Imaging Diagnostic Systems say their CT laser mammography technology (CTLM) has achieved greater sensitivity than MRI in following angiogenesis response to chemotherapy. Imaging Diagnostic Systems, a pioneer in laser optical breast imaging systems, say their CT laser mammography technology (CTLM) has achieved greater sensitivity than MRI in following angiogenesis response to chemotherapy.

The findings were presented at the 'Progress in Diagnostics of Breast Cancer' Symposium in Szczawnica, Poland, January 4-6, 2007. The symposium will focus on state-of-the-art devices for medical imaging of the breast and standards for biopsy, among other topics.

The symposium was organized by the Krakow Branch of the Maria Sklodowska-Curie Memorial Institute of Oncology in conjunction with the Krakow Foundation for the Oncology Surgery Clinic.

Imaging Diagnostic Systems exhibited clinical cases from global user sites and featured a presentation of the CT laser mammography system's unique breast cancer detection capabilities. IDSI is represented in Poland by its exclusive distributor, EDO MED, of Warsaw, Poland and has operating systems at the Regional Center of Oncology, Bydgoszcz, Poland, and the Gliwice branch of the Maria Sklodowska-Curie Memorial Institute of Oncology, Gliwice, Poland, under clinical collaboration agreements.

"We are pleased to have CTLM technology featured at the symposium, as it is targeted to oncology centers in Poland who handle the bulk of breast cancer screening, diagnostic work-ups, and treatment follow-up with various imaging devices.

"We see a growing interest in CTLM from oncology centers not only in Poland but globally, based on our results. In December, IDSI released work-in-process results from Catholic University in Rome, comparing the sensitivity of CTLM to MRI in following angiogenesis response to chemotherapy; CTLM had better sensitivity in these cases," stated Deborah O'Brien, IDSI's Senior Vice President.

The CTLM(R) system is a new continuous wave laser breast imaging system that utilizes state-of-the-art 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 radiation or require breast compression.

In the United States, Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography (CTLM(R)) system to be used as an adjunct to mammography.

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 limited by United States Federal Law to investigational use only in the United States. The Imaging Diagnostic Systems CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.

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