Medical DevicesXCounter Announces Positive Results Following Independent Clinical Evaluation Of XC Mammo -3T Prototype
XCounter AB (publ) (AIM:XCT), a technology leader in the development of tomosynthesis-based 3D medical imaging, announced positive initial results from the first clinical evaluation of its innovative breast screening device XC Mammo - 3T. The device is the world"s first dedicated 3D digital mammography system for the detection of breast cancer, the most common form of cancer found in women.
Conducted in April 2009, the independent study by the mammography departments of Danderyd University Hospital and the Karolinska University Hospital evaluated the clinical benefits of using the new tomosynthesis-based 3D imaging compared with traditional 2D digital mammography. The study was based on 150 patients, each selected on the basis they required additional scanning due to suspicious lesions found during initial scans.
The results indicate that the XC Mammo - 3T, offers the same sensitivity from one tomosynthesis image compared to two images from 2D digital mammography, despite the fact that the patient selection was based on the 2D images by expert radiologists that currently have limited training in reading tomosynthesis images.
Dr. Gunilla Svane, associate professor of radiology at Karolinska University Hospital highlighted the XC Mammo - 3T prototype demonstrated a number of benefits over traditional 2D imaging:
"One of the major limitations of 2D images is that it is difficult to discern individual features in dense breasts which mean that we may get false negative findings. The tomosynthesis technique makes each structure stand out in a way which makes it easier to detect tumours. In the 3D images the extent of the feature is also more obvious, particularly for spiculated masses. Micro-calcifications are as clearly visible in the XC Mammo -3T images as they are in 2D. In addition, it is easier to see the extension and the growth pattern of the calcifications in the three dimensional representation than in the 2D images where one is limited to two views."
Dr. Edward Azavedo, associate professor of radiology at Karolinska University Hospital continued:
"The ability of the XC Mammo -3T images to detect malignancy is just as high as the 2D images. However, the possibility to single out masked lesions in dense breasts also means that we will probably be able to detect more abnormalities and cancers in this category without additional examinations, such as ultrasound. The patient response has been very positive and the patients have stated that the 3D examination was much more comfortable than the regular 2D exam where amongst other things the compression force on the breast in general is higher".
Mikael Strindlund, CEO of XCounter said:
"The positive results of our first prototype installation in a clinical environment is a major achievement for XCounter. I am particularly encouraged to hear that, unlike other imaging systems, XC Mammo - 3T can confidently detect micro-calcifications, helping to identify abnormalities earlier in their development."
The findings from the independent clinical evaluation will be developed into a comprehensive clinical report during 2009.
For further information regarding the patient study and patient images see http://www.xcounter.se/clinical_images
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