CTLM system in Malaysia and one in Indonesia, we will be able to bring laser breast imaging technology to the women in Southeast Asia, especially for younger women or those with dense breast tissue,” stated Dr. Mukesh Jain, Jainsons’ Chairman and CEO.
Dr. Jain, who has been personally involved in the distribution of medical products for over twenty years, has developed a strong network and established key relationships with principals of medical companies throughout his career, as well as with agents throughout the region.
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.
Wednesday, July 15, 2009 :: IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES GERMAN UNIVERSITY STUDY AIMED AT EXPANDING THE CLINICAL UTILITY OF ITS CTLM LASER BREAST IMAGING SYSTEM
Fort Lauderdale, Florida, July 15, 2009 —Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser breast imaging systems, announced today the commencement of a breast cancer imaging study at the Charité, Medical University in Berlin, Germany. The study will examine the potential role of its model 1020 CTLM® laser breast imaging system as an enhanced breast cancer screening tool when used in combination with the fluorescent dye, Indocyanine Green (ICG). The study will be conducted at the Campus Virchow-Klinikum and the principal investigator is radiologist Dr. Alexander Poellinger.
“In other studies, optical imaging using fluorescent dyes have shown great promise to detect and differentiate malignancies. By using a fluorescent dye in a clinical breast cancer study, we hope to demonstrate an enhancement of the sensitivity and the specificity of diffuse optical tomography. For this purpose we will use a modified CTLM breast scanner that is capable of acquiring both absorption and fluorescence images," stated Dr. Alexander Poellinger.
The ICG fluorescent dye has a distribution pattern in the human body similar to that of extracellular MRI and CT contrast agents and it is already approved for other medical applications. The IDSI model 1020 CTLM scanner that will be used in the study has been specially modified to be able to both excite the ICG dye and image its fluorescence in breast tissue. Following injection of ICG into the patient, the scanner produces 3D images of the localized concentration of the dye. These images are expected to show increased extravasation and accumulation of the dye in malignant tissue.
IDSI users have performed over 15,000 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.
Wednesday, July 15, 2009 :: IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES GERMAN UNIVERSITY STUDY AIMED AT EXPANDING THE CLINICAL UTILITY OF ITS CTLM LASER BREAST IMAGING SYSTEM
IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES GERMAN UNIVERSITY STUDY AIMED AT EXPANDING THE CLINICAL UTILITY OF ITS CTLM LASER BREAST IMAGING SYSTEM
Fort Lauderdale, Florida, July 15, 2009—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser breast imaging systems, announced today the commencement of a breast cancer imaging study at the Charité, Medical University in Berlin, Germany. The study will examine the potential role of its model 1020 CTLM® laser breast imaging system as an enhanced breast cancer screening tool when used in combination with the fluorescent dye, Indocyanine Green (ICG). The study will be conducted at the Campus Virchow-Klinikum and the principal investigator is radiologist Dr. Alexander Poellinger.
“In other studies, optical imaging using fluorescent dyes have shown great promise to detect and differentiate malignancies. By using a fluorescent dye in a clinical breast cancer study, we hope to demonstrate an enhancement of the sensitivity and the specificity of diffuse optical tomography. For this purpose we will use a modified CTLM breast scanner that is capable of acquiring both absorption and fluorescence images," stated Dr. Alexander Poellinger.
The ICG fluorescent dye has a distribution pattern in the human body similar to that of extracellular MRI and CT contrast agents and it is already approved for other medical applications. The IDSI model 1020 CTLM scanner that will be used in the study has been specially modified to be able to both excite the ICG dye and image its fluorescence in breast tissue. Following injection of ICG into the patient, the scanner produces 3D images of the localized concentration of the dye. These images are expected to show increased extravasation and accumulation of the dye in malignant tissue.
IDSI users have performed over 15,000 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,
Thursday, June 11, 2009 :: MAGING DIAGNOSTIC SYSTEMS RETAINS SENIOR BUSINESS MANAGEMENT CONSULTANT TO PROVIDE BUSINESS DEVELOPMENT LEADERSHIP AND STRATEGIC GUIDANCE
MAGING DIAGNOSTIC SYSTEMS RETAINS SENIOR BUSINESS MANAGEMENT CONSULTANT TO PROVIDE BUSINESS DEVELOPMENT LEADERSHIP AND STRATEGIC GUIDANCE
Fort Lauderdale, Florida, June 11, 2009,—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast imaging systems announced today that it has retained the services of Karsten Damgaard-Iversen as senior Business Management Consultant. Mr. Damgaard-Iversen will work with Linda Grable, CEO/Imaging Diagnostic Systems to accelerate and strategically focus the company’s business development efforts through the preparation and execution of a US and European business development plan; the launch of new technology initiatives in the field of laser fluorescence imaging and the completion of the company’s imminent Pre-Market Approval (PMA) submission to the Food and Drug Administration (FDA).
“Rarely do we see the emergence of new medical technology with such a tangible potential to help resolve an urgent differential diagnostic problem. The potential for the CTLM® system to substantially increase the detection rate of primary breast cancer in younger women and women with dense breast tissue is truly remarkable, and the fact that this technology neither involves the use of ionizing radiation (X-ray) nor requires any form of breast compression, is likely to substantially increase the speed with which it will be adopted into routine clinical practice,” stated Mr. Damgaard-Iversen. “I am delighted to be given the privilege of providing leadership and business development guidance to a company with such an obvious and worthwhile mission to fulfill,” continued Mr. Damgaard-Iversen.
A proven strategic leader with 30 years experience in the medical imaging industry with a strong track record in global business and product development; Mr. Damgaard-Iversen has served in executive positions such as Managing Director and Chief Group Executive of Toshiba Medical Systems Europe BV, Vice President of International Operations of Fisher Imaging Corporation and Director of Sales & Marketing of Storz Medical AG. In addition to his executive and business management achievements, Mr. Damgaard-Iversen has also been directly engaged in the development of other laser based medical technologies where he has contributed as an inventor (e.g. US Patent 5,009,658) and a scientific publication co-author. He holds an MBA from Emory University and a BSc in electronic engineering from Copenhagen University College.
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 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 Company’s filings with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
Wednesday, April 29, 2009 :: IMAGING DIAGNOSTIC SYSTEMS APPOINTS NEW DISTRIBUTOR FOR ITALY
Fort Lauderdale, Florida, April 29, 2009—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) announced today that Socrate Medical SRL located in Milan, Italy has been selected as a distributor for the CT Laser Mammography (CTLM®) system in Northern and Central Italy. The company will market the system to the private and public sector of these regions.
“The partnership with CTLM paves the ground to pursue the broader social objectives such as the massive extension of the screening programs to the women under age 49. We will pursue this with the full involvement of the radiologists by utilizing the CTLM systems currently installed and collaborating with present users,” stated Giulio Ottavio Battagliarin CEO of Socrate Medical SRL. “We want to contribute to reaching the goal of reducing the mortality rate among women by adding the latest technical advancements of breast cancer detection devices to the medical community,” continued Giulio Ottavio Battagliarin CEO of Socrate Medical SRL.
Based in Milan and established in 2003, Socrate Medical strives to distribute and market the latest and most advanced diagnostic imaging technologies while serving as a single point of contact to meet clients’ specific requirements. Socrate Medical has been a forerunner in the identification and proposal of non radiant solutions suitable for targeted early diagnosis in women aged between 20 and 49. This has been done in collaboration with prestigious institutions, such as the Macchi Foundation of Varese, the Zucchi Hospital in Monza and the IPA in Rome, where 5,000 women will be screened each year. Socrate Medical has proposed solutions involving breast cancer detection equipment coupled with advance ultrasound scanners.
“We are pleased to have Socrate Medical as our representative in North and Central Italy, which have been important markets for IDSI,” stated IDSI Senior Vice President Deborah O’Brien. “The enthusiasm and interest that this emerging company is capable of generating could be significant.”
IDSI exhibited at the European Congress of Radiology (ECR 2009), where they met with various distribution companies interested in marketing the CTLM system throughout Europe. The company will continue to select additional distributors in strategic locations.