MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, June 28, 2018 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, announced today that the Institutional Review Boards of five leading U.S. research institutions have approved ReWalk's clinical study of the ReStore soft exo-suit device.
"We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,'' said ReWalk CEO Larry Jasinski. ''The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market."
ReWalk anticipates commercializing the ReStore device for use by stroke patients in Europe and the United States in the first half of 2019, subject to the timing and receipt of CE mark and FDA clearance, respectively. Enrollment for the multi-center study is underway. The five research centers participating in the study include:
- The Shirley Ryan AbilityLab in Chicago, IL;
- Spaulding Rehabilitation Hospital in Boston, MA, in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College;
- MossRehab Stroke and Neurological Disease Center in Elkins Park, PA;
- TIRR Memorial Hermann in Houston, TX; and
- Kessler Foundation in West Orange, NJ.
"The ReWalk ReStore is an unobtrusive wearable robotic technology that can seamlessly interact with and enhance everyday clinical care, allowing stroke patients to walk effectively and efficiently," explained Arun Jayaraman, PT, PhD who is Director of the Max Nader Lab for Rehabilitation Technologies & Outcomes Research at Shirley Ryan AbilityLab and lead investigator for the study.
This first-of-its-kind device unveiled in 2017, the novel ReStore soft exo-suit is the second product developed by ReWalk. Designed to be a versatile, cost-effective gait therapy solution, the ReStore provides therapists with the ability to adjust and optimize a patient's treatment using real-time analytics. The ReStore promotes an improved gait with coordinated plantarflexion and dorsiflexion assistance to a patient's impaired foot and ankle. Power is transmitted from waist belt-mounted motors through cables to attachment points on the calf and an insole which is placed in the patient's shoe. Sensors clipped to the patient's shoes detect motion and inform timing of the assistance. Using a handheld smartphone controller, a trained therapist is able to adjust assistance level, monitor key metrics such as session progress and gait symmetry, and record standard gait training assessments. The company has announced pricing of under $20,000 for the device.
For more information about the ReStore, or the clinical study, 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.
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 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 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; the risk of substantial dilution resulting from the issuance to Timwell; the significant voting power and de facto voting control Timwell may acquire; the risk that the remaining Timwell issuances will fail to close and the China joint venture will not form; 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.
SOURCE ReWalk Robotics Ltd.