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Lifeward Enters Transformative Strategic Investment and Partnership Agreement with Oramed to Create a Diversified Biomedical Innovation Company
Globenewswire· 2026-01-13 13:00
Core Insights - Lifeward is positioning itself as a MedTech platform with a clear path to profitability and long-term Biotech potential through a strategic partnership with Oramed Pharmaceuticals [1][2] Investment and Financial Structure - Lifeward will receive up to $47 million in strategic investment from Oramed and another investor, which includes equity, convertible notes, milestone-based funding, and warrant coverage [2][14] - The investment structure aims to support Lifeward's journey to profitability while allowing for selective investments in high-value innovations [2] Technology Acquisition - Lifeward is acquiring Oramed's Protein Oral Delivery (POD™) technology, which targets the $600+ billion injectable drugs market, including the potential for ORMD-0801 to become the first commercialized oral insulin [1][3] - The POD™ technology is designed to transform injectable biological therapies into oral medications, addressing a significant market opportunity in diabetes and other metabolic diseases [3][10] Clinical Development and Management - Oramed will manage and fund the clinical development of the POD™ technology, allowing Lifeward to focus on profitability and cash generation while retaining exposure to biotech opportunities [4][8] - The POD™ technology has shown promise in clinical trials, with the lead drug candidate ORMD-0801 achieving significant results in reducing HbA1c levels [12] Strategic Goals and Diversification - The partnership with Oramed marks the beginning of Lifeward's broader diversification strategy across medical technology and biotechnology [5] - Lifeward aims to achieve sustainable profitability from existing FDA-approved products while building a balanced biomedical portfolio that combines near-term revenue with long-term biotech innovation [6][7]
Oramed and Lifeward Announce Strategic Transaction
Prnewswire· 2026-01-13 12:58
Core Viewpoint - The strategic transaction between Oramed Pharmaceuticals and Lifeward involves the transfer of Oramed's proprietary Protein Oral Drug (POD™) delivery technology to Lifeward, positioning Oramed as a significant shareholder with a 49.9% beneficial ownership interest in Lifeward [2][3][4] Transaction Overview - Oramed will transfer its POD™ technology to Lifeward, which will result in Oramed obtaining a 49.9% beneficial ownership interest in Lifeward, along with warrants [5][6] - Lifeward will issue $10 million in senior secured convertible notes in a private placement, with Oramed investing $9 million, and an additional milestone-based $10 million note, also with Oramed investing $9 million, both having 100% warrant coverage [2][14] Strategic Vision - The transaction is seen as a strategic evolution for Oramed, allowing it to maintain exposure to oral drug delivery innovation while participating in a medical robotics company poised for significant growth [3][4] - Lifeward's acquisition of the POD™ technology is expected to enhance its capabilities in advancing oral insulin programs and diversifying its biomedical innovation portfolio [4][6] Leadership and Management - Lifeward's leadership under President and CEO Mark Grant, who has over 25 years of experience in healthcare and medical technology, is expected to drive the advancement of the newly acquired oral drug delivery platform [4][6] - Oramed will manage the upcoming anticipated clinical trial related to the POD™ technology [3][7] Financial Performance - Lifeward's FDA-approved products, ReWalk® and AlterG®, generated $26 million in revenue over the last four quarters, indicating a solid financial foundation for the company [6]
Lifeward Appoints Bob Marshall as Chairman of the Board
Globenewswire· 2025-12-19 21:05
Core Insights - Lifeward Ltd. has appointed Bob Marshall as the new Chairman of the Board, effective January 1, 2026, succeeding Joseph Turk who is transitioning to a new role at Fresenius Medical Care [1][2] Company Overview - Lifeward is a global leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities [3] - The company designs, develops, and commercializes solutions for physical rehabilitation and recovery, with a mission to drive innovation for individuals with disabilities [3] - Lifeward's product portfolio includes the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System [3] - Founded in 2001, Lifeward operates in the United States, Israel, and Germany [3] Leadership Changes - Bob Marshall has been a member of Lifeward's Board and Chair of the Audit Committee since 2024, bringing financial leadership and healthcare expertise to the role [2] - Prior to joining Lifeward, Bob Marshall served as Chief Financial Officer and Treasurer of Lantheus Holdings since 2018 and held various positions at Zimmer Biomet Holdings [2]
Lifeward Expands International Distribution of its ReWalk® Personal Robotic Exoskeleton into Mexico, Thailand, and the United Arab Emirates
Globenewswire· 2025-12-17 13:00
Core Insights - Lifeward Ltd. has entered into a distribution agreement with Verita Neuro to expand access to the ReWalk Personal Exoskeleton for spinal cord injury patients, targeting a total addressable market of approximately $1.75 billion [1][3] Group 1: Distribution Agreement - The agreement allows Verita Neuro to be the exclusive distributor of ReWalk in Mexico, Thailand, and the UAE, leveraging its established international presence [1][3] - Verita Neuro has a database of over 25,000 spinal cord injury patients and a network of rehabilitation centers, enhancing the reach of ReWalk [2] Group 2: Commercial Strategy - Lifeward's hybrid commercial model combines direct sales in the U.S. with third-party distribution in select international markets, aiming for increased sales volumes while managing operating expenses [3] - The partnership with Verita Neuro is intended to integrate ReWalk into their multi-modal treatment methodologies, which include surgical neural stimulation and stem cell therapy [3][4] Group 3: Rehabilitation Approach - Verita Neuro will implement a new delivery model that includes intensive in-patient training and rehabilitation for ReWalk, differing from the traditional outpatient training [4] - This approach is expected to enhance clinical adoption of ReWalk in various rehabilitation settings globally [4]
事关机器人,美国政府或有新动作
Xin Lang Cai Jing· 2025-12-04 00:18
Core Viewpoint - The U.S. government is accelerating the development of robotics technology, leading to a significant rise in several robotics stocks, including Nauticus Robotics and iRobot, which both saw increases of over 60% [1][5]. Group 1: Stock Performance - Nauticus Robotics (KITT) rose by 61.92%, reaching a price of $1.1700 [2][4]. - iRobot (IRBT) increased by 61.28%, with a price of $3.145 [2][4]. - Other notable performers include Vicarious Surgical (RBOT) up 15.77%, Lifeward (LFWD) up 13.18%, Serve Robotics (SERV) up 10.87%, and Richtech Robotics (RR) up 10.12% [2][4]. Group 2: Government Initiatives - The U.S. Commerce Secretary has been meeting with various CEOs in the robotics industry, indicating a push for advancements in this sector [5]. - The government is considering an executive order on robotics technology to be announced next year, emphasizing the importance of robotics in bringing critical manufacturing back to the U.S. [3][5]. - A robotics task force is being prepared by the U.S. Department of Transportation, with an announcement expected by the end of the year [3][5]. Group 3: Industry Insights - Robotics is becoming a crucial area of international competition, with rising interest from U.S. lawmakers, including proposals for a national robotics committee [3][5]. - Advances in artificial intelligence are enabling humanoid robots to process large amounts of data and handle increasingly complex tasks, positioning robots as the "physical form" of AI [3][5]. - Industry leaders believe that investing in robotics can lead to greater efficiency for workers and potentially create more job opportunities, as companies that invest in robots are likely to invest in more employees as well [3][5].
事关机器人,美国政府或有新动作
财联社· 2025-12-04 00:14
Core Viewpoint - The article highlights a significant surge in robot-related stocks, driven by potential government initiatives to advance robotics technology in the U.S. [3][5] Group 1: Stock Performance - Several robotics stocks experienced substantial gains, with Nauticus Robotics and iRobot both rising over 60% [3][4]. - Nauticus Robotics (KITT) increased by 61.92% to $1.1700, while iRobot (IRBT) rose by 61.28% to $3.145 [4]. Group 2: Government Initiatives - The Trump administration is reportedly accelerating the development of robotics technology, with the Commerce Secretary meeting various CEOs in the robotics sector [5]. - There are plans for an executive order on robotics technology to be announced next year, indicating a strong governmental push in this area [5]. - The U.S. Department of Transportation is preparing to establish a robotics working group, potentially announced by the end of the year [5]. Group 3: Industry Implications - The growing interest in robotics is seen as a critical aspect of international competition, although it may conflict with the goal of reviving U.S. manufacturing jobs [5]. - Advances in artificial intelligence are enabling humanoid robots to process data more efficiently and take on complex tasks, positioning robots as the "physical form" of AI [5]. - Industry leaders emphasize the importance of a national robotics strategy to maintain competitiveness in the emerging sector [6].
Lifeward Broadens Reimbursement Coverage for ReWalk 7 Personal Robotic Exoskeleton as Humana Medicare Advantage Plan Issues Prior Authorization Approval
Globenewswire· 2025-12-03 13:00
Core Insights - Lifeward Ltd. has received prior authorization from Humana Medicare Advantage Plan for its ReWalk 7 Personal Exoskeleton, marking a significant step in expanding access to innovative medical technology for individuals with spinal cord injuries [1][2][3] - Humana and UnitedHealthcare, the two largest Medicare Advantage providers in the U.S., now account for 47% of all Medicare Advantage enrollees eligible for reimbursement for the ReWalk 7 [1][3] Company Developments - The approval from Humana is expected to enhance Lifeward's revenue and cash flow dynamics, providing a clearer foundation for scalable growth in the U.S. market [1][3] - Lifeward has been actively submitting claims for reimbursement under both traditional Medicare and Medicare Advantage Plans since the Centers for Medicare & Medicaid Services (CMS) implemented a formal reimbursement pathway for personal exoskeletons in 2024 [3] Industry Context - The approval of coverage for the ReWalk 7 under Humana's Medicare Advantage Plan reflects a broader trend of increasing acceptance of innovative medical technologies within the healthcare system [2][3] - Nearly half of all Medicare Advantage enrollees are now eligible for prior authorization and reimbursement for the ReWalk 7, indicating a growing recognition of the clinical and functional value of personal exoskeleton technology [3]
UnitedHealthcare Medicare Advantage Plan Issues Prior Authorization Approval for a ReWalk 7 Personal Exoskeleton
Globenewswire· 2025-11-17 13:00
Core Viewpoint - Lifeward Ltd. has received its first prior authorization from a UnitedHealthcare Medicare Advantage Plan for the ReWalk 7 Personal Exoskeleton, marking a significant step in expanding reimbursement pathways for advanced assistive technology for individuals with spinal cord injuries [1][2][3]. Company Summary - Lifeward is a global leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities, with a mission to drive innovation and deliver groundbreaking solutions [5]. - The company’s product portfolio includes the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, and it operates in the United States, Israel, and Germany [5]. Industry Summary - UnitedHealthcare's approval for the ReWalk 7 demonstrates a commitment to providing access to advanced assistive technology, enhancing mobility and quality of life for individuals with spinal cord injuries [2][3]. - The approval reflects a proactive approach in expanding reimbursement pathways, ensuring reliable access to personal exoskeletons as part of a comprehensive care strategy [3]. - The Centers for Medicare & Medicaid Services (CMS) implemented a reimbursement pathway for personal exoskeletons in 2024, leading to an acceleration in prior authorizations as payer adoption expands [4].
ReWalk(LFWD) - 2025 Q3 - Quarterly Report
2025-11-14 21:17
Financial Performance - Total revenues for the three months ended September 30, 2025, were $6,195,000, a slight increase from $6,128,000 in the same period of 2024, representing a growth of 1.1%[20] - Gross profit for the nine months ended September 30, 2025, was $7,340,000, compared to $6,372,000 for the same period in 2024, indicating an increase of 15.2%[20] - Operating loss for the three months ended September 30, 2025, was $3,140,000, slightly improved from a loss of $3,174,000 in the same period of 2024[20] - Net loss for the three months ended September 30, 2025, was $3,170,000, compared to a net loss of $3,084,000 for the same period in 2024, reflecting a 2.8% increase in losses[20] - For the nine months ended September 30, 2025, the company reported a net loss of $14.6 million, compared to a net loss of $13.7 million for the same period in 2024[24] - The company reported a net financial income of $8,000 for the nine months ended September 30, 2025, compared to $495,000 in 2024[94] - The company reported a net cash flow of $(4.748) million for the nine months ended September 30, 2025, compared to $(17.778) million for the same period in 2024[161] Assets and Liabilities - Total current assets decreased to $17,346,000 as of September 30, 2025, down from $21,294,000 as of December 31, 2024, a decline of 18.5%[16] - Total liabilities decreased to $10,413,000 as of September 30, 2025, compared to $11,638,000 as of December 31, 2024, a reduction of 10.5%[18] - Shareholders' equity as of September 30, 2025, was $12,755,000, down from $18,849,000 as of December 31, 2024, indicating a decrease of 32.5%[18] - The company’s cash and cash equivalents as of September 30, 2025, totaled $2.0 million, a decrease from $10.7 million at the end of the same period in 2024[29] - Trade receivables as of September 30, 2025, were $6,126,000, an increase from $6,004,000 as of December 31, 2024[51] - The company has non-cancelable purchase commitments amounting to approximately $7.5 million as of September 30, 2025[68] - The company has contractual obligations totaling $7.737 million as of September 30, 2025, with $7.490 million due within one year[166] Cash Flow and Financing - The negative operating cash flow for the nine months ended September 30, 2025, was $13.3 million, an improvement from $17.7 million for the same period in 2024[29] - The company raised approximately $8.4 million in net cash from financing activities during the nine months ended September 30, 2025, primarily from offerings in January and June 2025, and the ATM program[164] - The company sold 1,146,629 and 2,110,747 shares under the ATM program for total gross proceeds of approximately $0.7 million and $1.9 million, respectively, during the three and nine months ended September 30, 2025[155] - The company secured a $3.0 million loan from Oramed Ltd. to support ongoing operations and strategic initiatives[119] - As of September 30, 2025, the company had $3.0 million outstanding under a loan agreement with Oramed, secured by cash and accounts receivable[160] - The company anticipates continuing operating losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance of the financial statements[29] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $721,000, down from $998,000 in the same period of 2024, a decrease of 27.8%[20] - Research and development expenses for the three months ended September 30, 2025, decreased by $0.3 million, or 27.8%, to $0.7 million compared to the same period in 2024[128] - The company is in the research stage of the ReBoot device, which received Breakthrough Device Designation from the FDA in November 2021, although further investment has been paused pending clinical and commercial evaluations[107] Product and Market Development - The company completed the acquisition of AlterG, Inc. on August 11, 2023, which is now a wholly owned subsidiary and has been rebranded as LCAI[27] - The company has developed the ReStore Exo-Suit device, which began commercialization in June 2019, aimed at rehabilitation for individuals with lower limb disabilities[26] - The AlterG Anti-Gravity systems are utilized in over 4,000 facilities globally across more than 40 countries, enhancing the company's market presence[105] - The company received CE mark approval for the ReWalk 7 Personal Exoskeleton, enabling commercial sales in Europe, which currently represents approximately 40% of the company's exoskeleton sales[119] - The company finalized an agreement with BARMER in February 2025 to formalize the reimbursement process for the provision of ReWalk exoskeletons to eligible beneficiaries in Germany[114] Shareholder Information - The company issued 1,146,629 ordinary shares under at-the-market offerings, net of issuance costs of $44, resulting in an increase in additional paid-in capital[22] - The Company approved a one-for-seven reverse share split, reducing the number of outstanding ordinary shares from approximately 60.1 million to about 8.6 million[76] - As of September 30, 2025, the Company has a contingent liability to the IIA amounting to $1.6 million, with royalty payments contingent on actual sales[72] - The company has 8,486,475 warrants outstanding as of September 30, 2025, with various exercise prices ranging from $0.65 to $52.50[85] Compliance and Governance - The company received a deficiency letter from Nasdaq due to the closing bid price of its ordinary shares being below $1.00 for 30 consecutive business days, risking potential delisting if compliance is not re-achieved by February 2, 2026[150] - Certifications of the Principal Executive Officer and Principal Financial Officer were filed in accordance with the Sarbanes-Oxley Act[190] - The report was signed by the President and Chief Executive Officer, William Mark Grant, and the Chief Financial Officer, Almog Adar, on November 14, 2025[190]
Iberia eyes 25% more Brazil capacity in 2026, boosted by Airbus jets
Reuters· 2025-11-14 16:30
Core Insights - Spanish airline Iberia plans to significantly expand its operations in Brazil for the second consecutive year in 2026, driven by the introduction of new Airbus jets [1] Company Expansion Plans - Iberia aims to open more routes in Brazil, capitalizing on the growth potential in Latin America's large market [1]