Serenno Medical, a developer of medical devices for hospitalized patients, said Wednesday that Israel’s Elcam Medical, a producer of medical devices, has invested $1.5 million in the company and will also manufacture the startup’s urine monitoring device.
Serenno, based in Yokne’am Illit, Israel, has developed an output and intra-abdominal pressure digital monitoring device for the detection of acute kidney injury (AKI).
The company said that its Sentinel device offers a “simple and cost-effective solution” for precise, continuous measurement of urine volume and flow rate in real time. The system promotes early detection of kidney injury by detecting small changes in kidney function. This allows remote detection by medical staff, allowing for intervention to prevent further damage.
Continuous kidney function assessment allows the early detection of AKI, a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization. Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring changes in kidney function. UO is currently monitored intermittently and manually by ICU staff, so acute changes in urine flow are difficult to detect. Thus, kidney injury is often detected relatively late, sometimes too late to prevent further progression.
Acute kidney injury often afflicts patients hospitalized with COVID-19, the illness caused by the coronavirus. The hands-free non-invasive Sentinel device allows medical personnel to reduce their exposure to patients yet allows them to be alerted to conditions that require immediate attention, the company said.
A first multicenter clinical trial conducted with the Sentinel system showed high reliability and accuracy in a wide range of environments and patient conditions, including low and high urine flow rates, regardless of patient position, during surgical procedures, and including continuous monitoring of patients in a mobile hospital bed. The clinical trial, conducted at three ICU units in Sheba and Rabin Medical centers in Israel, included more than 40 patients and over 1,300 hours of monitoring. Results showed over 96% accuracy and reliability, the company said last year.
The partnership with Elcam will combine Serenno’s technology with Elcam’s manufacturing ability to deliver “high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments,” Serenno said in a statement.
“The investment by Elcam Medical…will allow us to swiftly move toward commercialization of our device,” said Tomer Lark, Serenno’s co-founder and CEO. “Elcam’s world class production capabilities and experience, will enable mass production and increased market access of Sentinel. Our plan is to begin deployment of the devices in several US hospitals towards the end of 2021, in the hope to eventually reduce kidney failure risk for every patient at ICUs.”
Elcam Medical joins existing investors Alon Medtech and entrepreneur Shimon Eckhouse.
“Our investment in Serenno and the establishment of a production line for its device is aligned with Elcam’s strategy to cooperate with promising Israeli startups to deliver products with added value for the patient,” said Igal Kohn, Elcam Medical’s CEO, in the statement.
Founded in 2017 by Noam Hadas and Tomer Lark, Serenno is a portfolio company of Alon Medtech Ventures, an incubator founded and owned by Eckhouse, an inventor, entrepreneur, and investor in the field of medical devices and medical technologies. Sentinel is Serenno’s flagship product.
Elcam Medical is a producer of disposable medical devices and components for the OEM market. The firm has manufacturing facilities in Israel and Italy and representation within the US, Europe, China, Japan and South America.
Based in Yokne’am, Israel, Alon MedTech Ventures incubator is supported by the Israel Innovation Authority (IIA) and operates under the IIA incubator program. Alon MedTech invests in and partners with entrepreneurs to grow innovative medical device ideas into companies.