The US Food and Drug Administration (FDA) has granted breakthrough device designation for Locate Bio’s bone graft technology for patients with degenerative disc disease (DDD).

The Nottingham, UK-based company is developing a bone graft that releases osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2), a protein that drives cell differentiation and bone formation. The protein is released from a three-dimension, resorbable tissue scaffold and provides extended release as the scaffold system degrades.

The graft will be used for anterior lumbar interbody spinal fusion (ALIF) procedures for patients with DDD. There are an estimated 400 million people diagnosed globally with pathologic disc degeneration each year.

GlobalData forecasts the bone grafts and substitutes global market will be worth $4.2bn by 2033. In April 2023, Bone Biologics received approval to conduct a pilot study for its graft in patients with DDD at one spine level from L2-S1. Locate Bio’s will be used in procedures at one level from L3-S1.

“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,” said John von Benecke, Locate Bio’s CEO.

“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.”

In September 2021, the company secured £10m in funding to advance its orthobiologics portfolio, which, alongside the protein release bone graft, includes a ceramic bone graft and an antibiotic-loaded gel for joint infections.