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Real-time renal diagnostic to prevent ICU-acquired Acute Kidney Injury (AKI).

Periodic Reporting for period 1 - Clarity (Real-time renal diagnostic to prevent ICU-acquired Acute Kidney Injury (AKI).)

Reporting period: 2019-11-01 to 2020-02-29

Hospital-acquired Acute Kidney Injury (AKI) is a prevalent and serious problem, associated with significantly increased morbidity and mortality. According to the Global Burden of Disease (GBD), each year around 1.7 million people worldwide are estimated to die from AKI. AKI develops in over 57% of ICU patients, requiring an average of 3.5 additional hospital days and €13,000 of additional hospital costs per patient. The best treatment for AKI is prevention. Although there is no curative therapy for AKI, research over the past decade identified various means to prevent or limit AKI. Unfortunately, these are not widely known and are variably practiced worldwide resulting in lost opportunities to improve the care and outcomes of patients with AKI.

RenalSense introduces Clarity Stream, the first critical care monitoring system that continuously measures urine flow, automatically transmitting to the medical staff real-time data and alerts of fluctuations, on a 24/7 basis. Clarity Stream measures, analyses and interprets the continuously changing composition and flow volume of urine. This way, it contributes to prevent AKI insurgence or, if AKI develops, support healthcare personnel in the monitoring and assessment of treatment efficacy.
From November 2019 to February 2020, RenalSense completed a full analysis of the technical and business potential of Clarity Stream during the EIC Accelerator Phase 1 project.

In terms of technical feasibility, RenalSense produced a Product Development Plan, confirming the main steps to make new generation Clarity Stream ready for the market: product finalisation, clinical validation, and preparation & submission of CE marking application. The company investigated user needs and how the device can overcome current challenges related with AKI prevention and treatment. It was confirmed that the solution meets hospitals' requirements and has the potential to lead to significant advances in AKI diagnosis and monitoring compared to the state-of-the-art practices. During Phase 1, the company identified all the needed external parties to ensure the product development plan is successfully implemented, including all manufacturers for device production and the medical centres for the conduct of clinical studies. Finally, as the regulatory pathway of medical devices is complex and a new Directive is going to enter into force in May 2020, RenalSense revised the regulatory requirements to achieve market authorisation in the EU.

In terms of business feasibility, RenalSense confirmed the most suitable and scalable business model and drafted a commercialisation plan defining the best approach for an accelerated and effective market uptake. RenalSense will sell to healthcare providers through distributors. RenalSense will start commercialisation in the EU, later followed by the USA, Asia, Middle East and Africa. RenalSense expanded its knowledge about competitors and confirmed that the value propositions of Clarity Stream go beyond the technological solutions currently available on the market.

With positive financial projections and promising results emerged from the feasibility assessment, RenalSense concluded that it is vital to pursue the proposed development of Clarity Stream in order to have a wide impact on the EU patient monitoring device market and increase health outcomes of AKI patients.
The best treatment for AKI is prevention. There is increasing recognition that even a minor acute reduction in renal function is independently associated with a poor outcome, including higher risk of complications, longer hospital stays, high mortality, and increased risk of needing long-term dialysis. Nevertheless, urine flow is the only vital parameter that is still monitored manually and intermittently.

Clarity Stream is the response to this still unmet medical need. The technology will be able to provide accurate, constant monitoring of critically ill patients, which is crucial to prevent kidney failure or manage exacerbations and minimise outcome severity and costly interventions. The reliable and continuous real-time information on urine flow assessed by Clarity Stream will help prevent AKI, as well as help to monitor the stage of the disease and responsiveness of patients to fluids and diuretics. Reducing the impact of AKI and improving fluid management will improve both patient care and hospital economics. Shorter lengths of stay and reduced readmissions can dramatically lower costs, increase patient turnover and improve the critical care wards' efficiency and performance. The device will also contribute to avoid complications or morbidities in the long term (e.g. dialysis), overall increasing health outcomes and better quality of life for patients.
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