MARLBOROUGH, Mass.
and YOKNEAM ILIT, Israel,
July 20, 2018 /PRNewswire/
-- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the
"Company") announced that the U.S. Department of Veterans Affairs
has issued a revision to its national policy on exoskeleton medical
device training and procurement for qualifying Veterans with spinal
cord injury (SCI). The updated policy includes further
guidance on the evaluation process and expands access to training
program locations among the VA network and private rehabilitation
centers through the VA's Veterans Choice Program.
This policy, issued in June 2018,
is an update to the original standard operating policy (SOP) issued
by the VA in December 2015. The
evaluation process will now have all Veterans flow through one of
24 designated spinal cord injury VA centers (SCI/D). Once a Veteran
is determined to be qualified for training and procurement of his
or her own exoskeleton system, the individual may be allowed to
pursue training in one of three ways: at the applicable SCI/D hub
center, at a qualified VA hospital designated by the VA's "hub
& spoke" program, or at a qualified private rehabilitation
center through the VA's Veterans Choice Program; a program through
which Veterans can receive care from a community provider paid for
by the VA.
The policy stipulates as follows:
"If a Veteran with SCI/D is unable or unwilling to travel to
a VA Exoskeleton Training Center for training, case-by-case
consideration will be given to enable the Veteran and companion to
receive training at a VA facility that does not have an exoskeleton
training program or at a non-VA facility."
"This revised policy is a great step forward that will
potentially help many paralyzed Veterans who simply seek to walk
again," said ReWalk CEO Larry
Jasinski. "These significant SOP updates mean that numerous
injured Veterans who have expressed an interest in obtaining a
ReWalk, but have not been able to participate due to a lack of
availability in their area, can now have access. We are pleased to
see the VA build upon the SOP, taking into account the Department's
own extensive research and its ongoing national trial."
The Department of Veterans Affairs is a leader in providing a
national policy for the training and procurement of exoskeleton
systems for qualifying beneficiaries. The SOP applies for any
Veteran who has sustained a spinal cord injury, be that service or
non-service related. ReWalk Robotics has been working with the VA
since the policy was issued in 2015 to help provide training and
devices nationwide to facilitate its implementation. Further,
ReWalk has been advocating for use of the Veterans Choice Program
for those qualifying Veterans who could not travel to their nearest
SCI/D for training to obtain an exoskeleton system.
As a result of the revised policy, there are now 142 ReWalk
certified private and VA SCI/D training centers across the US
potentially available to train Veterans to use ReWalk. Furthermore,
the network of VA SCI/D spoke sites may now be eligible to conduct
training and provide additional opportunity.
For more information about the VA policy, or to learn about the
ReWalk 6.0 system, please visit: www.rewalk.com.
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets
wearable robotic exoskeletons for individuals with lower limb
disabilities as a result of spinal cord injury or stroke. The
Company's 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 United
States, 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," "should," "would," "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 and
achieve its planned expense reductions; the conclusion of ReWalk's
management and the previous opinion of ReWalk's auditors in that
there are substantial doubts as to ReWalk's ability to continue as
a going concern; ReWalk's ability to maintain and grow its
reputation and the market acceptance of its products; ReWalk's
ability to achieve reimbursement from third-party payors for its
products; ReWalk's expectations as to its clinical research program
and clinical results; ReWalk's expectations as to the results of,
and the Food and Drug Administration's potential regulatory
developments with respect to, ReWalk's mandatory post-market 522
surveillance study; the outcome of ongoing shareholder class action
litigation relating to ReWalk's initial public offering; ReWalk's
ability to repay its secured indebtedness; 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 secure capital from its equity and debt
financings in light of limitations under its Form S-3, the price
range of its ordinary shares and conditions in the financial
markets, and the risk that such financings may dilute ReWalk's
shareholders or restrict its business; ReWalk's ability to use
effectively the proceeds of offerings of securities; ReWalk's
ability to maintain relationships with existing customers and
develop relationships with new customers; the impact of the market
price of ReWalk's ordinary shares on the determination of whether
ReWalk is a passive foreign investment company; ReWalk's compliance
with medical device reporting regulations to report adverse events
involving its products and the potential impact of such adverse
events on ReWalk's ability to market and sell its products; the
risk of substantial dilution resulting from the issuance to
Timwell; the significant voting power and de facto voting control
Timwell may acquire; the risk that the remaining Timwell issuances
will fail to close and the China
joint venture will not form; and other factors discussed under the
heading "Risk Factors" in ReWalk's Annual Report on Form 10-K for
the fiscal year ended December 31,
2017 filed with the U.S. Securities and Exchange Commission
(the "SEC") and other documents subsequently filed with or
furnished to the SEC. 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 Ltd.