Empirical Spine, Inc.

Empirical Spine, Inc. manufactures the LimiFlex Dynamic Sagittal Tether, an FDA-approved (PMA, February 12, 2026) minimally invasive spinal implant designed as a motion-preserving alternative to spinal fusion for patients with Grade I lumbar degenerative spondylolisthesis with stenosis. The device is inserted without screws, augments the posterior tension band to restore natural segmental motion and stability, and maintains lordosis while providing elastic resistance to flexion. LimiFlex engages selectively during flexion (unlike interspinous spacers) to avoid excess spinous process loading and is compatible with current decompression techniques. The implant targets the substantial clinical need for alternatives to traditional fusion surgery, which carries documented drawbacks including invasiveness, high costs, and risk of adjacent-level degeneration (occurring in 30–50% of fusion patients within 5–10 years). Empirical Spine positions LimiFlex for orthopedic surgeons managing degenerative lumbar spine disease in hospital and ASC settings.