Meta analysis of literature of efficacy and safety of exoskeleton-assisted walking in patients with spinal cord injury.- ReWalk Robotics Ltd.

ReWalk Robotics Ltd. announced the publication of the first systematic review and industry-wide meta-analysis of existing published literature assessing the clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury ("SCI"). The report summarizing the research concluded that "powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits." The report is published in the most recent edition of Medical Devices: Evidence and Research, and is co-authored by Larry E. Miller, who led the review and report with colleagues Angela K. Zimmerman and William G. Herbert. The meta-analysis—a first of its kind for the review of exoskeleton systems—examined 14 published studies representing 111 patients and focused on ambulatory performance, physiological demand, health benefits and safety. The studies incorporated in this analysis utilized a number of powered exoskeleton systems across the industry.

The authors offer a number of key conclusions: 1. 76% of patients studied were able to ambulate without any physical assistance from another human being following completion of the exoskeleton training program. 2. Powered exoskeleton systems allow patients a safe means of ambulation conducive to prolonged use. 3.Routine use of the exoskeleton system is known to yield health benefits, including improvement in muscle spasticity and bowel movement regularity.

The analysis and systematic review did not identify any serious adverse events, and reports a low incidence rate of tethered falls and fractures subsequently addressed by refinements to exoskeleton design and patient selection criteria.