Biogennix develops, manufactures and distributes implantable medical devices for spine fusion. Our novel bone graft substitutes, osteoSPAN and Morpheus, are resorbable, osteoconductive scaffolds. The composites of calcium phosphate and calcium carbonate have complete interconnected porosity and the optimal pore diameter for bone reconstruction, approximately 500 microns and 65% porosity.
All the porous surfaces have a very thin layer (approximately 4 microns) of calcium phosphate (CP), the mineral content of bone. Below the slowly resorbable calcium phosphate layer is the highly resorbable calcium carbonate. Biogennix has engineered this CP layer to be the optimal thickness because the thickness of this layer controls the resorption rate of the product.
Our osteoSPAN bone graft substitute is available in either granular form (1-4mm) or in blocks, called “Fusion Kits.” Granules and blocks serve as bone graft substitues or they are mixable with autograft for use as a bone graft extender in the posterolateral spine. Handling characteristics favored by surgeons include their compressive strength, wettability, and easy integration with autogenous bone.
Our osteoSPAN Fusion Kits provide a scaffold with continuous interconnected porosity designed to bridge the transverse process in posterolateral spine surgeries.
Morpheus is a moldable form of the original osteoSPAN product. The 1-2mm osteoSPAN granules are suspended in a rapidly resorbable carrier to facilitate placement and containment of the implant. The organic binder provides improved intraoperative handling and does not interfere with the osteoconductive properties of the granules. The organic binder rapidly (within days) dissolves revealing the granule porosity.
The osteoconduction and resorption of osteoSPAN and Morpheus was evaluated at 6 and 12 weeks in the posterolateral spine and in tibial defects created in skeletally mature rabbits¹. Evaluation was performed by quantitative/qualitative micro-CT, as well as standard light microscopy and SEM-BSE histology. After osteoSPAN or Morpheus is mixed with autograft and implanted next to viable bone, new bone and soft connective tissue grows throughout the interconnected pores when placed in the posterolateral gutter of the spine. By 3 months, osteoclasts resorb the outer hydroxyapatite layer, exposing the more rapidly resorbable calcium carbonate, while osteoblasts replace the implant material with additional bone.
Figure 8 illustrates osteoconduction and resorption of Morpheus at 12 weeks in the posterolateral spine of a skeletally mature rabbit¹. The image is from non-decalcified histology viewed under a scanning electron microscope with backscatter electron emission (SEM-BSE) and colorized. Before resorption occurs, the approximately 4 micron thick outer layer of calcium phosphate (white) covers all the surfaces of the osteoSPAN granules. As can be seen in the image, resorption is beginning to occur by 12 weeks. There are intermittent breaches in the layer (e.g., near the apex of the wave shaped layer). This has allowed regenerated bone (yellow) to replace a large portion of the calcium carbonate that is underneath the calcium phosphate layer.*
1. - Data on file at Biogennix.