ExoStat Medical, Inc.

Important section on POMCO2 vs. blood lactate with our #MicroTREND System in the recent Resuscitation Plus journal article by Dr. Raúl J. Gazmuri: ✅Outperforming blood lactate measurements ✅ Of substantial translational relevance is that POMCO2 outperformed blood lactate measurements, timely tracking the changes on blood volume and the corresponding hemodynamic and metabolic effects. Lactate is commonly measured in circulatory shock to aid in the diagnosis, assessment of severity, monitoring responsiveness to treatment, and prognosis; especially in septic shock despite receiving only a “weak recommendation” by the surviving sepsis campaign guidelines. Lactate is a multifunctional signaling molecule influenced by a variety of metabolic process beyond tissue ischemia and also by sympathetic stimulation. In addition, as observed in our study, the lactate increase during hemorrhagic shock is slow and its reversal delayed upon correction of hemorrhagic shock, in part attributed to diminished plasma clearance. Moreover, blood lactate levels are measured intermittently, e.g., every two to four hours, lagging behind the underlying physiologic event (as observed in our study) precluding timely adjustment of interventions. In the ANDROMEDA-SHOCK clinical trial, guiding treatment base on capillary refill time compared to lactate measurements resulted in less vasopressor therapy, less fluid administration, less organ dysfunction at 72h, and a robust trend toward lower mortality. However, we believe these measurements are complimentary, with POMCO2 directly and continuously monitoring tissue perfusion enabling real-time titration of interventions and blood lactate intermittently assessing the severity of tissue ischemia along with effects that follow including resolution of sympathetic response, decreased catecholamine administration, lactate metabolism, and repayment of oxygen debt.

Another important section of this #hemorrhagic shock study done by Dr. Raúl J. Gazmuri in the December 2024 edition of Resuscitation Plus: ✅ Tissue PCO2: An early sensitive Sign of ischemia ✅ Elevation in tissue PCO2 during low-flow states results from two distinct sequential additive processes. Initially, a reduction in tissue blood flow while maintaining oxygen demands (i.e., before development of ischemia) prompts CO2 accumulation consequent to reduced clearance of aerobically generated CO2. Subsequently, further reduction in blood flow to levels that fail to meet the metabolic tissue demands prompts ischemia with anaerobic H+ generation following breakdown of high-energy phosphate compounds such as ATP. The excess of H+ is buffered by HCO3–producing CO2 (i.e., [H+] + [HCO3–] ⇆ [H2O] + [CO2]) accentuating tissue PCO2. 🩸🩸 Accordingly, an increase in tissue PCO2 is an early and sensitive marker of reduced organ blood flow enabling, if detected, to initiate therapeutic interventions even before tissue ischemia develops. 🩸🩸 #MicroTREND #shock #sepsis

A remarkable study done in the Dec 2024 edition of the journal Resuscitation Plus on #hemorrhagic shock using our recently FDA-cleared #MicroTREND System. The entire paper is an fascinating read and its conclusion is particularly important as it found that our non-invasive #MicroTREND System outperformed blood lactate measurement: “In conclusion, measuring POMCO2 with the MicroTrend™ System may provide a clinically practical means to monitor hemorrhagic shock, assessing its severity, clinical course, treatment effect, and reversal. POMCO2 outperformed lactate measurement which exhibited a delayed response, providing a quick real-time measurement by only clipping a sensor to the cheek of a patient.“ Thanks to Dr. Raúl J. Gazmuri MD, PhD, FCCM and the entire Rosalind Franklin University of Medicine and Science team for their impressive work. https://lnkd.in/ewimXDSi

✅ ExoStat Medical Receives FDA Clearance For Novel, Real-Time, Oral Tissue Perfusion Sensor System ✅ The first-of-its-kind MicroTREND provides early detection of symptoms of tissue hypoperfusion, allowing for rapid intervention and treatment of this life-threatening medical emergency November 12, 2024 - ExoStat Medical, a privately-held medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its MicroTREND System. The MicroTREND was designed to directly detect and monitor tissue hypoperfusion at the microcirculatory hemodynamic level (oral mucosa) as it manifests into a dangerous medical emergency. The MicroTREND incorporates an electro-conductance platform with a disposable sensor that is seated non-invasively in the oral mucosal tissue of a patient, a convenient and accessible site from which to measure pCO2 , a clinically proven marker for tissue hypoperfusion. See link below for full press release. https://lnkd.in/gh9c4ewq

A short, simple overview of our FDA-cleared #MicroTREND System. Know. Now. #tissuehypoperfusion #shock #sepsis #microcirculation

Thanks for the shout out, Synapse Partners. We’re excited about our FDA 510(k) clearance for our #MicroTREND system after well over a decade of dedicated R&D. We believe understanding and monitoring the world of #microcirculation and tissue #hypoperfusion can improve patient outcomes in the world of #criticalcare. Lots of good things to come! The MicroTREND System - Know. Now. #sepsis #shock

Check out our recently FDA approved MicroTREND device - it can help with the microcirculation monitoring in a novel way.

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis - Part III: Buccal CO2 as a Measure of Convenience   by Michael R. Pinsky, MD and Jacques Creteur, MD Buccal CO2 as a Measure of Convenience: The oral mucosal constitutes an ideal site to measure tissue CO2, especially if the sensing probe is isolated from ambient air and can be seated in a patient’s mouth with minimal discomfort. Numerous studies have documented that both sublingual and buccal mucosal CO2 levels track circulatory stress in a quantitative fashion. In experimental models of hemorrhagic shock, sublingual CO2 levels rapidly rise before hypotension develops and fall during resuscitation only after total cardiac output is restored, even though blood pressure is restored earlier.   All forms of circulatory shock, if associated with an initial decrease in cardiac output, will be associated with a rise in buccal CO2, and this rise will occur early during the adaptive stage of shock when blood pressure remains normal. The two most common forms of shock are hemorrhagic and septic shock. Both initially present with decreased blood flow, though for different reasons. Thus, monitoring buccal CO2 levels for its increase in a patient at risk for sepsis or bleeding constitutes a reasonable cost-effective early warning monitor. Indeed, buccal CO2 monitoring may represent an ideal tool for a non-invasive monitor that can be applied early so as to target high-risk patient subgroups without fear of iatrogenic complications or false negative results. Buccal CO2 may also be used to titrate resuscitation therapies, although most clinical studies show that the major benefit of any monitoring in septic shock comes from its early identification, triggering early appropriate antibiotic use and initial fluid resuscitation.

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis - Part II: Tissue CO2 as a Solution   by Michael R. Pinsky, MD and Jacques Creteur, MD   Tissue CO2 as a Solution:  What is needed is a monitoring device that can identify decreasing tissue blood flow prior to impaired metabolic function. Since tissue can sustain oxidative phosphorylation (the central process of energy production of the cell) well into low blood flow states, both O2 extraction by the tissue and carbon dioxide (CO2) production remain relatively constant in a tissue bed as local blood flow initially declines. Although tissue O2 can be measured, owing to the heterogeneity of metabolic rates and the slow diffusion of O2 into the tissues from the blood, its measure to assess early forms of circulatory shock is poor. CO2 can also be measured and, in contrast to O2 measurement, changes in tissue CO2 levels can accurately track changes in local blood flow within physiologic limits owing to the high diffusing capacity of CO2 to cross lipid barriers and fluid spaces. Thus, a device that measures tissue CO2 levels could be very helpful in identifying early shock, as CO2 levels will rise well before tissue ischemia. This same device could be used to tract the effectiveness of resuscitation efforts, as CO2 levels will decline to their baseline values again once local blood flow returns to its baseline values.

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis - Part I: The Problem   by Michael R. Pinsky, MD and Jacques Creteur, MD   The Problem:  Circulatory shock is defined as an inadequate oxygen (O2) delivery to tissue to sustain metabolic demand. If arterial oxygen content is adequate, then tissue ischemia develops only at the very extremes of low blood flow. Well before that time, normal physiologic adaptive mechanisms controlled by the autonomic nervous system and mediated primarily through increased sympathetic tone tend to sustain an adequate central arterial blood pressure despite falling total blood flow. Once this regulatory process is exhausted, however, systemic hypotension develops. Thus, systemic hypotension, defined as a mean arterial pressure <65 mmHg or a systolic arterial pressure <90 mmHg, occurs late in shock when tissue hypoperfusion is already compromising metabolic function. If circulatory shock associated with systemic hypotension persists, then generalized tissue ischemia manifests as end-organ failure, lactic acidosis and autonomic failure. If the bedside clinician waits for systemic hypotension to recognize circulatory insufficiency before treating their patient for circulatory shock, then he will have waited too long. #shock #hypoperfusion #sepsis #circulation