German National Health Insurance Agency Announces Addition of ReWalk 6.0 System to National Medical Device Directory
German GKV-Spitzenverband to Provide Exoskeleton Devices for all Qualifying Beneficiaries in Landmark National Policy Decision
MARLBOROUGH, Massachusetts and BERLIN and YOKNEAM, Israel, Feb. 2, 2018 /PRNewswire/ -- GKV-Spitzenverband, the head office of German statutory health insurance (SHI), confirmed their decision to list the ReWalk (Nasdaq: RWLK) Personal 6.0 Exoskeleton System in the German Medical Device Directory (MDD, Hilfsmittelverzeichnis), according to §139 SGB V. The MDD is a comprehensive list of all medical devices which are principally and regularly reimbursed by German SHI providers. This decision means that ReWalk will be listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.
The ReWalk Personal will be classified as "an innovative device for the immediate compensation of a handicap" in the MDD, and will be listed under a new subcategory for product group 23. The official publication of the MDD, which is issued annually, is expected within the next three months.
Addition to the MDD is a significant policy milestone, allowing for any eligible German SHI beneficiary in the country to seek procurement of a ReWalk system to stand and walk again. If their assessment is approved by physical exam, the SHI will then reimburse for purchase of a system. Ninety percent of the German population are beneficiaries under SHI coverage, which creates the potential for thousands of individuals with spinal cord injury (SCI) in Germany to have access to exoskeleton devices for the first time.
"We are pleased to see the German healthcare system embracing biotechnology innovations that will be life changing for beneficiaries nationwide," said ReWalk CEO Larry Jasinski. "This is a landmark decision—one of progressive policy by SHI in Germany, and one that will be critically important to SCI individuals across the country. We are excited to announce that patients and O&P shops will soon be able to access ReWalk systems as a part of the standard reimbursement process."
The GKV decision follows a similar policy issuance by German accident insurer BG in 2017, which provided for rental and procurement of ReWalk 6.0 Personal Systems for qualifying beneficiaries. Receiving its CE Mark in 2012, ReWalk has been working with insurers across the EU on policy development for SCI beneficiaries. There are more than 400 ReWalk systems in use worldwide today.
To learn more about the ReWalk 6.0 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.
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, 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.
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