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Mission

Argo Medical aims to
fundamentally change
the health and life
experiences of
individuals with spinal
cord injury.
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
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
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
Current Patients T1 and below
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
The Platform / Features

• Independent
walking –
stairs
• Individual
control
• Carries own
weight
• Works in
multiple
environments
• All day use
How it works:
Computer,
software, &
Batteries
Communicator to
select functions
Tilt Sensor for
operating functions
Pelvic Support
Manual Buttons

Motors, Gears,
software

Crutches
- Sensing
ground
- Safety
A Day in Radi’s (New) Life

The Market
of Akko
Technion alumni did. In May 2012, paraplegic Claire Lomas finished the London
Marathon in 16 days using ReWalk, a lightweight, computer-assisted exoskeleton
PM Netanyahu & President Obama

Jerusalem, March 2013

Technion, Haifa, June 2012
Clinical Data / Experience
Clinical Studies
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)

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

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

• 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)
Ongoing Medical Benefits Study
Experience
Percent Change in Lean Tissue Mass (n=3)

VA Bronx, New York, Interim Data, Medical Benefits Study 2012
Mean Fat Mass Loss after Exoskeletal-Assisted
Walking (N=5)

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

Health Benefits
Number of
Sessions when
the changes
were noted

Total Bowel
Evacuation Time
per Bowel Day

Bowel Evacuation

Bristol Stool Scale

(frequency per week)

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

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)

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)

Change from 4
to 5

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

6

7

9

↑ from 2-3 to
3-4x/week

16

↓ from 90 to
<30 min

20

Bowel program was
Change from 3 to
↓ from 120 to performed 6-7x/wk to
4; ↓ in amount
45 min
avoid accidents; able to ↓
of liquid leakage
to 3-4x/wk

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

Bowel Specific
Medication Use

Eliminated laxative use and
decreased amount of
additional dietary fiber
supplements
Business Case
What are the benefits of walking again?

Health Impact
Cardiovascular (lower risk of heart attack,
diabetes, high blood pressure, stroke)
Improved bone density
Better GI track function
Weight control
Social
Inclusion in society
Self esteem
Economic
Reduction in medical cost
Capacity to work
SOLID RETURN ON INVESTMENT FOR PAYERS


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

1

Preliminary data from literature and survey of 4 ReWalkers

BOD 11 December 2012
LARGE POTENTIAL MARKET
ABI Research: Exoskeletons ~$300M in 2020

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

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Jeff dyken 02-rewalk

  • 1. Mission Argo Medical aims to fundamentally change the health and life experiences of individuals with spinal cord injury.
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. Current Patients T1 and below 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
  • 6. 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
  • 7. The Platform / Features • Independent walking – stairs • Individual control • Carries own weight • Works in multiple environments • All day use
  • 8. How it works: Computer, software, & Batteries Communicator to select functions Tilt Sensor for operating functions Pelvic Support Manual Buttons Motors, Gears, software Crutches - Sensing ground - Safety
  • 9. A Day in Radi’s (New) Life The Market of Akko
  • 10. Technion alumni did. In May 2012, paraplegic Claire Lomas finished the London Marathon in 16 days using ReWalk, a lightweight, computer-assisted exoskeleton
  • 11. PM Netanyahu & President Obama Jerusalem, March 2013 Technion, Haifa, June 2012
  • 12. Clinical Data / Experience
  • 13. Clinical Studies 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) • Ongoing single center study of 20 patients: o James J. Peters VA (Bronx, NY) • Primary Outcomes: o Safety A/E’s o Tolerance o Ease of use • 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
  • 15. Percent Change in Lean Tissue Mass (n=3) VA Bronx, New York, Interim Data, Medical Benefits Study 2012
  • 16. Mean Fat Mass Loss after Exoskeletal-Assisted Walking (N=5) VA Bronx, New York, Interim Data, Medical Benefits Study 2012
  • 17. Participant # Health Benefits Number of Sessions when the changes were noted Total Bowel Evacuation Time per Bowel Day Bowel Evacuation Bristol Stool Scale (frequency per week) (1=hard to 7=liquid; 4-6 ideal) 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) 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) Change from 4 to 5 Reduction in use of a stool softener (Colace) and/or a laxative (Senna) from weekly to ≤1x/month 6 7 9 ↑ from 2-3 to 3-4x/week 16 ↓ from 90 to <30 min 20 Bowel program was Change from 3 to ↓ from 120 to performed 6-7x/wk to 4; ↓ in amount 45 min avoid accidents; able to ↓ of liquid leakage to 3-4x/wk VA Bronx, New York, Interim Data, Medical Benefits Study 2012 Bowel Specific Medication Use Eliminated laxative use and decreased amount of additional dietary fiber supplements
  • 19. What are the benefits of walking again? Health Impact Cardiovascular (lower risk of heart attack, diabetes, high blood pressure, stroke) Improved bone density Better GI track function Weight control Social Inclusion in society Self esteem Economic Reduction in medical cost Capacity to work
  • 20. SOLID RETURN ON INVESTMENT FOR PAYERS  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 1 Preliminary data from literature and survey of 4 ReWalkers BOD 11 December 2012
  • 21. LARGE POTENTIAL MARKET ABI Research: Exoskeletons ~$300M in 2020 ABI Research: Exoskeletons, Powered Prostheses and Optical Sensory Devices 2010
  • 22. 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
  • 23. 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