JUNE 12, 2009--Imaging Diagnostic Systems, Inc., (Plantation, FL), maker of laser optical imaging systems for breast cancer detection, says it has retained the services of a senior business management consultant to accelerate and strategically focus the company's business development efforts. Karsten Damgaard-Iversen will work with Imaging Diagnostic's CEO Linda Grable to prepare and execute a US and European business development plan, to launch new technology initiatives in the field of laser fluorescence imaging, and to complete the company's imminent Pre-Market Approval (PMA) submission to the Food and Drug Administration (FDA).
Imaging Diagnostic Systems designed its new imaging device to aid in the detection and management of breast cancer. The Computed Tomography Laser Mammography (CTLM) system uses 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.
"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," said 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."
Damgaard-Iversen is a proven strategic leader with 30 years experience in the medical imaging industry with a strong track record in global business and product development. He 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 and 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.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the 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.