Jeff dyken 02-rewalk
-
Upload
innovationday2013 -
Category
Health & Medicine
-
view
310 -
download
0
Transcript of 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