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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.