A Proof of Concept Prototype for Novel Synthetic Bone Substitute Consisting of a Nano Composite of Extracellular Matrix and Hydroxyapatite

Bone graft substitutes are increasingly being used by Orthopaedic surgeons, Dental surgeons and Neurosurgeons to fill up the bone loss and defects resulting from trauma and deformity. Autografts, allografts and mineral bone substitutes are being used for bone grafting. To address the downsides of autograft, allograft and mineral bone graft we developed a novel bone substitute using the proprietary ECM technology platform and nano Hydroxyapatite. The ECM component of the nano composite provides natural growth factors. It will boost the conductive and osteogenic properties of the bone graft. Deposition of nano crystals of Hydroxyapatite atthe inter tropocollagen junction is the first step. We prepared anECM solution with suitable organic solvent and it is blended with simulated body fluid (SBF) for deposition of crystals ofHydroxyapatite Optimization of ECM emulsion and SBF was done after achieving hierarchal nucleation and growth of HA crystals. Scanning Electron Microscopy (SEM) and Xray diffraction (XRD) were used to characterize the nano composite of ECM and HA. The Scanning Electron Microscopy (SEM) demonstrated the HA deposition and pore size was found to be adequate for migration of osteoblasts. Calcium crystal deposition was evident in Xray diffraction (XRD) data. These novel bioceramic devices are developed by nanostructure processing of inorganic and organic biomaterial with ultra fine structure. These devices with excellent mechanical and biological properties are for orthopaedic and dental implant applications. This promising technology can address the downsides of existing bone graft substitutes viz., autograft, allograft and synthetic bone substitutes. Moreover multiple device formats like cortical, cancellous, granules, paste etc can be fabricated from this novel technology. All these devices are considered as predicate as per USFDA and route to the market is faster.