CGBIO's NOVOSIS PUTTY Achieves FDA IDE Approval, Paving the Way for U.S. Entry

CGBIO Secures FDA IDE Approval for NOVOSIS PUTTY

CGBIO, a prominent South Korean firm at the forefront of bio-regenerative medicine, has achieved a substantial milestone with the FDA's Investigational Device Exemption (IDE) approval for its innovative bone graft substitute, NOVOSIS PUTTY. This vital approval allows the company to move forward with clinical trials aimed at spinal fusion procedures in the United States.

This recent achievement highlights the company's expansion into the estimated $750 million U.S. spinal bone graft market, a sector known for its level of difficulty when it comes to approval and competition. In December 2023, NOVOSIS PUTTY had already been acknowledged by the FDA as a Breakthrough Device, which set the stage for this latest development.

One key to NOVOSIS PUTTY's success lies in its dual-carrier system, which utilizes Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP). These materials are combined with CGBIO's proprietary SLOREL™ technology, designed to manage the release of the recombinant human bone morphogenetic protein-2 (rhBMP-2). This advanced system aims to maximize bone formation in high-density areas while reducing the risk of ectopic bone growth—an issue that has hampered other rhBMP-2-based products.

The efficacy and safety of NOVOSIS PUTTY were substantiated through peer-reviewed studies published in the Journal of Clinical Medicine. During the evaluation process for the IDE application, the FDA conducted a rigorous examination of the manufacturing processes and the Chemistry, Manufacturing, and Controls (CMC) data, emphasizing the careful scrutiny applied to bio-combined implant products.

Jumi Han, the Head of U.S. Development at CGBIO USA, expressed enthusiasm over the FDA's decision. She stated, "Obtaining IDE approval for our clinical program demonstrates our commitment to high product quality and our strong global clinical infrastructure. We are dedicated to executing a thorough clinical trial that will expand NOVOSIS PUTTY’s distribution not only in the U.S. but also in other significant markets."

Furthermore, Hyun Seung Yu, CEO of CGBIO, emphasized the significance of this approval for the company's long-term strategy. He stated, "This IDE approval embodies the culmination of years of dedicated research and development efforts, enhancing our competitiveness on a global scale. The U.S. bone graft market is notoriously challenging, and this achievement is a testament to the global potential of NOVOSIS PUTTY. We will keep focusing on providing innovative treatment options that elevate patient quality of life."

Adding to the company's momentum, in February 2025, CGBIO and its subsidiary CG MedTech signed a strategic agreement with Johnson & Johnson MedTech. This partnership allows for the exclusive supply of NOVOSIS and NOVOSIS TRAUMA in Korea and other regions in Asia, further enhancing CGBIO’s foothold in the global market.

With the recent IDE approval of NOVOSIS PUTTY, CGBIO is poised for accelerated growth and expansion, not only in the United States but also worldwide, as it prepares to cater to the increasing demand for effective bone graft solutions. The company is already in the process of constructing a new manufacturing facility to support this growth, while Daewoong Bio has established a large-scale plant dedicated to the production of rhBMP-2, thereby ensuring a steady supply for upcoming market demands.

CGBIO stands as a global leader in medical devices specializing in regenerative medicine technologies and advanced biomaterials. Their focus remains steadfast on creating innovative medical solutions that can markedly improve patient outcomes and quality of life. As they progress towards bringing NOVOSIS PUTTY to market, the industry will certainly be watching closely.

As the demand for impactful regenerative solutions grows, CGBIO's NOVOSIS PUTTY is on track to become a transformative product in spinal surgery, enhancing surgical outcomes for patients across the globe.