South Korean bio-regenerative medicine company CGBio has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its NOVOSIS PUTTY, a bone substitute material.
NOVOSIS PUTTY is the first Korean-developed implantable device for spine surgery and incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2).
The designation, which acknowledges the potential of the material to offer more effective treatment for spine implantation, is expected to facilitate faster approval in the US by providing priority support from the FDA.
By combining bone-forming proteins and ceramic scaffolds, NOVOSIS PUTTY induces rapid bone formation.
It features a ceramic-based synthetic scaffold and advanced sustained-release formulation technology (SLOREL).
Daewoong Pharmaceutical has been selected for mass-producing rhBMP-2, a key ingredient in NOVOSIS PUTTY.
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The protein is said to play a key role in bone regeneration, transforming stem cells into bone cells in cases of defects. Globally, it is known as “Nebotermin”.
CGBio has completed preclinical studies and is conducting clinical trials to determine the optimal dosage for NOVOSIS PUTTY.
The company plans to apply for US confirmatory clinical trials in the first half of this year, moving closer to bringing this treatment to patients.
CGBio CEO Hyun Seung Yu said: “The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio’s technological prowess, innovation, and potential. With the designation’s emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY.”
CGBio US Development Center head Jumi Han said: “The ‘breakthrough device designation’ for NOVOSIS PUTTY confirms that regulatory authorities are prioritising support for our product development. We are accelerating US clinical trials to demonstrate its efficacy and safety.”