MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, April 25, 2019 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), announced today that an independent reviewer has declared the ReWalk Personal 6.0 Exoskeleton medically necessary for a paralyzed Mississippi woman. This marks the 17th ReWalk System reimbursed under a regional Blue Cross Blue Shield plan.
In 2018 ReWalk adopted a patient-based reimbursement submission process which leverages elements of the U.S. Patient Protection and Affordable Care Act, including the right to have ReWalk appeal a coverage denial on a patient's behalf before independent medical review boards. ReWalk is also working to educate payors on the medical benefits of exoskeletons with the goal of expanding coverage policies.
"It is important to see that patients are uniformly gaining a determination that ReWalking is medically necessary and not being found to be experimental or investigational when reviewed by a qualified independent medical expert," said ReWalk CEO Larry Jasinski. "We have seen two major US insurers remove the designation of experimental; the VA continues to provide this for all qualified patients, Germany provides the systems for qualified users, and Italy offers the benefits of walking to its injured workers. Allowing a qualified paralyzed individual who simply wants the quality of life and benefits that come from exoskeletal walking should become a standard for all insurers."
The National Spinal Cord Injury Statistical Center (NSCISC) estimates there are about 17,730 new spinal cord injuries cases each year and the number of people with SCI living in the United States is currently estimated to be approximately 291,000 persons.1
"We look forward to building upon this positive momentum with Blue Cross and other insurers across the country to help craft coverage policies to best serve the patient population," Jasinski added.
About 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.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel and 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 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 China; 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.
1 NTD: Updated according to the NSCISC 2019 SCI Data Sheet:
https://www.nscisc.uab.edu/Public/Facts%20and%20Figures%202019%20-%20Final.pdf
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SOURCE ReWalk Robotics Ltd.
Jennifer Wlach, E: media@rewak.com; Ori Gon, Chief Financial Officer, ReWalk Robotics Ltd., T: +972-4-9590123, E: investorrelations@rewalk.com
