Locate Bio, a UK-based orthobiologics company, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to LDGraft. LDGraft is currently in development to address anterior lumbar interbody spinal fusion (ALIF) procedures at a single level (L3-S1) for patients suffering from degenerative disc disease.
Degenerative disc disease (DDD) is a debilitating condition that progressively impacts daily functioning. If left untreated, it can result in worsening low back pain and potential complications such as radiculopathy, myelopathy, spinal stenosis, degenerative spondylolisthesis, and herniations. In the United States alone, there are approximately 700,000 spinal fusion procedures performed annually, with a market value nearing $2 billion.
LDGraft has been meticulously designed to provide an osteoconductive scaffold along with a controlled and extended release of osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2). Unlike conventional approaches that involve liquid or surface-attached rhBMP-2, LDGraft utilizes a proprietary polymer scaffold system to encapsulate the osteoinductive agent. This unique system allows for gradual degradation over several weeks, enabling a continuous release of rhBMP-2 throughout the process.
https://locatebio.com/locate-bios-ldgraft-granted-fda-breakthrough-device-designation/
