FDA approves Israeli ReWalk robotic exoskeleton technology
Until recently, spinal cord injuries have meant a short, painful and immobile life in bed or in a wheelchair. The Israeli-based ReWalk changed that in 2011, when it developed the first version of its revolutionary bionic body suit, the the ReWalk I.
The system has since been upgraded and advanced, and sold in Israel and Europe. Now, with the approval of Device Evaluation department of the US Food and Drug Administration last week, it can be sold and distributed in the United States, changing countless lives and bringing financial success to the owners and founders of the company. .
The ReWalk system consists of an external motorized casing that can be strapped to paralysed legs and lower torso. The system is attached to a computer and batteries, which have to be carried in a backpack, and a remote control unit attached to the wrist. For stability, users have to use crutches. The rechargeable batteries last for approximately four hours, and warn the user several times before emptying.
ReWalk is the main product of Argo Medical Technologies, an Israeli start-up which has grown to an international firm with headquarters in Israel, Germany and the US. In 2013, they announced a strategic partnership with the Japanese robotics firm Yaskawa Electric Corporation.
The change in mobility and quality of life that comes with ReWalk is phenomenal. According to Larry Jasinsky, CEO of Argo, anecdotal evidence points to a saving of $30,000 a year, from decreased hospitalization, skin ulcers, infections, and personal carer hours. This is in addition to the immeasurable non-material benefits of increased independence, mobility and freedom.
After many rigorous clinical studies and trials, the eventual FDA approval includes a demand for ReWalk to monitor and report on any adverse incidents occurring during its training program. The approval may pave the way for insurance companies to cover the costs of the ReWalk equipment, dramatically increasing the market reach and sales revenue for Argo Medical Technologies.
One of the first Americans to make use of the ReWalk exoskeleton is Derek Herrera, a captain in the US Navy Marines, who was shot in the leg by Taliban fighters in Afghanistan. He made several trips to Israel to try out the system before purchasing it and bringing it back home as part of his effort to rehabilitate his life. The complete set of equipment costs approximately $69,000, which will be covered for Herrera by the Marine Special Operations Command Foundation (MARSOC Foundation).