Applied Spine Technologies (AST), Inc. announced that in its ongoing clinical trial for Stabilimax Dynamic Spine Stabilization System, a cohort of 15 patients reached two years mark. The Stabilimax System is a posterior dynamic stabilization device intended for the support of an injured or degenerative spine without eliminating motion.
“It is encouraging to see such significant progress within the Stabilimax IDE,” said Craig Corrance, CEO of Applied Spine Technologies. “The two year product milestone marks an exciting moment in the companies’ history and reinforces our strategy for the future commercialization of the Stabilimax System.”
The company recently received approval from the FDA to resume a multi-center, randomized, controlled clinical trial to compare posterior dynamic stabilization using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. The trial enrolled more than 100 patients to date.
Stabilimax is being developed to offer advantages over current spinal fixation products and even new artificial disc products which includes a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease.
Stabilimax is limited by United States (US) Federal Law for investigational use only.