ExoStat Medical, Inc.

? 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

Presentation from Dr. Jacques Creteur on tissue perfusion. His conclusions? - Tissue perfusion alterations are commonly observed in patients with severe sepsis and septic shock - Persistent tissue perfusion alterations are associated with a poor outcome - These alterations are, in some cases, independent of systemic variables and are difficult to be detected using the classical systemic hemodynamic monitoring devices - Tissue perfusion monitoring could be used to identify patients with persistent alterations in tissue perfusion and to ensure that an improvement of the macrocirculation really results in an improvement of the tissue perfusion - The impact of tissue perfusion-targeted resuscitation on survival of critically ill patients needs yet to be investigated https://lnkd.in/g9d-DZEq

The Next Generation of Bedside Monitoring: Tissue pCO2?and Microcirculation Dr. Wanchun Tang (one of our Senior Medical Advisors) was invited to address the National Critical Care and Emergency Conference in China. He focused on using pCO2?data as a guide to monitoring tissue ischemia (hypoperfusion). This data will allow for a rapid response in a compromised critical care patient. The slides of this presentation are at the link below. https://lnkd.in/g23AWrbY

The SEPSIS Act Via the American Hospital Association: “Recently, Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa.…introduced the?SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care.“ We believe our newly approved FDA device, the MicroTREND, can play an important role in studying and improving sepsis care through real-time, non-invasive monitoring of tissue hypoperfusion. We believe advancements in tracking microcirculation can lead to advancements in both preventing and treating sepsis and other forms of shock. https://lnkd.in/g3wc7U2b