The US Food and Drug Administration (FDA) has granted expanded 510(k) marketing clearance for Nanotherapeutics' bone void filler product, NanoFUSE demineralised bone matrix (DBM), for use in spinal fusion surgery.
The bone void filler has received FDA clearance specifically for use with autograft, where a bone is transplanted from a patient's own body, as a bone graft extender in the posterolateral spine.
NanoFUSE DBM is a new composite allograft, or human tissue graft, designed to improve surgical handling performance, graft stability and osteoproductivity.
The product features bioactive glass that facilitates operative site graft containment through rapid bone bonding and activation of cellular osteogenesis (bone formation).
According to Nanotherapeutics, the combined properties of DBM and bioactive glass create a highly favourable environment for bone fusion, as it remodels into the recipient's skeletal system.
Surgeons will place the NanoFUSE DBM in bony voids or gaps within the skeletal system that are not intrinsic to the stability of the structure.
The bony voids or gaps may be surgically created osseous defects or the result of prior traumatic injury.
NanoFUSE DBM is formulated so that it reconstitutes into a paste upon addition of a sterile fluid, such as saline, water for injection and/or autologous blood.
It is supplied as a pyrogen-free implant, in a sterile, single-use, pre-filled syringe, immediately ready for reconstitution.
Nanotherapeutics is focused on developing and marketing biodefence, infectious disease and influenza products worldwide.