U.S. Department of Veterans Affairs Purchases 28 Additional ReWalk Exoskeleton Systems to Support National Multi-Center Trial
YOKNEAM ILIT, Israel andMARLBOROUGH, Mass., April 6, 2017/PRNewswire/ ReWalk Robotics Ltd.(RWLK) ("ReWalk"), leading manufacturer and producer of exoskeleton systems, announced today that the U.S. Department of Veterans Affairs (VA) purchased 28 ReWalk Personal Exoskeleton Systems to support an ongoing national multi-center clinical trial. ReWalk confirmed shipment of 20 systems to the VA in the first quarter of 2017; the remaining eight systems from this purchase will be shipped in the second quarter of this year.
"We are pleased to be able to support this clinical trial with the Department of Veterans Affairs as the study progresses and offers more Veterans with paralysis access to exoskeleton technology in their home," said Larry Jasinski, CEO of ReWalk Robotics. "The VA remains a national leader in its study of the impact of exoskeletons on the health and well-being of individuals utilizing these devices. ReWalk is proud to contribute to these efforts to those who have served."
The 28 system purchase follows an initial purchase of 20 systems by the VA in 2016, which helped with the initiation of the multi-year, multi-center study. The clinical trial is the first-ever study conducted in the United States to study the impact of exoskeleton use in a personal setting. The study is enrolling 160 randomized patients, half of whom use ReWalk Robotics' exoskeleton system and half of whom use standard wheelchairs. Currently, there are six VA centers actively enrolling participants in the study, with four more VA centers set to be included by this summer. At the end of the study, all participating patients could qualify for procurement of a ReWalk exoskeleton system.
The Department of Veterans Affairs is the largest healthcare provider in the U.S. for people with spinal cord injury (SCI). In 2015, the VA issued a national coverage policy to provide qualifying veterans with SCI access to evaluation, training, and supply of ReWalk Personal systems. ReWalk is also the first exoskeleton manufacturer in the United States to receive FDA clearance for use in the home, the community, as well as in the rehabilitation setting.
For more information on the clinical trial and participating centers, visit the NIH website: www.clinicaltrials.gov Identifier: NCT02658656.
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our 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 U.S., 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.
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; the conclusion of ReWalk's management, and the opinion of ReWalk's auditors in their report on the Company's consolidated financial statements for the fiscal year ended December 31, 2016, 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 to achieve and maintain market acceptance of its products; ReWalk's ability to achieve reimbursement from third-party payors for its products; ReWalk's ability to repay its secured indebtedness; 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 actions 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 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 use effectively the proceeds of its 2016 follow-on offering; ReWalk's ability to secure capital from its at-the-market equity distribution program based on the price range of its ordinary shares and conditions in the financial markets; ReWalk's ability to maintain relationships with existing customers and develop relationships with new customers; ReWalk's ability to regain compliance with NASDAQ continued listing requirements; and other factors discussed under the heading "Risk Factors" in ReWalk's Annual Report on Form 10-K for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission. 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.
SOURCE ReWalk Robotics Ltd.