CGBio Medtech's Spinal Implant 'UniSpace' Receives FDA Clearance

Full-Scale Entry into the U.S. Market

CGBio Medtech, a company specializing in the research and manufacturing of orthopedic implants, announced on November 7 that its spinal fusion device, "UniSpace® TPLIF Cage (Lumbar Cage)," has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The newly approved lumbar "UniSpace" device was designed to be compatible with CGBio's next-generation bone substitute, "NOVOSIS PUTTY." With NOVOSIS PUTTY having received Investigational Device Exemption (IDE) approval for clinical trials from the FDA in April of this year, the earlier FDA clearance of UniSpace further increases the likelihood of clinical success for NOVOSIS PUTTY in the future.

UniSpace is a spinal implant structure (cage) that is inserted between vertebrae after removal of a damaged disc during the treatment of degenerative spinal diseases. It enhances stability and supports bone regrowth and fusion. The device utilizes titanium 3D printing technology to create a dual pore structure similar to human cancellous bone, and is available in a total of 256 specifications, allowing for customized application based on each patient's anatomical conditions.

The internal space of the cage is designed to allow ample injection of bone substitute material, and the surface features a biomimetic porous pattern to promote bone cell growth. In particular, when used in conjunction with NOVOSIS, the structural optimization maximizes clinical efficacy.

Last year, CGBio Medtech received FDA clearance for the "UniSpace Stand-Alone C Cage (Cervical Cage)" for cervical (neck) fusion surgery, marking the company's full-fledged entry into the North American market. With this latest FDA clearance, the company has now completed its lineup of both cervical and lumbar cages, which is highly significant.

Meanwhile, NOVOSIS is currently being distributed through the global medical device leader "Johnson & Johnson MedTech," and NOVOSIS PUTTY, having received FDA IDE approval, is set to begin full-scale clinical research in the United States.

Yoo Hyunseung, CEO of CGBio Medtech, stated, "This FDA clearance is not merely an achievement for a single product, but a meaningful milestone that accelerates our entry into the U.S. market with an integrated treatment platform combining the technologies of CGBio Medtech and CGBio. By leveraging the technological capabilities and global networks of both companies, we aim to establish a new standard of care in the fields of spinal reconstruction and regenerative medicine."