U.S. Department of Veterans Affairs Issues National Coverage Policy for ReWalk Robotics Exoskeleton Systems for Qualifying Veterans with Spinal Cord Injury
Landmark Policy Will Provide Veterans Across
the U.S. with Access to Evaluation, Training and Supply of ReWalk Personal
Systems
YOKNEAM
ILIT, Israel and MARLBOROUGH, MA-- ReWalk Robotics
Ltd. (Nasdaq: RWLK) (“ReWalk”), the leading global exoskeleton developer
and manufacturer, announced today that the U.S. Department of Veterans Affairs (“VA”)
has issued a national policy for the evaluation, training and procurement of
ReWalk Personal exoskeleton systems for all qualifying veterans across the
United States. The VA policy, which is
exclusive to ReWalk Robotics exoskeleton systems, is the first national coverage
policy in the United States for qualifying individuals who have suffered spinal
cord injury (“SCI”).
“This historic policy will provide
access to our life-changing technology for thousands of veterans across America,”
said ReWalk CEO Larry Jasinski. “We want
all U.S. veterans with a spinal cord injury to know that they now have a path
to securing their own ReWalk Personal exoskeleton system. The policy outlines a sound process to
educate, train and importantly, to provide individual veterans with a ReWalk
Personal device so that they may walk at home and in the community. We expect
this landmark national policy will substantially improve the health and quality
of life of many veterans in the years ahead,” Jasinski added.
The comprehensive policy put forth by the VA provides veterans with
spinal cord injury access to referral and evaluation at all designated ReWalk
Training Centers across the country.
Veterans who meet the physical criteria for ReWalk will be referred for
training on the use of the device.
Successful candidates will then be eligible to obtain a Rewalk Personal
system.
“We are also very pleased that the
VA’s fundamental clinical research conclusively demonstrated that there are
significant medical benefits associated with enabling an individual with a
spinal cord injury to walk again,” Jasinski said. “Based on their data, the VA’s
national policy now defines use of an exoskeleton as the standard of care for
qualifying veterans with spinal cord injury. We are hopeful the VA policy will
pave the way for additional positive national coverage decisions.”
ReWalk is the only FDA cleared exoskeleton system in the U.S., with
clearances for both personal use at home and in the community, as well as for
the rehabilitation setting.
Some additional details of the new VA national policy:
·
Veterans with SCI may be evaluated for
use of the device at one of the 24 Veterans Health Administration SCI Centers
nationwide, according to detailed protocols.
·
All SCI Centers are encouraged to
pursue designation as a ReWalk Training Center.
·
Once preliminary criteria for ReWalk
training are met, the veteran will be referred to a VA SCI Center designated as
a VA ReWalk Training Center.
·
Training begins on an outpatient basis
and proceeds to the home or community settings.
·
Successful training by an individual
will be followed by consideration of procurement for a personal unit for use at
home and in the community
About ReWalk Personal 6.0
ReWalk Personal
6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion
to enable individuals with spinal cord injury to stand upright and walk. The
system provides user-initiated mobility through the integration of a wearable
brace support, a computer-based control system and motion sensors. The system
allows independent, controlled walking while mimicking the natural gait
patterns of the legs. The ReWalk device is the most studied exoskeleton in the
industry. Studies have identified a
number of health benefits including: improved bladder
and bowel function, improved mental health, improved sleep, reduced fatigue, decreased
body fat, decreased pain and improved posture and balance.
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 US, Israel and Germany. For more
information on the ReWalk systems, please visit http://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,” “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; ReWalk’s ability to
maintain and grow its reputation and the market acceptance of our products;
ReWalk’s ability to achieve reimbursement from third-party payors for our
products; ReWalk’s expectations as to its clinical research program and
clinical results; 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 maintain relationships with existing customers and develop
relationships with new customers; and other factors discussed under the heading
“Risk Factors” in ReWalk’s U.S. Annual Report on Form 20-F for the year
ended December 31, 2014 filed with the U.S. Securities and Exchange
Commission on February 27, 2015 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.
Media Contact:
Jennifer Wlach
202-261-4000
Investor Relations Contact:
Lisa M. Wilson
In-Site Communications, Inc.
917-543-9932