MR3 Health, Inc. — Department of Defense SBIR Phase I: AF211-CSO1

Description

Every 23 seconds, someone is diagnosed with diabetes in the U.S. and the country spends more than $327 billion on diabetes treatment and research. Compared to civilians, veterans are 2.5 times more likely to have diabetes due to the past physical strain with chronic pain and degenerative joint damage, and each year, the Department of VA spends over $1.5 billion to treat diabetic patients. One complication of diabetes is diabetic peripheral neuropathy (DPN), which reduces sensitivity in the feet, affecting 50% of patients and increasing their chances of developing ulcerating wounds (diabetic foot ulcers – DFUs). DFUs have become a silent killer of veterans, with 40% of those diagnosed with the problem dying within 5 years. DFUs precede 85% of diabetes related amputations, and in 2018 alone, over 9,000 veterans had lower extremity amputations (LEAs), with more than 3,000 involving foot loss. In 2019, the V.A. treated more than 75,000 DFUs at an average cost of $47,000 each, translating to over $3.5 billion just for foot care. The lack of sensation by DPN patients leads to catastrophic delays in the identification of foot ulcers. Patients only notice them when they have fully developed and now requiring extensive and costly treatment or, at worst – amputation. For such patients, there is a need for daily skin temperature monitoring to provide early warning signs of inflammation and tissue injury. MR3 Health has developed a preventive tool- TempTouchTM (dermal thermometer device) (TempTouchTM) to reduce DFUs and LEAs. TempTouchTM offers a dependable, simplified solution to monitor diabetic patients daily, identifying those with negative physiologic trends and communicating alerts to the patient, clinician and healthcare payer indicating a high risk of an acute health event if any. To date, the solution has demonstrated up to a 70% effectiveness rate in preventing DFU's and LEA's during clinical trials and is FDA approved. MR3 is customising TempTouchTM to the DoD’s department of Veterans Affairs through its healthcare facilities and medical centres across the U.S to fight against DFU in veterans diagnosed with diabetes. The Phase 1 proposed objective aims to evaluate and validate the technical feasibility of our technology for use by diabetic veterans.