Locate Bio was granted Breakthrough Device designation by FDA for LDGraft, currently in development for anterior lumbar interbody spinal fusion to treat degenerative disc disease.
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 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 worldwideii. 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 FDA for LDGraft, our exciting controlled and extended-release rhBMP-2 for spinal fusion.”
Locate Bio was granted Breakthrough Device designation by FDA for LDGraft, currently in development for anterior lumbar interbody spinal fusion to treat degenerative disc disease.
LDGraft is designed to provide both an osteoconductive scaffold and a controlled and extended release of osteoinductive recombinant human bone morphogenetic protein...
Locate Bio was granted Breakthrough Device designation by FDA for LDGraft, currently in development for anterior lumbar interbody spinal fusion to treat degenerative disc disease.
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 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 worldwideii. 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 FDA for LDGraft, our exciting controlled and extended-release rhBMP-2 for spinal fusion.”
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