The US Food and Drug Administration (FDA) has granted clearance to Spineart for its Scarlet AC-Ti anterior cervical cage.
Cages are interbody devices used in spinal fusion surgeries to act as a space holder between vertebrae to help decompress the spinal cord and nerve root. The cages are hollow, allowing bone to grow through it.
Switzerland-based Spineart says its Scarlet AC-T system combines an “implant interbody device and cervical plate” in one.
Spineart designed the device for cervical use based on the company’s Scarlet system – which also bore cages for anterior lumbar use.
The company differentiates its devices based on its Ti-LIFE technology, an additive manufacturing process. According to Spineart, this technology gives the devices a porous titanium framework that closely mimics the trabecular bone structure.
Spineart says the technology gives its devices an average pore diameter of 0.9mm, giving a porosity between 70% and 75%, enabling cell colonisation.
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
The global metal interbody device market for spinal fusion was worth $293m in 2023 and is predicted to decrease to $233m by 2033, according to analysis by GlobalData. This is in part due to the increasing popularity of non-metal interbody devices, such as those made from carbon fibre, and polyetheretherketone (PEEK) cages. The PEEK market is estimated to grow to $4.6bn by 2033, up from $2.7bn in 2023.
According to research carried out in sheep, Spineart’s 3D-printed interbody cages outperformed PEEK cages in terms of bone cell proliferation.
Spineart’s chief commercial officer Alessia Erlingher said: “This approval underscores our commitment to innovation, continuously evolving our most successful products, such as the Scarlet system.”
It is another successful milestone for the company, which raised $22m (SFr20m) in financing in March.
Part of the funding will go towards two investigational device exemption (IDE) studies for a cervical intervertebral disc replacement device.
Other portions of the funds will be used to open a new research and development centre in the US, along with the completion of a new factory currently in Geneva by the end of 2024.
