Potrero Medical said today the National Institute of Health is sponsoring the Prescient study, which will examine the company’s Accuryn monitoring system designed to detect physiological signatures of critical illness, including sepsis.
Potrero’s Accuryn critical care monitoring system uses a urinary catheter to deliver real-time, actionable data on urine output, core temperature and intraabdominal pressure, the company said.
“This study is intended to test the Accuryn system as a potential new tool for patient monitoring and treatment in the ICU. The device has the potential to provide an early indication of sepsis and, perhaps more importantly, future studies of the additional capabilities of this device could lead to actionable data in guiding resuscitation,” Potrero clinical advisor Dr. Phillip Dellinger of Camden, N.J.’s Cooper University Health Care said in a prepared statement.
The San Francisco, Calif.-based company said it received $2.25 million in Small Business Innovation Research grants from the NIH’s National Institute of General Medical Sciences to run the study.
“We are excited to have enrolled our 1st patient in the Prescient study which will contribute significantly to the understanding of the physiologic signatures of a variety of critical illnesses in the ICU. This understanding may ultimately lead to earlier detection, and possibly even prediction, of these highly morbid and costly illnesses,” lead study investigator Dr. Raul Coimbra of the University of California San Diego, Hillcrest said in a press release.
The multi-center Prescient study is slated to enroll up to 100 patients in the U.S. to study the Accuryn system, which currently has an investigational device exemption from the FDA.
“Initiation of this study is another important milestone for us and another step on the path to creating what we believe will be a new gold standard diagnostic platform for the detection and treatment of critical illness. We are thrilled to have the support of Dr. Coimbra, Dr. Dellinger and other leaders in critical care who share our vision for Accuryn as a potentially life-saving and cost-saving solution,” CEO Dr. Daniel Burnett said in prepared remarks.