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Human and Robotic Intersection

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Page 1: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

Human and Robotic

Intersection

Page 2: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Forward Looking Statements

In addition to historical information, this presentation contains forward-looking statements within the meaning of the U.S. Private SecuritiesLitigation 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. Suchforward-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 onmanagement’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many ofwhich are outside of ReWalk’s control. Important factors that could cause ReWalk’s actual results to differ materially from those indicated in theforward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in itsexisting geographic markets and to expand to new markets; ReWalk’s ability to maintain and grow its reputation and to achieve and maintainmarket acceptance of its products; ReWalk’s ability to achieve reimbursement from third-party payors for its products; ReWalk’s expectations as toits clinical research program and clinical results; ReWalk’s expectations as to the results of, and the Food and Drug Administration’s potentialregulatory actions with respect to, ReWalk’s mandatory post-market 522 surveillance study; the outcome of ongoing shareholder class litigationrelating to ReWalk’s initial public offering; ReWalk’s ability to repay its secured indebtedness; ReWalk’s ability to improve its products and developnew products; ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rightsof others; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to secure capital from its “at-the-market” offering programbased on the price range of its ordinary shares and conditions in the financial markets; ReWalk’s ability to maintain relationships with existingcustomers and develop relationships with new customers; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Reporton Form 10-K for the year ended December 31, 2016, as amended, filed with the U.S. Securities and Exchange Commission and other documentssubsequently filed with or furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this presentationspeaks only as of the date hereof. Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein mayemerge 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 topublicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Page 3: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Investment Highlights

• Market leading global exoskeleton developer with both FDA & CE mark clearance for both Personal and Rehabilitation use; sixth generation device

• 200+ systems placed for home and community use; 150+ systems in rehab centers

• Global commercial infrastructure with demonstrated sales and reimbursement success

• Only exoskeleton company with extensive relationship with Department of Veterans Affairs, the single largest provider of care for spinal cord injury (SCI) patients

• Addressing unpenetrated, multi-billion dollar SCI market opportunity

• Collaboration with Harvard University’s Wyss Institute to develop lightweight soft suit exoskeleton technologies for lower limb disabilities that will provide new market opportunity in other indications including multiple sclerosis (MS) and stroke patients

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Key Catalysts

• Expanded Reimbursement Coverage both in US and OUS

• Expect SCI coverage by national payors and a corporate self-insuring company in the US, which will be a pivotal milestone in driving continued market adoption of system

• Expect SCI coverage by a large contracted commercial group in Germany, where system has already been deemed medically necessary

• Expansion of U.S. Department of Veteran’s Affairs (VA) SOP program

• Facilitating expansion of the VA’s SOP clinical training capacity and growth in the number of patients trained

• Key R&D Initiatives to Harness Potential of New Future Markets

• Approaching design freeze for lightweight soft suit for stroke patients

• Development of next-generation ReWalk system

Page 5: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Our Mission

Fundamentally change the Quality of Life for individuals

with lower limb disability through the creation and

development of market leading robotic technologies

Page 6: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Market Opportunity

Significant Disability TODAY

• 282,000 people in the U.S. living

with SCI1

• 17,000 new cases annually

FUTURE

• 1,000 EU and 900 US stroke clinics

• 600K stroke patients3 in EU & US

that apply

• 400K MS cases2 in EU & US that

apply

• 10M WW Parkinson’s4; those that

apply TBD

• 600K CP in US and EU that apply

• Elderly assistance TBD___________________________

1. Source: https://www.nscisc.uab.edu/Public/Facts%202016.pdf

2. US prevalence 2014, American Heart Association

3. JACHO data,

4. Parkinson’s Disease Foundation

Institutional Use

Mild DisabilityIn market

Pipeline – soft suit

SCI

ReWalk Rehab

SCI

ReWalk Personal

Stroke

Multiple Sclerosis

Elderly Assist

Parkinson’s

Cerebral Palsy

Home Use

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The SCI Need

Wheelchair confinement can cause severe physical and psychologicaldeterioration resulting in significant costs to the healthcare system

Difficulty with bowel and urinary tract function

Osteoporosis

Loss of lean mass / gain in fat mass

Insulin resistance

Diabetes

Heart disease

87% of spinal cord injury patients discharged to private, non-institutional residences

Secondary Medical Consequences of Paralysis:

___________________________

1. Source: https://www.nscisc.uab.edu/Public/Facts%202016.pdf

$520K

Avg. Cost of

Healthcare

First Year of Injury

for Paraplegia1

$69K

Avg. Annual Cost

of Healthcare

for Paraplegia1

$2.3M

Est. Lifetime Cost

of Healthcare

for Paraplegia

Injury at age 251

$1.5M

Est. Lifetime Cost

of Healthcare

for Paraplegia

Injury at age 501

Page 8: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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• For every five point increase in the FIM motor score, the number of hospitalizations per year is

reduced by 0,0221

• Hospitalizations and assistive care represent almost 90% of the direct costs attributable to

SCI2

FIM ( Functional Independence Measure)

1 Cohen JT et al, 2012 2 De Vivo MJ et al, 2011

Economic Benefits of Activity in SCI Patients

Page 9: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

99

The ReWalk Solution

ReWalk designed to fundamentally change the health and life expectancies of users

• Light, wearable exoskeleton designed for all-day use

• User-initiated walking

• Utilizes patented tilt-sensor technology

• Enables walking in multiple environments: ability to sit, stand, turn, climb and descend stairs (1)

• Supports its own weight; user does not expend unnecessary energy while walking

• Rechargeable battery power

___________________________

1. Use of stairs is cleared under the CE mark, Canadian and Israeli registration; not

cleared for stairs by the FDA in the U.S.

Page 10: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Functionality: Everyday Life

• Most customizable exoskeleton

• User initiated walking

• Walking speeds as high as .71 m/s (1.6 mph/ 2.6 km/h)*

Fastest walking speed and most precise fit

of any exoskeleton on the market or in clinical trials

*In-Hospital Walking Velocity, Ajax Yang, Topics in Spinal Cord Injury Rehabilitation: Spring 2015, Vol. 21, No. 2, pp. 100-109.

Page 11: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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How it works / Futbol!

Page 12: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Established Commercial Infrastructure

Only exoskeleton company with market leading infrastructure supporting global commercialization

• Direct Sales Organization – United States & Germany

• Distribution Network – Rest of the World

• R&D Team – Israel

• Experienced Management Team

Sales

Distribution Org.

Physical Therapist

Field Service & Support Team

Reimbursement Team

Clinical Specialists

Case Managers

Commercial Team

Page 13: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Expand Market Awareness & Demand

Patient Physician/Rehab Center

• In 8 of 10 leading rehab centers in the U.S.; 189

training centers WW

• Largest existing body of published data for any

Exoskeleton

• Partnering with Rehab Centers for ReWalk Clinic Days

• Participation with SCI community events

• Support from advocacy groups and Veterans

organizations

• Direct Patient Outreach & Education

Strategy has built a large revenue pipeline

94 109 149 199 194

Q12016

Q22016

Q32016

Q42016

Q12017

Pending Insurance Claims (1)

10

1813

1015

Q12016

Q22016

Q32016

Q42016

Q12017

Insurance Payments

Page 14: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Expanding Partnership with the VA

• First national coverage policy

• For evaluation, training and issuance of ReWalk

exoskeletons

• Exclusive to ReWalk exoskeletons

• Large multi-center community based

exoskeleton study

• Evaluating quality of life and health

benefits of walking

Scope • Subset of 43,000 veterans that are paraplegic and

meet the VA inclusion criteria

(as many as 10,000 over time)

• Plus, subset of 450 new injuries annually who qualify

• 160 SCI veterans

• Duration: 4 years

Facilities • 24 centers for evaluation

• 12 centers for training

• 10 centers over 18 months

VA Department • Clinical group – prosthetics (same area that provides

legs and arms)

• Research department only

Units • 15 • 56

National Coverage Policy Research Study

Page 15: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Multi-Channel Reimbursement Strategy

ReWalk market education activities improving reimbursement environment

VA coverage Dec 2015

Active discussions

with regional and

national payers

Active discussions

with employers

Favorable German

Social Court Decision

Won multiple external

appeals (US & Germany)

194 Pending claims as

of Q1 2017

Clinical studies that

were base for FDA

Enrollment in FDA

522/Outcomes study

started in 2H 2016

VA/other data

49 papers now exist on

exoskeleton use

ReWalk – largest body

of data supporting safety

and benefits

First-ever meta analysis

finds exoskeletons to be

safe and effective

Coverage Decisions

Insurers & Direct

Case

by Case

Supporting

Clinical Data

Peer Reviewed

Publications

Page 16: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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R&D Pipeline: Expand & Extend our Leadership

Next generation

technology

More efficient drive

mechanism

Slimmer profile

Lighter body

Addressable

Market

In MarketToday

Near-Term2016-2019

Long-Term Potential2019+

Stroke Power boost and sensors that determine and adjust force

600KUS/EU

MultipleSclerosis

Assist actuation in hips and ankles

400K US/EU

Cerebral Palsy

Enhance the physio and hydro therapy possibilities via motorized skeleton

600KUS/EU

Parkinson’s Assistive walking TBD

Elderly Assistive walking TBD

Page 17: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

Stroke / Overground Walking

15

Page 18: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

Next to Commercialize

15

Page 19: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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KOL Feedback – Clinical Need

4 Leading Rehab Centers reviews at Harvard / Wyss

• “Plantarflexion is a significant differentiator, would be meaningful to all clinicians”

• “Algorithm is impressive, crucial for better treatment and results”

• “Capacity to adjust was impressive and effective with today’s patient”

• “ease of use along with minimal size and weight are ideal for the lab”

• “strongly feel a unilateral plantar / dorsi flexion device would be relevant for a subset of MS patients”

Page 20: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

2020

Company Highlights

• Q1 2017: Revenue of $2.5 million• Q1 2017: 37 ReWalk systems placed

Financial

• Q1 2017: $17.1 million in cashLiquidity

• VA national coverage policy in force• First industry meta-analysis supports health benefits of exoskeleton use• Targeting US & German commercial coverage decisions in mid-2017

Reimbursement

• 194 pending insurance claims as of the end of Q1 2017• Active outreach programs in process• 3-9 month sales lead cycle

Demand Generation

• Focused on next generation of ReWalk device• Soft exo-suit collaboration with Wyss Institute to address stroke and MS

populationsR&D

Page 21: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Financial Snapshot

$3,951 $3,746

$5,869

$2,499

2014 2015 2016 Q1 2017

Revenue($ in ‘000s)

43 48

80

37

2014 2015 2016 Q1 2017

Units Placed

3

107

10

1813

1015

Q2 '15Q3 '15Q4 '15Q1 '16Q2 '16Q3 '16Q4 '16Q1 '17

Units Covered by Insurance Reimbursement

54 72 90 94 109149

199 194

Q2 '15Q3 '15Q4 '15Q1 '16Q2 '16Q3 '16Q4 '16Q1 '17

Pending Insurance Claims

Page 22: Human and Robotic Intersection - Jefferies Robotics.pdf · Human and Robotic Intersection. 2 Forward ... technologies for lower limb disabilities that will provide new market opportunity

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Investor Contact

Lisa Wilson

In-Site Communications, Inc.

T: (212) 452-2793

E: [email protected]