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% of total revenue for the year ended December 31, 2023, with 42 units placed under their policy[50] - The geographical breakdown of revenue shows significant growth in the U.S. market, increasing from $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]

Core Insights - ReWalk Robotics Ltd. has officially rebranded as Lifeward, reflecting its commitment to innovative technology aimed at empowering individuals with physical limitations or disabilities [1][2] - The rebranding includes a new name, stock ticker (LFWD), logo, and website launch, showcasing a full portfolio of life-changing solutions [1][2] Company Overview - Lifeward designs, develops, and commercializes solutions that span the continuum of care in physical rehabilitation and recovery, delivering functional and health benefits in clinical and community settings [4] - The company's mission is to drive innovation to change the lives of individuals with physical limitations or disabilities, offering products like the ReWalk Exoskeleton, AlterG Anti-Gravity systems, ReStore Exo-Suit, and MyoCycle FES systems [4] Strategic Goals - The transformation into Lifeward aims to elevate the standard of care for individuals overcoming physical limitations, with a unified commercial team to better support customers across the rehabilitation spectrum [2] - The company believes that the rebranding will drive growth through improved customer support and a comprehensive portfolio of innovative solutions [2]

MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILLIT, Israel, Jan. 12, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (NASDAQ:RWLK) ("ReWalk" or the "Company"), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, announced today that the Company is expanding its direct sales coverage to Canada. This expansion occurs as the result of the integration between the former ReWalk and AlterG commercial teams follow ...

MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILIT, Israel, Jan. 11, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (NASDAQ:RWLK) ("ReWalk" or the "Company") announced that Larry Jasinski, Chief Executive Officer, and Mike Lawless, Chief Financial Officer, will provide an overview presentation and host one-on-one meetings with investors at the Sidoti January Virtual Investor Conference, taking place on January 17-18, 2024. The presentation will begin at 2:30 PM EST on January 17, 2024 and can be accessed live he ...

MARLBOROUGH, Mass. and BERLIN and YOKNEAM ILIT, Israel, Jan. 11, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”) announced that Larry Jasinski, Chief Executive Officer, and Mike Lawless, Chief Financial Officer, will provide an overview presentation and host one-on-one meetings with investors at the Sidoti January Virtual Investor Conference, taking place on January 17-18, 2024. The presentation will begin at 2:30 PM EST on January 17, 2024 and can be accessed live h ...

ReWalk Robotics Ltd. (NASDAQ:RWLK) Q3 2023 Earnings Conference Call November 14, 2023 8:30 AM ET Company Participants Mike Lawless - Chief Financial Officer Larry Jasinski - Chief Executive Officer Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Operator Hello, and welcome to the Q3 2023 ReWalk Robotics Ltd. Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation there will be an opportunity to ask questions. [Operator ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Israel Not applicable (State or other juris ...

ReWalk Robotics Ltd. (NASDAQ:RWLK) Q2 2023 Earnings Conference Call August 11, 2023 8:30 AM ET Company Participants Mike Lawless - CFO Larry Jasinski - CEO Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Operator Hello, and welcome to the Q2 2023 ReWalk Robotics Ltd. Earnings Conference Call. [Operator Instructions] Please note today's event is being recorded. I'd now like to turn the conference over to Mike Lawless, Chief Financial Officer. Please go ahead, sir. Mike Lawless Thank you ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Israel Not applicable | --- | --- | |----------- ...

ReWalk Robotics Investor Presentation May 2023 NASDAQ:RWLK 1 Confidential –ReWalk Robotics 2023 Forward Looking Statements ...