The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) study for a novel bone graft substitute.
What makes this novel, is that this bone graft substitute uses a dual-carrier system that employs Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP) in combination with a proprietary technology called SLOREL™ that controls the release of recombinant human bone morphogenetic protein-2 (rhBMP-2). According to the company, the system is “engineered to enhance high-density bone formation while minimizing ectopic bone growth, a common adverse effect in earlier rhBMP-2-based products.”

An IDE enables the use of an investigational device in a clinical study to allow for the collection of safety and effectiveness data. In most instances, a clinical study is used to support FDA premarket approval (PMA). Per the FDA website, a PMA is “the most stringent type of device marketing application required by the FDA.”

CGBIO, a global medical device company, requested the IDE approval. Its bone graft substitute is called NOVOSIS PUTTY. The approval means that there can now be a clinical trial utilizing NOVOSIS PUTTY in spinal fusion.
CGBIO CEO Hyun Seung Yu said, “This IDE approval reflects years of consistent R&D efforts and strengthens our global competitiveness.”
Yu continued, “The U.S. bone graft market is notoriously difficult to penetrate, and this achievement underscores the global potential of NOVOSIS PUTTY. We will continue to provide transformative treatment options that improve quality of life for patients worldwide.”
CGBIO and its subsidiary CG MedTech have already began expanding its NOVOSIS and NOVOSIS TRAUMA products. Earlier this year, the companies entered into a partnership agreement with Johnson & Johnson MedTech. The agreement provided for the exclusive supply of those products across Korea and other Asian territories.
The IDE approval will enable the company to further its expansion efforts. Notably, according to the press release, NOVOSIS PUTTY is “the first Korean-developed bio-combined medical device to reach this stage (IDE) in the U.S., signifying a significant step toward Premarket Approval (PMA) and subsequent commercialization.”

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