U.S. Department of Veterans Affairs Issues National Coverage Policy for ReWalk Robotics Exoskeleton Systems for Qualifying Veterans with Spinal Cord Injury
Landmark Policy Will Provide Veterans Across the U.S. with Access to Evaluation, Training and Supply of ReWalk Personal Systems
YOKNEAM ILIT, Israel and MARLBOROUGH, MA – ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk”), the leading global exoskeleton developer and manufacturer, announced today that the U.S. Department of Veterans Affairs (“VA”) has issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States. The VA policy, which is exclusive to ReWalk Robotics exoskeleton systems, is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury (“SCI”).
“This historic policy will provide access to our life-changing technology for thousands of veterans across America,” said ReWalk CEO Larry Jasinski. “We want all U.S. veterans with a spinal cord injury to know that they now have a path to securing their own ReWalk Personal exoskeleton system. The policy outlines a sound process to educate, train and importantly, to provide individual veterans with a ReWalk Personal device so that they may walk at home and in the community. We expect this landmark national policy will substantially improve the health and quality of life of many veterans in the years ahead,” Jasinski added.
The comprehensive policy put forth by the VA provides veterans with spinal cord injury access to referral and evaluation at all designated ReWalk Training Centers across the country. Veterans who meet the physical criteria for ReWalk will be referred for training on the use of the device. Successful candidates will then be eligible to obtain a Rewalk Personal system.
“We are also very pleased that the VA’s fundamental clinical research conclusively demonstrated that there are significant medical benefits associated with enabling an individual with a spinal cord injury to walk again,” Jasinski said. “Based on their data, the VA’s national policy now defines use of an exoskeleton as the standard of care for qualifying veterans with spinal cord injury. We are hopeful the VA policy will pave the way for additional positive national coverage decisions.”
ReWalk is the only FDA cleared exoskeleton system in the U.S., with clearances for both personal use at home and in the community, as well as for the rehabilitation setting.
Some additional details of the new VA national policy:
- Veterans with SCI may be evaluated for use of the device at one of the 24 Veterans Health Administration SCI Centers nationwide, according to detailed protocols.
- All SCI Centers are encouraged to pursue designation as a ReWalk Training Center.
- Once preliminary criteria for ReWalk training are met, the veteran will be referred to a VA SCI Center designated as a VA ReWalk Training Center.
- Training begins on an outpatient basis and proceeds to the home or community settings.
- Successful training by an individual will be followed by consideration of procurement for a personal unit for use at home and in the community
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 U.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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