Sam Brusco, Associate Editor01.03.24
Korean bio-regenerative medicine company CGBio has won U.S. Food and Drug Administration (FDA) breakthrough device designation for its advanced bone substitute material, Novosis Putty.
The material incorporates recombinant bone morphogenetic protein 2 (rhBMP-2). Novosis Putty marks the first Korean-developed medical device for spine implantation.
The second-generation product has a ceramic-based synthetic scaffold with moldability and osteoconductive properties, incorporating sustained-release formulation technology (SLOREL) from its predecessor, Novosis Ortho. The rhBMP-2, mass produced by Korea’s Dawoong Pharmaceutical, transforms stem cells into bone cells in cases of bone defect.
The hydroxyapatite ceramic material both acts as a scaffold of rhBMP-2 and allows for its controlled release to reduce risk of unwanted bone growth and soft tissue swelling. Its Poloxamer 407 hydrogel also permits customizable shaping.
CGBio said it has finished preclinical studies for U.S. confirmatory clinical trials of Novosis Putty. The company is conducting trials to determine optimal dosage, with plans to apply for confirmatory trials in H1 2024.
Hyun Seung Yu, CEO of CGBio, commented, "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."
The material incorporates recombinant bone morphogenetic protein 2 (rhBMP-2). Novosis Putty marks the first Korean-developed medical device for spine implantation.
The second-generation product has a ceramic-based synthetic scaffold with moldability and osteoconductive properties, incorporating sustained-release formulation technology (SLOREL) from its predecessor, Novosis Ortho. The rhBMP-2, mass produced by Korea’s Dawoong Pharmaceutical, transforms stem cells into bone cells in cases of bone defect.
The hydroxyapatite ceramic material both acts as a scaffold of rhBMP-2 and allows for its controlled release to reduce risk of unwanted bone growth and soft tissue swelling. Its Poloxamer 407 hydrogel also permits customizable shaping.
CGBio said it has finished preclinical studies for U.S. confirmatory clinical trials of Novosis Putty. The company is conducting trials to determine optimal dosage, with plans to apply for confirmatory trials in H1 2024.
Hyun Seung Yu, CEO of CGBio, commented, "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."