CGBio signs Novosis commercialization deal with DePuy Synthes in US, Canada, Australia

CGBio, a Korean regenerative medicine company, said Wednesday that it has signed a global clinical development and exclusive commercialization agreement with DePuy Synthes for its bone graft substitute product family, Novosis, covering the U.S., Canada and Australia.

Under the agreement, DePuy Synthes will secure exclusive commercialization rights for the Novosis portfolio in the three markets. The two companies will jointly pursue global clinical development and regulatory approvals, including Investigational Device Exemption (IDE) approval and Premarket Approval (PMA) from the U.S. FDA.

Novosis Putty (Courtesy of CGBio)

CGBio previously signed an exclusive distribution and promotion agreement with Johnson & Johnson in 2025 for Novosis in Korea, Taiwan, Thailand, India, Hong Kong and Macau, with the partnership later expanding to Malaysia and Singapore. With the latest deal extending collaboration into North America and Australia, the company said it has further strengthened its foundation for global market expansion beyond the Asia-Pacific region.

The companies plan to establish a joint steering committee to oversee project selection and development strategies. IDE clinical trials in the U.S. are being prepared for initiation in the second half of 2026.

North America is regarded as a key region in the global bone graft substitute market. According to market research firm Fortune Business Insights, the global bone graft substitute market is projected to grow from about $3.78 billion in 2022 to $5.71 billion by 2029, with North America accounting for the largest regional market at around $1.53 billion.

Novosis is a bone regeneration product family that combines rhBMP-2 (recombinant human bone morphogenetic protein-2)-based bone regeneration technology with CGBio’s sustained-release carrier platform technology. The company said its proprietary SLOREL sustained-release carrier technology is designed to control rhBMP-2 release and create a stable bone-regeneration environment. The product also incorporates a calcium hydroxyapatite (CaHA)-based ceramic scaffold that mimics the structural environment of natural bone.

CGBio noted that growing demand for spinal fusion and bone regeneration procedures, driven by strong bone fusion performance and ease of handling, has increased attention on Novosis’ global market potential.

“This agreement is meaningful in that our partnership has expanded from the existing Asia-Pacific collaboration into North America and Oceania,” said Yu Hyun-seung, CEO of CGBio. “Through global regulatory approvals and commercialization efforts, including the FDA's IDE and PMA processes, we aim to establish Novosis as one of the new standards in the global bone regeneration market.”