CGBio, a Korean regenerative biopharmaceutical company, said Tuesday that Novomax Fusion, aitsnext-generation osteo-active bioglass ceramic cage, has received approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA).

According to CGBio, Novomax Fusion is a synthetic glass-ceramic spacer inserted into where the damaged disc is removed to replace the height and angle of the disc when spinal fusion is performed to connect the upper and lower vertebrae of the cervical spine due to degenerative spinal diseases. It is commonly used for damage to the “herniated cervical disc.”

Novomax Fusion received CE approval for medical devices in Europe in 2018 and Therapeutic Goods Administration (TGA)’s clearance in Australia in 2021.

CGBio emphasized that Novomax Fusion is a third-generation product that addresses the shortcomings of the first- and second-generation cages.

The first-generation titanium cage had muscular strength but had the limitation of the phenomenon of subsidence. The second-generation PEEK cage was developed with plastic material and had similar strength to the bone but did not adhere directly to the bone, requiring additional bone grafting materials.

The third-generation cage, Novomax Fusion, is made of BGS-7. This bioactive glass-ceramic directly adheres to the bone on the surface after insertion into the body, eliminating the need for additional bone grafting materials.

“This PMDA approval in Japan is a validation of Novomax Fusion’s excellent technology,” CEO Yu Hyun-seung said. “We will also actively enter other foreign cervical cage markets based on our original technology."

Meanwhile, the global fixed cage market is expected to reach $2.16 billion (2.78 trillion won) in 2022 and $2.73 billion by 2028, recording an annual average growth rate of 3.78 percent from 2023 to 2028.