ReWalk Robotics Exoskeleton Deemed Medically Necessary by Independent Medical Review Organization
Recipient is a surgeon whose exoskeleton will allow him to stand and walk at home and at work
YOKNEAM ILIT, Israel and MARLBOROUGH, MA – ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or “Company”), the leading global exoskeleton developer and manufacturer, announced today that a commercial health plan in the Northwest region of the United States has approved coverage and reimbursement for a ReWalk Personal exoskeleton system, following the ruling of an external independent review organization that overturned the health plan’s initial denial of coverage. The beneficiary of the ReWalk device is a surgeon who suffered a spinal cord injury and currently uses a manual custom wheelchair 11 hours a day at work. Use of the ReWalk will permit the beneficiary to stand up and ambulate both at work and in the home.
The health plan provider’s coverage approval follows the ruling of an external independent review organization, which overturned the health plan’s initial denial of coverage. After a review of the beneficiary’s case, and a review of the most up-to-date published studies and clinical evidence demonstrating the clinical benefits that stem from use of the ReWalk, the review organization directed the health plan to cover and reimburse the ReWalk system
Importantly, the independent medical review organization determined that the ReWalk system is not an experimental or investigational technology, citing “sufficient evidence found in current peer-reviewed medical literature to support the use of the ReWalk device in patients with spinal cord injury.”
Furthermore, the independent medical review organization’s report concludes that clinical literature documents the safety and benefit of the ReWalk system. The report also states that, “powered exoskeletons like the ReWalk provide non-ambulatory individuals with spinal cord injury such as the patient the ability to walk at modest speeds.” Therefore, the report concludes that the ReWalk is medically necessary for the beneficiary.
“The ruling by the independent medical organization marks an important moment for exoskeletons being accepted as protocol technology for those with spinal cord injury,” said Larry Jasinski, ReWalk CEO. “Health benefit providers have historically been hesitant to acknowledge the clinical benefits in their case assessments. This ruling, and subsequent coverage and reimbursement will help ReWalk in our efforts to facilitate greater patient access to the device.”
ReWalk continues to make inroads in its efforts to make the Personal exoskeleton system available to all eligible patients, working diligently with health coverage providers on individual patient cases, as well as in the development of general coverage policies. A growing number of health plans and health systems worldwide have recognized the benefits of exoskeletons, and provided coverage and reimbursement to beneficiaries.
The Company worked extensively with both the patient and the health plan in this case, further demonstrating ReWalk’s dedication to facilitating increased patient access to its device.
This commercial health plan approval follows the recent news that the U.S. Department of Veterans Affairs (“VA”) issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States.
ReWalk is the only FDA cleared exoskeleton technology for individuals with spinal cord injury. ReWalk has Class II FDA clearances for exoskeleton use in the rehabilitation and personal setting, with the latter intended for home and community use.
ReWalk is working with the recipient and the health plan provider to deliver the Personal exoskeleton system in the coming weeks. The recipient will be able to utilize the technology immediately, having completed all necessary training modules.
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.
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.
Tel: 202 261-4000
Investor Relations Contact:
Lisa M. Wilson
In-Site Communications, Inc.
Date: February 16, 2016