GEMS (Malaysia) & GEM-SE (Australia) combined clinical results.
Comparison of disability reduction (Oswestry Disability Index) of the Intralink-Spine Disc Stabilization Device - GENTIS (Rejuve) with published data from studies of conventional and emerging treatments for disc related chronic low back pain. Other treatments do not present results at early time-points, presumably due to lack of early efficacy. Competitive data shown here is from peer-reviewed, randomized controlled trials with representative or superior efficacy in their class of treatment (references below).
These data suggest that the GENTIS injectable medical device (Rejuve) is comparable or superior to the best current and emerging treatments for relieving chronic low back pain and disability.
Manchikanti L, et al., Analysis of efficacy differences between caudal and lumbar interlaminar epidural injections in chronic lumbar axial discogenic pain, International J of Med Sci, 2015, 12(3)214-222
Noriega DC, et al., Intervertebral disc repair by allogeneic mesenchymal bone marrow cells - a randomized controlled trial, Transplantation, 2017, 101(8)1945-1951
Fischgrund JS, et al., Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain - a prospective randomized double-blind sham-controlled multi-centered study, Eur Spine J, 2018, 27(5)1146-1156
Siepe CJ, et al., Influence of lumbar intervertebral disc degeneration on the outcome of total lumbar disc replacement - a prospective clinical histological X-ray and MRI investigation, Eur Spine J, 2012, 21(11)2287-2299
This graph shows clinical efficacy results based on pain (VAS) and disability (ODI) patient reported outcomes from 2-weeks through 2-years (2-year data for only the first 5 treated patients). These results are from the first 17 treated chronic low back pain patients meeting study inclusion and exclusion criteria. Eighty percent (80%) or more of patients demonstrated Good (clinically meaningful reduction of pain or disability or both) or Excellent (50% or greater reductions in pain and disability) results at all time points.