First Participant Treated in Groundbreaking LDGraft RESTORE Study for Spinal Fusion
Nottingham, UK, November 18, 2024 — The RESTORE study, a prospective randomised clinical trial evaluating the safety and efficacy of LDGraft™ in single-level anterior lumbar interbody fusion (ALIF), has achieved a significant milestone with the treatment of its first participant. LDGraft™ is an innovative combination product that delivers a biomimetic release of recombinant human bone morphogenetic protein-2 (rhBMP-2) through a biodegradable polymer, developed to address bone defects in spinal fusion surgeries.
The RESTORE (A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion) study aims to show the potential of LDGraft™ to promote optimal bone growth and fusion at the surgical site, advancing options for patients undergoing ALIF. Through its unique encapsulation technology, LDGraft™ tempers the bioavailability of the molecule, particularly during the initial high inflammatory phase of bone healing. LDGraft™ received a US Food and Drug Administration (FDA) breakthrough device designation in 2023.
“This is an important study, and we are optimistic that LDGraft’s biomimetic release technology could represent a major step forward in spinal fusion treatment,” said Robyn Cochrane, QARA and Clinical Director. “By addressing the limitations of current fusion materials, LDGraft™ has the potential to revolutionize how we treat spinal fusion patients with the opportunity to bring this technology to many other applications.”
Tyler Lipschultz, President of Locate Bio Inc, said:
“I am very excited to have recently joined Locate Bio with a focus on building the business in the USA and to be able to share in this key milestone. This is an incredible moment for the team at Locate Bio.”
John von Benecke, CEO added:
“Inspired by nature, our product design intent was based on the clear understanding that, with a molecule like BMP-2, signal-saturation-causes-side-effects. Our dose shielding for a tempered release has the potential to make LDGraft™ the most relied upon bone graft globally – a market valued at over $3.5 billion per annum*.”
The RESTORE study is currently enrolling eligible participants and will evaluate both clinical fusion outcomes and patient-reported outcomes over the coming months.
LDGraft is an investigational device exclusively for pre-market clinical investigations only.
*Source: Bone Graft Substitutes Market Insights, 2023 Clarivate
ENDS
About Locate Bio
Locate Bio is a UK-based, pioneering orthobiologics company committed to advancing medical innovation and transforming patient care. Locate Bio is a spin-out from the University of Nottingham, UK. The Company is backed by Mercia Ventures and BGF.
For more information, please contact
John von Benecke, CEO
info@locatebio.com
www.locatebio.comMedia enquiries
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Ciara Martin, Tim Stamper+44 (0) 203 727 1000
LocateBio@fticonsulting.com
