ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, has announced the finalization of national agreements with top German Statutory Health Insurers ("SHI") Techniker Krankenkasse ("TK") and Deutsche Angestellten-Krankenkasse – Gesundheit ("DAK-Gesundheit"). These new policies will allow any eligible beneficiary with a spinal cord injury ("SCI") to seek procurement of a ReWalk 6.0 exoskeleton system. TK and DAK, representing 10.6 million and 5.6 million beneficiaries in Germany, respectively, are two of the largest SHIs in the country; these agreements are expected to help set the standard for exoskeleton procurement in Germany.
"The agreements with TK and DAK are monumental for national procurement policies for exoskeletons, both in Germany and worldwide," said ReWalk CEO Larry Jasinski. "The manner in which the SHIs in Germany have embraced procurement agreements is proof positive of what can be done by other leading countries to provide lifechanging technology for eligible beneficiaries."
"The advantages of this highly innovative supply have convinced us," said Mr. Thomas Bodmer, Board Member at DAK-Gesundheit. "The quality of this complex care is important to us. This is where the contract comes into play by clearly describing and regulating the interaction between the manufacturer, physiotherapists and orthopedic technicians in the contract on medical aid for the first time. In this way, we make it possible for those affected to make optimal use of the exoskeleton."
Under these agreements, eligible beneficiaries will be able to obtain a ReWalk 6.0 exoskeleton device that will enable them to stand and walk in their homes and communities after successful training and verification by the medical service. To date, the Company has 20 cases in the TK and DAK pipeline that are being reviewed as a direct result of these agreements.
TK, which has been voted Germany's best health insurance company for 13 years in a row, has moved swiftly to process procurements.
DAK-Gesundheit is the third largest SHI in the country, providing insurance for 5.6 million people. Its history dates to 1775, making DAK Germany's oldest health insurance company.
ReWalk announced a similar agreement with another SHI earlier this year, which signaled the start of a series of agreements with leading SHIs across Germany. In 2018, the ReWalk 6.0 personal exoskeleton system was added to the German National Health Insurance Agency's National Medical Device Directory ("MDD"), which includes all medical devices that are principally and regularly reimbursed by German statutory health insurance providers. That addition enabled Germany's 105 SHIs to pursue national policies for ReWalk procurement, which are coming to fruition today.
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 www.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.
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: ReWalk's management's conclusion, and its independent registered public accounting firm's statement in its opinion relating to its consolidated financial statements for the fiscal year ended December 31, 2019, that there is a substantial doubt as to the Company's ability to continue as a going concern; the current COVID-19 pandemic has adversely affected and may continue to affect adversely 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; ReWalk's ability to establish a pathway to commercialize its products in China; 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 expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; 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; the outcome of ongoing shareholder class action litigation relating to its initial public offering; 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; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; 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; and other factors discussed under the heading "Risk Factors" in ReWalk's annual report on Form 10-K for the year ended December 31, 2019 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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