Acquisition and Market Strategy - The company acquired AlterG for approximately 19million,withpotentialadditionalpaymentsbasedonrevenuegrowthoverthenexttwoyears[34]−ThecompanyhasceasedsalesoftheReStoreExo−SuitintheEUasofMay2024,indicatingastrategicshiftinmarketfocus[33]−ThecompanyisworkingtosecureformaloperatingcontractswithadditionalSHIstoestablishprocessesforobtainingReWalkexoskeletonsforbeneficiaries[42]−ThecompanyhasdistributionagreementsinseveralEuropeancountries,withongoingeffortstosecurebroaderreimbursementcoveragefromvariousinsurers[69]−ThecompanyhasrebrandedunderthenameLifewardtoemphasizeitscommitmenttoinnovativetechnologiesforrehabilitation[92]ProductDevelopmentandRegulatoryCompliance−ThecompanyisintheresearchstageoftheReBootdevice,whichreceivedBreakthroughDeviceDesignationfromtheFDA,butfurtherinvestmentiscurrentlyonhold[36]−Thecompanyhassubmittedapremarketnotificationforits7thgenerationReWalkdesign,currentlypendingFDAreview[48]−ThecompanyisworkingonproductdesignimprovementsandexpandedlabelingfortheReWalkPersonalExoskeleton,withplanstolaunchfollowingregulatoryclearance[106]−ThecompanyiscurrentlyreviewingitsapplicationforMDRassessmentoftheReWalk7PersonalExoskeleton,submittedinAugust2024[139]−ThecompanyhasreceivedaNotifiedBodyCertificateofConformityunderthepreviousMedicalDevicesDirective(MDD)foritsReWalksystems,allowingcontinuedmarketpresenceintheEUduringthetransitiontothenewMedicalDevicesRegulation(MDR)[139]MarketOpportunitiesandCoverage−Approximately5791,032 as per the revised DMEPOS Fee Schedule by CMS[67] - In Germany, agreements with various SHIs, including BARMER and DGUV, have been formalized to provide coverage for ReWalk exoskeletons to eligible users[42] - As of February 2025, approximately 45% of the 70 million people in Germany covered by Statutory Health Insurance have defined reimbursement processes for personal exoskeletons[71] - The VHA accounted for 4.5% of total revenue for the year ended December 31, 2024, with 49 units placed under the VHA policy[60] Financial Performance - Total revenue for 2024 reached 25.663million,a85.513.854 million in 2023[181] - Revenue from the United States was 14.425millionin2024,up89.57.636 million in 2023[181] - Revenue from Europe increased to 9.546millionin2024,a89.15.044 million in 2023[181] - The company had 80 employees as of December 31, 2024, with the majority engaged in sales and marketing activities[177] Research and Development - The company continues to support clinical research and academic publications to strengthen the case for insurance coverage of its products[70] - The ReStore Exo-Suit technology was developed in collaboration with Harvard University, focusing on improving walking for stroke survivors[85] - The stroke incidence rate in the United States is approximately 800,000 per year, with 80% of survivors experiencing some form of lower limb disability, creating a significant market for ReStore[89] - The AlterG Anti-Gravity system is designed to support rehabilitation for lower extremity injuries, with a potential market of approximately 1,180 certified inpatient rehabilitation facilities in the U.S.[81] Legal and Regulatory Risks - The civil False Claims Act (FCA) can impose treble damages and civil penalties for false claims, potentially aggregating into millions of dollars[145] - The company may face penalties for violations of healthcare laws, including exclusion from federal healthcare programs and significant civil monetary penalties[152] - The commercial success of product candidates depends on adequate coverage and reimbursement from governmental and private payors[154] - Government authorities and third-party payors are increasingly regulating the price of medical products, leading to lower average selling prices[156] Manufacturing and Supply Chain - The company relies on Sanmina Corporation and Cirtronics Corporation for manufacturing, with contracts allowing termination under specific conditions[172][173] - The company has not experienced significant volatility in component prices, although temporary increases were noted during the COVID-19 pandemic[175] Innovation and Patents - The company holds 12 issued patents in the United States and 24 issued patents outside the United States for its ReWalk product line as of December 31, 2024[117] - The company has 28 issued patents in the United States and 9 issued patents outside the United States for its DAP and AlterG technology as of December 31, 2024[117] Employee and Organizational Commitment - The company maintains a commitment to diversity and inclusion across its organizational structure[180]
