MARLBOROUGH, Mass.,
June 2, 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 and Medicaid Services ("CMS") conducted a
public hearing to discuss requests for new billing codes including
CMS's positive preliminary decision for ReWalk's request for a
Healthcare Common Procedure Coding System (HCPCS) Level II
Code. The preliminary decision is an important moment for
exoskeleton devices, which to date, have not had a distinct HCPCS
billing code for claim submissions.
HCPCS Level II codes are used primarily to identify medical
products and supplies, such as durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS). These codes
facilitate insurance claim submissions and processing for items
described as DMEPOS. The Company participated in the HCPCS DMEPOS
public hearing on June 1st
to discuss the positive preliminary decision and anticipates
updates on code finalization later in the year.
"This positive preliminary decision for an HCPCS code is a
significant step forward. A specific HCPCS code will help
break down administrative barriers and support access for all
individuals with paraplegic spinal cord injury (SCI). We have seen
firsthand the positive impact these devices have on the physical
and mental health of those who use them, and strongly feel that
individuals with SCI who meet the criteria for use should have
access to these devices in their homes," said Kathryn Vaughn, PT, DPT and Director of Market
Access at ReWalk Robotics.
After the HCPCS code is established, ReWalk will be able to work
with payers such as Medicare, state Medicaid and private insurers
to establish an appropriate payment rate and pursue coverage
policies for home-use. If and when positive coverage policies are
established, those who meet the inclusion criteria as established
by the Food and Drug Agency (FDA) and complete the training program
would 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 paraplegic. At time of injury,
49% of these individuals are covered by private insurers and 35%
are on Medicare of Medicaid programs. By year five post-injury, the
percent who are primarily covered by Medicare and Medicaid programs
rises to 55%.
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 achieve reimbursement from
third-party payors for its products, including its ability to
establish coverage policies from programs such as Medicare, state
Medicaid and private insurance; 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
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 FDA'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 Securities
and Exchange Commission (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.