Data Driven Performance - In Vivo Study Results
 

Data Driven Performance - In Vivo Study Results

  • Bioactive glass has typically been used in a particulate form consisting of irregular particles and a broad size range (32-710 um).    

 

  • Instead of creating a bone graft with these "off-the-shelf" particles, İDEA utilized a unique spherical particle shape and conducted an in vivo optimization study to determine the size range that provided the best bone healing. 
     

  • Testing in a rabbit bone defect model showed that the Putty composed of 10:90 mix of 90-180 um spheres and 355-500 um spheres provided the best healing.

MicroCT

  • At 6 weeks, BioMold Putty showed complete healing with bone formation throughout the entire implant area. By comparison, the competitive products showed progressing bone formation only at the periphery of the defect. 

 

  • By 12 weeks, the BioMold Putty showed that the new bone was remodeling and had the appearance of the surrounding bone.  The 12 week images for the competitive products showed additional bone formation, but there was still a void at the center of the defect.

Faster bone growth throughout the entire implant site*

* ”In Vivo Evaluation of Biomold® Bioactive Bone Graft Putty:
Improved Bone Formation”, white paper on file

Histology

  • Biomold Putty histology showed bone formation directly on the surface and in between of the BioSphere particles at both 6 and 12 weeks.

 

  •  The histology also showed the presence of a bioactive calcium phosphate layer on the particles.

Histomorphometry

  • Quantification of the amount of bone at 6 and 12 weeks
    showed that Biomold had the highest amount.

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