Device for early detection of
diabetic neuropathy and
predicting foot ulcer
development
Amputation Prevention for Diabetics
Rosemary French
IC2 Institute, The University of Texas at
Austin
rfrench@ic2.utexas.edu
©2012 IC2 Institute at the University of Texas at Austin
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Market / Problem
• Problem: Every year about 25 percent of diabetics
(approximately 20 million in the U.S.) develop ulcer-related
complications, many resulting in amputation.
• Diabetics use glucometers to monitor their blood glucose level
at a specific point in time. Glucometers however are incapable
of measuring the functioning of an organ that has deteriorated
from exposure to high glucose containing blood.
• Solution: This non-invasive method detects the onset of
neuropathy as early as 7% nerve damage, pin-pointing high
risk ulcer prone zones in the feet.
• Market Opportunity: 346 million worldwide are diabetic –
expected to double in 18 years without intervention
– U.S. market for diabetes drugs, devices and monitoring
systems expected to exceed $55 billion by 2016.
©2012 IC2 Institute at the University of Texas at Austin
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©2012 IC2 Institute at the University of Texas at Austin
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Underlying Technology
• Nerves are one of the earliest parts of the body to be
affected by diabetes.
• The technology is a device for measuring the progression of
diabetic neuropathy (damage to nerves) and predicting foot
ulcer development.
– Regular screening with this device enables a physician to
assess and benchmark progression of neuropathy, then
initiate early preventive measures.
• Key Benefits:
– Noninvasive procedure; ease of training; User friendly
software interface.
– obtains early (just 7% nerve damage) & accurate (87%)
assessment of progression of diabetic neuropathy & pin
points ulcer prone zones.
©2012 IC2 Institute at the University of Texas at Austin
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©2012 IC2 Institute at the University of Texas at Austin
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IP Status
• Patented By C.Jairaj Kumar ( CHE/1028/2009)
• PCT filed
• Patent pending In India, North America, Europe.
• Patent covers both the hardware and software components of
the device.
©2012 IC2 Institute at the University of Texas at Austin
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Competitive Advantage
• Current technologies on the market are unable to provide
early and accurate detection of ulcer-prone areas
– Tactilus by Sensor Products and Podiscan by Diabetik Foot
Care India measure foot pressure distribution and
magnitude (low sensitivity (30%) & does not measure
nerve activity but just identifies high pressure bearing
zones in feet).
– Biothesiometer: false positives, cannot pinpoint ulcer
prone zones in feet, identifies all individuals in
developing and under developed world without using foot
wear as having neuropathy
©2012 IC2 Institute at the University of Texas at Austin
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Competitive Advantage continued
– ANSAR: cannot provide very early detection of the onset
of diabetic neuropathy, nor can it locate patient’s ulcer
prone zones.
– Nerve Conduction Study: painful, identifies after 50%
nerve damage, can’t pinpoint ulcer prone areas.
– Neuropad provides early detection of sweat gland
disturbances as an expression of diabetic neuropathy
(Cannot pin point ulcer prone zones, give extent of
damage nor track the progression of neuropathy).
• Dr. Kumar’s technology is unique: obtains early (just 7%
nerve damage) & accurate (87%) assessment of progression
of diabetic neuropathy & pin points ulcer prone zones.
©2012 IC2 Institute at the University of Texas at Austin
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Value Proposition and Market
Strategy
• Physicians conduct regular screening with this diagnostic tool
to assess and benchmark the early stages of neuropathy and
prescribe preventive treatment
– Early adopters: GP champions
– Average treatment cost of an ulcer: $8,000, infected ulcer:
$17,000, and major amputation: $45,000.
– Development strategy: license the technology to a large
medical device company, taking advantage of their existing
sales and marketing channels
– Next steps: Seeking research funding and clinical partner
for joint beta-prototype development and preclinical
studies
©2012 IC2 Institute at the University of Texas at Austin
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Development Status
• Production model ready. $5 million to get necessary
regulatory approvals (FDA), infrastructure and production
scalability.
• Three year, 600 patient data analysis using device:
– Control group: 300 with normal glucose tolerance test &
no foot ulcer or injury.
– Test group: 300 with diabetes mellitus diagnosed in past
5 years:
• 150 with no intervention: 87% of predicted points
developed into ulcers.
• 150 with intervention: 17% of predicted points
developed into ulcers.
©2012 IC2 Institute at the University of Texas at Austin
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Management Team
• Innovator: Dr. C. Jairaj Kumar, Deputy Director,
Justice K.S. Hegde Medical Academy, Mangalore
575001, Phone: +91-9700651386 / +91-9248173223,
jairaj.kumar@ymail.com
• Additional information:
– James Booth (512-475-7790, jbooth@ic2.utexas.edu)
– Jim Vance (512-232-3590, jvance@ic2.utexas.edu)
IC2 Institute Global Commercialization Group
©2012 IC2 Institute at the University of Texas at Austin
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