CGBIO Wins FDA IDE for NOVOSIS PUTTY Spine Trial

Seoul, South Korea | April 24, 2025

CGBIO has achieved a major regulatory milestone with the U.S. Food and Drug Administration (FDA) granting Investigational Device Exemption (IDE) approval for its innovative NOVOSIS PUTTY, enabling a pivotal clinical trial in spinal fusion procedures in the United States. This advancement marks a critical step toward Premarket Approval (PMA) and positions the company for entry into the highly competitive $750 million global spinal bone graft market, reinforcing its ambitions in bio-regenerative and implantable medical technologies.

Breakthrough Bio-Combined Device Targets Bone Regeneration

NOVOSIS PUTTY represents a next-generation bio-combined bone graft substitute that integrates recombinant human bone morphogenetic protein-2 (rhBMP-2) with an advanced dual-carrier system. The product previously received the FDA Breakthrough Device designation, highlighting its potential to address significant unmet clinical needs in spinal fusion and bone regeneration.

The technology combines Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP) with CGBIO’s proprietary SLOREL™ sustained-release platform, enabling controlled delivery of rhBMP-2. This innovative mechanism is designed to enhance high-density bone formation while minimizing complications such as ectopic bone growth, a known limitation in earlier-generation rhBMP-2 therapies.

The FDA’s IDE approval reflects rigorous evaluation of manufacturing processes and Chemistry, Manufacturing, and Controls (CMC) data, emphasizing the increasing regulatory scrutiny applied to bio-combined implants. Clinical validation published in peer-reviewed journals further supports the product’s safety, efficacy, and translational potential, strengthening its positioning as a differentiated solution in orthopedic and spinal surgery markets.

Strategic Partnerships Strengthen Global Expansion Path

A key component of NOVOSIS PUTTY’s development is its collaboration with Daewoong Pharmaceutical, which manufactures the rhBMP-2 protein, ensuring high-quality biologic integration within the device platform. Additionally, CGBIO has expanded its commercial reach through a strategic partnership with Johnson & Johnson MedTech, securing exclusive supply agreements across Korea and other Asian markets for the broader NOVOSIS product portfolio.

This IDE approval is expected to accelerate global commercialization efforts, enabling CGBIO to leverage its clinical infrastructure and regulatory expertise to penetrate major international markets. Company leadership emphasized that entering the U.S. market represents a significant validation of its long-term R&D investment and technological capabilities, particularly given the complexity and competitiveness of the spinal implant sector.

The upcoming pivotal trial will play a crucial role in demonstrating clinical superiority and real-world performance, supporting regulatory submissions and future adoption by surgeons and healthcare systems worldwide.

Positioning for Leadership in Regenerative MedTech Innovation

The approval of NOVOSIS PUTTY for clinical evaluation underscores CGBIO’s growing influence in the global regenerative medicine and MedTech landscape. As healthcare shifts toward biologically integrated solutions, the demand for advanced bone graft substitutes is expected to rise, driven by increasing rates of spinal disorders, aging populations, and orthopedic interventions.

By combining biologics, biomaterials, and controlled-release technologies, NOVOSIS PUTTY exemplifies the convergence of biotechnology and medical devices, a trend reshaping modern treatment paradigms. The product’s ability to enhance bone healing while reducing adverse effects positions it as a potential game-changer in spinal fusion procedures, where achieving reliable and safe bone growth remains a clinical priority.

Looking ahead, CGBIO aims to expand its pipeline of bio-regenerative products, leveraging its expertise to deliver innovative, patient-centric solutions that improve surgical outcomes and quality of life. The IDE approval not only validates the company’s scientific approach but also reinforces its role as a key innovator in next-generation orthopedic and regenerative technologies.

Source: CGBIO press release