German Social Court Ruling Deems ReWalk Exoskeleton Medically Necessary as Medical Aid for Recipient with Spinal Cord Injury
YOKNEAM ILIT, Israel and MARLBOROUGH, Mass.,
The claimant,
In
"Only an individual with a spinal cord injury can fully appreciate the moment of pure happiness when you are able to stand up and walk again," said
The ruling delivered by the
- ReWalk is a medical aid that compensates the malfunction of the body directly. As such, it does not require a positive recommendation by the
German Joint National Committee (GBA) or a listing in the German catalogue of medical aids (Hilfsmittelverzeichnis). - The ReWalk exoskeleton technology is not comparable to wheelchairs as only ReWalk enables the insured to walk again. Therefore, the principle of efficiency pursuant to Section 12 of Book V of the German Social Security Code (SGB V) is not applicable.
- The reimbursement of a ReWalk Personal Exoskeleton System cannot be denied based upon the argument that the supply of a wheelchair is sufficient because a wheelchair does not compensate the malfunction of the body completely.
- The fact that the insured still needs assistance when using the ReWalk Personal System does not justify the denial of the payor to cover the cost of the system.
- The insured still needing a wheelchair in addition to a ReWalk does not qualify as a basis for denial because exoskeleton technology gives the insured the possibility to stand up for a few hours per day.
"This ruling is a milestone for insurance coverage of exoskeleton technology, both in
ReWalk Robotics 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. ReWalk is the first exoskeleton system to receive
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ReWalk® is a registered trademark of
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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 to achieve and maintain market acceptance of its products; ReWalk's ability to achieve reimbursement from third-party payors for its products; ReWalk's expectations as to its clinical research program and clinical results; ReWalk's ability to improve its products, 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 repay its secured indebtedness; 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 Annual Report on Form 10-K for the year ended
1 The period to file an appeal of the Social Welfare Court's decision has not yet expired.
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Media Contact: ReWalk Robotics, Jennifer Wlach, 202-261-4000, media@rewalk.com; Investor Relations Contact: Lisa M. Wilson, In-Site Communications, Inc., 917-543-9932, lwilson@insitecony.com