NanoFUSE^® DBM

Bone void fillers comprised of human demineralized bone matrix (DBM) in a biologically acceptable carrier are an important tool for the orthopedic surgeon. DBM-based bone-void fillers aid in bone healing, minimize the need for autologous graft material and eliminate donor site complications. With the inclusion of calcium-based 45S5 bioactive glass, the first human-made material to release calcium and form a direct chemical bond with tissue,  there develops an exceedingly strong interfacial bond between the graft and adjacent boney tissue within minutes. The original formulation of 45S5 bioactive glass was invented in 1971 (Hench, et al). The capacity for rapid 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. This rapid bone bonding ensures positional stability of the graft during the critical period immediately following surgery. The ability of bioactive glass to rapidly bond with native tissue and trigger the cellular process of healing has prompted its use in an increasing number of clinical settings.

 

NanoFUSE^® DBM is the first off-the-shelf DBM with bioactive glass product available for use in an orthopedic clinical setting. As an adjuvant to demineralized bone matrix, bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis. The combined properties of DBM and bioactive glass create a favorable environment for bone fusion. NanoFUSE^® DBM is a novel composite allograft expressly designed to optimize surgical handling performance, graft stability, and osteoproductivity.
NanoFUSE^® DBM, a FDA cleared product, is a malleable putty-like bone void filler that is indicated for use in general orthopedic procedures (both elective surgeries and trauma injuries). NanoFUSE^® DBM is gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system. NanoFUSE^® DBM has been formulated to reconstitute into a paste upon addition of a sterile fluid (e.g. sterile saline, water for injection) and comes in 2, 5, and 10cc sizes in a sterile, single-use, pre-filled syringe ready for reconstitution and is pyrogen free.

 

• NanoFUSE^® DBM Instructions for Use
• NanoFUSE^® DBM User Manual
• NanoFUSE^® DBM Sales Sheet
• NanoFUSE^® DBM White Paper

• Hench LL, et al. Bioactive Glasses for in situ Tissue Regeneration. Journal of Biomaterial Science and Polymer Education Volume 15, Number 4, 2004.
• Day RM. Bioactive Glass Stimulates the Secretion of Angiogenic Growth Factors and Angiogenesis in Vitro. Tissue Engineering Volume 11 Number 5/6; 2005.
• Xynos, I.D., et al. Gene-Expression Profiling of Human Osteoblasts Following Treatment With the Ionic Products of Bioglass 45S5 dissolution. J. Biomed. Mater. Res. 2001;55(2):151-157.
• Allan, I., et al. Antibacterial Activity of Particulate Bioglass Against Supra- and Subgingival Bacteria. Biomaterials. 2001;22(12):1683-1687.

 

Available for Distribution

NanoFUSE^® DBM is available for distribution.  Nanotherapeutics will also supply the product for distribution under private label.