Nexgel Biotech Co. Ltd. and CG Bio Co. Ltd. agreed to co-develop a thermosensitive polyphosphazene hydrogel-based long-acting drug delivery platform through a new collaboration agreement signed Oct. 31.
Korean med-tech firm Innosys Co. Ltd. recently launched two new injectable spine bone graft substitute products – Velofuse Gel and Velofuse Putty – and announced a name change to CG Medtech Co. Ltd., effective Nov. 4, 2024.
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
After Novosis Putty gained U.S. FDA breakthrough device designation of bio-fusion spine implantation device, South Korea’s Cgbio Co. Ltd. posted positive findings of similar ceramic bone graft, Novosis, to lay groundwork for U.S. market entry.
South Korea’s Cell & Growth Factor Biotechnology Co. Ltd. (CG Bio) became the largest shareholder of Busan-based Inosys Korea after claiming a 34.7% stake in the embattled orthopedic implant med-tech firm.
The U.S. FDA granted breakthrough device designation to CG Bio Co. Ltd.’s spine implantation device, Novosis putty, making it the first bone substitute material developed in South Korea to gain the agency’s priority support. Novosis putty, successor to CG Bio’s first generation Novosis Ortho, combines a bone-forming protein called recombinant human bone morphogenetic protein 2 (rhBMP-2; Nebotermin) with ceramic scaffolds to accelerate bone growth.