Korean regenerative medicine company CGBio has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) for its bone graft substitute, Novosis Putty. This regulatory milestone paves the way for pivotal clinical trials in the United States, the company announced on Monday.
The approval represents a significant achievement as Novosis Putty becomes the first Korean-developed bone graft substitute to advance to pivotal clinical trials in the US market. This development brings CGBio closer to securing premarket approval (PMA), a critical requirement for full commercialization in the global medical device market.
Innovative Technology Platform
Novosis Putty builds upon CGBio's established Novosis platform, incorporating a combination of hydroxyapatite and tricalcium phosphate to more effectively mimic natural bone structure. The product's putty-like consistency offers improved handling characteristics for surgeons during procedures.
A key differentiating factor is CGBio's proprietary Slorel technology, which enables controlled and sustained release of recombinant human bone morphogenetic protein-2 (rhBMP-2). This mechanism is specifically designed to optimize bone regeneration while reducing common side effects associated with BMP-2 products, such as ectopic bone formation outside the target area.
Rigorous Regulatory Review
Despite being classified as a medical device, Novosis Putty underwent FDA evaluation using standards comparable to those applied to biopharmaceuticals. This rigorous assessment reflects the product's complex nature and biological activity.
The rhBMP-2 component, a critical bone-forming protein in the product, was successfully localized and mass-produced by Daewoong Pharmaceutical, CGBio's affiliate company. The IDE review process included comprehensive evaluation of chemistry, manufacturing, and controls data, requiring close collaboration between the two companies across research and development, production, and quality management functions.
Market Potential and Global Expansion
CGBio is positioning Novosis Putty to compete in the US BMP-2-based bone graft market, which is currently valued at approximately 1 trillion won ($705 million). Following this regulatory achievement, the company has outlined plans to expand into additional global markets, including Europe and Australia.
The product has already demonstrated promising clinical results, having completed Phase 1 and 2 clinical trials in Japan. Additionally, Novosis Putty received Breakthrough Device Designation from the FDA in December 2023, highlighting its potential to address significant unmet needs in bone regeneration.
Executive Perspective
"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."
The successful IDE approval represents the culmination of extensive research and development efforts by CGBio, positioning the company to potentially disrupt the bone graft substitute market with its novel technology platform.
