PRO-DENSE® Graft Pre-Clinical Findings:
Stronger, Faster, and More Dense Bone vs. Autograft.

Stronger New Bone: Mechanical properties at 13 and 26 weeks: The PRO-DENSE® regenerate on average demonstrated over six times the compressive strength vs. autograft at 13 weeks, and over three times greater ultimate compressive strength than normal, unoperated bone.

Faster, Denser Bone Regeneration: Histology at 13 weeks: The PRO-DENSE® specimen (right) demonstrated consistently denser and thicker trabeculae vs. autograft (left) at the same time point. Basic fuchsine and toluidine blue, 75x s All claims are based on a critically sized canine proximal humerus defect model.

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 signifi cant 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.