R&D for a Virtual Ward Sensing Device for High-Risk Chronic Patients

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WarnerPatch is a medical device for non-invasive remote monitoring (virtual ward). It measures tissue health to predict disease worsening using a specifically designed sensing method and developed AI-algorithm. While being used at the hospital or at home, early degrading symptoms are identified so clinicians can give preventive care to improve patient outcomes and reduce care costs.We are focusing on diabetes and vascular diseases (i.e. peripheral vascular disease (PVD)), which can be the result of, or cause, heart attack, stroke, general infection, ulceration or gangrene, potentially leading to amputation and death.Worldwide, 200M people are at risk of developing this condition accounting for 13M in EU27, slightly more in the USA and 5M in the UK. Amputation is performed on 600K patients a year, with 50% death rate within two years after amputation and 30% of unnecessary amputation due to late recognition of disease-worsening.During the pandemic and with the long COVID-19 syndrome, the number of patients requiring emergency hospital care has increased by 60%, significantly stretching the current remaining resources.The minimum viable product development was finalised with its AI-algorithm and tested/validated in a simulated environment.The goal of this project is to finalise the R&D of the physical product under regulatory requirement while improving the product manufacturability including recycling/refurbishment processes of non-critical parts. At the end of the project, we will be able to start the certification processes for commercial activities. We will continue working with the Leeds-Teaching-Hospital-NHS-Trust (LTHT) and NHS-Arden-and-Greater-East-Midlands-Commissioning-Support-Unit (AGEM) for a more detailed data-pack development with health-economics (budget-impact and cost-effectiveness).Using our device will improve patient outcomes while reducing care costs by:1. Quickly identifying patients at risk of developing life threatening conditions, to treat patients earlier and stop the illness from worsening: reducing hospital ICU and A&E admission/visits.2. Helping clinicians stratifying patients for closer monitoring.3. Assisting in social distancing of fragile and high-risk patients with continuous remote monitoring.4. Assisting in the safe early discharge of low-risk patients whilst monitoring their condition status remotely; reducing bed-days and staff burden, and, freeing-up capacity in clinical facilities.