ExoStat Medical, a Minnesota-based private medical device company, has received US Food and Drug Administration (FDA) 510(k) clearance to market its MicroTREND System.
The MicroTREND System detects and monitors tissue hypoperfusion at the microcirculatory haemodynamic level, specifically in oral mucosa, as it develops into a medical emergency.
This device uses an electro-conductance platform with a disposable sensor that non-invasively attaches to the oral mucosal tissue of the patient. It measures pCO2, a proven marker for tissue hypoperfusion.
This allows for quick intervention and treatment of this life-threatening medical emergency.
The medical device company has been developing the MicroTREND System since 2008.
ExoStat Medical CEO Jim Hays said: “As a result of their keen understanding of the need to know a patient’s microcirculatory status, several of them have advised and supported our efforts to create the MicroTREND.
“These key opinion leaders will lead the early adoption efforts needed to make pCO2 monitoring a standard of care.
“The 510(k) clearance of the MicroTREND marks an important commercial milestone for ExoStat, and we look forward to working with key strategic partners to advance the next steps of the journey to improve patient care.”
Clinical research began in the late 1990s at the Weil Institute of Critical Care Medicine (WICCM) under Max Harry Weil, known as the Father of Critical Care Medicine.
Weil and his team focused on using oral tissue to measure microcirculatory perfusion, specifically gut perfusion.
He published numerous studies highlighting the importance of oral tissue pCO2 data to detect early signs of microcirculatory hypoperfusion.
The MicroTREND System is the result of decades of research. It is said to be the world’s first real-time, bedside, non-invasive sensor system approved to monitor microcirculatory tissue hypoperfusion due to low blood flow.
ExoStat Medical senior medical and technical adviser and WICCM professor and long-time president Wanchun Tang said: “Knowing microcirculatory tissue perfusion status early in septic shock’s predictable cascade will provide physicians with evidence-based data that could lead to better patient outcomes.
“Monitoring pCO2 data later in the resuscitative process will also aide the care providers in determining the most effective end-point of resuscitation which is also critical to better outcomes for gravely ill ICU patients.”
In a similar development, InnoVoyce secured the FDA 510(k) clearance for its VYLO Laser System in May 2024. The system is designed for soft tissue procedures, including incision, excision, vaporisation, haemostasis, ablation, and coagulation.
