close
close

Spineart wins FDA approval for anterior cervical spine

Posted on by darion

Earlier this year, Spineart raised $22 million. Image source: Shutterstock / Prostock-studio.

The U.S. Food and Drug Administration (FDA) has given Spineart approval for the Scarlet AC-Ti anterior cervical cage.

Cages are interbody devices used in spinal fusion surgeries that function to maintain space between the vertebrae, helping to decompress the spinal cord and nerve root. The cages are empty, which can cause bones to grow through.

Swiss company Spineart says its Scarlet AC-T system combines an “interbody implant and cervical plate.”

Spineart designed the device for cervical use based on the company’s Scarlet system, which also included cages for anterior lumbar use.

The company distinguishes its devices based on Ti-LIFE technology, i.e. the additive manufacturing process. According to Spineart, this technology allows the devices to have a porous titanium structure that closely mimics the structure of trabecular bone.

Spineart claims that this technology gives its devices an average pore diameter of 0.9 mm, which provides a porosity of 70% to 75%, which allows for cell colonization.

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive advantage.

Company Profile – free sample

You will receive a download email shortly

We are sure of the exceptional quality of our company profiles. However, we want you to make the most beneficial decision for your business, which is why we offer a free sample, which you can download by submitting the form below

By GlobalData







Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information about your rights in relation to your personal data and how you can unsubscribe from future subscriptions marketing messages. Our services are intended for corporate subscribers and you warrant that the email address you submit is your corporate email address.

According to an analysis by GlobalData, the global metal interbody spinal fusion device market was worth $293 million in 2023 and is expected to decline to $233 million by 2033. This is due in part to the growing popularity of non-metallic interbody devices such as those made from carbon fiber and polyetheretherketone (PEEK) cages. The PEEK market is expected to grow to $4.6 billion by 2033, up from $2.7 billion in 2023.

According to a study conducted on sheep, Spineart’s 3D printed interbody cages were superior to PEEK cages in terms of bone cell proliferation.

Spineart commercial director Alessia Erlingher said: “This approval underlines our commitment to innovation, continuously improving our most successful products such as the Scarlet system.”

This is another successful milestone for the company, which raised $22 million (SFr20 million) in financing in March.

Part of the funding will go towards two investigational device release (IDE) studies of a cervical intervertebral disc replacement device.

The remaining funds will be used to open a new research and development center in the US and complete the new factory currently located in Geneva by the end of 2024.