Reimbursement of the device marks a key milestone in the Company's relationship with major U.S. private insurers.
MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel , April 16, 2019 /PRNewswire/ -- ReWalk Robotics, Ltd. ( RWLK ) ("ReWalk" or the "Company"), announced today that the first Cigna Corporation (Cigna) insurance beneficiary has received a ReWalk Personal 6.0 exoskeleton for use at home and in his community.
The beneficiary is a New York man who sustained a spinal cord injury in a motorcycle accident in 2016. After learning about ReWalk's technology and going through the proper examinations, he became eligible to receive a ReWalk Personal 6.0 exoskeleton. He has started training in his ReWalk system and when finished he will be able to take it home and utilize the device in his daily life. The Company has several other Cigna cases in the pipeline that are currently being processed.
"This coverage by Cigna, a leading global health service company in the United States , is the latest example of progress in the acceptance of exoskeletons by the payor community," said ReWalk CEO Larry Jasinski . "We continue to actively engage insurers regarding exoskeleton policy provision for eligible beneficiaries and are pleased to see recent progress with Cigna and other providers worldwide. The expansion of peer-reviewed publications on the benefits of exoskeleton use has led to meaningful discussions and advancements, which we believe will continue to expand across the industry."
In February of this year, Cigna revised its policy regarding coverage of exoskeleton medical devices for persons with spinal cord injury. Cigna, which previously had a non-coverage policy, will now review submissions from beneficiaries on a case-by-case basis to consider providing coverage based on medical criteria. This policy revision is the first of its kind by a major U.S. private insurer, joining the U.S. Department of Veterans Affairs, which in December 2015 issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeletons for all qualifying Veterans across the United States .
"Since our inception, we have delivered more than 500 exoskeleton systems, the majority of which are used by individuals at home, though many more are awaiting coverage of their own devices. As payors evaluate the benefits of exoskeleton technology we are confident more will follow Cigna's lead and make this life changing technology available to its members," Jasinski added.
ReWalk Robotics, Ltd.
ReWalk Robotics, Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke. The Company'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 .
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 include those relating to 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 ability to secure capital from equity and debt financings in light of limitations under its effective registration statement on Form S-3, the price range of its ordinary shares and conditions in the financial markets, and the risk that such financings may dilute its shareholders or restrict its business; ReWalk's ability to regain compliance with continued listing requirements of the Nasdaq Capital Market, and the risk that its ordinary shares will be delisted if it regains compliance; the risk of decreased liquidity in the market for ReWalk's ordinary shares and a reduced market capitalization of the Company following the reverse share split, and the risk of dilution following the related increase in authorized share capital; ReWalk's expectations regarding future growth, including its ability to increase sales in its existing geographic markets, and to expand to new markets and achieve its planned expense reductions; the conclusion of ReWalk's management and the previous opinion of ReWalk's auditors in 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 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 ability to improve its products and develop new products; ReWalk's ability to repay its secured indebtedness; ReWalk's compliance with medical device reporting regulations to report adverse events involving its products 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, ReWalk's mandatory post-market 522 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 ReWalk's information technology systems significantly disrupting its business operations; ReWalk's ability to establish a pathway to commercialize its products in
; the risk of substantial dilution resulting from periodic issuances of its ordinary shares; the outcome of ongoing shareholder class action litigation relating to ReWalk's initial public offering; ReWalk's ability to maintain relationships with existing customers and develop relationships with new customers; the impact of the market price of ReWalk's ordinary shares on the determination of whether ReWalk 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, 2018
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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