CGBio, a South Korean specialist in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY," has received the 'Breakthrough Device Designation' (BDD) from the U.S. Food and Drug Administration (FDA). This designation marks a significant achievement, as NOVOSIS PUTTY becomes the first implantable device from Korea to receive such recognition.
NOVOSIS PUTTY is a second-generation product known for its innovative features, incorporating recombinant human bone morphogenetic protein 2 (rhBMP-2). It boasts a ceramic-based synthetic scaffold with outstanding moldability and osteoconductive properties, building upon the advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho. The inclusion of rhBMP-2, a vital protein for bone regeneration, distinguishes it on the global stage.
Daewoong's rhBMP-2, internationally known as 'Nebotermin,' has received acclaim from reputable organizations, including the World Health Organization (WHO), for its positive impact on health. The use of hydroxyapatite (HA) ceramic material as a scaffold for rhBMP-2 ensures controlled release, mitigating the risk of undesirable bone growth and soft tissue swelling compared to collagen sponge-based scaffolds. This unique feature allows NOVOSIS PUTTY to promote high-density bone formation with lower rhBMP-2 doses. Moreover, its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, enables customizable shaping.
The FDA's granting of the 'Breakthrough Device Designation' for NOVOSIS PUTTY underscores CGBio's prowess in technology, innovation, and market potential, highlighting its commitment to swiftly bringing valuable products to market.