Preclinical Data: *CMFlex implantation in a multi-centimeter porcine ramus defect

Study Objective: The objective of this study was to evaluate the performance of CMFlex bone grafts in a large irregular multi-centimeter mandibular defect and its ability to recover the bony contour of the jaw.

Methods: Irregular shaped 25-35mm ramus defects in two adult Yorkshire pigs were treated with CMFlex bone grafts or left untreated (negative control). Animals were sacrificed at 16 and 32 weeks postoperatively and specimens were analyzed for new bone formation by computed tomography (CT), micro-CT scans (uCT), histology, and mechanical testing (nanoindentation).

Est. AREA (Planar 1 side) = 12.7cm²

Results: CT imaging demonstrated that ramus defects implanted with CMFlex grafts were filled with bone by 8 weeks and the contour of the jaw restored in 2 of 3 implants, with the third filling the defect but producing an extrusion of new bone instead of precisely restoring the contour, likely due to the scaffold being partially dislodged after implantation.

High resolution uCT imaging demonstrated presence of scaffold material embedded in the regenerated bone and in associated soft tissue at 16- and 32-weeks post implantation, which may have contributed to the maintenance of volume as remodeling occurred over time. ​

Histological sectioning confirmed the association of mature bone forming around and within the scaffold and demonstrated remodeling of the graft. Nanoindentation measurements yielded no difference in Young’s Modulus in regenerated bone and natural mature bone, suggesting mechanical properties of bone tissue regenerated in CMFlex implanted defects are similar to natural mature bone.

Right Side: No Implant

Conclusion: At eight weeks, the CMFlex treated defect demonstrated near-complete filling of new bone throughout the defect and recovery of the jaw contour in contrast to the non-treated control. 

Left Side: CMFlex

Implant outline (defect space) is rough approximation
Significant amount of mature bone formed within defect space after 16 weeks (red)

This study was conducted in collaboration with the University of Illinois at Urbana-Champaign

* Data on file with Dimension Inx