3Spine, Inc.

3Spine, Inc. is a medical device company specializing in lumbar spine total joint replacement technology. The company develops and commercializes MOTUS®, the first total joint replacement (TJR) system for the lumbar spine, designed to replace the function of intervertebral discs and facet joints while preserving spinal motion and range of motion—contrasting with traditional spinal fusion approaches that eliminate motion. MOTUS is indicated for biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level (L1/L2 to L5/S1) in patients with degenerative disc disease, spinal stenosis, facet arthrosis, spinal instability, and associated symptoms. The device employs a posterior surgical approach using a novel pedicle-based osteotomy technique that allows up to 20 degrees of lordotic correction at a single level. 3Spine originated as a Medtronic spin-out; Medtronic developed the foundational three-column intellectual property in 2004 under the KENAI device program. The portfolio was spun to private ownership in 2014, acquired by International Surgical in 2016 (rebranded as BalancedBack and later MOTUS), and is now fully independent and capitalized. The MOTUS device is currently approved for investigational use only in the United States under FDA Investigational Device Exemption (IDE NCT05438719), with enrollment completed in 2023. 3Spine obtained FDA Breakthrough Device Designation in 2020 and plans to pursue Pre-Market Approval (PMA) for commercial distribution as IDE data matures. Clinical pilot studies showed 2.4× improvement in Oswestry Disability Index (ODI) Substantial Clinical Benefit, 3.3× improvement in Minimum Symptom State, and 4.1× improvement in Minimally Important Clinical Benefit versus fusion at 12 months, with sustained improvements at 24 months. The procedure is tracked under CPT code 0719T. The company serves orthopedic surgeons and spine centers in the United States and operates a cadre of clinical, regulatory, and product development expertise.