MARLBOROUGH, Mass.
and YOKNEAM ILIT, Israel,
Nov. 15, 2018 /PRNewswire/ -- ReWalk
Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company") applauds
United Spinal Association's recommendation, dated November 9, 2018, that health insurance providers
consider the use of powered exoskeleton devices as medically
necessary for eligible individuals with spinal cord injuries (SCI)
in both the institutional and home settings who meet the applicable
Food and Drug Administration (FDA) indications for use.
United Spinal Association is the largest nonprofit organization
dedicated to enhancing the quality of life of individuals with SCI
and other paralyzing conditions, and is one of the nation's leading
disability advocacy groups. Its recommendation is based on
the organization's review of current peer-reviewed medical
literature on the use of powered exoskeleton devices in the
rehabilitation and home settings.
According to United Spinal Association, exoskeletons have the
potential to enable more than 40% of the SCI population to resume
ambulation, which can lead to a healthier and improved quality of
life, and the benefits of increased physical activity translate
into improvements in health outcomes and decreased utilization of
high healthcare costs.
The recommendation states:
Across the continuum of care, United Spinal supports the
foundational goals of safety and efficacy for individuals with
spinal cord injury when using a powered exoskeleton.
United Spinal strongly encourages the use of exoskeletons for
eligible individuals to help restore functional walking and to reap
the health benefits that accrue from walking.
Therefore, United Spinal highly recommends health insurance
providers consider the use of powered exoskeleton devices as
medically necessary for eligible individuals with spinal cord
injuries who meet the FDA indications for use and complete approved
exoskeleton training for either institutional or in-home
settings.
Currently, there is one national coverage policy for exoskeleton
devices, issued by the U.S. Department of Veterans Affairs, in
2015. In the United States,
insurance coverage of an exoskeleton device is handled on a
case-by-case basis. In many cases, medical boards and other
appeals processes have determined exoskeleton devices to be
medically necessary.
"We are thrilled that United Spinal Association has made this
recommendation, which supports our shared mission to improve the
quality of life of individuals with spinal cord injuries," said
Larry Jasinski, CEO of ReWalk.
"This recommendation furthers the goal of increasing access to
life-changing technology for paralyzed individuals, and will
undoubtedly impact the efforts of all beneficiaries who pursue
coverage through their insurer."
"Our mission is to help individuals with SCI live fulfilling,
independent and healthy lives," said James
Weisman, President and CEO of United Spinal
Association. "Allowing coverage for this innovative
technology can make all the difference in the world in someone's
recovery."
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 and the United
States.
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 regain compliance with the
continued listing requirements of the Nasdaq Capital Market and the
risk that its ordinary shares will be delisted if it cannot do so;
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; the risk that the remaining Timwell
Corporation Limited ("Timwell") issuances will fail to close and
the China joint venture will not
form, and the resulting effect on ReWalk's liquidity and financial
condition; the risk of substantial dilution resulting from
additional issuances, if any, to Timwell; the significant voting
power and de facto voting control Timwell may acquire upon
additional issuances, if any; 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; 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 ability to maintain
relationships with existing customers and develop relationships
with new customers; 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; 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/united-spinal-association-issues-recommendation-for-insurers-to-consider-powered-exoskeleton-devices-medically-necessary-for-paralyzed-individuals-300751103.html
SOURCE ReWalk Robotics Ltd.