VisionQuest Biomedical founder and CEO Peter Soliz (PhD) has just been awarded a $1 million Commercialization Readiness Pilot Program (CRP) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (part of the US National Institutes of Health) for his work on early detection of DPN. With the support of this grant, Dr. Soliz will develop a commercial prototype and seek FDA approval of i-RxTherm, his device for detecting DPN (diabetic peripheral neuropathy or diabetic foot).
What Is DPN?
DPN is the most common co-morbidity of diabetes: it affects up to half of all people living with diabetes and contributes directly to lower-limb amputations in over 100,000 Americans every year. Both diabetes and DPN disproportionately affect people of color, including those in Black, Latino, and Native American communities. The economic cost of DPN in the US exceeds $10 billion annually, and those with the disease experience direct medical costs 5 times higher than those with diabetes alone. Personal costs include decreased quality of life, frequent travel for medical care, and lower life expectancy—only 5 years for someone who has experienced a lower-limb amputation.
Early Detection of DPN
Because this disease can be asymptomatic, the identification of early stage DPN can lead to timely interventions and better long-term health outcomes for the many people affected. However, current diagnostic tools are invasive, expensive, or time-consuming, or they produce highly subjective results. VisionQuest’s device, i-RxTherm, detects the signs of DPN quickly, accurately, and non-invasively, thus providing a new and better tool for the early detection and diagnosis of this debilitating complication of diabetes.
DPN first affects nerve function in the hands and feet, and it also affects the blood flow controlled by these nerves, which respond to external changes in temperature. i-RxTherm records infrared (thermal) video of the blood flow to the bottom of a subject’s foot after their foot has been cooled with a gel pad. The software then charts temperature differences initially, after cooling, and during recovery. These graphs of rising temperature (i.e., increasing blood flow after removal of the cold pad) look different for subjects with and without DPN and show the physician which patients may require additional testing and treatment.
Path to Commercialization
Dr. Soliz will be working with endocrinologists, podiatrists, and other physicians to finalize the commercial prototype and collect data needed for FDA approval of the device. “By partnering with medical experts, we will be able to create a tool that fits within the clinical workflow and provides quantitative data to the physician while producing little to no discomfort for the patient,” says Dr. Soliz. “As a diagnostic aid, this device has numerous applications in and beyond the primary care clinic, and we believe it will revolutionize early detection of DPN, as well as care for those with this disease.”