NanoFUSE

NanoFUSE

Bioactive glass is the first human-made material to form a direct chemical bond with bone. The capacity for interfacial bonding, which is the defining characteristic of a bioactive material, is the result of chemical reactions that take place on the surface of bioactive glass when it is exposed to bodily fluids. Bioactive glass is also the first synthetic material shown to exercise control over the cell cycle and the molecular mechanisms of osteoblastic cell differentiation and proliferation.

NanoFUSE® Bone Graft has been formulated to reconstitute into a paste upon addition of a sterile fluid (Figure 6), e.g. water for injection (WFI). NanoFUSE® is provided in a sterile, single-use syringe. NanoFUSE® is provided in 2, 5, and 10cc sizes in a pre-filled syringe ready for reconstitution and is pyrogen free.

Nanotherapeutics has conducted GLP compliant studies to evaluate if the proprietary formulation of NanoFUSE® Bioactive Glass bone graft enhances bone formation and subsequent healing. Evaluation of a critical-size defect in the rabbit radius was demonstrated. A comparison was made among Origen DBM® with Bioactive Glass, NanoFUSE® 45S5 Bioactive Glass bone grafts, two identified Predicate Devices, and the autogenous bone graft (which is the gold standard in clinical practice). The histological findings for NanoFUSE® demonstrate that the product is substantially equivalent to those of the predicate device. Implantation into 6 mm Defects in Rabbit Condyle Sections in additional studies revealed mineralization occurring in the void space at 3 weeks and significant bone formation throughout the defect at 6 weeks.