ExoStat Medical Shares Early Positive Results of Septic Shock Study

Early conclusions from an ICU observational septic shock study show that ExoStat Medical Inc.’s MicroTREND System can help validate oral mucosal partial pressure CO₂ (PomCO₂) as an early indicator of septic shock in critically ill patients.

The MicroTREND System, which non-invasively monitors microcirculatory tissue perfusion in real-time at the bedside, produces data that could—as an adjunct tool—enhance the value of information currently gathered by macrohemodynamic tools currently considered standard protocol, the study concluded.

ExoStat Medical recently completed the world’s first IRB-approved, ICU observational septic shock study to assess the efficacy and clinical utility of oral mucosal partial pressure PomCO₂ as a parameter for determining microcirculatory tissue perfusion status. Conducted at the Second Affiliated Hospital of Anhui Medical University (Hefei, China) the study enrolled 23 septic shock patients and assessed the role of bedside oral mucosa tissue monitoring PomCO₂ as an early septic shock dysfunction indicator. The study completed a comparative analysis of current standards of care including serum lactate, currently considered the gold standard for tissue perfusion evaluation. Principal Investigators of the study are currently preparing the results for near-future publication.

“This first-ever study marks a major milestone for critical care, for ExoStat, and for me as it has been a 40-year project that started with the Weil Institute in the 1980’s,” ExoStat Senior Technology and Medical Advisor Wanchun Tang, M.D., said. “For the first time ever, physicians were able to view, in real time, the very early and ongoing signs of microcirculatory dysfunction due to tissue hypoperfusion. Every moment matters in septic shock and delays can be devastating to the patient. This device can produce actuals that can provide the physician with more reaction time. It is now well-understood that the current macrohemodynamic tools do not fully capture real-time metrics of the patient under care. This study finally brought what was hypothesis into reality. It was exciting to observe.” Dr. Tang later admitted that it was difficult to see the first measures on the monitor due to tears of joy.

The MicroTREND is a patented, U.S. Food and Drug Administration-cleared non-invasive monitoring system that detects PomCO₂ using a microsensor that sits atop the inner cheek buccal tissue. There are no needles, blood, catheters, or “lag in time” for required lab work. The importance of time cannot be overstated in treating all shock states, especially sepsis. All shock cases begin with tissue hypoperfusion—it is a common denominator.

“This study achieved the ultimate objective of ExoStat’s mission which was to provide microcirculatory perfusion awareness to physicians who treat the sickest of the sick”, ExoStat CEO Jim Hays stated. “We are excited to embark now on our second phase of pre-market clinical testing being planned with iconic research institutions where we will focus on achieving a better understanding of the effect of current standards of care on microcirculation. These are exciting times indeed.”

ExoStat Medical Inc. is a privately-held medical device company in Prior Lake, Minn. The research and development quest to create the MicroTREND began in 2008 as a vision of Max Harry Weil, M.D., who is often called “the father of critical care medicine.” The technology platform developed by ExoStat provides data to enable physicians to assess and to treat microcirculatory hypoperfusion, a life-threatening medical emergency.