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.
Imaging Diagnostic Systems, Inc.
Deborah O'Brien,
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