Coverage for ReWalk Personal Exoskeleton Expands as Hungary Joins the U.S. and Germany with a Policy Providing Access to Exoskeletons

Rhea-AI Summary

Lifeward (Nasdaq: LFWD) announced that Hungary has established a new state insurance code providing coverage for ReWalk exoskeleton training for individuals with spinal cord injury. This decision follows research at Semmelweis University's Rehabilitation Clinic in Budapest, which studied the long-term therapeutic benefits of ReWalk Exoskeleton rehabilitation. Hungary joins Germany and the United States in providing coverage for exoskeletons. ReWalk is currently the only exoskeleton with both US FDA and EU CE/MDR certification that can be used at home. Hungary reports approximately 300 new cases of spinal cord injury annually.

Positive

• Expansion of insurance coverage to a new market (Hungary)
• ReWalk is the only exoskeleton with both US FDA and EU CE/MDR certification for home use
• Government-backed insurance coverage provides reliable payment pathway

Negative

• market size with only 300 new spinal cord injury cases annually in Hungary

Insights

Healthcare Policy Analyst

The expansion of exoskeleton coverage to Hungary represents a significant development in the medical device reimbursement landscape. With approximately 300 new spinal cord injury cases annually in Hungary, this policy creates a new revenue stream for Lifeward. The company now has coverage in three major markets: the U.S., Germany and Hungary. Most importantly, this policy validation could accelerate adoption in other European countries, creating a domino effect for market expansion. The state insurance coverage model, while case-by-case, establishes a precedent for other national healthcare systems. For investors, this demonstrates growing market acceptance and potential revenue growth, though the immediate financial impact may be modest given Hungary's market size relative to existing territories.

Medical Device Market Analyst

ReWalk's position as the only exoskeleton with both FDA and CE/MDR certification for home use creates a significant competitive advantage in the European market. This certification distinction, combined with the new Hungarian coverage policy, strengthens Lifeward's market leadership position. The company's strategy of pursuing coverage expansion through clinical research validation is proving effective, as demonstrated by Dr. Cserháti's research influence on policy decisions. While the Hungarian market alone isn't large enough to dramatically impact financials, it provides a valuable blueprint for entering other European markets and validates the product's medical necessity to other potential payers.

Research at the prestigious Semmelweis University, Budapest, Hungary has led the way in achieving government coverage in Hungary with a code for exoskeleton training that expands access to additional spinal cord injury centers

Case processing for individuals will be sponsored by the Hungarian State Insurance on a case-by-case basis

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MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Lifeward Ltd. (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market leader delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, today applauded the decision by the government of Hungary to establish a new state insurance code to provide coverage for exoskeleton training for individuals living with spinal cord injury.

This coverage policy follows research conducted by Dr. Péter Cserháti MD, PhD, Director of the Semmelweis University Rehabilitation Clinic in Budapest, Hungary, which examined the long-term therapeutic benefits of rehabilitation with the ReWalk Exoskeleton. "The active lifestyle achieved by exoskeletons has a proven positive effect on the prevention of potential health complications for those living with spinal cord injury," emphasized Dr. Cserháti. He reported that the ReWalk system has been available in Hungary since 2019 at the National Medical Rehabilitation Institute, the legal predecessor of Semmelweis University's Rehabilitation Clinic.

“The leadership of Hungary’s government, medical community and administrators has the potential to improve the lives of many of its citizens living with spinal cord injury. With this decision, access to exoskeletons has now been expanded to include Germany, the United States and Hungary, and these policies are essential drivers for our industry,” said Larry Jasinski, CEO of Lifeward. “Our ongoing strategic path is expansion of coverage by Private Insurers, Medicare Advantage and others in the United States and adding further contracts in Germany. We also encourage health care systems in other countries to follow Hungary’s progressive vision for the paralyzed community.”

Zoltán Vadászi, the business line manager of the national distributor Fototronic Kft., emphasized that ReWalk is currently the only exoskeleton that has both US and EU official certification (FDA, CE/MDR) and is also allowed to be used at home to ensure independent walking. There are about 300 new cases of spinal cord injury in Hungary annually.

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 MyoCycle FES System, and the ReStore Exo-Suit.

Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward product portfolio, please visit GoLifeward.com.

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, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements may include projections regarding Lifeward's future performance and future regulatory interactions 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 Lifeward’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements are more fully discussed in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described under the heading "Risk Factors" in the Company’s annual report on Form 10-K and 10-K/A for the year ended December 31, 2023 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, Lifeward 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
VP Marketing & New Business Development
Lifeward
E: media@golifeward.com

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

FAQ

What countries now provide insurance coverage for ReWalk exoskeletons (LFWD)?

As of November 2024, ReWalk exoskeletons are covered by insurance in the United States, Germany, and Hungary.

How many new spinal cord injury cases occur annually in Hungary where LFWD's ReWalk could be used?

Hungary reports approximately 300 new cases of spinal cord injury annually.

What certifications does ReWalk exoskeleton (LFWD) currently hold?

ReWalk is the only exoskeleton that has both US FDA certification and EU CE/MDR certification, and is approved for home use.