ReWalk(RWLK) - 2023 Q4 - Annual Report

Acquisition and Product Development - The company acquired AlterG, Inc. on August 11, 2023, enhancing its product offerings in physical and neurological rehabilitation with Anti-Gravity systems utilized in over 4,000 facilities globally[23] - The ReBoot personal soft exo-suit is in the research stage, aimed at post-stroke rehabilitation, and received Breakthrough Device Designation from the FDA in November 2021[24] - The company is currently offering its 6th generation ReWalk Personal Exoskeleton and is in research and development for the 7th generation device[36] - The company is working on product design improvements for the ReWalk Personal Exoskeleton, with plans to launch following regulatory clearance[94] - A new model of the AlterG system is planned for mid-2024, aimed at reducing manufacturing costs to make it more affordable for rehabilitation clinics[95] - The company has entered into a research collaboration with Harvard to develop lightweight soft suit exoskeleton technologies for lower limb disabilities[98] Regulatory Approvals and Reimbursement - On November 1, 2023, CMS confirmed that personal exoskeletons will be included in the Medicare brace benefit category starting January 1, 2024[29] - CMS proposed a preliminary payment determination of $94,617 for the ReWalk Personal Exoskeleton under HCPCS code K1007, reflecting the unique features of the technology[30] - The ReWalk Personal Exoskeleton received FDA clearance for use on stairs and curbs in March 2023, expanding its usability in real-world environments[34] - The ReWalk Personal Exoskeleton is included in the Medicare brace benefit category, with claims to be billed using HCPCS code K1007 starting January 1, 2024[54] - A preliminary payment determination of$94,617 for the ReWalk Personal Exoskeleton was proposed by CMS, effective from April 1, 2024[55] - The GKV-Spitzenverband confirmed the listing of the ReWalk Personal Exoskeleton in the German MDD, allowing for reimbursement on a case-by-case basis[59] Market and Financial Performance - Record annual revenue for 2023 was $13.9 million, compared to$5.5 million in 2022, an increase of 151%[169] - Revenue based on customer location for 2023: United States $7.636 million, Europe$5.044 million, Asia-Pacific $0.387 million, Rest of the world$0.787 million[164] - Cash position remained strong with $28.1 million as of December 31, 2023, with no debt[169] - The VHA accounted for 12$2.303 million in 2022 to $7.636 million in 2023[164] Clinical and Community Engagement - The company has established relationships with clinics and rehabilitation centers, professional sports teams, and organizations in the SCI community to enhance product distribution[25] - The company actively engages with the spinal cord injury community to promote the adoption of exoskeleton technology through partnerships and education[91] - The company recognizes the need for further clinical evidence and education to accelerate the adoption of the ReStore soft exosuit in stroke therapy programs[79] - The Stride Smart software provides real-time data analytics for clinicians, focusing on five key performance indicators to enhance rehabilitation[68] Challenges and Compliance - The company must navigate complex compliance efforts due to varying state and federal laws regarding healthcare privacy and security[135] - The commercial success of the company's product candidates will depend on governmental payor programs, including Medicare and Medicaid, providing adequate coverage and reimbursement levels[138] - The company faces potential penalties and enforcement actions if found in violation of healthcare laws, which could adversely affect operations and results[137] - Future healthcare reform measures could limit government payments for healthcare products, impacting coverage and demand for the company's products[150] Research and Development Funding - The company has received$2.6 million in funding from the Israel Innovation Authority for research and development efforts through December 31, 2023[96] - The Human Robot Interaction Consortium has allocated NIS 1.745 million for ReWalk-specific projects over the first 18-month period, with an additional NIS 1.336 million for the second 18-month period[96] Product Features and Market Potential - The ReWalk Personal Exoskeleton is designed for daily use and consists of a battery-powered wearable exoskeleton with integrated motors and sensors for user-controlled movement[34] - The ReStore soft exo-suit device offers competitive advantages such as a design that supports natural walking patterns and is lighter and less expensive than rigid exoskeletons[89] - The ReStore system targets a market of approximately 800,000 stroke incidences annually in the U.S., with 80% of survivors facing lower limb disabilities[79] - The ReBoot product, a soft exoskeleton for home use, has an estimated market of approximately 400,000 annual stroke patients requiring walking assistance[81] Global Operations and Compliance - The company has distribution agreements in several European countries, successfully achieving reimbursement policies, such as the one established in Italy for exoskeleton systems[64] - The company must navigate various foreign regulations for clinical trials and marketing, which can vary significantly by country[128] - Following Brexit, the UK has established its own medical device regulations, requiring compliance with the Medical Devices Regulations 2002[127] - The company has received a Notified Body Certificate of Conformity under the MDD for all ReWalk systems, allowing continued marketing in the EU during the transition period[126]