A COMBINATION EFFECT OF ENGINEERED NANOTECHNOLOGY WITH SILICATE CHEMISTRY
INSTRUCTS BONE FORMATION IN BOTH VASCULAR AND AVASCULAR ENVIRONMENTS INCLUDING THE HYPOXIC CENTER OF THE FUSION MASS WHERE NON-UNIONS ARE KNOWN TO OCCUR
RAPID BONE REMODELING ACROSS ENTIRE FUSION MASS AS SOON AS 6 WEEKS IN A PROVEN SPINE MODEL
FDA CLEARED FOR USE STANDALONE OR AS AN EXTENDER DEPENDING ON INDICATION (see 510(k))
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The 7 Key Handling Properties of OssDsign Catalyst
OCG = OssDsign Catalyst Granule; EB = Endochondral Bone
Histology showing bone formation via the endochondral bone formation pathway, adjacent to OssDsign Catalyst (EB) at the center of the fusion mass, in an uninstrumented, posterolateral spine fusion model
OCG = OssDsign Catalyst Granule; IB = Intramembranous Bone; MNC = Multinucleated Cells (graft remodeling)
Histology showing intramembranous bone formation (IB) on and between OssDsign Catalyst granules (OCG), coupled with remodeling of the granules by endogenous multinucleated cells (MNC).
Data from a recently published pre-clinical study show that OssDsign Catalyst instructs rapid and reliable bone formation and that successful fusion was achieved in 100% of the studied subjects at 26 weeks, compared to 60% in the group where a comparable market-cleared device was used.In hypoxic environments OssDsign Catalyst engages the endochondral ossification pathway, leading to rapid bone formation at the center of a fusion mass, even in challenging, poorly vascularized environments.
In well vascularized environments OssDsign Catalyst engages the intramembranous ossification pathway via the recruitment of endogenous mesenchymal stem cells.
The engagement of these dual bone formation pathways results in rapid and reliable bone formation throughout the fusion mass.
OSSDSIGN CATALYST IN AN UNINSTRUMENTED POSTEROLATERAL SPINE FUSION MODEL
*Data from preclinical models may not be representative of clinical outcomes.
OSSDSIGN CATALYST IN A STANDALONE TRAUMA DEFECT MODEL