Yokne’am Illit-based med-tech company Serenno Medical has pioneered a device that automatically monitors kidney function and detects kidney damage in hospitalized patients.
According to Serenno Medical, continuous assessment of kidney function allows for the early detection of acute kidney injury (AKI), “a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization.”
AKI affects approximately 19 million patients worldwide every year, with 300,000 deaths yearly in the US . It occurs in 60% of all ICU patients and 10% of all hospital admissions.
Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring kidney function, Serenno Medical said.
But the problem is that “UO is currently monitored intermittently and manually by ICU nurses,” CEO Tomer Lark told The Jerusalem Post last Wednesday.
“The overworked nursing staff measures a single patient once every hour, sometimes only once every two hours,” he said. “It is the only parameter still measured manually in the ICU, while the monitoring of all the other vital signs is fully automatic.”
As a result, instances of reduced urine flow, indicating possible kidney damage, can go undetected.
“The completely automated Serenno system offers a solution to this problem,” Lark said. “Using our device, nurses receive dramatically more UO data and are also automatically alerted to any change in kidney function, thus have more time to attend to their patients’ needs.”
He said the idea of the system began when University Hospital Brussels ICU director Dr. Manu Malbrain approached Serenno founder Noam Hadas with a problem about how to monitor a different parameter in the ICU called intra-abdominal pressure (IAP).
“During the research phase and while developing the solution to the IAP problem, we discovered a new way to monitor both IAP and UO,” Lark said. “Monitoring both conditions is critical to the patient and lifesaving. As UO is better understood by most physicians and monitored in all ICU patients, we decided to focus first on this parameter.
“But our device accurately measures both parameters in a fully automatic and continuous manner,” he said.
The kidneys are the body’s waste-filtering system, Lark said.
“They clear the body of unwanted materials by separating blood from waste, which is then excreted from the body in the form of urine in a stable and ongoing process,” he said. “Changes of little to no urine, even in short durations, are indicative of developing kidney problems.”
Serenno’s system offers continuous and automated monitoring of UO, and it is able to pick up on these changes “in real time and immediately alert the medical staff while there is still time to intervene and prevent further damage,” Lark said.
The Sentinel device offers a simple and cost-effective solution for the precise, continuous measurement of urine flow rate in real time, the company said in a statement.
“The device works in synergy with existing hospital equipment (any catheter and bag) and requires a short and simple, non-invasive installation,” it said. “It fits the complicated ICU and operating room environments and is fully functional in any patient condition or hospital environment.”
The company hopes to receive FDA clearance this year, which will be followed by initial sales in the US by the end of the year, Lark told the Post. The plan is to add additional countries pending regional regulatory approvals.
In addition to securing funding and strategic partnerships, Serenno Medical “will focus on manufacturing of the Sentinel device for market penetration later this year,” he said. “To support this process, we will also continue with additional clinical trials in Europe and the US.”
In 2021, the company plans to add more features to the device, including the sampling of additional urine parameters and monitoring of intra-abdominal pressure, Lark said.
Serenno Medical was founded in 2017 and is a portfolio company of Alon Medtech Ventures, owned by Dr. Shimon Eckhouse, an entrepreneur and investor in the field of medical devices and medical technologies.