A new multiple sclerosis device steps forward

Nine companies have developed powered exoskeletons that are cleared for sale in the US, with almost all of these devices intended to aid walking by patients with spinal cord injury or stroke. But last week Ekso Bionics moved into an entirely new indication, as the FDA cleared its EksoNR robotic exoskeleton for use by multiple sclerosis patients. The clearance, more specifically for rehabilitation use in patients with MS, will significantly expand the device’s reach, Ekso said. It already claims that EksoNR is the latest-generation version of the “most clinically used” robotic exoskeleton on the market. Nearly a million people in the US are living with MS, according to the National MS Society, though only a small minority of these patients would be expected to develop mobility issues serious enough to warrant the use of an exoskeleton. News of the clearance prompted Ekso’s share price to close up 23% yesterday. Unfortunately the stock has lost 99% of its value since Ekso floated in early 2014, with sales having disappointed. The company is not profitable, and reported sales of just $2.6m in the first quarter of this year.

FDA-cleared powered exoskeletons
Company Device Indication and date cleared
Rewalk Robotics ReWalk SCI in Jun 2014* and Jul 2016
ReWalk Restore Hemiplegia or hemiparesis due to stroke in June 2019
ReWalk P6.0 SCI in May 2020
Parker Hannifin Indego SCI in Feb 2016 and Sep 2017; SCI and hemiplegia due to cerebrovascular accident in Jan 2018
Ekso Bionics Ekso and Ekso GT SCI and hemiplegia due to stroke in April and again in Jul 2016
EksoNR Acquired brain injury, including traumatic brain injury and stroke, and SCI, in Jun 2020; multiple sclerosis in Jun 2022
Cyberdyne Hal SCI in Dec 2017; SCI, post-stroke paresis and paraplegia due to progressive neuromuscular diseases in Oct 2020
Honda  Honda Walking Assist Device Stroke with gait deficits in Dec 2018
US Bionics Phoenix SCI in Apr 2019
B-Temia Keeogo Dermoskeleton Stroke with gait deficits in Sep 2020
Exoatlet Asia ExoAtlet-II SCI in Jul 2021
Samsung Electronics Gems-H Stroke with gait deficits in Apr 2022
SCI = spinal cord injury. *De novo clearance; all others are 510(k) clearances or supplements. Source: Evaluate Medtech, FDA. 

The EksoNR system

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