3Spine Announces Completion of FDA Clinical Trial Enrollment Achieving 325 Surgeries in 2023

 

 
[10-January-2024]
 
 

 CHATTANOOGA, Tenn., Jan. 10, 2024 /PRNewswire/ -- 3Spine, Inc., a medical device company developing a transformational alternative to lumbar spinal fusion, today announced 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. The company enrolled a larger fusion cohort in an adaptive statistical design to improve propensity score matching between data sets. The trials involved patients experiencing chronic leg and back pain ranging in age from 23 to 79 across 14 U.S. states. 3Spine plans to seek FDA approval through the Premarket Approval pathway.

3Spine's MOTUS device is a 'first-of-kind' breakthrough medical technology indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1. MOTUS replaces the function of the disc and facet joints through a posterior approach, where the dual bearings resist rotation and shear much like the two native facet joints, while carrying compressive axial loads like the disc. The technology is similar to other modern orthopaedic joint replacements, utilizing highly cross-linked antioxidant vitamin E polyethylene, compression molded into a CoCr, titanium plasma sprayed substrate.

MOTUS has been in development for over two decades. In 2020 the FDA designated MOTUS as a Breakthrough Device, a category that identifies and accelerates life-saving treatments for significant disease states affecting the U.S. population. 80% of Americans will experience low-back problems in their lifetime, resulting in an estimated 500,000 lumbar spine surgeries in the U.S. per year. A growing body of evidence suggests that preserving low back flexibility is far more important than once thought, even for simple activities like sitting at a desk or comfortably riding in a car. The FDA Investigational Device Exemption (IDE) to study joint reconstruction of the lumbar spine as an alternative to rigid spinal fusion was approved in June 2022.

"I would like to personally thank my friends and colleagues across the U.S. who contributed to this important research," said Jeffrey A. Goldstein, MD, 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 at NYU suggests that we have developed something with remarkable significance."

Pierce D. Nunley, MD, chairman of the American Board of Spine Surgery, continued, "True change only comes along once in a generation. 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."

MOTUS utilization 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 by the American Medical Association in 2022. A full list of indications and contra-indications for MOTUS lumbar total joint replacement is available at NCT05438719. Information on the real-world fusion clinical trial is available at NCT04823858.

About 3Spine

3Spine, Inc. is a privately financed healthcare company headquartered in Chattanooga, Tennessee. Following two Medtronic clinical pilot studies in South Africa with a novel posterior total joint replacement, Drs. Scott Hodges, Craig Humphreys, and Marc Peterman formed the independent, private spinout 3Spine, Inc. to develop and commercialize MOTUS lumbar total joint replacement.

MOTUS has the potential to transform the treatment of lumbar spine conditions worldwide, improving care and expanding the market similar to other total joint replacements such as artificial hips, knees, shoulders, and ankles, which are considered some of the most important medical innovations of all time.

Learn more at LinkedInFacebook, X, or by visiting www.3Spine.com.

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SOURCE 3Spine

 

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