Real-time renal diagnostics technology



This project is dedicated to real-time renal diagnostics. Its flagship product changes the practice of ICU and critical care management by providing continuous, automatic monitoring of urine flow. This facilitates early detection of changes in renal function and the risk of Acute Kidney Injury (AKI) - enabling rapid intervention, better patient care, and improved ICU economics.

Over 50% of ICU patients develop AKI (a rapid deterioration of kidney function), requiring an average of 3.5 additional hospital days and $15,000 of additional hospital costs per patient. Mortality rate is increased 5-fold in ICU patients with AKI. In China, around 4 million has developed AKI every year, and its amount is continuously growing. Especially, according to international multi-center research, the mortality has reached 60.3%.


Currently Technology VS This Project's Technology

Current approaches for monitoring kidney function are unreliable or too late:

Urine Bags: Unreliable Manual & intermittent measurements of urine volume

Detection of Creatinine: Too Late Creatinine can only be detected after 50% loss of kidney function. While In the ICU, time is of the essence. Especially for patients at risk of Acute Kidney Injury (AKI). Early detection of changes in renal function is critical for preventing disease progression. That’s where real-time monitoring of urine flow can make all the difference. This project’s technology can continuously measures urine flow, automatically transmitting to the medical staff real-time data, and alerts of fluctuations, on a 24/7 basis. This information, which reflects changes in renal function, provides an early sign of AKI risk and facilitates rapid intervention. In addition, it is invaluable for monitoring treatment efficacy and managing fluid balance.

The system consists of the following components:

Electronic Sensor – easily connects to the external end of a Foley catheter, where it continuously and reliably measures critical fluctuations in urine flow. Real-time core body temperature can be measured with a temperature-sensing Foley catheter. ·

Console – embedded technology in the battery-powered, cordless bedside monitor calculates and transmits real-time data from the sensor directly to all hospital information systems, simultaneously displaying it graphically onscreen. ·

Intelligent Alarm System – alerts the medical team as soon as the patient’s urine flow rate is below the threshold set by the user for urine output/hour, based on the RIFLE, AKIN, and KDIGO criteria.


Market Potential

Market Potential(based on 400,000 ICU beds): 

1 console * $500 + 60 sensor kits * $80 = > $2 billion/year


Stage

Clinical Validation: Scientific papers of clinical trials conducted in 2016-17 at Hadassah Medical Center and Herzog Medical Center in Jerusalem have been published in peer-reviewed, critical care journals, and presented at international conferences. New York’s Mount Sinai Hospital ICUs have been using the product since mid-2017, and two multi-center trials are running since beginning of July 18 at leading US medical centers. And From 2010 to 2016 the Company raised over $7.5M. In 2017 the company raised a $3M convertible bridge loan from current shareholders, in anticipation of a first venture round of $10-12M in Q3 2018. This upcoming round will take the company to commercialization and break-even.


Project Needs

This company is going to raise $10 million to fund company through break-even.