Locate Bio’s LDGraft receives US FDA breakthrough device designation
Locate Bio, a UK-based innovative orthobiologics company with a proprietary, regenerative medicine pipeline, developing a range of exciting orthobiologics products with great disruptive potential, is pleased to announce that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for LDGraft, currently in development for anterior lumbar interbody spinal fusion (ALIF) procedures at one level from L3-S1 for patients with degenerative disc disease. The FDA Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
Degenerative disc disease (DDD) is an irreversible and debilitating disease that has a substantial impact on day-to-day functioning. If left untreated, the condition of a patient with DDD will worsen, causing increasing low back pain and potential radiculopathy, myelopathy, spinal stenosis, degenerative spondylolisthesis, and herniations. It is estimated that there are over 700,000 spinal fusions performed in the US each year[i], representing a market approaching $2 billion.