We have submitted our third Commercialization Readiness Pilot (CRP) Program grant application to the National Institutes of Health (NIH). In it, we describe our plan to commercialize i-RxTherm, our device for early diabetic peripheral neuropathy detection and diagnosis.
Why We Developed i-RxTherm for Early Detection of DPN
On their Diabetes Fast Facts website, the CDC reports that over 37 million Americans have diabetes. One in five are unaware of their condition. Furthermore, the diabetic population has more than doubled over the last 20 years, as the US population ages and becomes more obese.
While the diabetic population grows, however, the number of specialists trained to treat diabetic patients is shrinking. Annual costs associated with DPN, the most common complication of diabetes, top $10 billion in the US, and costs associated with DPN patients are five times higher than those of patients with diabetes alone.
Overall, people with diabetes face medical costs twice as high as those without, and people of African American, Latino, and Native American descent live with a greater risk of developing Type II diabetes.
This burden of this disease thus has social, ethnic, economic, and educational components that affect all of us, whether we are aware of them or not. The burdens of disability and cost disproportionately affect communities of color in the US. Economic and educational burdens affect our health-care providers, who have less time to spend with each patient and fewer resources to focus on preventative care.
How i-RxTherm Improves Early DPN Detection
We aim to support both patients and providers with technology that improves detection of DPN and thus patient outcomes. Our i-RxTherm device facilitates quick, noninvasive testing and supplies accurate, repeatable results accessible to any provider, who can use the data to refer patients to a specialist early in the progression of the disease. Early interventions often lead to better long-term patient outcomes, easing the burden of disability and cost on patients and their families, as well as the broader health-care system.
Our Plan and Vision
The Class I i-RxTherm device, which will enter the market at the end of this year, will aid caregivers by providing them with additional data that they can use to detect and diagnose DPN and refer patients. The Class II device, which will begin the FDA presubmission process as the Class I version enters the marketplace, will use our AI-based software to analyze patient images, identify biomarkers of DPN, and alert providers to the need for specialist review.
As we shift from the purely technical work to implementing the commercialization plan, we are drawing on a team of experts who will help us to reach the market segments and populations that would most benefit from our work. Our research and past commercialization experience have shown us the great need for better diagnostic tools. We believe that the tools we have developed will support the physiological and economic health and well-being of our communities, here and around the world.