MARLBOROUGH, Mass. and
YOKNEAM ILIT, Israel, June 12, 2017 /PRNewswire/ -- ReWalk Robotics
Ltd. (Nasdaq: RWLK) ("ReWalk"), leading manufacturer of exoskeleton
systems, today announced a Florida
court ruling that found Blue Cross Blue Shield of Florida must provide coverage of a ReWalk
exoskeleton system for a plan member with a spinal cord injury
("SCI"). This court decision is the latest of several in
the United States that have ruled
in favor of the individual after original denial of claims by
commercial insurers.
Following an extensive formal evidentiary hearing, the
State of Florida Division of Administrative Hearings held that
there is "persuasive evidence", including current clinical studies
and medical literature that show "exoskeletons (including the
ReWalk) are no longer 'experimental or investigational.'" The
judge's finding was echoed by a medical expert whose testimony
determined exoskeleton technology for spinal cord injured
individuals meets a common standard of medical practice. In ruling
for coverage for this individual, the Judge concluded:
"…. the ReWalk and other exoskeleton devices have been
studied extensively. They have been tested in different
environments and on many different individuals. They are already
used extensively even as testing continues."
ReWalk CEO, Larry Jasinski
said, "The recent Florida ruling is
significant and consistent with the growing body of
established scientific data that supports the value of
exoskeletal walking. We are encouraged by the chorus of
experts who are supporting paralyzed individuals in their appeals
processes, and heartened by the trend of coverage rulings that
continues to increase in states across the U.S. It is our
fervent hope that insurance companies will stop this arduous
process of appeals and formulate standard operating policies for
coverage of all eligible SCI plan members."
In over 80% of appeals decided, independent experts have
ruled in favor of coverage. As of
the end of Q1 2017, 86 paralyzed SCI individuals who
wanted the right to be able to walk again have been approved
for insurance coverage. There are now 49
scientific papers analyzing
exoskeletons and a peer-reviewed detailed
meta-analysis of a large subset of studies.
The data that supported ReWalk's 2014 FDA
clearance—the first-ever for an exoskeleton for
those in the SCI community—included 756 sessions on a range of
surface finishes and in multiple environments with no incidents of
falls or clinical issues. These environments included: crossing at
streetlights, homes, stores, restaurants and offices. In 2015, the
Veterans Administration issued a standard operating policy for
procurement of any eligible retired service member who qualifies
for home use of a ReWalk system.
"We will continue to advocate for the rights
of the disabled in providing them technology that can
enable them to walk again and enjoy the
demonstrated health benefits that occur with use of the
device," Jasinski added.
About ReWalk Robotics Ltd.
ReWalk Robotics
Ltd. develops, manufactures and markets wearable robotic
exoskeletons for individuals with spinal cord injury. Our 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 U.S., 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.
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, 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 expectations regarding
future growth, including its ability to increase sales in its
existing geographic markets and to expand to new markets; the
conclusion of ReWalk's management, and the opinion of ReWalk's
auditors in their report on the Company's consolidated financial
statements for the fiscal year ended December 31, 2016, that there are substantial
doubts as to ReWalk's ability to continue as a going concern;
ReWalk's ability to maintain and grow its reputation and to achieve
and maintain market acceptance of its products; ReWalk's ability to
achieve reimbursement from third-party payors for its products;
ReWalk's ability to repay its secured indebtedness; ReWalk's
expectations as to its clinical research program and clinical
results; ReWalk's expectations as to the results of, and the Food
and Drug Administration's potential regulatory actions with respect
to, ReWalk's mandatory post-market 522 surveillance study; the
outcome of ongoing shareholder class action litigation relating to
ReWalk's initial public offering; ReWalk's ability to improve its
products and develop new products; ReWalk's ability to maintain
adequate protection of its intellectual property and to avoid
violation of the intellectual property rights of others; ReWalk's
ability to gain and maintain regulatory approvals; ReWalk's ability
to use effectively the proceeds of its 2016 follow-on offering;
ReWalk's ability to secure capital from its at-the-market equity
distribution program based on the price range of its ordinary
shares and conditions in the financial markets; ReWalk's ability to
maintain relationships with existing customers and develop
relationships with new customers; ReWalk's ability to regain
compliance with NASDAQ continued listing requirements; and other
factors discussed under the heading "Risk Factors" in ReWalk's
Annual Report on Form 10-K for the year ended December 31, 2016 filed with the U.S. Securities
and Exchange Commission and other documents subsequently filed with
or furnished to the U.S. Securities and Exchange Commission. 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/florida-blue-cross-blue-shield-to-cover-rewalk-exoskeleton-for-paralyzed-plan-member-following-court-decision-deeming-the-device-medically-necessary-300472169.html
SOURCE ReWalk Robotics Ltd.