ICYMI: ReWalk’s Restore technology for stroke patients featured in MD&DI
MARLBOROUGH, MA / YOKNEAM ILIT, ISRAEL—November 30, 2017– ReWalk Robotics’ innovative Restore soft exoskeleton system was featured in a recent story as one of the cutting edge technologies seeking to help stroke survivors heal and retain critical motor skills. The story published in Medical Device & Diagnostic Industry (MD&DI), a leading industry trade magazine.
The article examines the latest advancements in technology for stroke-assistive medical devices, and outlines the inspiration for a soft suit exoskeleton, with interviews with ReWalk CEO Larry Jasinski and Kathleen O’Donnell, lead of the medical exosuit program at Harvard’s Wyss Institute, ReWalk’s collaborative partner on the Restore system. The story also walks the reader through the device’s components:
The exosuit is powered by a motor unit worn on a waist belt, which activates sheathed Bowden cables anchored in two spots: one in a calf-worn fabric sleeve and one in the insole of the shoe the unit is activating to achieve a more natural gait.
In his interview, Jasinski speaks to the different pieces ReWalk and the Wyss Institute bring to the table, and the effort to obtain FDA clearance and offer a commercial system:
“They [Wyss] are doing a high level of fundamental research that, generally, small companies cannot afford to do. They are making it work for that individual situation. We are going to be able to take it through the FDA, through the reimbursement processes, and manufacture it at a price point with the quality control and functional level that can meet a mass audience. That is why it’s a good marriage.“
The Restore is a soft suit exoskeleton designed for the stroke survivor patient community; exosuits are expected to offer additional use for other patient populations, including individuals with Parkinson’s Disease, Multiple Sclerosis or other mobility challenges where normal walking gait is impacted. ReWalk recently unveiled the commercial Restore unit, which is already in use in a pre-clinical study and is preparing to expand to the US Pivotal Clinical trials in Q1 2018. Priced at $19,500, the soft exosuit is anticipated to begin commercialization in late 2018 or early 2019.
For more information about the Restore system, please visit: www.rewalk.com.
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 U.S., Israel and Germany.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.
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, expand to new markets and achieve its planned expense reductions; the conclusion of ReWalk’s management for the financial statements for the third quarter of 2017 and for fiscal 2016, and the opinion of ReWalk’s auditors in their report on the Company’s financial statements for fiscal 2016, 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 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; 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; 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; ReWalk’s ability to comply 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 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 year ended December 31, 2016, as amended, filed with the U.S. Securities and Exchange Commission 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.
Lisa M. Wilson
In-Site Communications, Inc.
Datum: November 30, 2017