MARLBOROUGH, Mass.,
July 15, 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 Centers for Medicare and
Medicaid Services ("CMS") issued Healthcare Common Procedure Coding
System ("HCPCS") Level II Code K1007 in response to the Company's
application. This decision, which will be effective on October 1, 2020, establishes the first such code
for exoskeletons.
"Establishment of this code is a breakthrough towards making an
innovative and needed medical device more broadly available to the
spinal cord injury community," said Dr. Ann
Vasile, who is Board Certified in Physical Medicine and
Rehabilitation in addition to a Specialty Board Certification in
Spinal Cord Injury Medicine. "With greater than 25 years of
clinical and leadership experience in the field of spinal cord
injury, it has been gratifying to witness firsthand the positive
impact ReWalk devices can have on a spinal cord injured person's
physical and mental wellbeing for those who have been able to
acquire one. I feel strongly that persons with a spinal cord injury
should have access to one if medically appropriate. I thank ReWalk
and CMS for their efforts to finalize this coding."
HCPCS Level II codes are used to identify medical products and
supplies and to facilitate insurance claim submissions and
processing for these items. This code was announced in CMS's First
Biannual 2020 Durable Medical Equipment (DME) and Accessories;
Orthotics, Prosthetics (O & P), and Supplies HCPCS code
application review cycle update.
"We are committed to developing powered solutions for persons
with lower limb disability as well as pursuing policies which make
them available to those who may benefit from them," said
Andy Dolan, Vice President of
Marketing and Reimbursement at ReWalk Robotics. "We are also proud
to be pioneers in this industry. This successful coding application
follows previous key company achievements such as earning the first
FDA clearance for an exoskeleton, the first - and to date most -
positive coverage decisions by U.S. private insurers for their
beneficiaries, collaboration with the Department of Defense to
establish a policy for injured U.S. Veterans to have access to
exoskeletons, and finalization of coverage policies and contracts
with leading German insurers."
The Company intends to work with payers such as Medicare, state
Medicaid and private insurers to establish an appropriate payment
rate and pursue coverage policies for personal ownership of ReWalk
devices. If and when these coverage policies are established, those
who meet the inclusion criteria as established by the Food and Drug
Agency (FDA) and complete the training program will have a pathway
to seek a ReWalk Personal Exoskeleton for use at home. According to
the National Spinal Cord Injury Statistical Center , there are an
estimated 294,000 persons in the United
States living with a spinal cord injury, roughly half of
which are classified as paraplegic.
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. (Nasdaq: RWLK) 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.