Locate Bio, a UK-based orthobiologics company, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) 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.
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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 U.S. each year, representing a market approaching $2 billion.
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.
John von Benecke, CEO of Locate Bio, said: “According to the World Health Organisation, chronic low back pain is already the leading cause of disability worldwide, with 570 million prevalent cases worldwide. With a rapidly ageing global population, there is now an urgent need for next-generation products to relieve suffering and improve the quality of life for millions of patients. We are delighted therefore to have been granted a Breakthrough Device designation from the FDA for LDGraft, our exciting controlled and extended-release rhBMP-2 for spinal fusion.
“We are proud that the FDA has recognised the potential of LDGraft. Having recently completed our final preclinical work, we are looking forward to progressing LDGraft into human clinical trials later this year and ultimately, regulatory approval. More broadly, the announcement is another important milestone for Locate as we seek to achieve our ambition of building a world-leading orthobiologics business that addresses clear unmet needs of both surgeons and patients.”
