CGBio (CEO Hyun Seung Yu) announced on the 11th that they have obtained a permit from Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for Novomax-Fusion, a next-generation osteo-active bioglass ceramic cage.
Novomax-Fusion is an implant designed to replace a damaged disc that has been removed during spinal fusion surgery, performed to address degenerative disc diseases. It is positioned at the height and angle of the disc to facilitate the connection of spinal bones above and below the cervical vertebrae. It is used for treating damage in cervical disc, often referred to as ‘neck disc.’
Novomax-Fusion obtained its third permit from the PMDA in Japan, following the CE certification for medical devices in Europe in 2018 and the permit from the Therapeutic Goods Administration (TGA) of Australia in 2021. The PMDA, a pharmaceutical and medical device registration management agency under the Japanese Ministry of Health, Labor and Welfare, is known for rigorous permit procedures, making the acquisition of the permit to serve as a strong indication of capabilities of the product, according to the company.
Novomax-Fusion is a third-generation product that overcomes the limitations of its predecessors, the first and second-generation products. The first-generation titanium cage, known for its high strength and bio-compatibility, was widely used in transpetrosal fusion procedures, but it had a limitation that it caused subsidence due to its excessive strength. The second-generation PEEK cage, made of a plastic material with strength similar to bones, had a limitation that it did not directly bond with bones and therefore required an additional bone implant.
The third-generation cage, Novomax-Fusion, made of a bioactive glass ceramic material called BGS-7, is designed to directly bond with the surface of bones within the body, without requiring an additional bone implant. According to a published paper, Novosis-Fusion showed a bonding strength that is approximately 15 times higher than that of the existing PEEK cage.
The development of BGS-7 began from research papers in Japan, a country renowned for its advancements in ceramic artificial bones. Japan was the world’s first to commercialize artificial bones using ceramic materials in the 1980s, leading the artificial bone market. However, the early artificial bones made of ceramic materials during that time had limitations in mechanical strength, which hindered their widespread utilization.
To address the problem, CGBio CEO Hyun Seung Yu developed a new Korean ceramic material, BGS-7, which is bioactive (directly bonding within the body), and has robust mechanical strength, and incorporated it into Novomax-Fusion. Born that way, the high functional spinal cage, Novomax-Fusion is now being re-exported to Japan.
In addition, during the permit procedure in Japan, the packaging was simplified and scaled down, facilitating storage and increasing user convenience.
CEO Hyun Seung Yu said, “The acquisition of PMDA permit in Japan is practically showing the remarkable capabilities of Novomax-Fusion,” adding, “With our core technology, we will make an aggressive advance into international cervical cage markets, starting from the Japanese market”.
The global fixed-type cage market was valued at USD2.16 billion (KRW2795.8 billion) in 2022 and is projected to grow at an annual rate of 3.78% from 2023 to 2028, reaching USD2.73 billion (KRW3536.7 billion) by 2028.
▲ Novomax-Fusion Holder
