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*FASTER THAN AUTOGRAFT: The
accelerated rate of healing of the
PRO-DENSE® treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase
in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.
*DENSER THAN AUTOGRAFT: Histomorphometry
reveals that the amount of newly regenerated bone of the PRO-DENSE® injectable treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus
defects treated with autograft. PRO-DENSE® injectable new bone area fraction is on average 170% denser than autograft at 13 weeks.
*STRONGER THAN AUTOGRAFT: The newly regenerated bone in the PRO-DENSE® injectable treated defects
exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.
*STRONGER THAN NORMAL BONE: At 13 weeks; Urban, et al. CORR, June 2007.
All claims are based on a critically sized canine proximal humerus defect
model. It is unknown how results
from the canine model compare
with clinical results in humans.