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Device for early detection of diabetic neuropathy and predicting foot ulcer development

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. Market / Problem.

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Device for early detection of diabetic neuropathy and predicting foot ulcer development

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  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

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