The invention proposes an innovative system for the early diagnosis of acute renal failure (AKI) by monitoring diuresis for hospitalized patients in intensive care. The system is able to provide the attending physician in real time with the information necessary to be able to intervene promptly and prevent the onset of AKI with proprietary artificial intelligence algorithms.
U-Care Medical market is represented by all healthcare facilities (public hospitals, private hospitals, nursing homes) having catheterized patients at risk of developing AKI. The market is then segmented as follows:
- Intensive and sub-intensive care unit: patients staying in this department have a high incidence of AKI, thus they need to be constantly monitored and cause high expenditures for the hospital; in addition, ICUs have a high nurse/patient ratio;
- Department with high AKI risk in the post-surgery: nephrology-urology, cardio-surgery, cardiology, pneumology, thoracic surgery. These patients have a high probability of incurring in AKI; thus, they have a lower monitoring than the ICUs patients, but still highly monitored and they have a high nurse/patient ratio;
- Long-term: AKI incidence is slow, plus they are less monitored, thus having a low nurse/patient ratio;
- Nursing homes: in these facilities AKI is relatively low; however, there’s a high incidence of catheterized patients and a low nurse/patient ratio.
Acute Kidney Injury (AKI) is a syndrome attacking kidneys causing a rapid decline in their functional capabilities. In most cases AKI occurs in conjunction with other diseases, typically related to cardiovascular and respiratory systems. For this reason, patients with the highest risk of incurring in AKI are older people, diabetic people, or people affected by hypertension and those having heart failure.
In a general context of critical medical status of the patient, the lack of the function of purification and regulation carried out by the kidneys worsen the clinical condition turning out to be a fatal aggravating, contributing to the death of the hospitalized in 13% of cases and causing a 10 fold increase in mortality rate.
The main problem related to AKI is the difficulty in having a timely diagnosis of the syndrome. Indeed,
the gradual loss of renal function, which leads to an AKI episode, is not clinically observable by monitoring physiological parameters or by looking at clinical examinations results. Therefore, the physician is not able to conduct specific therapies to prevent AKI, since there isn’t information about renal function and the risk of getting AKI.
Current Technology Limitations
The market for predicting acute kidney failure is currently characterised by a low level of competition. The competitors are divided in 2 groups: companies using Biomarker (indirect competitor) and companies developing devices for continuous monitoring of kidney functions (direct competitors). Some competitors have announced to be starting a software development phase to develop a technology based on artificial intelligence for the prediction of AKI risk levels. However, no data on clinical trials of such algorithms have been made public to date, nor any information on the progress of their development. On the global market there is one main direct competitor (Potrero), operating in the United States, which uses different and complex physical principles to monitor urine outuput. The two indirect competitors (Astute Medical and BioPorto) have developed chemical biomarkers for the early detection of AKI, operating in the US and European markets.
The U-Care product consists of an early prediction system for acute kidney injury episodes in patients admitted to intensive care units. In this context, the high incidence of acute kidney injury and high healthcare costs allow U-Care to deliver the highest value to its customers. The product consists of a sensor to monitor the patient and an AI algorithm to predict kidney failure.
Our Technology and solutions
U-Care Medical is willing to bring to the market a digital biomarker able to solve the problems related to late and underestimated diagnosis of AKI. For this purpose, it has been filed a patent focused on a new method of measurement urine output and prediction of renal failure, made of a hardware and a software component
In order to perform its functions, the device uses two different algorithms:
- Monitoring algorithm: it consists of an algorithm having more input data about the patient (gender, age, creatinine, etc.) and real-time gathers data of urine output. Besides, after 6 hours of data gathering, the algorithm is able to provide the actual AKI risk score of the patient;
- Artificial Intelligence algorithm: it’s an algorithm that starts running after 6 hours from the beginning of patient stay within the ICU. Through artificial intelligence models, it quantifies automatically, continuously and real-time the risk for the patient to develop an AKI episode in the next 12 hours, thus providing the physician with an instrument to determine the best therapeutic strategy to prevent and avoid future AKI episodes.
U-Care Medical has the advantage of being very accurate and very simple at the same time, thus allowing keeping production costs low and offering an extremely accurate output data; this results in a cost advantage.
Chemical biomarkers, such as those offered by companies Astute Medical and BioPorto, have the disadvantage of being discreet tests over time, not guaranteeing a continuous monitoring of the patient’s health status; plus, they are manual, thus requiring the intervention of an operator. Secondly, the accuracy of the device is one of the key features, as the competition in the industry is mainly based on the performance offered by the technology. The performance of Astute Medical and BioPorto, in terms of sensitivity and accuracy in assessing the level of risk of developing patient AKI are low, which is why market penetration is still very limited and their use is mainly for research purposes.
The activities of the next few years aim to bring U-Care technology to the market. To achieve this, it will be necessary to obtain CE certification and FDA approval. To this end, several prospective multicenter clinical trials are being prepared for the clinical validation of the technology. A 500k € Seed round and a subsequent 2M € round A will be required to obtain the certifications and enter the market.