CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions.
The bone graft incorporates rhBMP-2 and is designed to enhance high-density bone formation and minimize ectopic bone growth, according to a news release. The rhBMP-2 protein in Novosis is manufactured by a strategic partner of CGBIO.
The FDA’s IDE approval opens up the opportunity to study the bone graft in spinal fusions in the U.S.
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