CG MedTech announced on Friday that its bone substitute for fracture treatment, Novosis Trauma, has received product approval from the Malaysian Medical Device Authority.
This marks the first international registration for Novosis Trauma. Novosis is a brand of bone regeneration medical devices based on rhBMP-2, a gene-recombinant bone morphogenetic protein that promotes bone regeneration.
The company has built expertise in spinal fusion surgery over the years, and Novosis Trauma extends this technology to treat fractures and trauma in limbs.
Novosis Trauma is a bone substitute used to fill areas where bone loss occurs due to accidents or surgeries. Once implanted, it gradually absorbs while stimulating new bone formation.
The approval received is the highest grade in Malaysia’s medical device classification, requiring a stringent review of safety and efficacy. The company stated that this recognition officially validates the product’s technological prowess and quality competitiveness by international regulatory bodies.
CG MedTech is currently pursuing licensing procedures in key markets, including Singapore, Indonesia, Japan, and China through their respective health authorities.
Chief Executive Officer (CEO) Yoo Hyun-seung commented that this Malaysian approval represents a significant milestone as Novosis Trauma enters the global market. Building on the sales collaboration with Johnson & Johnson MedTech, it will continue to refine the quality systems to meet regulatory standards worldwide and strengthen the position in the global fracture treatment market.