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The Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization ("WHO") criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of calcium and vitamin D, and smoking); and (2) compare the BMD estimate with reference populations of young normals and age matched normals to compute T-scores and Z-scores, respectively.

The Pronosco X-posure System™ estimates BMD based on established principles of radiogrammetry. A standard x-ray is first scanned into the system. then analyzed by computer to assess cortical thickness and textural characteristics in the pre-defined region of interest, which consists of the radius, the ulna, and the second through fourth metacarpals. The BMD estimate may be compared to a reference database of young normals and age matched normals to compute T-scores and Z-scores, respectively.