Form 8-K - Current report

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): October 13, 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))

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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		The Nasdaq Stock Market LLC

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 The Nasdaq Stock Market LLC

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 October 13, 2023, 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.

This information is being furnished pursuant to Item 7.01, “Regulation FD Disclosure,” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

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: October 13, 2023	By:	/s/ Michael Lawless
	Name:	Michael Lawless
	Title:	Chief Financial Officer

Exhibit 99.1

ReWalk Robotics Investor Presentation October 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

Recovery After Neurological or Physical Injury and Disability Confidential – ReWalk Robotics 2023 ReWalk Robotics Mission: To fundamentally improve the quality of life for individuals with physical or neurological injury and disability through innovative technologies that enable mobility and wellness in rehabilitation and daily life. YouTube Link: youtu.be/UwIUJaYJ3iM

Neurologic and physical 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 physical and neurological rehabilitation 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 Acquisition of AlterG Anti-Gravity Systems CMS approval for Medicare reimbursement of exoskeletons FDA submission of next-generation of exoskeleton Market-leading innovation – First-to-market personal exoskeleton for spinal cord injury, with over 600 placements worldwide Large and growing market opportunity – Neurorehabilitation market valued at $1.1 billion and 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 neurological and physical rehabilitation solutions Experienced management – Multi-disciplinary leadership with successful track records in medical technology, life science tools, and biopharmaceuticals A Leader in Neurological and Physical Rehabilitation Solutions Confidential – ReWalk Robotics 2023

A History of Innovation Confidential – ReWalk Robotics 2023 ReWalk Robotics has consistently pioneered the rehabilitation industry to establish novel solutions as standard of care First to: 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 …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 …pursue the consolidation strategy with AlterG acquisition

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.

Product Portfolio Confidential – ReWalk Robotics 2023 8

Portfolio of Solutions in Neurological and Physical Rehabilitation 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 Differential Air Pressure (DAP) technology that reduces the effects of gravity and enables users to move with calibrated support and reduced pain. AlterG Anti-Gravity System

Flagship Product – ReWalk Personal Exoskeleton 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 2022 German Federal Court case was withdrawn, upholding prior court decision that Exoskeletons directly compensate for disability 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 2023 Medicare proposed Home Health Rule explicitly defines benefit category for Personal Exoskeletons Increasing Progress of Reimbursement/Coverage

SCI Market Potential to Be Determined 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

Expert & proven development – NASA-derived DAP technology to reduce the effects of gravity and allow people to move in new ways with finely calibrated support and reduced pain Established user base – Installed base of over 6,000 units at customers globally Highly synergistic – combined market presence creates sales and support efficiencies across all product lines, expanding penetration into clinics with current and upcoming new designs Accelerates drive to profitability – $20 million revenue and positive operating profit in 2022. Grew at a CAGR of 10% for 10 years pre-Covid. Acquired Product – AlterG Anti-Gravity System Confidential – ReWalk Robotics 2023

AlterG Market Potential Confidential – ReWalk Robotics 2023 Potential Total Addressable Market US 14,000 Germany 3,500 Global 40,000 Potential Global TAM $1.2B Inpatient Facilities Outpatient Clinics Professional & Elite Sports US 1,15215 44,00016 1,400 Germany 28817 11,00017 350 Global 3,50017 130,00017 4,200 Appropriate customer based on patient/athlete population and sufficient capital budget

ReStore Exo-Suit for Stroke Rehabilitation 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 Additional Product Lines Confidential – ReWalk Robotics 2023 Distributed Product – MyoCycle FES Broad indications – widely applicable across the physical and neurological rehabilitation 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

Exo-Suit Stroke Market Potential Confidential – ReWalk Robotics 2023 Stroke Rehabilitation Centers18 Direct Sales Presence In-Clinic Sales Inpatient Facilities Outpatient Clinics US 1,15215 44,00016 Germany 28817 11,00017 Global 3,50017 130,00017 Clinic Market 1,824 Potential Total Addressable Market Potential TAM $55M

MyoCycle FES Market Potential Confidential – ReWalk Robotics 2023 SCI Stroke MS US 296,00019 7M20 1.0M21 Personal (Home Use) Sales Medical Eligibility22 US Clinic Market 3,600 US Personal Market 13,200 Total 16,800 Potential Total Addressable Market NeuroRehab Focused Clinics26 ReWalk Dist. Rights23 Inpatient Facilities Outpatient Clinics US 1,15224 44,00025 Capital (In-Clinic) Sales Potential TAM $420M

Consolidation Strategy Confidential – ReWalk Robotics 2023 19

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 Strategy Adds Scale and Supplements 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 OrganicGrowth Acquisition Criteria

Distribution of NeuroRehabilitation Technology Providers NeuroRehabilitation Market Attractive for Further 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

Transaction Summary Confidential – ReWalk Robotics 2023 A transformational step in our long-term strategy for growth from both our existing portfolio of products and from synergistic acquisitions

Significantly enhances ReWalk’s position as leader in innovative neurorehabilitation technologies that enable mobility and wellness Key Attributes of Transaction Confidential – ReWalk Robotics 2023 Strategy Adds novel technology – Differential Air Pressure – with proven commercial success and potential for further applications and growth Technology Creates comprehensive commercial sales team focusing on clinics and hospitals, as well as sales to individuals for use in the home Scale Combined clinic sales team to capitalize on CMS proposed rule that would provide Medicare reimbursement for exoskeletons for home use Execution

ReWalk Key Capabilities Powerful and Complementary Combination Confidential – ReWalk Robotics 2023 Field Sales for Home Use Marketing & Product Mgmt. Clinical / Training Regulatory / Quality Reimbursement / Access Operations / R&D Public Company Resources Creates a Formidable Platform for Consolidation in Neurological and Physical Rehabilitation AlterG Key Capabilities Commercial Track Record of Growth Field Sales for Clinic Use Extensive Service Engineer Network Global Distributor Network Manufacturing / Sourcing Innovation / Product Development / IP ReWalk Exoskeleton ReStore Exo-suit MyoCycle (Distributed) Anti-Gravity Systems

Perpetuating Cycle of Lead Generation Confidential – ReWalk Robotics 2023 Clinic Customers Individual Customers Traditional AlterG lead generation Traditional ReWalk lead generation AlterG System MyoCycle Pro ReStore Exo-Suit MyoCycle Home Clinic Network for Patient Training ReWalk Personal Exoskeleton Patient Referrals from Clinical Customers Combined portfolio strengthens engagement with clinics, driving more patient referrals and additional clinic opportunities

Deep and Talented Leadership Team Larry JasinskiChief Executive Officer Mike LawlessChief Financial Officer Charles RemsbergChief Sales Officer Miri ParienteVice President, Operations, Regulatory & Quality David Hexner Vice President, Research & Development Ami KraftExecutive Advisor to the CEO Almog AdarVice President, Finance Confidential – ReWalk Robotics 2023 Jeannine LynchVice President, Strategy & Market Access Kathleen O'DonnellVice President, Marketing & New Business Development Judy KulaVice President, Customer Service & Human Resources

Financial Summary Confidential – ReWalk Robotics 2023 $38 million* Cash & cash equivalents (as of June 30, 2023) Cash No debt Debt Path to profitability by 2026 with existing cash balance Cash Runway Well Positioned for Funding Internal Growth and Integration Strategy *Note: Estimated cash balance after the impact of the acquisition of AlterG which had an initial cash outlay of approximately $20 million at closing on August 11, 2023.

2023 Milestones & Catalysts  Confidential – ReWalk Robotics 2023 FDA clearance for use of our ReWalk Personal exoskeletons on stairs and curbs extends competitive advantage Predictable and simplified Medicare payment and claims processing system established for exoskeletons 510k submission for FDA clearance of the next-generation ReWalk 7 exoskeleton Successful acquisition of complementary product line 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 Physical and Neurological Rehabilitation 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 MedPAC 2021 Report: www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf 16 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023) 17 Estimates based on scaling US statistics for total German and Global population sizes 18 Designated Primary Stroke Center www.ncbi.nlm.nih.gov/pmc/articles/PMC8886184/ 19 National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2021. 20 www.strokeinfo.org/stroke-facts-statistics/ 21 www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#1 22 Estimated eligibility across multiple disease states 23 Population percentage with enrolled VA benefits (2.7%) https://department.va.gov/about/# 24 MedPAC 2021 Report: www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf 25 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023) 26 Locust Walk commissioned report. Sources: Wall Street Research, Locust Walk Analytics, GlobalData Confidential – ReWalk Robotics 2023 References (cont’d)

Document and Entity Information	Oct. 13, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 13, 2023
Entity Registrant Name	ReWalk Robotics Ltd.
Entity Incorporation, State or Country Code	L3
Entity File Number	001-36612
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	3 Hatnufa St.
Entity Address, Address Line Two	Floor 6
Entity Address, City or Town	Yokneam Ilit
Entity Address, Country	IL
Entity Address, Postal Zip Code	2069203
City Area Code	972
Local Phone Number	4.959.0123
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Entity Central Index Key	0001607962
Title of 12(b) Security	Ordinary Shares, par value NIS 0.25
Trading Symbol	RWLK
Security Exchange Name	NASDAQ