Nanotherapeutics has obtained expanded 510(k) approval from the US Food and Drug Administration (FDA) for its NanoFUSE demineralized bone matrix (DBM).
The bone void filler product has received FDA approval for use in spinal fusion surgery, specifically for use with autograft (transplanted bone from a patient’s own body) as a bone graft extender in the posterolateral spine.
NanoFUSE DBM is a composite allograft (human tissue graft), which has been developed to enhance surgical handling performance, graft stability and osteoproductivity.
It features bioactive glass, which facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation).
According to Nanotherapeutics, the combined properties of DBM and bioactive glass will provide a favorable environment for bone fusion, as it remodels into the recipient’s skeletal system.
The surgeons will place the NanoFUSE DBM in bony voids or gaps within the skeletal system, which are not intrinsic to the stability of the bony structure.
These gaps are said to be surgically created osseous defects or a result of prior traumatic injury, noted the company.
Nanotherapeutics develops and markets biodefense, infectious disease and influenza products across the globe.