MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, April 3,
2018 /PRNewswire-USNewswire/ -- ReWalk Robotics Ltd.
(Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading manufacturer
of robotic exoskeletons, announced today the official launch of its
clinical study of the ReStore soft exo-suit system (ReStore) for
the rehabilitation of individuals with lower limb disability due to
stroke. The first clinical study participant began using a
ReStore last week at the Spaulding Rehabilitation Hospital in
Boston, Massachusetts where the
study is being led by a team of researchers from the Boston University College of Health and
Rehabilitation Sciences: Sargent
College. The study seeks to enroll 40 participants at five
of the top rehabilitation hospitals in the U.S.
"Launching the clinical study is a crucial step forward in the
effort to offer the ReStore as a commercial product for the
rehabilitation of stroke survivors worldwide," said ReWalk CEO
Larry Jasinski. "We are
thrilled to continue our work with Spaulding—a renowned
rehabilitation facility—and help patients access this cutting edge
technology."
This first of its kind device, which was unveiled in 2017, is
the second product line from ReWalk and represents the Company's
next step in its efforts to develop new technologies designed to
serve patients with various forms of lower limb
disabilities.
The ReStore is designed to be a versatile, cost-effective gait
therapy solution intended to allow therapists to deliver treatment
with real time analytics and adjustability. It utilizes key
features from structural exoskeleton designs without the size,
structure and expense of current exoskeletons.
"The ReWalk ReStore is an innovative device with potential to
alter how we treat gait impairments after stroke," said
Lou Awad, PT, DPT, PhD, Assistant
Professor, College of Health and Rehabilitation Sciences at
Boston University, and Research Faculty
Member at Spaulding's Stroke Research & Recovery Institute, as
well as lead investigator for this study site. "We are excited to
work with industry-leader ReWalk Robotics to kick off the first
clinical trial of this next-generation rehabilitation
technology."
How It Works: The ReStore transmits power to key joints
of the legs with cable technologies, powered with software and
mechanics that are similar to the technologies used in the ReWalk
exoskeleton system for individuals with spinal cord injury. The
cables are connected to fabric-based designs that attach to the
legs and foot, thus lending the name "soft suit."
Anticipated delivery of a commercial ReStore soft suit is
targeted for the first half of 2019. ReWalk plans to
commercialize use of the ReStore system in Europe and the
United States subject to receiving CE and FDA clearance,
respectively, to market the device. The Company plans to apply for
CE and FDA clearances once clinical and laboratory testing are
completed.
For more information on the ReStore soft suit exoskeleton,
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, and to expand to new markets and
achieve its planned expense reductions; the conclusion of ReWalk's
management and the opinion of ReWalk's auditors for the Company's
financial statements for the fiscal year ended December 31, 2017, 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
ability to enroll participants in its clinical studies, including
for the ReStore; 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, including for the ReStore;
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
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 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
Corporation Limited ("Timwell"); the significant voting power and
de facto voting control Timwell will acquire; the risk that the
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 year ended December 31, 2017 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.