FDA Expands Indication for Nanotherapeutics’ Bone Putty

Nanotherapeutics Inc. received expanded 510(k) marketing clearance from the U.S. Food and Drug Administration for the use of its proprietary bone void filler—NanoFUSE DBM (demineralized bone matrix)—in spinal fusion surgery.

Specifically, NanoFUSE DBM has been cleared 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) designed to optimize surgical handling performance, graft stability, and osteoproductivity. According to the company, it is the first off-the-shelf DBM product containing bioactive glass available for use in an orthopedic clinical setting.

As an adjuvant to DBM, bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). In particular, the combined properties of DBM and bioactive glass come together to create a highly favorable environment for bone fusion, as it remodels into the recipient’s skeletal system.

The malleable, putty-like NanoFUSE DBM is placed by the surgeon into bony voids or gaps within the skeletal system that are not intrinsic to the stability of the bony structure (e.g., the extremities, pelvis and, as a bone graft extender, posterolateral spine). The gaps may be surgically created osseous defects or a result of prior traumatic injury. The substance 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. The product is supplied as a pyrogen-free implant, in a sterile, single-use, pre-filled syringe, immediately ready for reconstitution.

Nanotherapeutics is based in Alachua, Fla.