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SOURCE ReWalk Robotics Ltd.
Assessment of Nearly 1,000 User Sessions Yields Thorough Survey of Effective Use Without Any Falls or Complications to Patient Health
Ability to Safely Use ReWalk Systems Several Hours Per Day Led to a Number of Health Benefits for Patients
MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Oct. 5, 2017 /PRNewswire-USNewswire/ -- A new in-depth retrospective study and related white paper published in late September demonstrate the safe and effective use of ReWalk systems by individuals with spinal cord injury (SCI) in various community settings, as well as the impact to the physical health of the user across a number of medical benefits. These two reports add crucial new evidence to a growing set of data that assesses home use of exoskeleton medical devices for individuals with SCI who utilize the systems to stand and walk.
"We are pleased to add these two critical pieces to a growing volume of evidence providing insight into community use of exoskeleton systems," said ReWalk CEO Larry Jasinski. "ReWalk has committed to intensive study and data collection that show the safety and efficacy to users, and building a foundation of evidence on the medical benefits to SCI patients who are able to stand and walk each day."
This international study surveyed 48 patients over the course of 954 exoskeleton use sessions over a six-year period. Participants used the ReWalk systems for several hours per session, and were assessed across a number of environments, terrains and surfaces. In addition, study participants were asked to complete a number of tasks using the exoskeleton system, such as timely crossing of a street with traffic lights, entering and exiting an elevator and navigating ADA accessible doorways. The nearly 50 individuals in the study were all able to demonstrate effective use of the exoskeleton system across the parameters and tasks. In nearly 1,000 sessions, there were no falls or user complications reported.
"We anticipate that the in-depth study will prove useful in conversations with public and private insurers, some of which are considering broader coverage policies for eligible SCI beneficiaries," added Jasinski. "We can now add a large international study that shows safe daily use as a key proof point in our volume of research."
The new white paper, titled "Medical Benefits and Safety of the ReWalk Exoskeleton System", provides a thorough examination of the physiological impact of a computerized, robotic system by 11 participants. Co-authored by Mary Beth Schmidt, PhD and Michael L. Reed, DPT, OCS, the white paper finds a number of medical benefits to individuals with SCI who use the ReWalk system to ambulate. Patients studied for this report were able to use the ReWalk system for several hours per day, and demonstrated a number of clinical benefits, including decreased pressure ulcers, improved bowel and bladder functions, decreased pain and significantly decreased energy expenditure (when compared to other ambulatory devices). In addition, patients also demonstrated that ReWalk use was reported to significantly reduce fat mass and total body mass over an average of 36 training sessions during a 12-week period. The Schmidt and Reed white paper also states that "cost-savings for third-party payers can be achieved if patients can maintain or regain ambulatory function."
The findings of medical benefits in the report align with anecdotal evidence and other clinical reporting on the use of ReWalk exoskeletons in the rehabilitation setting. The Schmidt and Reed white paper is one of the first to examine clinical benefits with the device in the home/community setting.
The study and white paper can be accessed here.
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. 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, expand to new markets and achieve its planned expense reductions; the conclusion of ReWalk's management for the financial statements for the second 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 its 2016 follow-on 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; 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.
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