YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Feb. 16, 2016 /PRNewswire/ -- 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 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 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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SOURCE ReWalk Robotics