First Major U.S. Commercial Health Insurer Approves Purchase of ReWalk 7 Personal Exoskeleton

Rhea-AI Summary

Lifeward announced a significant milestone as the first major U.S. commercial health insurer approves coverage for the ReWalk 7 Personal Exoskeleton. This breakthrough follows the device's U.S. sales launch in April 2025 and its FDA clearance in March 2025.

The ReWalk 7 enables individuals with spinal cord injury (SCI) to stand, walk, and navigate stairs in everyday environments. This approval builds on the 2024 Medicare reimbursement pathway established by CMS, which covers approximately one-third of SCI individuals nationwide.

CEO Larry Jasinski emphasized this development as crucial for market expansion, noting that commercial insurers cover a significant portion of SCI individuals. The company views this approval as momentum for engaging more commercial insurers and strengthening growth prospects.

Positive

• First major U.S. commercial health insurer approval for ReWalk 7 device, opening new revenue stream
• Recent FDA clearance and commercial launch of ReWalk 7 in April 2025
• Medicare reimbursement pathway established in 2024, covering approximately one-third of SCI market
• Strategic expansion into commercial insurance market following Medicare coverage

Negative

• Only single patient approval so far, not yet a broad coverage policy
• Market penetration still in early stages with uncertain adoption rate

Insights

Medical Device Market Specialist

Lifeward secures first commercial insurance approval for ReWalk 7 exoskeleton, expanding reimbursement beyond Medicare to commercial insurance beneficiaries.

The approval of ReWalk 7 Personal Exoskeleton payment by a major U.S. commercial insurer marks a significant milestone in Lifeward's commercialization strategy. While covering only one beneficiary, it establishes a crucial precedent following the Medicare reimbursement pathway from 2024. Together, these developments address payment for a substantial portion of spinal cord injury (SCI) patients - with Medicare covering approximately one-third of individuals with SCI and commercial insurers covering another significant segment.

Reimbursement is typically the critical gating factor for adoption of advanced medical technologies, particularly for specialized devices like exoskeletons. The timing is strategically significant, coming shortly after both FDA clearance (March 2025) and the U.S. commercial launch (April 15, 2025), showing effective coordination of regulatory, commercial, and reimbursement strategies.

For medical device companies, establishing both public and private insurance coverage significantly improves commercial outlook. This first commercial approval represents an early but important step that could lead to broader coverage policies, though the evolution from individual approvals to formal coverage determinations typically progresses gradually.

Healthcare Financial Analyst

Commercial insurance approval creates path to revenue growth by removing critical adoption barrier following Medicare reimbursement pathway established in 2024.

The commercial insurance approval for Lifeward's ReWalk 7 Personal Exoskeleton represents a potentially significant revenue catalyst. This follows the Medicare reimbursement pathway established in 2024, creating a more comprehensive payment foundation that addresses both public and private insurance beneficiaries with spinal cord injuries (SCI).

Reimbursement approval is particularly critical for specialized medical devices, as it removes a major barrier to adoption. While this announcement concerns only a single patient approval rather than a formal coverage policy, it establishes an important precedent that often precedes broader coverage determinations.

The approval's timing - shortly after FDA clearance and commercial launch - is strategically advantageous, potentially shortening the typically lengthy gap between regulatory approval and commercial traction. For Lifeward, successfully establishing both Medicare and commercial insurance pathways suggests effective execution on the reimbursement front, which is often the most challenging aspect of medical device commercialization beyond regulatory approval.

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: media@golifeward.com

Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E: ir@golifeward.com

FAQ

How will ReWalk 7's insurance approval impact LFWD stock growth potential?

The first major U.S. commercial health insurer's approval to cover ReWalk 7 signals significant market expansion potential for LFWD, following Medicare's 2024 reimbursement pathway establishment. This opens access to a large portion of SCI patients covered by commercial insurance.

What is the market size for ReWalk 7 after the April 2025 insurance approval?

The market includes Medicare beneficiaries (approximately one-third of SCI individuals in the U.S.) plus patients covered by commercial health insurance, representing a significant expansion from the previous market following the first major insurer's approval.

When did ReWalk 7 receive FDA clearance and launch in the US market?

ReWalk 7 received FDA clearance in March 2025 and was launched for U.S. sales on April 15, 2025, with the first commercial insurance approval following shortly after.

What capabilities does the ReWalk 7 exoskeleton offer SCI patients?

ReWalk 7 enables paralyzed individuals to stand, walk, and ascend stairs and curbs in everyday environments, designed for health and wellness after spinal cord injury.

How does Medicare's 2024 coverage decision affect ReWalk 7's commercial adoption?

Medicare's 2024 reimbursement pathway for personal exoskeletons establishes a foundation for commercial insurers to follow suit, potentially accelerating market adoption of ReWalk 7.