ExoStat Medical’s PomCO2 monitoring breakthrough signals major step forward in septic shock detection

ExoStat Medical, a privately held medical device innovator based in Prior Lake, Minnesota, has completed the world’s first IRB-approved ICU observational study validating PomCO2 as a clinical indicator of microcirculatory dysfunction in septic shock. The American critical care technology company evaluated its patented MicroTREND system, a non-invasive bedside device that continuously measures oral mucosal partial pressure of carbon dioxide (PomCO2), in a cohort of patients diagnosed with septic shock. Results from the study demonstrated that the MicroTREND platform enabled real-time tracking of tissue perfusion changes, offering a potential breakthrough in critical care where early signs of sepsis-induced shock often go undetected by macrohemodynamic tools.

The 23-patient study was conducted at the Second Affiliated Hospital of Anhui Medical University in Hefei, China. It marks a pivotal moment for ExoStat Medical’s clinical validation roadmap as the firm prepares to initiate additional pre-market trials in collaboration with internationally recognized research hospitals. Institutional investors and critical care stakeholders are closely watching the device’s trajectory, as its real-time, needle-free functionality directly addresses long-standing gaps in sepsis management protocols.

How does PomCO2 measurement using MicroTREND improve early septic shock detection accuracy in ICU patients?

At the core of the ExoStat Medical innovation is its patented MicroTREND sensor, which monitors PomCO2 by gently adhering to the patient’s inner cheek, eliminating the need for needles, blood draws, or time-delayed laboratory diagnostics. This allows clinicians to continuously assess microcirculatory status in real time — a capability largely absent from standard ICU monitoring tools that focus on systemic, macro-level indicators such as blood pressure or lactate levels.

The foundational theory behind PomCO2 monitoring as a marker of microperfusion dysfunction has roots in the work of Dr. Max Harry Weil, widely regarded as the father of critical care medicine. Dr. Weil’s hypothesis, originating in the 1980s, centered on identifying indicators that could precede traditional shock symptoms. ExoStat’s study brings this long-held concept into bedside reality, according to Dr. Wanchun Tang, Senior Technology and Medical Advisor to ExoStat Medical and a principal architect of the study.

“For the first time, physicians were able to observe early-stage tissue hypoperfusion dynamically, rather than relying on lagging markers,” said Dr. Tang. “PomCO2 gives clinicians additional lead time to initiate potentially life-saving interventions.”

Why do macrohemodynamic monitoring tools fail to capture real-time microcirculatory dysfunction in sepsis?

Macrohemodynamic tools currently dominate ICU monitoring, including metrics like heart rate, mean arterial pressure, and serum lactate. However, analysts and institutional healthcare specialists point to a growing recognition that these indicators fail to fully capture perfusion at the tissue level. Serum lactate in particular, while considered the gold standard, reflects changes with significant time delay due to the nature of systemic metabolism.

In contrast, ExoStat’s MicroTREND platform enables continuous PomCO2 readings via buccal tissue, which are more directly tied to local tissue perfusion. According to the study’s initial findings, the onset of microcirculatory shock was detectable via PomCO2 before any discernible changes were visible in lactate levels.

This performance metric is especially relevant given the time-sensitive nature of septic shock. Studies estimate that every hour of delayed treatment increases mortality by 7–8%. ExoStat Medical’s device offers an immediate physiological feedback loop, a feature that aligns with current institutional imperatives focused on minimizing ICU dwell time and improving sepsis bundle response rates.

What are institutional expectations from ExoStat Medical’s follow-up clinical trials and commercial pathway?

Following the success of the Hefei-based ICU study, ExoStat Medical has announced the upcoming launch of a second-phase pre-market clinical trial series. These studies, to be conducted in partnership with leading research hospitals, will examine how standard ICU interventions influence microcirculatory patterns as measured by PomCO2, and whether the MicroTREND system can guide therapeutic adjustments in real time.

CEO Jim Hays described the forthcoming studies as “a direct continuation of ExoStat’s core mission — to bring actionable microcirculatory data to the clinicians treating the sickest patients.” He noted that discussions with academic partners have already begun and that institutional demand for a faster, needle-free approach to perfusion assessment is growing, particularly in ICU units where resource strain has escalated post-pandemic.

Industry observers suggest that broader market adoption of MicroTREND technology could hinge on the success of these expanded clinical evaluations, along with favorable reimbursement pathways and integration into existing ICU data platforms. There is growing alignment between ExoStat’s product capabilities and institutional efforts to transition from reactive to predictive critical care practices.

How does the MicroTREND system align with sepsis treatment protocols and ICU modernization goals?

Sepsis remains one of the leading causes of death in ICUs worldwide, with over 270,000 deaths annually in the United States alone, according to CDC data. Medical consensus continues to emphasize the need for rapid diagnosis and intervention. Yet, the absence of real-time microvascular data has limited the ability of clinicians to act on subtle physiological shifts before organ failure begins.

ExoStat Medical’s technology provides a novel solution to this clinical bottleneck. Unlike invasive catheter-based sensors or slow lab results, MicroTREND offers a bedside view into the tissue-level oxygenation landscape. As more ICUs integrate digital dashboards and automated alerting tools, the addition of PomCO2 as a real-time metric may offer a significant upgrade to standard sepsis protocol architecture.

From a commercial standpoint, this compatibility with modern digital infrastructure is expected to aid market penetration once regulatory expansion is pursued beyond the current FDA clearance. While the MicroTREND is not yet approved as a standalone diagnostic tool for sepsis, analysts believe it is well-positioned for future clearance pathways that support adjunctive monitoring.

What is the broader clinical significance of PomCO2 as a diagnostic tool in tissue hypoperfusion states?

While the ExoStat study focused on septic shock, the clinical relevance of PomCO2 monitoring may extend to other shock states involving tissue hypoperfusion, such as trauma, hemorrhage, or cardiac arrest. In each of these cases, early detection of declining microperfusion is critical to improving patient survival.

ExoStat Medical is exploring future studies that examine the role of PomCO2 in broader critical care use cases. The platform’s ease of application — requiring no special training and offering real-time display — makes it suitable for ERs, ambulances, and field hospitals, according to internal planning documents.

Given the broad potential and unmet need, institutional sentiment remains optimistic. Many healthcare systems continue to prioritize diagnostic tools that shorten response times while reducing procedural complexity, and MicroTREND appears well-aligned with that trend.

What do analysts expect from ExoStat Medical’s future development roadmap and market positioning?

While ExoStat Medical is privately held and does not publicly disclose revenue or funding metrics, analysts tracking ICU technology trends anticipate that the firm will pursue additional regulatory clearances and strategic partnerships as clinical validation accumulates. Some institutional observers believe the firm may explore targeted commercialization agreements with critical care device distributors or hospital procurement groups in 2026–2027.

The convergence of rising sepsis incidence, growing ICU technology budgets, and pressure to reduce time-to-intervention in emergency settings bodes well for next-generation platforms like MicroTREND. If future studies confirm what ExoStat’s initial trial suggests, the firm could become a breakout innovator in the diagnostic monitoring category — particularly within non-invasive, real-time perfusion sensing.