Surgalign Holdings, Inc. announced a key milestone for its recently introduced posterior fixation platform – the Cortera™ Spinal Fixation System. Surgalign received FDA 510(k) in August 2022 and Cortera and was introduced in a limited market release shortly thereafter. In a little over three months, the Company has successfully penetrated target markets and announced the completion of the 100th case utilizing this new flagship pedicle screw system.

During this initial market release, Surgalign's goal has been to collect clinical and design feedback on the system from a wide range of spine surgeons, representing the user needs and preferences of the broader market. Efforts are now underway to secure additional products and the Company intends to ramp up commercialization in the first half of 2023 as it looks to grow its market share in the estimated $2.2 Billion posterior fixation market. The Cortera system was designed based on feedback from some of the most experienced and knowledgeable surgeons and engineers in the world and at its core, 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. As previously communicated, the Company intends to develop additional implants and instruments to add to the Cortera System over the next 3-4 years and is also working to integrate Cortera with its HOLO Portal™ surgical guidance system.