Lifeward Achieves CE Mark Approval for the ReWalk 7 Personal Exoskeleton
Lifeward (Nasdaq: LFWD) has received CE mark approval for its ReWalk 7 Personal Exoskeleton, enabling commercial sales in Europe. The seventh-generation device features advanced capabilities including cloud connectivity, push-button control, customizable walking speeds, and improved stairs/curbs navigation.
Europe represents 40% of Lifeward's exoskeleton sales, with Germany being the second-largest market globally. The company has established reimbursement agreements with major German insurers, including BARMER, covering approximately 45% of people with statutory health insurance in Germany.
Lifeward (Nasdaq: LFWD) ha ottenuto il marchio CE per il ReWalk 7 Personal Exoskeleton, autorizzandone la vendita commerciale in Europa. Il dispositivo di settima generazione offre funzionalità avanzate come connettività cloud, controllo con pulsante, velocità di camminata personalizzabili e una migliore gestione di scale e marciapiedi.
L'Europa rappresenta il 40% delle vendite di esoscheletri di Lifeward, con la Germania come secondo mercato più importante a livello mondiale. L'azienda ha stipulato accordi di rimborso con i principali assicuratori tedeschi, tra cui BARMER, che coprono circa il 45% delle persone con assicurazione sanitaria statale in Germania.
Lifeward (Nasdaq: LFWD) ha obtenido la marca CE para el ReWalk 7 Personal Exoskeleton, lo que permite su venta comercial en Europa. El dispositivo de séptima generación incorpora funciones avanzadas como conectividad en la nube, control mediante botón, velocidades de marcha personalizables y mejor manejo de escaleras y bordillos.
Europa representa el 40% de las ventas de exoesqueletos de Lifeward, siendo Alemania el segundo mercado más grande a nivel mundial. La compañía ha alcanzado acuerdos de reembolso con los principales aseguradores alemanes, incluido BARMER, que cubren aproximadamente al 45% de las personas con seguro de salud estatutario en Alemania.
Lifeward (나스닥: LFWD)이 ReWalk 7 Personal Exoskeleton에 대해 CE 인증을 획득하여 유럽에서 상업적 판매가 가능해졌습니다. 7세대 기기는 클라우드 연결, 버튼식 제어, 사용자 설정 보행 속도, 계단 및 연석(보도턱) 이동 능력 향상 등 고급 기능을 갖추고 있습니다.
유럽은 Lifeward의 외골격 판매의 40%를 차지하며, 독일은 전 세계에서 두 번째로 큰 시장입니다. 회사는 BARMER를 포함한 주요 독일 보험사들과 환급 협약을 체결했으며, 이는 독일의 법정 건강보험 가입자 중 약 45%를 보장합니다.
Lifeward (Nasdaq: LFWD) a obtenu le marquage CE pour le ReWalk 7 Personal Exoskeleton, autorisant sa vente commerciale en Europe. Le dispositif de septième génération intègre des fonctionnalités avancées telles que la connectivité cloud, le contrôle par bouton, des vitesses de marche personnalisables et une meilleure gestion des escaliers et des bordures.
L'Europe représente 40% des ventes d'exosquelettes de Lifeward, l'Allemagne étant le deuxième marché mondial. La société a conclu des accords de remboursement avec les principaux assureurs allemands, dont BARMER, qui couvrent environ 45% des personnes assurées par l'assurance maladie statutaire en Allemagne.
Lifeward (Nasdaq: LFWD) hat für den ReWalk 7 Personal Exoskeleton die CE-Kennzeichnung erhalten, was den kommerziellen Vertrieb in Europa ermöglicht. Das Exoskelett der siebten Generation bietet fortschrittliche Funktionen wie Cloud-Anbindung, Tastenbedienung, anpassbare Gehgeschwindigkeiten und verbesserte Navigation bei Treppen und Bordsteinen.
Europa macht 40% der Exoskelett-Verkäufe von Lifeward aus, wobei Deutschland der weltweit zweitgrößte Markt ist. Das Unternehmen hat Erstattungsvereinbarungen mit großen deutschen Krankenkassen, darunter BARMER, abgeschlossen, die etwa 45% der gesetzlich Versicherten in Deutschland abdecken.
- CE mark approval enables commercial sales of ReWalk 7 in Europe
- Established reimbursement agreements with major German insurers covering 45% of statutory health insurance
- Europe represents 40% of company's exoskeleton sales
- Advanced features including cloud connectivity and improved navigation capabilities
- None.
Insights
CE Mark approval for ReWalk 7 unlocks immediate European sales with established German reimbursement pathways driving near-term revenue growth.
Lifeward has secured a significant regulatory milestone with CE mark approval for their ReWalk 7 Personal Exoskeleton, enabling commercial distribution throughout Europe. This represents the seventh generation of their spinal cord injury mobility solution, featuring substantial technological advances including cloud connectivity, push-button control, customizable walking speeds, and improved navigation of stairs and curbs.
The timing of this approval is particularly advantageous as Lifeward already has established reimbursement infrastructure in Germany, which constitutes their second-largest market globally. The company has secured supply contracts with major German insurers, including BARMER, covering approximately
Europe currently represents
This approval provides Lifeward with a dual advantage: immediate revenue potential in an established market and a proven reimbursement model they can replicate in other regions, including the United States. The regulatory strategy of leveraging European approval before US market entry is common in medical devices, as CE mark requirements often enable faster commercialization while companies pursue more lengthy FDA processes.
Seventh generation of industry-leading ReWalk Exoskeleton is now cleared for commercial launch in the European Union
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, announced today that the company has received CE mark approval for the ReWalk 7 Personal Exoskeleton, clearing it for commercial sale in Europe. The seventh generation of the ReWalk, which includes innovative new and enhanced features such as cloud connectivity, push-button control, customizable walking speeds, and seamless activation of stairs and curbs, will now be available to European customers, who currently represent approximately
“The ReWalk 7 represents a major advancement in personal exoskeleton technology, designed to deliver superior control, engagement, and real-world mobility for individuals with spinal cord injury (SCI),” said Mark Grant, CEO of Lifeward. “Achieving CE mark approval is a pivotal regulatory milestone for Lifeward. With reimbursement already broadly established in Germany, this foundation positions us to drive meaningful near-term commercial adoption and revenue growth in Europe, while also providing a proven model we are beginning to replicate in other strategic markets, including the United States.”
Previous generations of the ReWalk Exoskeleton have been available in Europe since the company received its initial CE mark in 2010. The European market is served through the Company’s Lifeward GmbH salesforce in Germany, which represents the second largest market worldwide for ReWalk personal exoskeletons. Lifeward has established supply contracts with several major insurance carriers in Germany, including BARMER, to facilitate the reimbursement and supply of exoskeletons for approximately
To learn more about the ReWalk 7 Personal Exoskeleton, please visit GoLifeward.com/ReWalk7
About Lifeward
Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the ReStore Exo-Suit, and the MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany.
Lifeward®, ReWalk®, ReStore®, and Alter G® are registered trademarks of Lifeward Ltd. and/or its affiliates.
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 the Company'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 the Company’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements include, among others: the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company'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; the Company's ability to maintain and grow its reputation and the market acceptance of its products; the Company's ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company's limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company's expectations as to its clinical research program and clinical results; the Company's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company's ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company’s ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer and transitioning the manufacturing of its ReWalk products to its in-house manufacturer; the Company's ability to improve its products and develop new products; the Company'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 the Company's ability to market and sell its products; the Company's ability to gain and maintain regulatory approvals; the Company'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 Company's ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading "Risk Factors" in the Company’s annual report on Form 10-K, as amended, for the year ended December 31, 2024 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 the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Lifeward Media Relations:
Kathleen O’Donnell
Vice President, Marketing & New Business Development
Lifeward Ltd.
E: media@golifeward.com
Lifeward Investor Contact:
Almog Adar
Chief Financial Officer
Lifeward Ltd.
E: ir@golifeward.com
FAQ
What new features does the Lifeward ReWalk 7 Personal Exoskeleton include?
What percentage of Lifeward's exoskeleton sales come from Europe?
How many people in Germany can potentially access ReWalk 7 through insurance?
When did Lifeward first receive CE mark approval for ReWalk exoskeletons?
What is the significance of the CE mark approval for Lifeward (LFWD)?
