Cizimedtech's "Novosis Trauma" Approved in Malaysia... Targeting the Fracture Treatment Market

Receives Top Class D Approval from Malaysian Medical Device Authority
First Overseas Registration for Novosis Trauma

Cizimedtech, a company specializing in the research and manufacturing of implants for use in the human body, announced on March 6, 2026, that its bone substitute for fracture treatment, "Novosis Trauma," has received product approval from the Malaysian Medical Device Authority (MDA).

Product image of bone substitute 'Novosis Trauma.' Cizimedtech

This approval marks the first overseas registration for Novosis Trauma. With this milestone, Cizimedtech plans to expand its application scope from its existing spine-focused business to include fracture and trauma treatment.

Novosis is a bone regeneration medical device brand based on the recombinant human bone morphogenetic protein "rhBMP-2," which stimulates bone regeneration. Previously, it was used in the field of spinal fusion surgery. Novosis Trauma applies this technology to the treatment of fractures in limbs, such as arms and legs.

Novosis Trauma is a bone substitute that is implanted at the site of bone loss. It is gradually absorbed in the body, inducing the formation of new bone. As a synthetic bone graft combining hydroxyapatite, an artificial bone component, and rhBMP-2, it is designed to release the protein progressively.

This approval corresponds to Class D, the highest classification among Malaysian medical device categories. According to the Ministry of Food and Drug Safety in Korea, this is equivalent to a Class 4 medical device, which is considered a high-risk group.

To enter the Malaysian market, Cizimedtech is also pursuing a sales partnership with Johnson & Johnson MedTech Malaysia, a global medical device company. The strategy is to accelerate market entry by leveraging local distribution networks.

The Novosis product lineup is supplied by Cizibio and Cizimedtech, each focusing on different markets. Cizibio has signed supply agreements targeting the spine and trauma markets in Taiwan, Thailand, India, Hong Kong, and Macau. Cizimedtech is targeting the markets in Korea, Malaysia, and Singapore, focusing on Novosis Trauma for fracture treatment.

The Malaysian Medical Device Authority is a regulatory body that applies the ASEAN Medical Device Directive (AMDD). Based on this approval, the company plans to expand global regulatory approvals, focusing on the Southeast Asian market. Registration procedures are currently underway with the Health Sciences Authority (HSA) in Singapore, the Ministry of Health (MOH) in Indonesia, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the National Medical Products Administration (NMPA) in China.

Hyunseung Yoo, CEO of Cizimedtech, stated, "The approval in Malaysia is the first step in Novosis Trauma's entry into the global market," adding, "We will expand rhBMP-2-based bone regeneration technology into the fracture and trauma treatment sector to strengthen our global competitiveness."

This content was produced with the assistance of AI translation services.