3Spine Completes FDA Clinical Trial Enrollment

3Spine Inc, alternative lumbar spinal fusion medical device company announced its achievement of US clinical trial enrollment with 151 completed MOTUS lumbar total joint replacement surgeries and 174 real-world posterior lumbar fusions as of December 2023. Trials involved patients experiencing chronic leg and back pain ranging from 23 to 79 throughout 14 US states. 3Spine plans to seek FDA approval through the Premarket Approval pathway.
 
3Spine’s MOTUS device is a ‘first-of-kind’ breakthrough medical technology for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1. 
 
Through a posterior approach, MOTUS replaces the function of the disk and facet joints where the dual bearings resist rotation and shear like the two native facet joins, while carrying compressive axial loads like the disk. This technology uses highly cross-liked antioxidant vitamin E polyethylene, compression molded into CoCr, titanium plasma sprayed substrate. 
 
“I would like to personally thank my friends and colleagues across the U.S. who contributed to this important research,” commented Jeffrey A, Goldstein, national principal investigator for the MOTUS IDE study. “Learning a totally new and potentially game-changing spine procedure has been incredibly rewarding, and our own experience here and NYU suggests that we have developed something with remarkable significance.”
 
MOTUS has been in development for over two decades. According to the company, 80% of Americans will experience low-back problems in their lifetime, resulting in an estimated 500,000 lumbar spine surgeries in the US per year. Also exceeding evidence suggests that preserving back flexibility is more important than it once was, even for simple actives like sitting at a desk or driving a car. 
 
In June 2022 the FDA Investigational Device Exemption (IDE) approved to study joint reconstruction of the lumbar spine as an alternative to rigid spinal fusion. In 2020 the FDA designated MOTUS a as Breakthrough Device, categorizing it as an accelerating life-saving treatment for significant disease affecting the US population.
 
“True change only comes along once in a generation,” said American Board of Spine Surgery chairman Pierce D. Nunley. “When I first saw the concept, it seemed too simple, but in medicine, simple is best. I believe MOTUS has the potential to fundamentally change spine care.”
 
Utilization of MOTUS was tracked throughout clinical enrollment under CPT code 0719T (posterior vertebral joint replacement, including bilateral facetectomy, laminectomy, and radical discectomy, including imaging guidance, lumbar spine, single segment) published in 2022 by the American Medical Association.