MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Nov. 30,
2017 /PRNewswire/ -- ReWalk Robotics' (Nasdaq: RWLK)
("ReWalk" or the "Company") innovative Restore soft exoskeleton
system was featured in a recent story as one of the cutting edge
technologies seeking to help stroke survivors heal and retain
critical motor skills. The story published in Medical Device
& Diagnostic Industry (MD&DI), a leading industry trade
magazine.
The article examines the latest advancements in technology for
stroke-assistive medical devices, and outlines the inspiration for
a soft suit exoskeleton, with interviews with ReWalk CEO
Larry Jasinski and Kathleen O'Donnell, lead of the medical exosuit
program at Harvard's Wyss Institute,
ReWalk's collaborative partner on the Restore system. The
story also walks the reader through the device's components:
The exosuit is powered by a
motor unit worn on a waist belt, which activates sheathed Bowden
cables anchored in two spots: one in a calf-worn fabric sleeve and
one in the insole of the shoe the unit is activating to achieve a
more natural gait.
In his interview, Jasinski speaks to the different pieces ReWalk
and the Wyss Institute bring to the table, and the effort to obtain
FDA clearance and offer a commercial system:
"They [Wyss] are doing a high
level of fundamental research that, generally, small companies
cannot afford to do. They are making it work for that individual
situation. We are going to be able to take it through the FDA,
through the reimbursement processes, and manufacture it at a price
point with the quality control and functional level that can meet a
mass audience. That is why it's a good marriage."
The Restore is a soft suit exoskeleton designed for the stroke
survivor patient community; exosuits are expected to offer
additional use for other patient populations, including individuals
with Parkinson's Disease, Multiple Sclerosis or other mobility
challenges where normal walking gait is impacted. ReWalk recently
unveiled the commercial Restore unit, which is already in use in a
pre-clinical study and is preparing to expand to the US Pivotal
Clinical trials in Q1 2018. Priced at $19,500, the soft exosuit is anticipated to begin
commercialization in late 2018 or early 2019.
For more information about the Restore system, please visit:
www.rewalk.com.
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
U.S., Israel and Germany.
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, expand to new markets and achieve its
planned expense reductions; the conclusion of ReWalk's management
for the financial statements for the third quarter of 2017 and for
fiscal 2016, and the opinion of ReWalk's auditors in their report
on the Company's financial statements for fiscal 2016, 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 ability to
comply 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 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 year ended December 31, 2016, as
amended, filed with the U.S. Securities and Exchange
Commission 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 Ltd.