ARTICLE SUMMARY:
ReWalk Robotics is the first to market wearable exoskeleton systems for both spinal cord injury and stroke rehabilitation patients in the inpatient, outpatient, and home settings, in the US and Germany. Reimbursement roadblocks have limited the technology’s commercial potential to date, but the company is seeing some positive progress, with a revised coverage policy from Cigna, coverage by the US VA, and at the federal level in Germany.
Exoskeleton devices conjure up images of behemoth, strength-enhancing, powered wearable robotics from movies such as Iron Man and Avatar, giving superhuman capabilities to the person wearing the futuristic technology. However, exoskeleton devices aren’t only a figment of Hollywood imagination, but are now being developed and used to assist people in real life.
This includes use in industries where repetitive, strength-requiring movements are common, such as automobile assembly line work. And in just the last several years, the technology has entered the healthcare space to address paralysis and other mobility impairments. A handful of exoskeleton medical devices have successfully navigated FDA and European regulatory pathways, to improve the mobility of patients suffering from spinal cord injury (SCI; for paraplegics) and the effects of stroke, both at rehabilitation facilities and during daily life. However, due to the high price point of exoskeleton technology (ranging from $30,000 to $150,000), challenges remain with a key component of market success and patient adoption: reimbursement.
Leading this emerging device space is ReWalk Robotics Ltd., which is focused on fundamentally improving the health and life experiences of individuals with mobility issues due to SCI or stroke with its wearable robotic exoskeletons. In 2014, the public company (Nasdaq: RWLK) with headquarters in the US, Israel, and Germany, was the first to receive FDA approval for its first-generation ReWalk robotic exoskeleton device to help SCI patients with lower-body paralysis to stand and walk upright. In the US, ReWalk is currently one of two companies with FDA clearance for both home and community use (the other is Parker Hannifin Corp. with the Indego exoskeleton). An additional next-generation product from ReWalk, the ReStore soft exo-suit system, was FDA 510(k)-cleared this past June for use in the treatment of stroke survivors with mobility challenges. The company, formerly known as Argo Medical Technologies, was founded in 2001 by prolific inventor Amit Goffer, PhD (now retired), following an all-terrain vehicle accident that rendered him a quadriplegic.
