Bone Solutions have announced a completed pilot study showing that OsteoCrete™ may be the first bone void filler to be successfully used as a fusion-facilitator in a rabbit posterolateral lumbar spine model. OsteoCrete™ is already FDA-cleared as a bone void filler (BVF). The Company also announced that it intends to commence production of OsteoCrete™ early in the fourth quarter of this year. BSI intends to submit future FDA 510(k) applications seeking approvalto market variations of its initial product as an anchor, bone cement, and fillerfor maxillofacial/cranial applications.
OsteoCrete™ Bone Void Filler is a magnesium-based bone void filler that is both injectable and moldable plus iuts biocompatible. It is indicated for bony voids or defects that are not intrinsic to the stability of the bony structure. OsteoCrete™ is designed to be injected into gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoCrete™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
Bone Solutions are now planning a second pilot study for further confirmation and to extend the time period to 12 weeks. If results are positive, they will initiate completing the full 510(k) FDA protocol for spinal applications.