Surgalign Holdings, Inc. announced FDA 510(k) clearance of the CorteraTM Spinal Fixation System. This new flagship product from Surgalign is a key piece to the foundational portfolio designed to drive the Company's future growth over the next 10 years and to enable market share gains in the estimated $2.2B US posterior fixation market. At its core, Cortera is a 5.5/6.0mm rod pedicle screw system, that has both open and MIS modules.

The system boasts a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism. The Cortera system was strategically designed to maximize adoption in the spine market—today and for the future of evolving techniques and technology. Cortera is yet another system that demonstrates how spinal implants will be deployed with technologies like the Company's HOLO PortalTM surgical guidance.

The Company will integrate the Cortera system with the HOLO Portal surgical guidance system designed to create an unrivaled user experience for pedicle screw navigation. The Company is planning additional implants and instruments to add to the Cortera system over the next 3-4 years to expand applications of the system into a majority of posterior fixation spinal procedures. The Cortera Spinal Fixation System limited market release is expected to positively contribute to Fourth Quarter 2022 results and in the coming years.

The Company expects Cortera will help accelerate adoption of the HOLO Portal surgical guidance system by offering surgeons and hospitals two state-of-the-art technologies packaged together to perform spinal fusion procedures.