CGBIO Gains FDA IDE Approval for NOVOSIS PUTTY, Advancing U.S. Entry

CGBIO, a prominent South Korean firm renowned for its expertise in bio-regenerative medicine, has announced a monumental development concerning its bone graft substitute, NOVOSIS PUTTY. The U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for this innovative product, facilitating a clinical trial aimed at spinal fusion procedures across the United States. This milestone not only marks progress for CGBIO but also for medical technology originating from Korea, as NOVOSIS PUTTY becomes the first Korean-developed bio-combined medical device to achieve such recognition in the U.S. market.

Originally designated as a Breakthrough Device by the FDA in late 2023, NOVOSIS PUTTY utilizes an advanced approach to meet the challenges of bone regeneration. This IDE approval is a crucial step toward obtaining Premarket Approval (PMA), further paving the way for its future commercialization.

NOVOSIS PUTTY is engineered with a sophisticated dual-carrier system that combines Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP). This is complemented by CGBIO's own sustained-release technology known as SLOREL™, which modulates the delivery of recombinant human bone morphogenetic protein-2 (rhBMP-2). This technology is designed to promote the development of high-density bone while reducing the risk of ectopic bone growth, a common side effect observed in previous rhBMP-2 formulations. The efficacy and safety of this product have been corroborated by studies published in peer-reviewed journals such as the Journal of Clinical Medicine.

Key to the production of NOVOSIS PUTTY is the rhBMP-2 protein, provided by CGBIO’s strategic ally, Daewoong Pharmaceutical. The IDE application process included a meticulous FDA review of the manufacturing and Chemistry, Manufacturing, and Controls (CMC) data, highlighting the rigorous standards applied to bio-combined implants.

Jumi Han, who leads U.S. Development at CGBIO USA, expressed that securing this IDE approval underscores the company's robust clinical infrastructure and product quality. She affirmed their commitment to conducting a comprehensive clinical trial and expanding the reach of NOVOSIS PUTTY throughout the United States and other major markets.

Hyun Seung Yu, CEO of CGBIO, emphasized that this approval is a testament to their sustained research and development efforts. He noted the challenges associated with entering the U.S. bone graft market and highlighted this achievement as a reflection of NOVOSIS PUTTY’s global potential. CGBIO remains dedicated to offering innovative treatments that enhance the quality of life for patients globally.

In a strategic move earlier this year, CGBIO, along with its subsidiary CG MedTech, entered into a partnership with Johnson & Johnson MedTech. This agreement focuses on the exclusive distribution of NOVOSIS and NOVOSIS TRAUMA products within Korea and other Asian regions. The recent IDE approval is anticipated to accelerate the global presence of the NOVOSIS product line.

CGBIO stands as a leader in the field of medical devices, concentrating on the development of advanced biomaterials and regenerative medicine technologies. The company is actively expanding its manufacturing capabilities to meet growing global demand. Daewoong Bio, a key partner, has already completed the construction of a large-scale facility for rhBMP-2 production, ensuring a stable supply for the anticipated rollout across the U.S. and other global markets.