CTLM^® Data Sheet

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OverView: CTLM^® Is A Revolutionary New Laser Imaging Modality. It Has Been Designed To Be An Adjunct To Mammography To Help Reduce The Number Of Negative Breast Biopsies.

The Clinical Problem: The technology of mammography has developed to the point that extremely sharp, detailed pictures can be obtained if the breast is tightly compressed (a rather painful and undignified procedure.) These pictures, in the hands of an expert radiologist, will reveal whether any abnormality is present in only approximately 70 out of 100 cases. This means that up to 30 out of 100 cancers are "missed" on the first set of mammograms and this occurs most frequently in breasts which are very dense.

Many of these missed lesions will subsequently be picked up by other imaging techniques, or by follow-up mammography. However, it is very important to note that the mammogram, no matter how good its quality, does not contain all of the necessary information for many radiologists, (no matter how expert), to say whether the abnormality detected is a cancer, requiring surgery, or a benign lesion which can just be followed by imaging.

Therefore, in order to avoid missing a cancer, the mammographer advises biopsy on many lesions which later turn out to be benign (up to 80%). Thousands of women sustain great emotional and/or physical trauma, removal of breast tissue, and considerable expense only to prove that the mammographic finding was a "False Positive".

The CTLM^® Solution: The high percentage of false positive biopsies also presents a substantial cost to the health care system. Reducing false positive biopsies therefore, can have a favorable effect on managing breast cancer detection and staging. The CTLM® may be an optimal tool to address these needs and opportunities.