ReWalk Featured in Details of Department of Veterans Affairs’ National Multi-Center Clinical Exoskeleton Trial
Six ReWalk Exoskeleton Systems Have Been Shipped for the Initial Phase of Four-Year VA Study
YOKNEAM ILIT, Israel and MARLBOROUGH, MA — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or “Company”), the leading global exoskeleton developer and manufacturer, announced that the Department of Veterans Affairs (“VA”) has publicly listed details of a national, multi-center study utilizing the Company’s Personal 6.0 Exoskeleton Systems. The VA released full details of the study titled, “Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life” on the clinical trials section of the National Institutes of Health (NIH) website. (www.clinicaltrials.gov Identifier: NCT02658656).
Several key components of the study outlined by the VA, include:
- Enrollment of 160 participants nationwide
- Eligibility criteria for study participants
- Study start date: October 2016
- Locations of six participating VA Medical Centers with Spinal Cord Injury Services in California, Florida, Massachusetts, Texas and Virginia
It was announced in January that 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 six ReWalk exoskeleton systems to support this first-of-its-kind national study. ReWalk is the only FDA cleared exoskeleton technology for individuals with spinal cord injury. The Company has already shipped the order of six systems for the multi-center trial to the VA, and continues to work in coordination with the department as the study leads prepare for its launch this year.
“This VA clinical trial is groundbreaking in both its purpose and scope, and will undoubtedly provide a wealth of quality research data to the department’s already impressive research,” said ReWalk CEO Larry Jasinski. “ReWalk is glad to provide our technology to enable this critical national study.”
The Department of Veterans Affairs is the largest single healthcare provider to persons with Spinal Cord Injury (SCI) in the United States. This is the first study in the United States to examine the impact of exoskeleton use in a home or daily life setting. ReWalk has Class II FDA clearances for exoskeleton use in the rehabilitation and personal setting, with the latter intended for home and community use.
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 while mimicking the natural gait patterns of the legs. 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/de.
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 the market acceptance of our products; ReWalk’s ability to achieve reimbursement from third-party payors for our products; ReWalk’s expectations as to its clinical research program and clinical results; 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 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 20-F for the year ended December 31, 2014 filed with the U.S. Securities and Exchange Commission on February 27, 2015 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.
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