MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, July 20, 2018 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company") announced that the U.S. Department of Veterans Affairs has issued a revision to its national policy on exoskeleton medical device training and procurement for qualifying Veterans with spinal cord injury (SCI). The updated policy includes further guidance on the evaluation process and expands access to training program locations among the VA network and private rehabilitation centers through the VA's Veterans Choice Program.
This policy, issued in June 2018, is an update to the original standard operating policy (SOP) issued by the VA in December 2015. The evaluation process will now have all Veterans flow through one of 24 designated spinal cord injury VA centers (SCI/D). Once a Veteran is determined to be qualified for training and procurement of his or her own exoskeleton system, 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, or at a qualified private rehabilitation center through the VA's Veterans Choice Program; a program through which Veterans can receive care from a community provider paid for by the VA.
The policy stipulates as follows:
"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 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."
The Department of Veterans Affairs is a leader in providing a national policy for the training and procurement of exoskeleton systems for qualifying beneficiaries. The SOP applies for any Veteran who has sustained a spinal cord injury, be that service or non-service related. ReWalk Robotics has been working with the VA since the policy was issued in 2015 to help provide training and devices nationwide to facilitate its implementation. Further, ReWalk has been advocating for use of the Veterans Choice Program for those qualifying Veterans who could not travel to their nearest SCI/D for training to obtain an exoskeleton system.
As a result of the revised policy, there are now 142 ReWalk certified private and VA SCI/D training centers across the US potentially available to train Veterans to use ReWalk. Furthermore, the network of VA SCI/D spoke sites may now be eligible to conduct training and provide additional opportunity.
For more information about the VA policy, or to learn about the ReWalk 6.0 system, please visit: www.rewalk.com.
About ReWalk Robotics Ltd. ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke. The Company's mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the United States, Israel and Germany. For more information on the ReWalk systems, please visit www.rewalk.com.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk's future performance and, in some cases, may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "should," "would," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk's control. Important factors that could cause ReWalk's actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk's expectations regarding future growth, including its ability to increase sales in its existing geographic markets, and to expand to new markets and achieve its planned expense reductions; the conclusion of ReWalk's management and the previous opinion of ReWalk's auditors in that there are substantial doubts as to ReWalk's ability to continue as a going concern; ReWalk's ability to maintain and grow its reputation and the market acceptance of its products; ReWalk's ability to achieve reimbursement from third-party payors for its products; ReWalk's expectations as to its clinical research program and clinical results; ReWalk's expectations as to the results of, and the Food and Drug Administration's potential regulatory developments with respect to, ReWalk's mandatory post-market 522 surveillance study; the outcome of ongoing shareholder class action litigation relating to ReWalk's initial public offering; ReWalk's ability to repay its secured indebtedness; ReWalk's ability to improve its products and develop new products; ReWalk's ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk's ability to gain and maintain regulatory approvals; ReWalk's ability to secure capital from its equity and debt financings in light of limitations under its Form S-3, the price range of its ordinary shares and conditions in the financial markets, and the risk that such financings may dilute ReWalk's shareholders or restrict its business; ReWalk's ability to use effectively the proceeds of offerings of securities; ReWalk's ability to maintain relationships with existing customers and develop relationships with new customers; the impact of the market price of ReWalk's ordinary shares on the determination of whether ReWalk is a passive foreign investment company; ReWalk's compliance with medical device reporting regulations to report adverse events involving its products and the potential impact of such adverse events on ReWalk's ability to market and sell its products; the risk of substantial dilution resulting from the issuance to Timwell; the significant voting power and de facto voting control Timwell may acquire; the risk that the remaining Timwell issuances will fail to close and the China joint venture will not form; and other factors discussed under the heading "Risk Factors" in ReWalk's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission (the "SEC") and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk's actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.