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MARLBOROUGH, Mass. - Lifeward Ltd. (NASDAQ:LFWD), a pioneer in medical technologies for individuals with disabilities, has announced the FDA’s 510(k) clearance for its latest ReWalk 7 exoskeleton. This wearable device enables people with spinal cord injuries to stand and walk, marking a significant advancement in assistive technology. According to InvestingPro data, the company has demonstrated impressive revenue growth of 85% over the last twelve months, while maintaining a healthy balance sheet with more cash than debt.
The ReWalk 7’s approval follows a series of developments, including the FDA’s clearance of the ReWalk 6.0 for navigating stairs and curbs in 2023 and the establishment of a national reimbursement policy by the Centers for Medicare & Medicaid Services in 2024. Lifeward has been at the forefront of exoskeleton innovation since 2014, when it became the first company to receive FDA clearance for such a device.
CEO Larry Jasinski expressed the company’s commitment to enhancing the quality of life for individuals with spinal cord injuries through continuous innovation. The ReWalk 7, with its new features and improvements, represents Lifeward’s dedication to this mission. InvestingPro analysis suggests the stock is currently trading below its Fair Value, with a strong current ratio of 2.08 indicating solid short-term financial stability.
Sales of the ReWalk 7 in the United States are set to commence as soon as the product becomes available. Lifeward’s portfolio includes a range of products designed for rehabilitation and recovery, such as the AlterG Anti-Gravity System, the ReStore Exo-Suit, and the MyoCycle FES System, operating across the United States, Israel, and Germany. For deeper insights into Lifeward’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks with expert analysis and actionable intelligence.
The forward-looking statements included in Lifeward’s press release reflect the company’s aspirations and are subject to risks, uncertainties, and changes that could affect actual outcomes. Factors such as clinical trial results, market acceptance, reimbursement policies, production processes, and regulatory compliance play a significant role in the company’s future.
This news is based on a press release statement from Lifeward Ltd. and does not include any speculative or promotional content. The information provided is intended to offer an unbiased, factual report on the latest developments concerning Lifeward’s ReWalk 7 exoskeleton and its FDA clearance.
In other recent news, Lifeward announced its fourth-quarter 2024 financial results, revealing a revenue of $7.5 million, which marked a 23% increase from the previous quarter but fell short of the anticipated $10.3 million. The company’s earnings per share (EPS) were reported at -$0.38, missing the forecast of -$0.19. Lifeward’s full-year 2024 revenue reached $25.7 million, representing an 85% increase year-over-year. H.C. Wainwright maintained a Buy rating for Lifeward with a $13 price target, expressing confidence in the company’s future growth prospects, particularly with its AlterG product line.
Lifeward is focusing on expanding the market reach of its ReWalk Personal product, targeting coverage by the Centers for Medicare & Medicaid Services, workers’ compensation insurance, and U.S. commercial insurers. The company anticipates FDA clearance for its 7th generation ReWalk in the first half of 2025, which could bolster future growth. Additionally, Lifeward plans to reduce operating expenses and target sustainable growth in 2025, projecting revenue between $28 million and $30 million. The company also aims to achieve an adjusted gross margin of 47-49% for the upcoming year.
Despite the recent earnings miss, Lifeward remains optimistic about its growth strategy, with over 110 ReWalk cases under evaluation for deployment in the U.S. and 44 cases in Germany. The company’s AlterG product concluded 2024 with a backlog of 25 systems, expected to be placed in the first half of 2025. Lifeward’s management is committed to improving reimbursement times and reducing operating losses, aiming for a Q4 2025 operating loss of no more than $1 million.
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