Department of Veterans Affairs Purchases 20 ReWalk Systems to Support National Multi-Center Trial Assessing Personal Exoskeleton System Use
VA Centers Across the U.S. are Preparing to Initiate Multi-Center Trial
YOKNEAM ILIT, Israel and MARLBOROUGH, MA — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or “Company”), the leading global exoskeleton developer and manufacturer, announced that the U.S. Department of Veterans Affairs (“VA”) has purchased an additional 20 ReWalk Personal Systems to support initiation of their national multi-center clinical trial.
The VA clinical trial is the first-ever U.S. study to examine the impact of exoskeleton use in the home or daily life setting. The study will include 160 participants across the country, with six VA medical centers participating in the first phase across California, Florida, Massachusetts, Texas and Virginia. The participating VA medical centers have received ReWalk systems to begin their training. Eligible participants will be enrolled later this year.
“The purchase of 20 additional systems is a critical acquisition for this groundbreaking clinical trial,” said ReWalk CEO Larry Jasinski. “The initiation of the study across these six VA Medical Centers will provide many veterans access to training with exoskeleton technology. We continue to work closely with the VA and offer our support as the trial gets underway.”
The Department of Veterans Affairs is the largest single healthcare provider in the United States to persons with Spinal Cord Injury (SCI). The VA awarded a delivery order to Veterans Healthcare Supply Solutions (VHSS), the Service Disabled Veteran Owned Small Business (SDVOSB) authorized distributor of ReWalk Robotics, for the 20 unit purchase of ReWalk exoskeleton systems. ReWalk is the first exoskeleton in the U.S. to receive FDA clearance both personal use at home and in the community, as well as for the rehabilitation setting. ReWalk and the Department of Veterans Affairs have worked together for years to provide America’s wounded retired service members with access to exoskeleton technology in the rehabilitation and personal settings.
For more information on the clinical trial and participating centers, please visit the NIH website:
www.clinicaltrials.gov Identifier: NCT02658656.
About ReWalk Personal 6.0
ReWalk Personal 6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. The system provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking similar to a natural gait pattern. The ReWalk device is the most studied exoskeleton in the industry. Studies have identified a number of health benefits including: improved bladder and bowel function, improved mental health, improved sleep, reduced fatigue, decreased body fat, decreased pain and improved posture and balance.
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 US, 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.
Forward Looking Statements
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,” “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; 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 expectations as to its clinical research program and clinical results; ReWalk’s ability to improve its products, 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 repay its secured indebtedness; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the U.S. Securities and Exchange Commission on February 29, 2016 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.
Investor Relations Contact:
Lisa M. Wilson
In-Site Communications, Inc.
Date: May 5, 2016