Therapy Areas: Devices
Locate Bio's LDGraft Granted FDA Breakthrough Device Designation
18 May 2023 - - The US Food and Drug Administration has granted Breakthrough Device designation for LDGraft, currently in development for anterior lumbar interbody spinal fusion procedures at one level from L3-S1 for patients with degenerative disc disease, UK-based orthobiologics company Locate Bio said.

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 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, representing a market approaching USD 2bn.

LDGraft has been designed to provide both an osteoconductive scaffold and a controlled and extended release of osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2). This extended release is achieved as the product does not contain any liquid phase or surface attached rhBMP-2.

Instead, the osteoinductive agent is encapsulated within a proprietary polymer scaffold system which degrades over several weeks, continuously releasing the rhBMP-2 as it does so.

Locate Bio is an orthobiologics company with a proprietary, regenerative medicine pipeline, developing a range of exciting orthobiologics products with great disruptive potential.

Locate Bio is a spin-out from the University of Nottingham. The company is backed by Mercia Asset Management PLC and BGF.