CGBIO Signs Global Clinical and Exclusive Commercialization Agreement for NOVOSIS in the U.S., Canada and Australia

• DePuy Synthes secures exclusive commercialization rights in North America and Australia; the two companies to jointly advance global clinical development and regulatory approvals, including FDA IDE and PMA pathways
• Full-scale entry into North America, the world's largest bone graft substitute market; strategic partnership to expand in orthopaedics and bone regeneration sectors 

SEOUL, South Korea, May 27, 2026 /PRNewswire/ -- CGBIO, a regenerative medicine company (CEO: Hyunseung Yu), announced that it has entered into a global clinical development and exclusive commercialization agreement with DePuy Synthes, a global orthopaedics solutions company, for the NOVOSIS bone graft substitute product portfolio in the United States, Canada, and Australia.

'Novosis Putty' Product image

Under the agreement, DePuy Synthes will secure exclusive commercialization rights for the NOVOSIS portfolio in the U.S., Canada, and Australia, while the two companies will jointly advance global clinical development and regulatory pathways, including U.S. FDA Investigational Device Exemption (IDE) and Premarket Approval (PMA).

CGBIO previously entered into an exclusive distribution and promotional agreement with Johnson & Johnson for NOVOSIS across South Korea, Taiwan region, Thailand, India, Hong Kong SAR, and Macau SAR in 2025, with the partnership subsequently expanded to include Malaysia and Singapore. Through this new agreement, the scope of collaboration has broadened to include North America and Australia, further strengthening the foundation for global market expansion beyond the Asia-Pacific region.

The two companies plan to establish a Steering Committee to jointly oversee project selection and development strategies. The U.S. IDE study is currently being prepared with the goal of initiation in the second half of 2026.

North America is widely regarded as a key market within the global bone graft substitute sector. According to Fortune Business Insights, the global bone graft substitute market is projected to grow from approximately USD 3.78 billion in 2022 to USD 5.71 billion by 2029, with the North American market accounting for approximately USD 1.53 billion, making it the largest regional market globally.

NOVOSIS is a bone graft substitute portfolio that combines rhBMP-2(recombinant human Bone Morphogenetic Protein-2)-based bone regeneration technology with CGBIO's sustained-release carrier platform technology. CGBIO has applied its proprietary SLOREL™ sustained-release carrier technology to regulate the release of rhBMP-2 and support a stable bone regeneration environment. In addition, the product incorporates a Calcium hydroxyapatite (CaHA)-based ceramic scaffold, designed to provide a structural environment similar to natural bone.

In particular, demand is increasing in spinal fusion and bone regeneration applications for products that can simultaneously deliver both bone fusion performance and ease of handling, highlighting the global market potential of NOVOSIS.

Hyunseung Yu, CEO of CGBIO, said, "This agreement is particularly meaningful as it expands our partnership beyond the existing Asia-Pacific collaboration into North America and Oceania. Through global regulatory approvals and commercialization efforts, including FDA IDE and PMA pathways, we aim to position NOVOSIS as one of the new standards in the global bone regeneration market."

 

source: CGBIO