ReWalk Announces Placement of 500th Exoskeleton System
MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Nov. 9, 2018 /PRNewswire/ — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”) announced today that the company has placed its 500th robotic exoskeleton medical device. The majority of these devices are personal systems used by individuals with spinal cord injury in their homes and communities, while others are located in rehabilitation centers to evaluate and train potential new device owners.
The first ReWalk device was placed in 2011 to the Vatican Hospital in Rome, and it became the first exoskeleton to be cleared by the FDA for sale in the United States in June 2014. To continue its growth, the Company is focused on expanding insurance coverage of exoskeletons for all persons with spinal cord injury and has helped develop national coverage policies with payers in several countries, including Germany, Italy and the U.S. Department of Veterans Affairs in the U.S.
The Company continues to work with payers on individual system procurements as well as the development of broad private coverage policies and additional national coverage policies for eligible beneficiaries. To date, 38 different payers in the United States and 39 in Germany have provided positive coverage decisions for ReWalk Personal systems to their clients.
“500 units placed is a wonderful milestone for the Company, and an important moment in our mission to improve the quality of life for individuals with lower limb disability,” said ReWalk CEO Larry Jasinski. “Most of all, we see this moment as a chance to reflect on the myriad lives that have been impacted by the technology. Every single patient was told he or she would never walk again. Innovation and their determination has helped spinal cord injured patients stand up and regain many of the daily life functions they thought were lost forever. It is hugely gratifying to see how these systems have changed the lives for ReWalkers and their families across the world.”
ReWalkers have made news using their systems over the years. Claire Lomas in the UK has completed multiple marathons in her ReWalk, including the 2012 London Marathon and the 2018 Greater Manchester Marathon. Retired Captain Derek Herrera, the first recipient of a ReWalk Personal system in the U.S., received the Bronze Star at his retirement ceremony from the U.S. Marine Corps while using his ReWalk. Captain Herrera achieved his goal of retiring from the military on his own two feet, the same as when he entered the armed forces. To learn more about ReWalk or hear the stories of ReWalkers around the world, please visit: www.rewalk.com
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.
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 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 regain compliance with the continued listing requirements of the Nasdaq Capital Market and the risk that its ordinary shares will be delisted if it cannot do so; 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 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 developments 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 repay its secured indebtedness; ReWalk’s ability to improve its products and develop new products; the risk that the remaining Timwell Corporation Limited (“Timwell”) issuances will fail to close and the China joint venture will not form, and the resulting effect on ReWalk’s liquidity and financial condition; the risk of substantial dilution resulting from additional issuances, if any, to Timwell; the significant voting power and de facto voting control Timwell may acquire upon additional issuances, if any; 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 secure capital from its equity and debt financings in light of limitations under its Form S-3, the price range of its ordinary shares and conditions in the financial markets, and the risk that such financings may dilute ReWalk’s shareholders or restrict its business; ReWalk’s ability to use effectively the proceeds of offerings of securities; the impact of the market price of ReWalk’s ordinary shares on the determination of whether ReWalk is a passive foreign investment company; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; 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; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission (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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SOURCE ReWalk Robotics Ltd.