MARLBOROUGH, Mass.,
June 22, 2020 /PRNewswire/
-- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the
"Company"), a manufacturer of robotic medical devices for
individuals with lower limb disabilities, today announced the
publication of the results of its multi-center clinical study of
the ReStore Exo-Suit for rehabilitation of individuals with lower
limb disability due to stroke. The study examined patient safety
and explored functional walking outcomes in stroke survivors who
completed a series of gait training sessions with the ReStore
device.
This research was conducted primarily to support the Company's
successful application to the U.S. Food and Drug Administration
(FDA) for clearance of the ReStore Exo-Suit, which was issued in
June 2019. The company also received
CE Marking for the device in May
2019.
The findings of the study were published in the June issue of
the Journal of NeuroEngineering and Rehabilitation, and were the
result of investigation by five leading U.S. rehabilitation institutions:
- Shirley Ryan AbilityLab in Chicago,
IL;
- Spaulding Rehabilitation Hospital in Boston, MA, in partnership with Boston University College of Health and
Rehabilitation Sciences: Sargent
College;
- MossRehab Stroke and Neurological Disease Center in
Elkins Park, PA;
- TIRR Memorial Hermann in Houston,
TX; and
- Kessler Foundation in West Orange,
NJ.
"This multi-site clinical trial of the safety and feasibility of
the ReStore Exo-Suit is an important milestone in the field of
rehabilitation technology," said Lou
Awad, PT, DPT, PhD, Director of Boston
University's Neuromotor Recovery Laboratory and the site
investigator at Spaulding Rehabilitation Hospital for this study.
"Physical therapists have historically relied on passive assistive
devices to help patients with post-stroke hemiparesis walk safely.
As an active assistive device, the ReStore soft robotic exo-suit
offers new opportunities to retrain walking after stroke."
Thirty-six study participants with hemiplegia due to stroke each
completed seven total study visits with the ReStore
Exo-Suit. In addition to establishing device safety, which was
the primary outcome for the study, several exploratory outcome
measures were investigated, including a pre- and post-assessment of
walking speeds, in which 64% of participants increased their
unassisted walking speed by a clinically meaningful margin.
"We are thrilled to see the results from the ReStore clinical
trial being published in a joint paper authored by the primary
investigators from all five of our highly regarded study sites,"
said Kathleen O'Donnell, Director of
Product Management and Strategy at ReWalk Robotics. "This work
summarizes the first results from the largest soft exo-suit trial
to date, and the positive findings in terms of safety and improved
walking speeds showcase the potential of this technology to
dramatically impact patient outcomes post stroke."
The first-of-its-kind ReStore Exo-Suit was unveiled in 2017 and
was designed to be a versatile, cost-effective gait therapy
solution to train for improved gait by providing coordinated
plantarflexion and dorsiflexion assistance to a patient's impaired
foot and ankle. Approximately 800,000 Americans suffer a stroke
annually, and the majority will experience some level of gait
impairment.
For more information on the ReStore Exo-Suit, 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 www.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: ReWalk's management's conclusion,
and its independent registered public accounting firm's statement
in its opinion relating to its consolidated financial statements
for the fiscal year ended December 31, 2019, that there is a
substantial doubt as to the Company's ability to continue as a
going concern; the current COVID-19 pandemic has adversely affected
and may continue to affect adversely 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;
ReWalk's ability to establish a pathway to commercialize its
products in China; 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 expectations regarding future growth, including
its ability to increase sales in its existing geographic markets
and expand to new markets; 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; the outcome of ongoing
shareholder class action litigation relating to its initial public
offering; 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; the risk of a
cybersecurity attack or breach of the Company's IT systems
significantly disrupting its business operations; 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; and other
factors discussed under the heading "Risk Factors" in ReWalk's
annual report on Form 10-K for the year ended December 31,
2019 and quarterly report on Form 10-Q for the quarter ended
March 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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SOURCE ReWalk Robotics Ltd.