In Vivo Bone Healing

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, Synergy 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, BioSphere® 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 BioSphere 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 BioSphere® Bioactive Bone Graft Putty:
Improved Bone Formation”, white paper on file

Histology

BioSphere® 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 BioSphere® had the highest amount.