Korean regenerative medicine company CGBio announced Monday that an investigational device exemption has been approved for CGBio's bone graft substitute, paving the way for pivotal clinical trials in the US.
The approval by the US Food and Drug Administration marks a major milestone, making Novosis Putty the first Korean-developed bone graft substitute to enter pivotal clinical trials in the US. It also brings CGBio one step closer to achieving the premarket approval, or PMA, required for full commercialization in the global medical device market.
Novosis Putty builds on CGBio’s existing Novosis platform, combining hydroxyapatite and tricalcium phosphate to better replicate natural bone structure. Its putty-like consistency allows for easier handling, while the company’s proprietary Slorel technology enables controlled, sustained release of recombinant human bone morphogenetic protein-2 (rhBMP-2), designed to maximize bone regeneration while minimizing side effects such as ectopic bone formation.
Although classified as a medical device, the product underwent FDA review under standards equivalent to those for biopharmaceuticals. RhBMP-2, a key bone-forming protein, was successfully localized and mass-produced by Daewoong Pharmaceutical, CGBio’s affiliate. The IDE review involved a rigorous assessment of chemistry, manufacturing, and controls data, with the two companies collaborating closely across research and development, production and quality management.
CGBio is targeting the US BMP-2-based bone graft market, which is valued at approximately 1 trillion won ($705 million). The company also plans to expand into additional global markets, including Europe and Australia, following this regulatory milestone.
Novosis Putty received Breakthrough Device Designation from the FDA in December 2023 and has already completed Phase 1 and 2 clinical trials in Japan.
“This approval is the result of nearly a decade of R&D and marks an important step in our global expansion,” said CGBio CEO Yu Hyun-seung. “We remain committed to providing innovative regenerative solutions worldwide.”
hyelimchung@heraldcorp.com
