Executive Summary :
Diabetes is a growing healthcare crisis in the US. According to the CDC, diagnosis of diabetes in U.S. adults has increased by over 90% in the past decade. By 2050, 1 in 3 Americans will have diabetes, compared to 1 in 11 adults in 2017. Currently 15% of the diabetic population develops a foot ulcer, leading to an amputation every 30 seconds. PediSense aims to prevent amputations resulting from diabetic foot ulcers (DFU). Our vision is to create effective and affordable products that help diabetes patients lead better daily lives. At PediSense, we have developed a strong team of four with expert engineers, diabetic researchers, business strategists and a patent attorney. Additionally, we have two mentors with over 50 years experience in the medical device industry and academic engineering labs. Diabetic foot ulcers progress from diagnosis and daily monitoring to the complete ulcer development followed by infection and eventual amputation. All current ulcer therapies either deal with daily monitoring of one biomarker for disease progression or focus on wound management using bandages and/or static pressure offloading boots.
Our Smart Offloading Boot has the common ability of sensing biomarkers around the foot, yet is unique in its ability to respond to these biomarkers. For example, if the area of the foot suffering from an ulcer has too much pressure on it, the boot can offload this pressure from the region.
Our strategy is to partner with hospitals and healthcare providers to ensure that our product is being used by patients and accepted as a reimbursable medical device by insurance companies. After creating a prototype, we will aim for FDA certification as a class 1 medical device. Regarding our financial model, insurance companies and hospitals systems are our main stakeholders as our product aims to reduce the 330,000 annual amputations in the US. An amputation costs roughly $25,000 while our ulcer boot costs $1,000, which is a huge cost savings benefit aside from improved patient quality of life.
PediSense will reduce the burden of diabetes in patient lives by preventing invasive, costly amputations.