Study Offers Key Evidence for Healthcare Providers, Development of Procurement Policies for Eligible Users
YOKNEAM ILIT, Israel, BERLIN and MARLBOROUGH, Mass., Jan. 27, 2016 -- ReWalk Robotics Ltd. (Nasdaq: RWLK) ("ReWalk"), the leading global exoskeleton developer and manufacturer, announced today the publication of a first-of-its-kind case study in the peer-reviewed journal Spinal Cord Series and Cases published by the International Spinal Cord Society (ISCOS) demonstrating that use of the ReWalk robotic exoskeleton resulted in significant improvements in the quality of life for an individual with spinal cord injury. The case study, co-authored by Prof. Dr. med. Karsten Krakow, studied the impact on ambulation ability as well as several quality of life measures as part of the SF-36 questionnaire, a 36-item, patient-reported survey of patient health. Following six months of ReWalk use in the rehabilitation setting, the subject was able to walk independently with limited supervision, and demonstrated significant improvements in several quality of life measurements including: mobility, risk of falling, motor skills and control of bladder and bowel functions.
"The study has confirmed what we can see with the ReWalk system also in daily practice: The ReWalk system on the one hand creates an additional possibility of mobility for the patient, but is moreover also an excellent therapy and training tool for people with complete or incomplete paraplegia. Use of the ReWalk device can immediately have a large effect on the quality of life of the user," said Professor Dr. med. Karsten Krakow.
"This case study offers critical analysis on the impact of exoskeleton use on the health and well-being of those with spinal cord injury," said ReWalk CEO Larry Jasinski. "We are pleased with the findings of the report, and readily support the report's recommendation for further studies with a greater number of participants. With this case study, Dr. Krakow and his team have provided a significant finding of the effects of the ReWalk device that we believe will encourage greater provision of exoskeleton systems by healthcare providers for those with spinal cord injuries."
The study measured patient progress utilizing the Short Form 36 Health Survey (SF-36) and noted significant percentage improvements in various quality of life outcomes, including pain, psychical well-being, vitality, general health, physical functioning and physical role function. In addition, the study reported American Spinal Injury Association (ASIA) Impairment Scale improvements in recovery of bladder and bowel control. The study also documented improvements in cardiovascular endurance and motor neurological status.
The study concludes:
"This case report of treatment of a patient with SCI using the ReWalk system gives evidence of a positive impact on quality of life, ability to walk, cardiovascular endurance and motor neurological status."
The case study also reported no complications such as falls, skin injuries or technical problems, supplementing the existing body of clinical literature demonstrating the safety of the ReWalk robotic exoskeleton.
ReWalk is CE marked, and is the only system in the U.S. that is FDA-cleared for personal use at home and in the community, as well as for the rehabilitation setting. ReWalk is the most studied exoskeleton system, with a number of clinical studies and trials conducted in the rehabilitation setting.
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 http://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 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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