Locate Bio Receives FDA IDE Approval to Expand RESTORE Clinical Study of LDGraft Bone Graft Substitute to US
核心洞察
Locate Bio (搜索) received FDA Investigational Device Exemption approval to expand its RESTORE clinical study of LDGraft bone graft substitute to the United States.
LDGraft is an investigational product that encapsulates recombinant human Bone Morphogenetic Protein-2 (搜索) to provide dose shielding during early inflammatory phases of bone healing.
The prospective, multi-center study evaluates LDGraft's safety and performance in patients undergoing single-level anterior lumbar interbody fusion procedures.
Locate Bio (搜索), a UK-based regenerative medicine company, announced that its RESTORE clinical study will expand into the United States following Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (搜索) (FDA). The study, already underway across multiple sites in Australia, is evaluating the company's lead product LDGraft in patients requiring anterior lumbar interbody spinal fusion.
Novel Approach to Bone Morphogenetic Protein Delivery
LDGraft represents an investigational bone graft substitute that employs a unique encapsulation approach for recombinant human Bone Morphogenetic Protein-2 (搜索) (rhBMP-2), rather than traditional surface attachment methods. The design intent is to provide dose shielding of the rhBMP-2 during the early inflammatory phase of bone healing and to allow a greater proportion of the rhBMP-2 to be available during the subsequent repair phase.
"We are thrilled to bring the RESTORE study to leading clinical centers in the United States," said John von Benecke, CEO of Locate Bio (搜索). "We are very excited by the potential that our technology has to refine the timing of rhBMP-2 presentation, in line with the body's natural bone healing cascade."
Clinical Study Design and Timeline
The RESTORE study is a prospective, multi-center clinical investigation designed to evaluate the safety and performance of LDGraft in patients undergoing single-level anterior lumbar interbody fusion. U.S. sites are expected to begin enrollment later this year, expanding the geographic reach of the ongoing clinical program.
Company's Broader Development Strategy
Locate Bio (搜索) is developing a pipeline of rhBMP-2 based orthobiologic products that aim to address the limitations of current technologies. The Nottingham, England-headquartered company focuses on orthobiologics through what it describes as insight-driven design and precision pharmaceutical engineering. With a focus on clinical relevance, the company is committed to delivering transformative solutions in spinal fusion and beyond.