Locate Bio, the UK-based regenerative medicine company reshaping rhBMP-2 perspectives, today 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 (FDA). Already underway across multiple sites in Australia, the study is evaluating Locate Bio's lead product LDGraft in patients requiring anterior lumber interbody spinal fusion.
LDGraft is an investigational bone graft substitute that encapsulates, rather than surface attaches, recombinant human Bone Morphogenetic Protein-2 (rhBMP-2). 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. "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."
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 enrolment later this year.
Locate Bio is developing a pipeline of rhBMP-2 based orthobiologic products that aim to address the limitations of current technologies. With a focus on clinical relevance, the company is committed to delivering transformative solutions in spinal fusion and beyond.
About Locate Bio
Locate Bio is a regenerative medicine company headquartered in Nottingham, England, focused on orthobiologics. Through insight driven design and precision pharmaceutical engineering, Locate Bio aims to reshape rhBMP-2 perspectives and redefine what is possible in bone healing.
For more information, please visit: www.locatebio.com
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Contacts:
Media Contact:
FTI Consulting
Ciara Martin, Tim Stamper
+44 (0) 203 727 1000
LocateBio@fticonsulting.com
