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- DePuy Synthes secures exclusive commercialization rights in North America and Australia; both parties to jointly advance global clinical development and regulatory approvals, including the U.S. FDA IDE and PMA pathways
- Official entry into the world’s largest bone graft substitute market—North America; strategic partnership to further expand orthopedic and bone regeneration portfolio
Seoul, South KoreaMay 27, 2026 /PRNewswire/ — Regenerative medicine company CGBIO (CEO: Hyunseung Yu) announced that it has signed a global clinical development and exclusive commercialization agreement with DePuy Synthes, a global orthopedic solutions company, to collaborate on the NOVOSIS bone graft substitute product portfolio in the United States, Canada, and Australia.
Image of ‘NOVOSIS Putty’ product
Under the agreement, DePuy Synthes will obtain exclusive commercialization rights for the NOVOSIS product portfolio in the United States, Canada, and Australia. Both parties will also jointly advance global clinical development and regulatory approvals, including the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and Premarket Approval (PMA) pathways.
Previously, in 2025, CGBIO signed exclusive distribution and promotion agreements with Johnson & Johnson for NOVOSIS in South Korea, Taiwan, China, Thailand, India, Hong Kong, China, and Macau, China, with the collaboration later expanding to Malaysia and Singapore. Through this new agreement, the partnership region further extends to North America and Australia, laying a stronger foundation for breaking beyond the Asia-Pacific market and accelerating global expansion.
The two parties plan to establish a Joint Steering Committee to jointly oversee project selection and development strategy. Currently, the U.S. IDE clinical study is in preparation, with a target to launch in the second half of 2026.
North America is widely regarded as the core market for the global bone graft substitute industry. According to Fortune Business Insights, the global bone graft substitute market size is expected to grow from approximately $3.78 billion in 2022 to $5.71 billion by 2029. Among this, the North American market is valued at approximately $1.53 billion, making it the largest regional market globally.
NOVOSIS is a bone graft substitute product portfolio that combines rhBMP-2 (recombinant human bone morphogenetic protein-2) bone regeneration technology with CGBIO’s sustained-release carrier platform technology. CGBIO regulates the release of rhBMP-2 through its proprietary SLOREL™ sustained-release carrier technology, thereby supporting a stable bone regeneration environment. Additionally, the product utilizes a ceramic scaffold structure based on calcium hydroxyapatite (CaHA) to provide a structural environment close to natural bone tissue.
Particularly in the fields of spinal fusion and bone regeneration applications, the market demand for products that offer excellent bone fusion performance and ease of use is continuously growing, further highlighting the global market potential of NOVOSIS.
CGBIO CEO Hyunseung Yu stated: “This agreement is significant, as it not only expands the existing Asia-Pacific partnership to North America and Oceania markets but also further strengthens the foundation for global collaboration. Moving forward, through the advancement of global regulatory approvals, including FDA IDE and PMA, and commercialization efforts, we are committed to establishing NOVOSIS as one of the new standards in the global bone regeneration market.”