The U.S. Department of Veterans Affairs (VA) in June 2018 revised its national policy for ReWalk Robotics‘ powered exoskeleton for qualifying veterans with spinal cord injuries (SCI). The revision expands access to training program locations among the VA network and private rehabilitation centers throughout the VA’s Veterans Choice Program. The updated policy also includes further guidance on the evaluation process.
An update to the original standard operating policy (SOP) issued by the VA in December 2015, the new evaluation process will have all veterans flow through one of 24 designated SCI VA centers (SCI/D). Once a veteran is determined to be qualified for training and procurement of an exoskeleton, the individual may be allowed to pursue training in one of three ways:
- At the applicable SCI/D hub center
- At a qualified VA hospital designated by the VA’s “hub & spoke” program
- At a qualified private rehab center through the VA’s Veterans Choice Program
The policy also says: “If a Veteran with SCI/D is unable or unwilling to travel to a VA Exoskeleton Training Center for training, case-by-case consideration will be given to enable the Veteran and companion to receive training at a VA facility that does not have an exoskeleton training program or at a non-VA facility.”
This is welcomed news for ReWalk Robotics, which recently expressed frustration with the VA. During its Q4 and Year-End 2017 financial results earnings call, ReWalk Robotics said the “VA continues to be slow to support veterans” who could benefit from an exoskeleton. At that time, ReWalk Robotics said only 16 veterans had been covered by insurance for its personal exoskeleton, with four more in progress.
“This revised policy is a great step forward that will potentially help many paralyzed veterans who simply seek to walk again,” said ReWalk CEO Larry Jasinski. “These significant SOP updates mean that numerous injured veterans who have expressed an interest in obtaining a ReWalk, but have not been able to participate due to a lack of availability in their area, can now have access. We are pleased to see the VA build upon the SOP, taking into account the department’s own extensive research and its ongoing national trial.”
As a result of the revised policy, there are now 142 ReWalk certified private and VA SCI/D training centers across the US. The network of VA SCI/D spoke sites may now be eligible to conduct training and provide additional opportunity.
ReWalk Robotics is also expanding clinical trials of its ReStore soft exoskeleton, which expected to launch in the first half of 2019 in Europe and the US. Designed to assist stroke patients, the ReWalk Robotics ReStore is used as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.
ReWalk Robotics shares down 25%
Despite the good news, ReWalk Robotics’ share price dropped 25% yesterday after it revealed a financing delay and missed the consensus with its preliminary second-quarter revenues. ReWalk said it expects to post sales of $1.8 million for the three months ended June 30, which would come in under the $2.0 million expectation on Wall Street.
ReWalk also said the second, $10 million tranche of the $20 million private placement it inked with Timwell Investment back in March missed its July 1 deadline. That tranche was contingent on the formation of a joint venture with Timwell in China, with license and supply agreements inked no later than 20 days after the ink on the JV dries.
Although the parties are working on closing the second tranche and ReWalk “expects to be able to move forward with the closing,” it hasn’t due to “the different jurisdictions involved and certain technical and administrative delays.”
Investors reacted to the news by sending RWLK shares down some -25.4% to 93¢ apiece yesterday in mid-afternoon trading.
Brad Perriello, co-founder & executive editor of sister publication MassDevice, contributed to this report.