CGBIO has received Investigational Device Exemption approval from the US Food and Drug Administration for its bone graft substitute, NOVOSIS PUTTY. This approval allows the company to begin clinical trials in spinal fusion procedures in the United States.
NOVOSIS PUTTY is designed to address gaps in current bone regeneration treatments. It is the first Korean-developed bio-combined medical device to achieve IDE approval in the US, marking a significant step towards future Premarket Approval (PMA) and commercial launch.
The product uses a dual-carrier system that includes Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP), along with CGBIO’s proprietary SLOREL™ technology. This combination enables the controlled release of recombinant human bone morphogenetic protein-2 (rhBMP-2), aimed at promoting high-density bone growth while reducing the risk of unwanted bone formation, a known issue with earlier rhBMP-2-based products. Its safety and effectiveness have been demonstrated in peer-reviewed studies, including in the Journal of Clinical Medicine.
The clinical trial in the US will be managed by CGBIO USA, focusing on demonstrating the product’s performance in spinal fusion applications. The IDE approval is seen as a significant validation of CGBIO’s research, development, and global clinical capabilities.
