The Korean regenerative biopharmaceutical firm CGBIO announced on November 11 that Therapeutic Goods Administration (TGA) in Australia approved its next-generation product NOVOMAX Fusion, a synthetic glass-ceramic spacer.
Put it simply, NOVOMAX Fusion is a prosthetic to substitute the height and angle of the intervertebral space of an operative segment. Bioactive glass-ceramic spacer-7 (BGS-7) contained in NOVOMAX Fusion can form a bone-like apatite layer immediately after insertion. This layer plays a role as an adhesive for bone union.
NOVOMAX Fusion is an osteo-active cage developed through a government-funded project from 2001(Osteo-Active Cage). It acquired CE marking in 2018.
NOVOMAX Fusion addresses disadvanges of conventional cages made of titanium and polyetheretherketone (PEEK). The first-generation titanium cage has better biocompatibility and strength. Thus, it has been widely used for intervertebral fusion. However, the incidence of subsidence is high because it has significantly higher strength than the bone.
The strength of the second-generation PEEK cage, which was developed as a plastic material, was relatively close to the strength of bone. Thus, its bio-functionality is excellent. However, it has no affinity with bone. As a result, additional use of bone graft is inevitable.
To overcome these shortcomings, NOVOMAX Fusion consisting of BGS-7 has proper affinity to a bone. In addition, it can lessen the occurrence of subsidence. After inserting into the body, BGS-7 has affinity to a bone without additional bone implants.
According to the TGA, Australian medical device market size is valued at $5.7 billion in 2020. It is expected to reach $6.2 billion by 2022. Australia has more than 95.5% import dependency on medical devices. Medical devices in areas of orthopedics and prosthetics are in greatest demand (except other medical devices).
“The approval of NOVOMAX Fusion in Australia with a big growth potential is a significantly meaningful outcome. To increase our presence in Australian medical device market, we will work together with the local partner by supplying good quality product and co-marketing. We wil also endeavor to gain approval of this product from the U.S. Food and Drug Administration,” said CGBIO CEO Hyun Seung Yu.
