August 4, 2021
ExoStat Medical announced today that the company has submitted a 510(k) application to the U.S. Food and Drug Administration for commercial clearance of its MicroTrend™ System, a new technology platform that provides a non-invasive, hands free, point of care, disposable diagnostic sensor to measure and to monitor oral pCO2 as a marker for gastric tissue perfusion.
“This is an important milestone on our journey to provide medical care providers with gut tissue hypoperfusion data in its earliest state. Numerous studies have demonstrated that tissue hypoperfusion is a medical emergency that, if left unattended, can lead to ischemia, multiple organ dysfunction syndrome (“MODS”) and even death“ said Jim Hays, President/ CEO of ExoStat. “The need for this sensor was identified over two decades ago by Dr. Max Harry Weil and his associate, Dr. Wanchun Tang, while doing extensive research for The Weil Institute of Critical Care Medicine. The solution has been elusive until now. This is a phenomenal medical breakthrough that will save thousands of lives each year.”
Executive Chairman, Rick Gordon, added, “Our extraordinary team at ExoStat has focused its R&D efforts on this non-invasive sensor solution since 2008. We overcame challenge after challenge, and, with the strong support and collaboration of physicians, researchers, and professors around the world, we realized the final breakthrough last year. The company engaged Deloitte Consulting to provide a market study which identified enormous market opportunities in various medical settings including ICUs, surgical units, dialysis units and burn centers. The medical community has long wanted a reliable non-invasive device that can facilitate the early detection of tissue hypoperfusion, and it is finally here.”