Imaging Diagnostic Systems Achieves Technical Breakthrough with New Reconstruction Algorithm

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (OTCBB:IMDS - News) a pioneer in laser optical breast cancer imaging systems, announced today that it has enhanced its CT Laser Mammography (CTLM®) system with a reconstruction algorithm that improves visualization of angiogenesis (cancer) in its images.

During a CTLM examination the breast is illuminated by a laser and the transmitted light is collected by a series of photo detectors and transformed into digital data. The reconstruction algorithm uses this data to create the various images of the breasts. The improved algorithm enhances the images by reducing the number of artifacts occasionally produced during an examination thereby making diagnosis easier.

“Our first-generation reconstruction algorithms were developed and evaluated using data acquired during our initial clinical trials. Since those trails, we have deployed over 26 systems worldwide, providing us with CTLM data from thousands of patients. IDSI’s Research & Development team used this data to optimize the reconstruction algorithms in order to provide better clarity and reduced artifact in CTLM images. We also incorporated streamlined numerical methods into the software so that the new algorithm does not require additional computing resources, allowing us to provide the improved functionality to existing customers as a software upgrade,” stated Steven Ponder, Ph.D., Director of Advanced Development/Imaging Diagnostic Systems.

“The new algorithm has improved the visualization and distinction of several known patterns of angiogenesis from normal patterns of breast perfusion, making it easier for the radiologist to detect cancer. Of even greater importance; breasts which are too dense to be penetrated by X-ray mammography are quite translucent to the laser beam. The CTLM system therefore has much greater sensitivity than mammography in the dense breast and can reveal between two and three times the number,” stated Dr. Eric Milne Director of Clinical Research/Imaging Diagnostic Systems Inc.

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

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