MARLBOROUGH, Mass.,
Oct. 20, 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 that the
Centers for Medicare & Medicaid Services ("CMS") authorized the
Company as a Medicare Provider. With this certification, the
Company can now bill Medicare directly for procurement of its
ReWalk Personal Exoskeleton for Medicare beneficiaries and is now
listed in the Medicare.gov Supplier Directory.
"As proud pioneers in this industry, gaining Provider status is
an important next step for improving access to our Personal
Exoskeleton," said Larry
Jasinski, ReWalk CEO. "However, accreditation does not
guarantee coverage policies, so the Company is evaluating pathways
and opportunities to adjoin accreditation with provider policies to
get our Personal Exoskeleton to more members of the spinal cord
injury community."
This certification follows the July issuance of the CMS
Healthcare Common Procedure Coding System ("HCPCS") Level II Code
K1007 for the ReWalk 6.0 Exoskeleton system. The July issuance
established the first such code for an exoskeleton medical device,
which became effective on October 1,
2020. This certification is immediately effective in the
majority of U.S. states, and the Company is working through
additional administrative tasks to achieve accreditation in most of
the remaining states.
As the HCPCS code goes into effect, ReWalk will pursue
in-network status with private insurance companies. This will open
access to individuals who do not have out-of-network Durable
Medical Equipment benefits and/or those who have high out of pocket
costs with out-of-network providers.
For more information, please visit www.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; 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.