LocateBio Receives FDA Breakthrough Device Designation for LDGraft

Locate Bio, a UK-based orthobiologics company, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for LDgraft, which is currently available at a level from L3-S1 for anterior lumbar interbody spinal fusion (ALIF) procedures. But developing. 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 treatments or diagnostics for life-threatening or irreversibly debilitating diseases or conditions.

Degenerative disc disease (DDD) is a degenerative 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, leading to increased low back pain and possible radiculopathy, myelopathy, spinal stenosis, degenerative spondylolisthesis, and herniation. It is estimated that more than 700,000 spinal fusions are performed in the US each year, representing a $2 billion market.

LDGraft is 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 because 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 that degrades over several weeks, continuously releasing rhBMP-2 as it does so.

John von Beneke, CEO of Locate Bio, said: “According to the World Health Organisation, chronic low back pain is the leading cause of disability worldwide, with 570 million prevalent cases worldwide. With a rapidly aging global population, now the next generation products are urgently needed to relieve pain and improve the quality of life for millions of patients. That’s why we’re pleased to have been granted Breakthrough Device Designation from the FDA for LDGraft, a new technology for spinal fusion. Ours is the exciting controlled and extended-release rhBMP-2.

“We are proud that the FDA has recognized the potential of LDgraft. Having recently completed our final preclinical work, we look forward to progressing LDgraft into human clinical trials and eventual regulatory approval later this year.” More broadly, this announcement is another important milestone for Locate as we seek to achieve our ambition of building a world-leading orthobiologics business that meets the clear needs of both surgeons and patients.