Nanotherapeutics Receives Expanded 510(K) Marketing Clearance from the FDA for NanoFUSE® DBM
Nanotherapeutics, Inc., a company focused on advanced development and manufacturing, today announced that the Company’s proprietary bone void filler product, NanoFUSE® DBM (demineralized bone matrix), has received expanded 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for use 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 novel composite allograft (human tissue graft) expressly designed to optimize surgical handling performance, graft stability, and osteoproductivity. 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). These gaps may be surgically created osseous defects or a 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. The product is supplied as a pyrogen-free implant, in a sterile, single-use, pre-filled syringe, immediately ready for reconstitution.