National Institute for Health and Care Excellence (NICE) Publishes Briefing on ReStore Soft Exo-Suit in the UK
Experts outline potential for improved stroke patient outcomes, cost effectiveness through use of the ReStore device in the rehabilitation setting
MARLBOROUGH, Mass., March 3, 2021 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a manufacturer of robotic medical devices for individuals with lower limb disabilities, today announced its ReStore Soft Exo-Suit was the subject of a recent Medtech Innovation Briefing (MIB) by the UK's National Institute for Health and Care Excellence (NICE). These briefings are designed to support National Health Services (NHS) and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
The briefing, titled "ReStore Soft Exo-Suit for gait rehabilitation" includes a description of the ReStore device, how it's used and why the technology is innovative for the treatment of patients during post-stroke gait training. The MIB also outlines a pathway to care using the technology and how much it costs.
"Publication of the NICE briefing is a critical step in achieving broad adoption of the ReStore Soft Exo-Suit for use in rehabilitation clinics throughout the United Kingdom," said ReWalk CEO Larry Jasinski. "These briefings are vital in informing the clinical teams who rely on NICE to make sure they are aware of the latest technologies that can help patients and deliver quality care. We are confident the support of NICE will help us to bring the ReStore to more patients in need across the UK."
Notably, the MIBs include expert commentary, to help inform NHS on the use of the device in the care setting. In the ReStore briefing, experts agreed that ReStore could improve outcomes by reducing falls and improving a user's balance and confidence. Experts also suggested that ReStore could reduce the number of staff needed in therapy sessions because fewer people would be needed to assist patients.
"Our initial impression is that the ReStore has the potential to influence neuro-plasticity, 're-wiring' of the nervous system, for a range of patients and presentations," said Tom McGregor, clinical lead for Hull and East Yorkshire at MOTIONrehab. "By using the ReStore patients have better gait biomechanics, which in turn is resulting in increased walking distances, faster walking speeds and greater confidence to walk. We're using ReStore as a therapy tool in clinic to optimize our treatment sessions. The clients that have tried it so far have reacted really well, so the plan is to utilize it on successive sessions over the coming weeks and months," he added.
While the experts agreed that the ReStore is likely to cost more than the current standard of care, one of the commentators noted the case for cost effectiveness could be proven with evidence the ReStore improved neuromuscular recovery more than standard care, and lowered resource impact.
The ReStore system is comprised of a soft, garment-like design which connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern. The system provides targeted assistance to the patient during forward propulsion (plantarflexion) and ground clearance (dorsiflexion), two key phases of the gait cycle. Real-time data from sensors in the shoes and on the affected leg are used to adjust the mechanical assistance to match the user's natural gait and to enhance propulsion symmetry. This provides the physical therapists with extensive data to inform strategies to optimize a patient's treatment and progress using real-time analytics.
For more information, please visit 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. ReWalk'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 rewalk.com.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel and the United States.
ReStore® is a registered trademark of ReWalk Robotics Ltd. in Europe and an allowed trademark in 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 may include 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: our ability to have sufficient funds to meet certain future capital requirements, which could impair our efforts to develop and commercialize existing and new products; the adverse effect that the current COVID-19 pandemic has had and may continue to have on the Company's business and results of operations; ReWalk's ability to have sufficient funds to meet certain future capital requirements, which could impair the Company's efforts to develop and commercialize existing and new products; ReWalk's ability to maintain 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; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; ReWalk's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; 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 obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; ReWalk's ability to repay its secured indebtedness; ReWalk's ability to improve its products and develop new products; ReWalk's compliance with medical device reporting regulations to report adverse events involving the Company's products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, 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 its mandatory 522 postmarket surveillance study; 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 establish a pathway to commercialize its products in China; the impact of substantial sales of the Company's shares by certain shareholders on the market price of the Company's ordinary shares; ReWalk's ability to use effectively the proceeds of its offerings of securities; the risk of substantial dilution resulting from the periodic issuances of ReWalk's ordinary shares; the impact of the market price of the Company's ordinary shares on the determination of whether it is a passive foreign investment company; the market and other conditions; and other factors discussed under the heading "Risk Factors" in ReWalk's annual report on Form 10-K for the year ended December 31, 2020 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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