CGBio gets FDA nod to begin final U.S. trial for bone graft

Korea's CGBio has received the green light from the U.S. FDA to begin a final-stage clinical trial for its bone graft substitute, NOVOSIS PUTTY, the company said Monday.

The FDA’s clearance, issued last week, allows CGBio to initiate a pivotal trial—a large-scale study required before applying for full U.S. marketing approval. According to the company, it marks the first time a Korean-developed bio-composite medical device has been cleared by the FDA to begin this type of trial.

“This approval confirms that our systems and technologies meet U.S. regulatory standards,” said Han Ju-mi, head of CGBio’s U.S. Development Center. “We’re now moving toward final-stage testing and preparing for market entry.”

NOVOSIS PUTTY is a moldable, injectable material designed to fill bone defects during spinal fusion and other orthopedic procedures. It builds on the company’s earlier synthetic bone graft, NOVOSIS, but incorporates a softer, more flexible formulation to improve handling during surgery.

The product combines two synthetic materials that resemble natural bone: hydroxyapatite, a biocompatible ceramic similar to bone mineral, and tricalcium phosphate, a calcium-based compound that acts as a temporary framework for new bone to grow around. These materials gradually dissolve as the body forms real bone in their place.

To promote bone growth, the graft also includes a lab-made version of a natural protein called bone morphogenetic protein-2 (BMP-2), which signals the body to start building new bone. CGBio said it uses its proprietary controlled-release system, SLOREL, to regulate how this protein is delivered over time. The goal is to encourage dense bone formation while lowering the risk of side effects like bone forming in the wrong place.

Because BMP-2 is a potent biologic, CGBio said the FDA classifies these types of grafts as high-risk and requires rigorous preclinical and early clinical data before larger trials can begin. The FDA’s recent clearance—formally called an Investigational Device Exemption (IDE)—permits CG Bio to begin such a pivotal trial in the U.S.

CGBio said it is also conducting clinical trials in Japan, where a phase 1/2 study was completed earlier this year. The company added that regulatory filings in Europe, Australia, and other markets are planned as part of its global expansion strategy.