Serenno Medical successfully concludes first human clinical study

Serenno Medical developing an innovative and robust medical device for automatically monitoring and detecting kidney damage in hospitalized patients, giving the medical staff early warning and allowing for an effective and minimal intervention when needed.

Ongoing kidney function assessment is enabling the medical staff to detect and avoid a common and life-threatening danger - Acute Kidney Injury (AKI), that significantly increase risk of mortality during and after hospitalization.

The Serenno Sentinel has shown good excellent performance in an ongoing multicenter ICU FIH clinical trial. The device is showing high accuracy for all ICU patients, including low and high flow rates, regardless of patient or tubing position, while patients are undergoing surgical procedures, including continuous monitoring of patients in a moving bed from the ICU to the OR or other areas of the hospital and back.

Serenno recently concluded the first clinical trial with the “Sentinel” system, showing high reliability and accuracy in a large range of patient conditions. The clinical trial included more than 40 patients and over 1,300 hours of monitoring. The trial was conducted in 3 ICU units in Sheba and Rabin Medical centers in Israel.

Patients in hospital wards in general and in ICU’s in particular, receive a wide variety of drugs and fluids as well as other interventions, some of which have a negative effect on kidney function resulting in a high percentage of patients developing mild to severe kidney damage that may require dialysis or a kidney transplant. This damage is irreversible by available treatments, so early detection to avoid it is critical. Accurate and high time resolution urine monitoring is clinically accepted world-wide as the best method of achieving this goal. Sereno’s Sentinal product is a simple, cost effective and very accurate solution to this critical patient monitoring need.

The Sentinel, Serenno’s first product, aims to detect small changes in kidney function, continuously, accurately and with significantly less workload by the nursing staff. The device works in synergy with existing hospital equipment and requires short and simple, non-invasive installation. It fits the complicated ICU and operating room environments, and is fully functional in any patient or environmental condition.

Serenno Medical, operating since August 2017 from Yokneam, is part of Alon Medtech Ventures, owned by Dr. Shimon Eckhouse, a pioneer technological entrepreneur and a leading investor in the field of medical devices. Leading the company are Tomer Lark and Noam Hadas, with significant experience in medical device development and vital sign monitoring.

“We are happy and proud to successfully complete our first human use of the device in leading medical centers in Israel proving the unique feature set of the device. This trial will allow the company to move forward to the device manufacturing phase and enable us to bring this best in class product to the global medical markets. We believe it will become a “must have” in the OR and ICU, benefiting millions of patients around the world.” Said Tomer Lark, co-founder and CEO of Serenno.

Dr. Shimon Eckhouse chairman and owner of Alon Medtech said "Sereno has developed an original product that will bring tremendous value to patients hospitalized in ICUs along with a simple digital solution that will bring great economic value to hospitals. Such a successful completion of Serno's clinical trial is a great testament to the company's product quality and performance."