Accuryn Medical Receives CE Mark for the Accuryn® Monitoring System.

Hayward, California – July 2, 2019 – Potrero Medical has received CE mark in the European Union for its technology platform, the Accuryn® Monitoring System.

The company received its FDA clearance in 2016 when it transformed the traditional urinary catheter into a smart sensing platform that helps to accurately monitor vital signs in real-time, such as urine output (UO) and intra-abdominal pressure (IAP). Traditional urinary catheters have issues draining urine from the bladder, causing inaccurate UO measurements. Using active drain line clearance, the Accuryn® Monitoring System automatically clears the drainage line as needed.

“Urine output monitoring is an important field that has stagnated for decades. Based on my personal experience using Accuryn® in our burn unit, I can say that this device establishes a new state of the art,” said Dr. Bruce Friedman, clinical care co-director of the Joseph M. Still Burn Center. “Accuryn® is able to eliminate the obstruction of urinary outflow that is ubiquitous in current urine drainage systems. Solving this problem significantly improves the accuracy and diagnostic value of urine output monitoring.”

The company is also developing an artificial intelligence platform that would analyze the clinical data to enable interventions hours before the standard of care. One of those interventions is focused on Acute Kidney Injury (AKI). 

Today, almost 50% of all ICU patients suffer from AKI, a devastating condition that is responsible for nearly 300,000 deaths a year in the U.S. alone.^1,2

In the United Kingdom, the annual cost of AKI-related inpatient care is estimated at £1.02 billion, just over 1% of the NHS budget.³  However, clinical reports have demonstrated that intensive monitoring of urine output can improve the early detection of AKI and reduce the risk of death.⁴

“Because Accuryn® finally provides accurate measurement of the kidney’s performance through real-time urine output, it opens up many future opportunities to improve patient care, reduce complications, and save money. Physicians will be able to have more precise fluid management, immediate insight into end-organ response to fluid/diuretic challenges, and quickly identify impending disease patterns such as acute kidney injury and sepsis” explained Dr. Gregory Schears, Professor of Anesthesiology & Critical Care, Mayo Clinic.

“Our mission is to give physicians deeper, scientific knowledge of how these complex fluid systems work in the body, providing hours instead of minutes to respond and prevent life-threatening events. That has the potential to shift paradigms” commented Joe Urban, CEO of Potrero Medical. “We are excited to expand our commercial footprint and bring our technology to European hospitals.”

1. Case J, Khan S, Khalid R, Khan A. Epidemiology of Acute Kidney Injury in the Intensive Care Unit. Crit Care Res Pract. 2013. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3618922/
2. Lewington AJ, Cerdá J, Mehta RL. Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney international. 2013;84(3):457-467. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3758780/pdf/nihms463902.pdf.
3. Kerr M., Bedford M., Matthews B., O’Donoghue D. The economic impact of acute kidney injury in England. Nephrol Dial Transplant. 2014;29(7):1362–1368. https://www.ncbi.nlm.nih.gov/pubmed/24753459The
4. Jin K, Murugan R, Sileanu F et al. Intensive Monitoring of Urine Output Is Associated with Increased Detection of Acute Kidney Injury and Improved Outcomes. Chest Nov 2017;152(5): 972-979. Available at: https://www.sciencedirect.com/science/article/pii/S0012369217309339

About Potrero Medical

Potrero Medical is a predictive health company that is developing the next generation of smart sensors and artificial intelligence.

The Accuryn® Monitoring System transforms the traditional indwelling urinary catheter (IUC) into a next-generation diagnostic tool for precise, real-time measurement of intra-abdominal pressure (IAP), urine output (UO) and core body temperature to help guide care. 

Currently, Potrero Medical is developing a predictive health platform to help medical teams better predict adverse outcomes in critical care settings. The Accuryn® Monitoring System is not cleared for prediction of disease states or clinical conditions.