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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): April 28, 2023
 
ReWalk Robotics Ltd.
(Exact name of registrant as specified in its charter)
  
Israel
001-36612
Not applicable
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
 
 
 
3 Hatnufa St., Floor 6, Yokneam Ilit, Israel
 
2069203
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: +972.4.959.0123
  
Not applicable
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
 ☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
  
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Ordinary Shares, par value NIS 0.25
 
RWLK
 
Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
  
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

Item 7.01          Regulation FD Disclosure.
 
On April 28, 2023, ReWalk Robotics Ltd. (the “Company”) posted to the “Investors” section of its website an investor presentation slideshow (the “Presentation”), which is furnished herewith as Exhibit 99.1. The Company intends to use the Presentation from time to time in making presentations to analysts, potential investors, and other interested parties.
 
The information in this Current Report on Form 8-K, including Exhibit 99.1 (this “Report”), shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “1934 Act”), nor shall it be deemed “incorporated by reference” into any filing under the Securities Act of 1933, as amended, or the 1934 Act, except as may be expressly set forth by specific reference in such filing. Information contained on, or that can be accessed through, the Company’s website does not constitute a part of, and is not incorporated by reference into, this Report.
 
Item 9.01          Financial Statements and Exhibits.
 
(d)
 
99.1 Investor presentation.*
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

*         Furnished herewith

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
ReWalk Robotics Ltd.
 
Dated: April 28, 2023
By:
/s/ Michael Lawless
 
Name:
Michael Lawless
 
Title:
Chief Financial Officer

Exhibit 99.1

 ReWalk Robotics  Investor Presentation  April 2023  Confidential – ReWalk Robotics 2023  NASDAQ:RWLK 
 
 Forward Looking Statements  This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. All statements contained in this presentation other than statements of historical fact are forward-looking statements. Such forward-looking statements may include projections regarding ReWalk's future performance and, in some cases, may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "should," "would," "seek," and similar terms or phrases. The forward-looking statements contained in this presentation are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk's control. Important factors that could cause ReWalk's actual results to differ materially from those indicated in the forward-looking statements are more fully described in ReWalk’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled "Risk Factors" in ReWalk's annual and quarterly reports that ReWalk files with the SEC.   In addition, this presentation contains estimates, projections and other information concerning market, industry and other data. ReWalk obtained this data from its own internal estimates and research and from academic and industry research, publications, surveys, and studies conducted by third parties, including governmental agencies. These data involve a number of assumptions and limitations, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed in ReWalk’s filings with the SEC. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by ReWalk. While management believes such information is generally reliable, ReWalk has not independently verified any third-party information.  Forward-looking statements made in this presentation are based on a combination of facts and factors currently known to management and speak only as of the date hereof. Factors or events that could cause ReWalk's actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.  Confidential – ReWalk Robotics 2023 
 
 Advancing Quality of Life After Neurological Injury or Disability  Confidential – ReWalk Robotics 2023  ReWalk Robotics Mission:  To fundamentally improve the quality of life for individuals with neurological injury or disability through innovative technologies that enable mobility and wellness in rehabilitation and daily life.  YouTube Link:   youtu.be/UwIUJaYJ3iM 
 
 Neurologic disease or injury, including spinal cord injury (“SCI”) or stroke, historically results in a lifetime of disability and chronic health complications from a sedentary lifestyle.  ReWalk Robotics provides solutions that leverage robotics and biomechanics to facilitate neurorehabilitation in the clinic and at home, profoundly restoring functional mobility for patients otherwise highly limited in their day-to-day lives.  Getting People Back to Doing What They Love  Confidential – ReWalk Robotics 2023 
 
 Strategic catalysts in 2023   FDA approval of stairs / curb capability  CMS approval for Medicare reimbursement of exoskeletons  FDA approval of next-generation of exoskeleton  Consolidation activity through strategic acquisitions   Market-leading innovation – First-to-market personal exoskeleton for spinal cord injury, with over 600 placements worldwide  Large and growing market opportunity – $1.1 billion market forecast to grow 8% annually  Strong cash position – Resources to fund organic growth, M&A, and internal development  Strategic vision – Leverage leadership position in exoskeletons to become consolidator of broad portfolio of high-value NeuroRehabilitation solutions  Experienced management – Multi-disciplinary leadership with successful track records in medical technology, life science tools, and biopharmaceuticals  A Leader in NeuroRehabilitation Solutions  Confidential – ReWalk Robotics 2023 
 
 A History of Innovation  Confidential – ReWalk Robotics 2023  ReWalk Robotics has consistently pioneered   NeuroRehabilitation solutions as standard of care  2014  2015  2019  2020  2021  2022  2023  …establish exoskeleton SOP with the Dept. of Veterans Affairs  …establish HCPCS code for exoskeletons with Medicare  …submit claim for Medicare coverage for personal exoskeleton use at home and in the community   First to:  …market exoskeleton with de novo FDA approval  …establish exoskeletons within the Medical Device Directory in Germany   …introduce soft-suit technology with the ReStore exo-suit for stroke rehabilitation  …achieve two separate FDA Breakthrough Device Designations for next-gen. exoskeletons and exo-suits  …earn FDA clearance of personal exoskeleton for use on stairs and curbs 
 
 NeuroRehabilitation Market is Sizeable and Growing  Confidential – ReWalk Robotics 2023  NeuroRehabilitation Equipment Market1  $ in billions  CAGR of 8.3%  NeuroRehabilitation Equipment Market by Product Type1  Neurorehabilitation: The rehabilitation and management of patients with diseases, injury, or disorders of the nervous system. Primary goals are to improve function, reduce symptoms, and improve the well-being of the patient. 
 
 NeuroRehabilitation: Growing Market Opportunities  Confidential – ReWalk Robotics 2023  Market tailwinds that ReWalk will leverage:  Technological advances. Continued innovation and efficiency improvements in robotics, sensors, power systems  Market adoption. Introduction of VR & app-based patient services likely to increase patient adherence and improve outcomes  Aging demographics. WHO forecasts proportion of age 65+ will grow from 7% (2000) to 16% (2050)  Industry headwinds that create opportunity:   Market access. ReWalk Robotics has been at the forefront of collaborating with payors, successfully navigating reimbursement hurdles in the US and Germany  Scalability. High-touch sales process limits scalability for small, undercapitalized, single-product companies, benefitting ReWalk Robotics in leveraging sales efficiencies across multiple product offerings 
 
 Product Portfolio     Confidential – ReWalk Robotics 2023  9 
 
 A Growing Portfolio of Solutions for NeuroRehabilitation  Confidential – ReWalk Robotics 2023  ReWalk Personal Exoskeleton  Cutting edge technology that provides paralyzed individuals with access to greater mobility and the health-related benefits of walking in daily life.  ReStore Exo-Suit  Versatile, robotic gait-training solution designed to promote restoration of functional walking patterns post-stroke through training in the clinic.     MyoCycle FES  Functional electrical stimulation (FES) bikes that enable users with weakness or paralysis to cycle under their own power in the clinic and at home.  Core Product  Distributed Product 
 
 Flagship Product – ReWalk Personal Exoskeleton  Confidential – ReWalk Robotics 2023     The ReWalk Personal Exoskeleton enables paralyzed individuals with spinal cord injury to stand, walk, and ascend or descend stairs and curbs during everyday activities.  The most widely available and utilized personal exoskeleton in the world  Received CE clearance in 2012  FDA de novo approval in 2014  FDA stairs clearance in 2023  Over 600 personal systems placed worldwide 
 
 The Leader in Exoskeleton Technology  Confidential – ReWalk Robotics 2023  Unprecedented freedom – Only personal exoskeleton enabling ambulatory access to real-world environments, including locations with stairs or curbs  Natural gait – Only personal exoskeleton with six adjustable degrees of freedom for more natural walking  Robust construction – Engineered and built for years of daily use to keep up with users wherever they want to go  Customized fit – Customizable exoskeleton individually configured to optimize safety, function, and comfort  Dedicated support – ReWalk customer support team available from initial evaluation through everyday use   Vibrant community – A worldwide community of ReWalk Personal Exoskeleton users that share common experiences 
 
 Regular access to exoskeleton-assisted walking results in a multitude of health and wellness benefits for people with spinal cord injury2-8  Frequently reported benefits in literature include reductions in common comorbidities after SCI, including:  Reduced spasticity  Improved bowel/bladder function  Reduced chronic pain  Proven Health Benefits  Confidential – ReWalk Robotics 2023  Health benefits reported by ReWalk users in a 2023 survey8 
 
 Confidential – ReWalk Robotics 2023   Germany  65M lives covered by DGUV (workers compensation) in Germany since 2019  Contractual coverage for 30% of all Germans through Statutory and Private health insurance plans  23.2M lives covered since 2020  Additional 2M covered lives added in 2021   US  9M US Veterans covered under VA Personal Exoskeleton policy since 2015  Over 225 systems covered through private and other insurance, on a case-by-case basis  Medicare HCPCS code established 2020  Case-by-case submissions with Medicare started late 2022  Increasing Progress of Reimbursement/Coverage 
 
 SCI Market Potential – Driven by CMS Coverage  Confidential – ReWalk Robotics 2023  Eligible Candidates11,12  Reimbursement Pathway13,14  Potential Total Addressable Market   Prevalence of SCI Survivors  US  296,0009  Germany  74,00010  Global  7.1 Million10  US  15,416  Germany  2,064  Global  17,480  Potential  TAM   $1.75B 
 
 Unique capabilities – only FDA and CE-cleared tool offering on-demand mechanical assistance to retrain post-stroke walking function during “push-off” (propulsion)  Enhanced gait training – improves training specificity and intensity by promoting power and symmetry in forward propulsion, as well as effective paretic limb advancement  Versatile solution – compatible with a wide array of clinic activities, from the treadmill to overground circuit training  Improved treatment efficiency – acts as a second set of skilled hands, eliminating the need for an aide and/or allowing a more holistic approach to gait training   Secondary Product Line – ReStore Soft Exo-Suit for Stroke  Confidential – ReWalk Robotics 2023 
 
 Stroke Market Potential  Confidential – ReWalk Robotics 2023  Personal Sales (Future State)  Stroke Rehabilitation Centers20  Direct Sales Presence  In-Clinic Sales (Current State)  Inpatient Facilities  Outpatient Clinics  US  115217  44,00018  Germany  28819  11,00019  Global  27,80019  1M19  Incidence  Prevalence  US  795,00021  7M22  Germany  198,00019  1.75M19  Global  7.1 Million19  168M19  Medical Eligibility23  Direct Sales Presence  Clinic Market  1,824  Personal Market  5.8M  Potential Total Addressable Market   Potential  TAM $55M 
 
 Stroke Market Potential  Confidential – ReWalk Robotics 2023  Personal Sales (Future State)  Stroke Rehabilitation Centers20  Clinic Market  1,824  Personal Market  5.8M  Direct Sales Presence  In-Clinic Sales (Current State)  Inpatient Facilities  Outpatient Clinics  US  115217  44,00018  Germany  28819  11,00019  Global  27,80019  1M19  Incidence  Prevalence  US  795,00021  7M22  Germany  198,00019  1.75M19  Global  7.1 Million19  168M19  Medical Eligibility23  Direct Sales Presence  Future product lines will leverage ReStore’s in-clinic presence to expand into the larger personal market  Potential  TAM $46B  Potential Total Addressable Market  
 
 Broad indications – widely applicable across the NeuroRehabilitation spectrum, with specialized models for in-clinic and at-home use  Easy to use – simple setup, with intuitive controls allowing home users and clinicians to rapidly achieve therapeutic goals   Proven – FDA cleared to prevent muscle atrophy, reduce spasms, increase blood flow, and increase range of motion   Engaging – stores workout data, providing weekly progress reports, with performance tracking and comparison to incentivize progress  Isokinetic technology – intuitively provides assistance or resistance as needed, depending on functional capabilities  Distributed Product Line – MyoCycle FES  Confidential – ReWalk Robotics 2023 
 
 MyoCycle FES Market Potential  Confidential – ReWalk Robotics 2023  SCI  Stroke  MS  US  296,00024  7M25  1.0M26  Personal (Home Use) Sales  Medical Eligibility27  US Clinic Market  3,600  US Personal Market  67,000  Total  70,600  Potential Total Addressable Market   NeuroRehab Focused Clinics31  ReWalk Dist. Rights28  Inpatient Facilities  Outpatient Clinics  US  115229  44,00030  Capital (In-Clinic) Sales  Potential  TAM $1.7B 
 
 Consolidation Strategy     Confidential – ReWalk Robotics 2023  21 
 
 Enhancements to technology and features of ReWalk Exoskeleton  Expansion of access through greater reimbursement coverage  Internal development of new products  Increasing penetration for distributed products  Consolidation Will Add Scale and Supplement Growth  Confidential – ReWalk Robotics 2023  Approved, commercially established, adjacent products   High clinical benefit to patients  Capitalizes on our key capabilities to maximize financial synergies  Profitable within twelve months of purchase  Consolidation Accelerates Path to Profitability  Organic  Acquisition 
 
 Distribution of NeuroRehabilitation Technology Providers  NeuroRehabilitation Market Attractive for Consolidation  Confidential – ReWalk Robotics 2023  Fragmented industry with many small players  Mostly private companies with limited access to capital  Innovative technologies with distribution constraints  Complementary products sold to the neurorehabilitation clinic or for home/community use  Opportunity for ReWalk Robotics to Leverage Its Leadership Position and Capital  For illustrative purposes from proprietary ReWalk research 
 
 Leverage Key Capabilities  Acquisition Program Designed to Accelerate Path to Profitability  Confidential – ReWalk Robotics 2023  Field Sales & Marketing  Clinical  R&D  Regulatory / Quality  Reimbursement  Operations / Integration  Public company resources  Opportunity for ReWalk Robotics to Leverage Its Position and Capital  Acquisition Criteria  Approved, commercially established, adjacent product(s)   High clinical value and benefit to patients  Leverages our key capabilities to maximize financial synergies and profit accretion  Profitable within twelve months of purchase  ReWalk Exoskeleton  ReStore  Exo-suit  Potential Acquisition   C  MyoCycle  (Distributed)  Potential  Acquisition A  Potential Acquisition B 
 
 Deep and Talented Leadership Team  Larry JasinskiChief Executive Officer  Mike LawlessChief Financial Officer  Jeannine LynchVice President, Strategy & Market Access  Kathleen O'DonnellVice President, Marketing & New Business Development  Miri ParienteVice President, Operations, Regulatory & Quality  David HexnerVice President, Research & Development  Ami KraftExecutive Advisor to the CEO  Judy KulaVice President, Customer Service, Human Resources & Business Affairs  Confidential – ReWalk Robotics 2023 
 
 Financial Summary  Confidential – ReWalk Robotics 2023  $67.9 M   Cash & Cash Equivalents   (as of Dec. 31, 2022)  Cash  No Debt  Debt  Expected cash into 2025+, depending on acquisitions  Cash Runway  Well Positioned for Funding Internal Growth   and Consolidation Strategy 
 
 2023 Milestones & Catalysts    Confidential – ReWalk Robotics 2023  FDA clearance for use of our ReWalk Personal exoskeletons on stairs and curbs extends competitive advantage  Exoskeleton reimbursement coverage by Medicare with claims processed and paid by MACs  510k submission for FDA clearance of the next-generation ReWalk 7.0 exoskeleton  Acquisition(s) of complementary product lines within NeuroRehabilitation market  Submission of 35+ additional claims to Medicare for reimbursement 
 
 Expanding addressable market in United States and Germany;   first Medicare claims ongoing   ReWalk Robotics Well Positioned for Future Growth  Large, growing and fragmented NeuroRehabilitation market with many attractive candidates for consolidation  Fundamentally changes lives for individuals with spinal cord injury  Leading Innovative Technology  Proven model for the distribution of complementary products to the clinical and home-use markets  Resources to fund multiple years of organic growth while also making acquisitions of adjacent product lines  Confidential – ReWalk Robotics 2023  Growing Reimbursement Coverage  Attractive Market Opportunity  Key Capabilities for Success  Strong Balance Sheet 
 
 NASDAQ:RWLK  Thank you!  Confidential – ReWalk Robotics 2023 
 
 1 Allied Health Neurorehabilitation Market Report: https://www.alliedmarketresearch.com/neurorehabilitation-market-A10461  2 Asselin et al., Arch Phys Med Rehab (2021)   3 Gorman et al., J Clin Med (2021)   4 Duddy et al., Sensors (2021)   5 Shackleton et al., J Rehab Med (2019) Juszczak et al., Topics Spin Cord Inj Rehab (2018)   6 Faulkner et al., Journ Spinal Cord Med (2021)   7 Knezevic et al., Arch Phys Med Rehab (2021)   8 ReWalk user survey, 2023 N=41  9 National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2021.  10 Estimates based on scaling US statistics for total German and Global population sizes.  11 31% meet LOI eligibility criteria based on 2020 NSCISC annual report: www.nscisc.uab.edu/public/2020%20Annual%20Report%20-%20Complete%20Public%20Version.pdf   12 Of LOI-eligible, an estimated 30% meet additional eligibility criteria based on aggregate of 50% screen failure rate in literature: https://pubmed.ncbi.nlm.nih.gov/32800962/ plus ReWalk’s historical experience related to additional limiters (e.g. available transportation and time to attend training, motivation, companion availability, etc.) which are not accurately reflected within research populations.  13 56% of US SCI prevalence market cite Medicare or Medicaid as primary   14 30% of German Market covered for exoskeleton coverage by insurance contracts   Confidential – ReWalk Robotics 2023  References 
 
 15 www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk   16 www.strokeinfo.org/stroke-facts-statistics/   17 www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf   18 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023)  19 Estimates based on scaling US statistics for total German and Global population sizes  20 Designated Primary Stroke Center www.ncbi.nlm.nih.gov/pmc/articles/PMC8886184/   21 www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk   22 www.strokeinfo.org/stroke-facts-statistics/   23.67% Survivors report persistent physical disability www.strokeinfo.org/stroke-facts-statistics/   24 National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2021.  25 www.strokeinfo.org/stroke-facts-statistics/   26 www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#1   27 Estimated at 30% eligibility across multiple disease states  28 Population percentage with enrolled VA benefits (2.7%) https://department.va.gov/about/#  29 MedPAC 2021 Report: www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf  30 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023)  31 Locust Walk commissioned report. Sources: Wall Street Research, Locust Walk Analytics, GlobalData  Confidential – ReWalk Robotics 2023  References (cont’d)