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, Inc. 3Spine, Inc.](https://mma.prnewswire.com/media/2315074/3SPINE_Horizontal_Black_Logo.jpg)
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 LinkedIn, Facebook, X, or
by visiting www.3Spine.com.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/3spine-announces-completion-of-fda-clinical-trial-enrollment-achieving-325-surgeries-in-2023-302031430.html
SOURCE 3Spine