Jeff dyken 02-rewalk

Mission

Argo Medical aims to fundamentally change the health and life experiences of individuals with spinal cord injury.

1

The Impact of a Spinal Cord Injury….

“the pathetic [paralyzed] patient lying long in a bed, the urine leaking from his distended bladder, the lime leaking from his bones, the blood clotting in his veins, the flesh rotting from his seat, the scybala stacking up in his colon, the spirit draining from his soul”…. British Medical Journal; ii:967-8, 1947.

Dr. Richard Alan J. Asher, an eminent British Endocrinologist and Haematologist during the 20th Century

2

Clinical / Impact SCI

“the pathetic [paralyzed] patient lying long in a bed, the urine leaking from his distended bladder, the lime leaking from his bones, the blood clotting in his veins, the flesh rotting from his seat, the scybala stacking up in his colon, the spirit draining from his soul”…. British Medical Journal; ii:967-8, 1947.

Dr. Richard Alan J. Asher, an eminent British Endocrinologist and Haematologist during the 20th Century

3

Extreme deconditioningOrthostatic Hypotension (Tetra)

Urinary tract infectionInvoluntary voiding

Bone lossFractures Deep venous

thrombosis

Pressure ulcers

Chronic constipationImpaction

Involuntary defecation

DepressionPsycho-Social challenges

Spinal Cord Injury = High Expense / Use at Home

• ~6 million US/Europe in Wheelchairs• 181,000 Registered SCI Germany• 42,000 are active in the VA system• 50% of injuries occur at age of 16 to 30• Lifetime SCI complications costs range

from $681k to over $3 million• 87.9% of all spinal cord injured

individuals discharged to private homes

*2011 Statistics from Christopher Reeve Foundation**QUERI Fact Sheet, April 2012

4

Current Patients T1 and below

5

Tetraplegia:Spinal cord lesion at C8 or above resulting in complete or incomplete paralysis of the arms and legs

Paraplegia:Spinal cord lesion at T1 or below resulting in complete or incomplete paralysis of the legs

Design Goals

• Health Improvement allowing physical activities that have been lost or diminished

• Restoration of more control of their living environment: regain self-sufficiency and independence

• Increase inclusion

6

The Platform / Features

• Independent walking – stairs

• Individual control

• Carries own weight

• Works in multiple environments

• All day use7

How it works:

8

Communicator to select functions

Computer, software, &

Batteries

Motors, Gears, software

Manual Buttons

Pelvic Support

Tilt Sensor for operating functions

Crutches- Sensing

ground- Safety

A Day in Radi’s (New) Life

The Marketof Akko

9

Technion alumni did. In May 2012, paraplegic Claire Lomas finished the LondonMarathon in 16 days using ReWalk, a lightweight, computer-assisted exoskeleton

10

PM Netanyahu & President Obama

Jerusalem, March 2013 Technion, Haifa, June 2012

11

12

Clinical Data / Experience

Clinical Studies

13

Safety and Function / Regulatory Long Term Medical Benefits• Multicenter study of 24 patients:o Moss Rehab. (US)o Sheba Medical Center (Israel)o Villa Baretta (Italy)

• Primary Outcomes:o Safety A/E’so Tolerance o Ease of use

• Ongoing single center study of 20 patients:o James J. Peters VA (Bronx, NY)

• Primary Outcomes:o Measure medical/clinical benefits

of vertical loading and walking with exoskeleton technology:

bowel function, urinary tract function, body composition, metabolism

Further studies: Rancho (Calif.); Stoke (UK); Murneau (Germany)

14

Ongoing Medical Benefits Study Experience

Percent Change in Lean Tissue Mass (n=3)

15

VA Bronx, New York, Interim Data, Medical Benefits Study 2012

Mean Fat Mass Loss after Exoskeletal-Assisted Walking (N=5)

16

VA Bronx, New York, Interim Data, Medical Benefits Study 2012

Health Benefits

17

Participant #

Number of Sessions when

the changes were noted

Total Bowel Evacuation Time per Bowel Day

Bowel Evacuation(frequency per week)

Bristol Stool Scale(1=hard to 7=liquid; 4-6 ideal)

Bowel SpecificMedication Use

1 18 ↓ from 90 to 30 min

↑ from 1-2 to 3-4x/week

Change from 3 to 4

No reported change in bowel medications

5 15 15 to 30 min, no change

↑ from 1-2 to 3-4x/week

Change from 2 to 4

Discontinuation of laxative (Dulcolax)

6 16 ↓ from 60 to 30 min

↑ from 2-3 to 3-4x/week

Change from 1 to 4

Discontinuation of the use of a stool softener (Colace) and laxative (Senna)

7 16 ↓ from 90 to <30 min

↑ from 2-3 to 3-4x/week

Change from 4 to 5

Reduction in use of a stool softener (Colace) and/or a laxative (Senna) from weekly to ≤1x/month

9 20 ↓ from 120 to 45 min

Bowel program was performed 6-7x/wk to

avoid accidents; able to ↓ to 3-4x/wk

Change from 3 to 4; ↓ in amount of liquid leakage

Eliminated laxative use and decreased amount of additional dietary fiber supplements

VA Bronx, New York, Interim Data, Medical Benefits Study 2012

18

Business Case

What are the benefits of walking again?

19

Health ImpactCardiovascular (lower risk of heart attack,

diabetes, high blood pressure, stroke)Improved bone densityBetter GI track functionWeight control

SocialInclusion in societySelf esteem

EconomicReduction in medical costCapacity to work

SOLID RETURN ON INVESTMENT FOR PAYERS

1 PRE-REWALK:Annualized SCI

data / ReWalkers Survey of Cost

POST-REWALK:Survey of cost

(n = 4)

Potential Annual Reduction

Medications 22,792.39 10,712.88 12,039.51

Hospital based therapy

17,748.00 0 17,748.00

Totals 40,540.39 10,712.88 29,787.51

Preliminary data from literature and survey of 4 ReWalkers

BOD 11 December 201220

LARGE POTENTIAL MARKETABI Research: Exoskeletons ~$300M in 2020

ABI Research: Exoskeletons, Powered Prostheses and Optical Sensory Devices 2010

21

Strong Intellectual Property Position

• Issued US Method / Apparatus IP with use of tilt sensors for control – blocker for competition – 14 years remaining

• Europe and selected Asia markets issued Apparatus IP

• Internal & external reviews show freedom to operate

• Multiple Divisionals and other filings• Tetraplegic and other applications in place

22

Summary

• Product launched!• Extensive lab testing; confirmatory clinical studies and

use• Over 400 trained representing >22,000 hours of use• Blocking patent position• Manufacturability scale-up in process• CE Clearance complete; FDA submission made• Global Management base in place• Strategic investment and partnership agreement with

Yaskawa Electric Japan

23

Thank You !

24