DEERFIELD, Ill., Aug. 24, 2022 (GLOBE NEWSWIRE) -- Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, today 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.
“The Cortera system is a testament to the spine engineering talent and expertise we’ve assembled in very short order, as we moved from zero engineers in the United States following the RTI divestiture two years ago, to approximately 30 today,” stated Terry Rich, President and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”
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.
“Cortera resulted from the culmination of efforts by some of the most experienced and knowledgeable surgeons, engineers, and project team members in the world. The system is hands down the most precise, elegant and comprehensive screw that currently exists in my opinion.” said Dr. Jeremy Smith, Chief of Spine, Hoag Orthopedic Institute. “I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”
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.
“What excites me about Cortera is how the system was forward-thinking to the technology evolution we are witnessing now in spine surgery,” said Dr. Craig Meyer, a Cedars-Sinai MIS Fellowship trained spine surgeon, practicing in Columbia, MO. “This is an exciting time to be a spine surgeon and hardware systems like Cortera will facilitate our rapid evolution of techniques to perform spinal surgery when integrated with technologies like HOLO Portal.”
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 Q4 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.