Experts outline potential for improved stroke patient
outcomes, cost effectiveness through use of the ReStore device in
the rehabilitation setting
MARLBOROUGH, Mass.,
March 3, 2021 /PRNewswire/
-- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the
"Company"), a manufacturer of robotic medical devices for
individuals with lower limb disabilities, today announced its
ReStore Soft Exo-Suit was the subject of a recent Medtech
Innovation Briefing (MIB) by the UK's National Institute for Health
and Care Excellence (NICE). These briefings are designed to support
National Health Services (NHS) and social care commissioners and
staff who are considering using new medical devices and other
medical or diagnostic technologies.
The briefing, titled "ReStore Soft Exo-Suit for gait
rehabilitation" includes a description of the ReStore device, how
it's used and why the technology is innovative for the treatment of
patients during post-stroke gait training. The MIB also outlines a
pathway to care using the technology and how much it costs.
"Publication of the NICE briefing is a critical step in
achieving broad adoption of the ReStore Soft Exo-Suit for use in
rehabilitation clinics throughout the United Kingdom," said ReWalk CEO Larry Jasinski. "These briefings are vital in
informing the clinical teams who rely on NICE to make sure they are
aware of the latest technologies that can help patients and deliver
quality care. We are confident the support of NICE will help us to
bring the ReStore to more patients in need across the UK."
Notably, the MIBs include expert commentary, to help inform NHS
on the use of the device in the care setting. In the ReStore
briefing, experts agreed that ReStore could improve outcomes by
reducing falls and improving a user's balance and confidence.
Experts also suggested that ReStore could reduce the number of
staff needed in therapy sessions because fewer people would be
needed to assist patients.
"Our initial impression is that the ReStore has the potential to
influence neuro-plasticity, 're-wiring' of the nervous system, for
a range of patients and presentations," said Tom McGregor, clinical lead for Hull and East
Yorkshire at MOTIONrehab. "By using the ReStore patients
have better gait biomechanics, which in turn is resulting in
increased walking distances, faster walking speeds and greater
confidence to walk. We're using ReStore as a therapy tool in clinic
to optimize our treatment sessions. The clients that have tried it
so far have reacted really well, so the plan is to utilize it on
successive sessions over the coming weeks and months," he
added.
While the experts agreed that the ReStore is likely to cost
more than the current standard of care, one of the commentators
noted the case for cost effectiveness could be proven with evidence
the ReStore improved neuromuscular recovery more than standard
care, and lowered resource impact.
The ReStore system is comprised of a soft, garment-like design
which connects to a lightweight waist pack and mechanical cables
that help lift the patient's affected leg in synchronized timing
with their natural walking pattern. The system provides targeted
assistance to the patient during forward propulsion
(plantarflexion) and ground clearance (dorsiflexion), two key
phases of the gait cycle. Real-time data from sensors in the shoes
and on the affected leg are used to adjust the mechanical
assistance to match the user's natural gait and to enhance
propulsion symmetry. This provides the physical therapists with
extensive data to inform strategies to optimize a patient's
treatment and progress using real-time analytics.
For more information, please visit 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. ReWalk'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 rewalk.com.
ReWalk® is a registered trademark of ReWalk Robotics
Ltd. in Israel and the United States.
ReStore® is a registered trademark of ReWalk Robotics
Ltd. in Europe and an allowed trademark
in 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
other statements that are not statements of historical fact 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: our ability to have sufficient
funds to meet certain future capital requirements, which could
impair our efforts to develop and commercialize existing and new
products; the adverse effect that the current COVID-19 pandemic has
had and may continue to have on the Company's business and
results of operations; ReWalk's ability to have sufficient funds to
meet certain future capital requirements, which could impair the
Company's efforts to develop and commercialize existing and new
products; ReWalk's ability to maintain 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;
the risk of a cybersecurity attack or breach of the Company's IT
systems significantly disrupting its business operations; ReWalk's
expectations regarding future growth, including its ability to
increase sales in its existing geographic markets and expand to new
markets; 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
limited operating history and its ability to leverage its sales,
marketing and training infrastructure; ReWalk's expectations as to
its clinical research program and clinical results; ReWalk's
ability to obtain certain components of its products from
third-party suppliers and its continued access to its product
manufacturers; ReWalk's ability to repay its secured indebtedness;
ReWalk's ability to improve its products and develop new products;
ReWalk's compliance with medical device reporting regulations to
report adverse events involving the Company's products, which could
result in voluntary corrective actions or enforcement actions such
as mandatory recalls, and the potential impact of such adverse
events on ReWalk's ability to market and sell its products;
ReWalk's ability to gain and maintain regulatory approvals;
ReWalk's expectations as to the results of, and the Food and Drug
Administration's potential regulatory developments with respect to
its mandatory 522 postmarket surveillance study; 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 establish a pathway to commercialize its
products in China; the impact of
substantial sales of the Company's shares by certain shareholders
on the market price of the Company's ordinary shares; ReWalk's
ability to use effectively the proceeds of its offerings of
securities; the risk of substantial dilution resulting from the
periodic issuances of ReWalk's ordinary shares; the impact of the
market price of the Company's ordinary shares on the determination
of whether it is a passive foreign investment company; the market
and other conditions; and other factors discussed under the heading
"Risk Factors" in ReWalk's annual report on Form 10-K for the year
ended December 31, 2020 filed with
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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