Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market

Rhea-AI Summary

Lifeward (NASDAQ: LFWD) has launched the ReWalk 7 Personal Exoskeleton in the U.S. market, following FDA clearance in March 2025. This seventh-generation exoskeleton for individuals with spinal cord injury (SCI) features significant improvements including:

• Customizable walking speeds for indoor/outdoor environments
• Crutch Control system for enhanced user control
• Wrist Control smartwatch and MyReWalk mobile app integration
• Improved battery life and seamless stairs/curbs navigation
• New therapist handheld device for training

The development involved extensive testing with dozens of end users and physical therapists. This launch follows two major milestones: the 2023 addition of stairs and curbs navigation capability to ReWalk 6.0, and the 2024 establishment of a Medicare reimbursement pathway by CMS for personal exoskeletons.

Positive

• FDA clearance received for ReWalk 7 in March 2025
• Medicare reimbursement pathway established in 2024, expanding market access
• Significant technological improvements enhancing product functionality
• Successful completion of extensive user testing

Negative

• None.

Insights

Medical Device Specialist

Lifeward's launch of the ReWalk 7 exoskeleton represents a significant product advancement in the specialized medical mobility device market. The seventh generation introduces critical user experience improvements addressing key barriers to adoption that have historically exoskeleton technology penetration.

The integration of cloud connectivity, customizable walking speeds, and enhanced control mechanisms directly responds to real-world usability challenges faced by individuals with spinal cord injuries. Particularly notable is the crutch control feature that puts operation at users' fingertips, which substantially enhances independence - a crucial factor for medical device adoption in home settings.

The 2024 CMS reimbursement pathway establishment is particularly consequential for commercialization prospects. Medicare coverage typically serves as a benchmark for private insurers, potentially triggering broader reimbursement adoption across the healthcare system. This regulatory/reimbursement progress, combined with the technological improvements, forms a potent commercial catalyst.

From a market development perspective, Lifeward's methodical approach to incrementally improving core mobility features while addressing practical usage barriers shows a mature product development strategy. The company's market cap of just $15.3 million suggests significant growth potential if the ReWalk 7 accelerates adoption through its improved feature set and broader insurance coverage.

Healthcare Finance Analyst

The ReWalk 7 launch timing is strategically aligned with the recently established Medicare reimbursement pathway for personal exoskeletons, creating a potential inflection point for Lifeward's revenue model. With a modest $15.3 million market capitalization, this product launch could materially impact financial performance if adoption accelerates.

The Medicare reimbursement pathway secured in 2024 is the critical enabling factor. Historically, advanced mobility devices faced commercial challenges despite technological capabilities due to their high cost and insurance coverage. The CMS pathway fundamentally alters the accessibility equation, potentially converting medical necessity into billable procedures.

The product improvements focus intelligently on enhancing user control and simplifying therapist training - both factors that could accelerate prescription rates and reduce abandonment. The digital connectivity features also create opportunities for usage data collection, which could strengthen future reimbursement negotiations with evidence of therapeutic benefit.

Investors should recognize that specialized medical device markets typically experience adoption curves rather than immediate sales spikes. However, the convergence of improved usability, FDA clearance, and established reimbursement channels positions Lifeward to potentially capture increased market share in the specialized exoskeleton segment. For a micro-cap company, successful commercialization of ReWalk 7 could drive significant percentage growth relative to the current valuation.

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 15, 2025 (GLOBE NEWSWIRE) -- Seventh generation of industry-leading personal exoskeleton is now available nationwide for individuals with spinal cord injury

New and improved features streamline user experience for greater control, engagement, and confidence during walking in everyday environments

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, today announced the U.S. national launch of the ReWalk 7 Personal Exoskeleton, the next generation of its groundbreaking personal exoskeleton technology. The Company will now begin sales of ReWalk 7, which includes innovative new and enhanced features such as cloud connectivity and customizable walking speeds, to provide a more functional and personalized walking experience for individuals with spinal cord injury (“SCI”).

“The ReWalk 7 was developed over several years, integrating advanced technological innovations with feedback from clinicians and patients to build upon the ReWalk’s world-class reputation for industry leadership,” said Larry Jasinski, CEO of Lifeward. “The result is a device that is optimized for real-world use, with an unmatched user experience and freedom of movement. We are thrilled to be able to provide paralyzed individuals across the country with a new option for integrating walking to everyday life.”

As part of the FDA clearance process, Lifeward worked with more than two dozen end users and physical therapists, respectively, to gather critical feedback on the impact of the device in both the rehabilitative and real-world settings.

“The feedback we received from clinicians and ReWalkers was invaluable,” said Jill Butler, PT, DPT, NCS, Director of Clinical Development for Lifeward and the Primary Investigator for usability testing. “Therapists felt that the handheld device will make training sessions much easier and more efficient, and ReWalk users were excited about the enhanced level of confidence and control they felt using the new crutch control unit. This feedback helped us to optimize the ReWalk to maximize success in real-world environments.”

Advancements of the ReWalk 7 include:

• Smoother Movement: Users can select from two customizable walking speeds, allowing for seamless transitions between indoor and outdoor walking environments.
• More Control: Crutch Control puts device control at the user's fingertips, allowing them to stand, walk, select speeds, and stop—all at the touch of a button.
• Smarter Walking: New Wrist Control smartwatch and MyReWalk mobile app make it easy for users to select operation modes, set goals and track their usage.
• More Accessibility: Users have the freedom to walk longer and more often with an improved battery and seamless activation of stairs and curbs.
• Improved Training: The all-new therapist handheld device and click-to-stop control allows for safer, more effective progression to optimal gait patterns.
  

The ReWalk 7 received FDA clearance in March 2025, building upon two other recent major advancements in technology and market access for the ReWalk product line. First, in 2023, Lifeward added the innovative capability for the ReWalk 6.0 system to allow users to navigate stairs and curbs, thereby enabling users’ access to a wider array of everyday environments. Second, in 2024, the Centers for Medicare & Medicaid Services (“CMS”) finalized a Medicare reimbursement pathway for personal exoskeleton use, further expanding access to the ReWalk Exoskeleton for more individuals living with SCI.

The ReWalk 7 is now available for purchase in the U.S. for personal use, as well as in the clinical setting. For more information, 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/452674c1-bcb0-484a-8e7e-ba17743c58e8

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d9622082-7def-44a6-8f30-195c9afe4f5b

This press release was published by a CLEAR® Verified individual.

FAQ

What new features does the ReWalk 7 exoskeleton (LFWD) offer compared to previous versions?

ReWalk 7 offers customizable walking speeds, finger-tip crutch control, smartwatch integration, improved battery life, stairs/curbs navigation, and enhanced therapist controls.

When did Lifeward (LFWD) receive FDA clearance for ReWalk 7?

Lifeward received FDA clearance for ReWalk 7 in March 2025.

Does Medicare cover the ReWalk 7 exoskeleton (LFWD)?

Yes, CMS established a Medicare reimbursement pathway for personal exoskeletons in 2024.

What improvements were made to ReWalk 6.0 (LFWD) in 2023?

In 2023, Lifeward added the capability for ReWalk 6.0 to navigate stairs and curbs.

How was the ReWalk 7 (LFWD) tested before launch?

The device was tested with over two dozen end users and physical therapists to gather feedback in both rehabilitative and real-world settings.