move beyond^™
spinal fusion.

MOTUS replaces the function of the disc and facet joints, reestablishing stability after discectomy and broad decompression. By reconstructing all three structures in the functional spinal unit, all pain generators are addressed, including spinal stenosis, facet arthrosis, disc degeneration, spinal instability, and associated muscle spasms. Total joint replacement is a new spinal procedure tracked by CPT code 0719T

Lumbar disc replacement is referred to synonymously as total disc replacement (TDR) or anterior disc replacement (ADR). There is currently one TDR/ADR disc replacement available in the United States: ProDiscL from Centinel Spine indicated for patients with degenerative disc disease. ProDiscL has demonstrated excellent clinical outcomes,^{1, 2, 3} replacing the function of a diseased disc. Additionally, the TOPS device from Premia Spine is a newly approved device that is intended to replace the function of the facet joints. The preliminary TOPS data are also encouraging for their specific indications. MOTUS is not a disc or facet replacement, but a first-of-kind device replacing the function of the disc and facet joints as a total joint replacement (TJR) for the lumbar spine.

Fusion locks the spine in one posture. Even the best surgeon with perfect patient selection and the most advanced fusion hardware and enabling technology must still choose either a standing posture, a sitting posture, or something in between. But as we transition from standing to sitting, the lumbar spine flattens and the pelvis rotates (retroverts). MOTUS allows this dynamic adaptation whereas fusion, by definition, does not. Sitting intolerance, residual pain, and adjacent segment breakdown are potential consequences of a fused lumbar spine. Simply put, the low back adapts and moves with the pelvis in daily life, and total joint replacement preserves this natural motion by reconstructing instead of eliminating flexibility. Hip/spine syndrome is well documented in the literature.^{5, 6, 7, 8, 9, 10, 11}

No. A segment of the degenerative spine population who meet the eligibility criteria may benefit from total joint replacement as an alternative to lumbar spinal fusion. Cancer patients who require reconstruction secondary to tumor resection; patients with spinal trauma; those requiring deformity correction; and other groups with low bone mineral density, very high BMI, poor diabetes management, smokers, etc. will likely continue to require spinal fusion. However, as lumbar total joint replacement matures, a new group of patients may emerge seeking care earlier in the disease process who may have otherwise deferred spinal fusion. This market-expanding trend has been seen with other total joints, and we believe that there may be an advantage to earlier intervention before mobilization of a diseased segment may not be possible.

The MOTUS device is approved for investigational use only in the United States under FDA Investigational Device Exemption (IDE) NCT 05438719. Enrollment for the MOTUS trial was completed in 2023 and 3Spine plans to seek Pre-Market Approval (PMA) to distribute commercially as our IDE data mature. Fourteen centers across the United States participated in the IDE and twenty centers participated in the control study. Upon PMA approval, we plan to continue clinical data collection as a post-market surveillance program and as a component of a compulsory certification and CME program for lumbar total joint replacement centers. We anticipate that Motion Surgery centers will emerge who specialize in cervical disc, lumbar disc, facet replacement, and/or total joint replacement as a surgical sub-specialty, much as orthopaedics is currently bifurcated into joint replacement and other specialties.

In the U.S., total joint replacement procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1.

Full List of Indications and Contraindication

3Spine enrolled three clinical pilots and a US pivotal IDE clinical trial. Pivotal study patients were propensity score matched to prospectively collected real-world spinal fusions. Pilot study patient reported outcomes, published in The Spine Journal,¹² showed a 2.4x improvement in Oswestry Disability Index (ODI) Substantial Clinical Benefit (SCB), 3.3x improvement in Minimum Symptom State (MSS), and 4.1x improvement in Minimally Important Clinical Benefit (MCID) as compared to fusion at one year. The first pivotal study outcomes were published in the ISASS Journal. The results of these studies are encouraging and suggest that MOTUS may provide for more effective treatment relative to the current standard of care, with a meaningful clinical improvement in function (disability), leg pain, and back pain.

The MOTUS procedure is performed using a posterior approach. A pre-operative plan is completed to calculate segmental parameters and appropriate segmental lumbar lordosis. The approach, decompression, and discectomy are nearly identical to a standard TLIF approach. Both facet joints are removed, and the surgeon can preserve or remove midline structures as indicated by pathology and preference. Whereas insertion of a TLIF or PLIF interbody implant is an additive maneuver, where height is added to the anterior aspect of the column to adjust segmental lordosis, sometimes requiring release if the anterior longitudinal ligament (ALL), the MOTUS procedure is a subtractive maneuver, where the posterior elements are adjusted to achieve the same effect and the ALL is always preserved. The tail of the prosthesis, coupled with a novel pedicle-based osteotomy, facilitate correction at a single level in the lumbar spine of up to approximately 20 degrees, including at L5/S1, as allowed by patient anatomy. Upon preparation, each side of the prosthesis is inserted as a unit in a neutral posture, yielding the standing lordotic posture indicated by the pre-operative plan. The technique is completed freehand. Total joint replacement using the MOTUS device is an entirely new procedure tracked by CPT code 0719T

3Spine is a Medtronic spin out. Medtronic purchased three-column IP in 2004 as the foundation for a posterior TJR IP portfolio, subsequently developing the KENAI device. In 2014 the portfolio was spun out to a private shell with Medtronic’s support to complete additional refinements and the US IDE, leveraging private capital. International Surgical purchased the IP in 2016, rebranding as BalancedBack and then MOTUS. International Surgical SEZC became 3Spine SEZC then 3Spine, Inc. 3Spine is now fully capitalized and entirely independent.

MOTUS is possibly the most researched biomechanical concept in spine history. Our team and prior teams at Medtronic completed primary research on spine morphology, nerve paths, movement patterns, new test methods, new materials including the first modern polyethylene¹³ in spine, and a first-of-kind technique. We were awarded Breakthrough Device Designation by FDA in 2020 and enjoy close collaboration with the FDA and CMS.

So why the name? 3Spine is built on some basic concepts: safely cross three columns of the spine (posterior, middle, and anterior) thereby gaining access, support, and correction; thereby replacing the function of three structures (two facets and the disc); thereby dynamically balancing the three curves of the spine; thereby transitioning safely between the three sagittal activities of daily living (standing, sitting, and slumped sitting).^{14, 15, 16, 17} After over 20 years of research and clinical use, we now have a 4th generation technology, capital, and a team who believe deeply in our mission of transforming outcomes for spine patients worldwide.