MARLBOROUGH, Mass and BERLIN, April 23,
2020 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq:
RWLK) ("ReWalk" or the "Company"), a leading manufacturer of
robotic medical devices for individuals with lower limb
disabilities, has announced the finalization of national agreements
with top German Statutory Health Insurers ("SHI") Techniker
Krankenkasse ("TK") and Deutsche Angestellten-Krankenkasse –
Gesundheit ("DAK-Gesundheit"). These new policies will allow any
eligible beneficiary with a spinal cord injury ("SCI") to seek
procurement of a ReWalk 6.0 exoskeleton system. TK and DAK,
representing 10.6 million and 5.6 million beneficiaries in
Germany, respectively, are two of
the largest SHIs in the country; these agreements are expected to
help set the standard for exoskeleton procurement in Germany.
"The agreements with TK and DAK are monumental for national
procurement policies for exoskeletons, both in Germany and worldwide," said ReWalk CEO
Larry Jasinski. "The manner in which
the SHIs in Germany have embraced
procurement agreements is proof positive of what can be done by
other leading countries to provide lifechanging technology for
eligible beneficiaries."
"The advantages of this highly innovative supply have convinced
us," said Mr. Thomas Bodmer, Board
Member at DAK-Gesundheit. "The quality of this complex care is
important to us. This is where the contract comes into play by
clearly describing and regulating the interaction between the
manufacturer, physiotherapists and orthopedic technicians in the
contract on medical aid for the first time. In this way, we make it
possible for those affected to make optimal use of the
exoskeleton."
Under these agreements, eligible beneficiaries will be able to
obtain a ReWalk 6.0 exoskeleton device that will enable them to
stand and walk in their homes and communities after successful
training and verification by the medical service. To date, the
Company has 20 cases in the TK and DAK pipeline that are being
reviewed as a direct result of these agreements.
TK, which has been voted Germany's best health insurance company for 13
years in a row, has moved swiftly to process procurements.
DAK-Gesundheit is the third largest SHI in the country,
providing insurance for 5.6 million people. Its history dates to
1775, making DAK Germany's oldest health insurance company.
ReWalk announced a similar agreement with another SHI earlier
this year, which signaled the start of a series of agreements with
leading SHIs across Germany. In
2018, the ReWalk 6.0 personal exoskeleton system was added to the
German National Health Insurance Agency's National Medical Device
Directory ("MDD"), which includes all medical devices that are
principally and regularly reimbursed by German statutory health
insurance providers. That addition enabled Germany's 105 SHIs to pursue national policies
for ReWalk procurement, which are coming to fruition today.
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 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.