Lifeward announces approval for ReWalk 7 coverage by a major U.S. health insurer, enhancing access for individuals with spinal cord injuries.
Quiver AI Summary
Lifeward Ltd. announced that a major U.S. health insurance company has approved payment for its ReWalk 7 Personal Exoskeleton, marking the first such approval for individuals with spinal cord injuries. This development follows the device's launch for sales in the U.S. on April 15, 2025, and signifies a key step in expanding access to this innovative technology for those with physical limitations. The approval is seen as a momentum booster for Lifeward's efforts to engage more commercial insurers, enhancing coverage for personal exoskeletons after the Centers for Medicare & Medicaid Services established a reimbursement pathway in 2024. Lifeward's CEO, Larry Jasinski, emphasized the importance of this approval in advancing the company's growth and aiding individuals with spinal cord injuries, reflecting the firm’s commitment to innovation in medical technology.
Potential Positives
- Approval from a major U.S. health insurer for the ReWalk 7 Personal Exoskeleton represents a significant milestone in expanding access for individuals with spinal cord injuries.
- This decision may lead to increased traction and credibility for Lifeward in the commercial insurance market, potentially driving future sales growth.
- The launch of the ReWalk 7 and its recent approval for insurance coverage position Lifeward as a leader in innovation within the medical technology industry.
Potential Negatives
- Approval for reimbursement by a major insurer comes shortly after the launch of the ReWalk 7, suggesting initial sales may be weaker without insurance coverage support.
- The press release contains numerous forward-looking statements that highlight uncertainties and risks that could adversely affect the company’s future performance, indicating a potentially unstable outlook.
- The company relies heavily on third-party payors for reimbursement, presenting a risk if future approvals are not secured, which could hinder growth and market acceptance.
FAQ
What is the ReWalk 7 Personal Exoskeleton?
The ReWalk 7 is a device designed to help paralyzed individuals stand, walk, and navigate everyday environments.
Who approved the coverage for the ReWalk 7?
A major U.S. health insurance company approved payment for the ReWalk 7 for its beneficiaries, marking a significant milestone.
When was the ReWalk 7 launched for U.S. sales?
The ReWalk 7 was launched for sales in the U.S. on April 15, 2025.
What does Medicare's approval mean for commercial insurers?
Medicare's approval establishes a foundation for commercial health insurers to cover personal exoskeletons for their beneficiaries.
How does Lifeward plan to expand access to the ReWalk?
Lifeward aims to engage more commercial health insurers to enhance access to the ReWalk for individuals with spinal cord injuries.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Approval signals important progress in U.S. market expansion as major commercial health insurers begin to follow precedent set with Medicare reimbursement for personal exoskeletons established in 2024
Decision to cover device arrives shortly after the launch of the ReWalk 7 Personal Exoskeleton, which was released for sales in the U.S. earlier this month
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 29, 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 a major U.S. health insurance company has approved the payment for a ReWalk 7 Personal Exoskeleton for one of its beneficiaries. This decision by one of the largest commercial health insurers in the U.S. marks the first approval for payment of the all-new ReWalk 7 Personal Exoskeleton for individuals with spinal cord injury (“SCI”), which was launched for U.S. sales on April 15, 2025.
“Expanding access for individuals with SCI to our ReWalk Personal Exoskeleton has been a key strategic initiative for Lifeward,” said Larry Jasinski, CEO of Lifeward. “Commercial health insurers cover a significant proportion of individuals with SCI in the U.S. The decision to cover this device demonstrates the momentum of our efforts to engage with more commercial health insurers and solidify a growth trajectory for the Company.”
In 2024, the Centers for Medicare & Medicaid Services (“CMS”) finalized a Medicare reimbursement pathway for personal exoskeleton use, which further expanded access to the ReWalk Exoskeleton for individuals living with SCI. Medicare beneficiaries make up approximately one-third of individuals living with SCI across the country.
“We believe this landmark decision by CMS establishes an important foundation for commercial health insurers to cover personal exoskeletons for their beneficiaries,” Jasinski added. “We will continue our efforts to expand commercial health insurance access to make the ReWalk a reality for more people with SCI.”
The ReWalk 7 is a personal exoskeleton device that helps paralyzed individuals to stand, walk, and ascend stairs and curbs in everyday environments for health and wellness after SCI. Lifeward launched sales of the ReWalk 7 earlier this month. The device received FDA clearance in March of this year. For more information on the ReWalk 7, 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; 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:
[email protected]
Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E:
[email protected]