Locate Bio has launched a novel breakthrough device, LDGraft, for the Degenerative Disc Disease Treatment.
The U.S. Food and Drug Administration has granted breakthrough device designation.
The device is currently under development specifically for patients with degenerative disc disease, targeting anterior lumbar interbody spinal fusion (ALIF) procedures at a single level ranging from L3-S1.
Degenerative disc disease (DDD) is a chronic and incapacitating condition that significantly affects daily functioning. Without proper treatment, DDD progressively worsens, leading to escalating lower back pain and the possibility of complications such as radiculopathy, myelopathy, spinal stenosis, degenerative spondylolisthesis, and herniations.
LDGraft is meticulously engineered to offer an osteoconductive scaffold while ensuring a precise and prolonged release of osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2).
The extended-release mechanism of LDGraft is achieved through its unique design, devoid of any liquid phase or surface attachment of rhBMP-2. Instead, the osteoinductive agent is enclosed within a proprietary polymer scaffold system. This scaffold gradually degrades over the course of several weeks, ensuring a continuous and controlled release of rhBMP-2.