MedPath

ExoStat Medical's MicroTREND System Receives FDA Clearance for Real-Time Oral Tissue Perfusion Monitoring

• ExoStat Medical's MicroTREND system, designed for real-time detection of tissue hypoperfusion via oral mucosa, has received FDA 510(k) clearance. • The MicroTREND system utilizes an electro-conductance platform with a non-invasive sensor to measure pCO2, a marker for tissue hypoperfusion. • This technology offers early detection of microcirculatory issues, potentially improving outcomes in critical conditions like septic shock. • The MicroTREND system is the first real-time, bedside, non-invasive sensor for monitoring microcirculatory tissue hypoperfusion.

ExoStat Medical has announced that its MicroTREND System has received FDA 510(k) clearance. The MicroTREND system is designed for the early detection and monitoring of tissue hypoperfusion at the microcirculatory hemodynamic level, using the oral mucosa as a measurement site.

Technology and Functionality

The MicroTREND system incorporates an electro-conductance platform with a disposable sensor. This sensor is placed non-invasively in the patient's oral mucosal tissue, a convenient and accessible location for measuring pCO2, which is a clinically proven marker for tissue hypoperfusion. The system provides real-time data, enabling physicians to assess and treat microcirculatory hypoperfusion, a life-threatening medical emergency.

Development and Research

ExoStat Medical has been developing the MicroTREND system since 2008, with initial clinical work dating back to the late 1990s at the Weil Institute of Critical Care Medicine (WICCM). Dr. Max Harry Weil, considered the Father of Critical Care Medicine, and his team focused on capturing and measuring microcirculatory perfusion data using oral tissue to measure gut perfusion. Their research highlighted the importance of oral tissue perfusion pCO2 data in identifying early symptoms of microcirculatory hypoperfusion.

Clinical Significance

Wanchun Tang MD, MCCM, FAHA, FNAI, professor and long-time President at WICCM and Senior Medical and Technical Advisor at ExoStat Medical, stated, "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."

Company Statement

"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," said Jim Hays, Chief Executive Officer of ExoStat.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

NextBioMedical's Nexsphere-F Receives FDA IDE Approval for Knee Osteoarthritis Trial

NextBioMedical's Nexsphere-F has received FDA IDE approval for a clinical trial (RESORB) to treat knee osteoarthritis via genicular artery embolization (GAE).
The RESORB trial is a multi-center, randomized, open-label study evaluating Nexsphere-F's efficacy in alleviating pain and improving mobility in OA patients.

Axcynsis Therapeutics' AT03-65 Receives FDA IND Clearance for CLDN6-Targeting ADC

Axcynsis Therapeutics received FDA clearance for its IND application for AT03-65, a differentiated CLDN6-targeting antibody-drug conjugate (ADC).
AT03-65 leverages Axcynsis' AxcynDOT™ technology for precise drug delivery to tumors expressing CLDN6, a target in various cancers.

SeaStar Medical's Selective Cytopheretic Device Receives FDA Breakthrough Designation for ESRD Inflammation

SeaStar Medical's Selective Cytopheretic Device (SCD) has been granted Breakthrough Device designation by the FDA for treating inflammation in end-stage renal disease (ESRD).
The SCD targets and neutralizes pro-inflammatory cytokines, aiming to mitigate hyperinflammation and improve clinical outcomes in ESRD patients.

RapidPulse's Cyclic Aspiration System Receives FDA Approval for Ischemic Stroke IDE Study

RapidPulse has received FDA approval to begin an Investigational Device Exemption (IDE) study for its cyclic aspiration system in acute ischemic stroke (AIS).
The IDE study will enroll patients in the U.S. and Europe in 2025 to evaluate the safety and efficacy of RapidPulse's pulsed aspiration method.

Nanox's ARC Imaging System Receives FDA Clearance for Expanded Use

Nanox's ARC imaging system secures FDA 510(k) clearance for general use, including pulmonary, intra-abdominal, and paranasal sinus indications, expanding its market potential.
The Nanox.ARC system utilizes digital X-ray technology with cold cathode tomosynthesis, providing enhanced 3D visualization compared to traditional 2D X-rays.

Xeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in Pivotal Trial

Xeltis' aXess, a synthetic vascular access device, has been granted Breakthrough Device designation by the FDA, expediting its path to market.
The pivotal trial, a prospective, single-arm, multi-center study, is evaluating the safety and performance of aXess in adults with end-stage renal disease needing dialysis.

Xeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in Pivotal Trial

Xeltis' aXess, a synthetic vascular access device, has been granted Breakthrough Device designation by the FDA, expediting its path to market through prioritized review and enhanced interaction with FDA experts.
The company has enrolled and treated the first patient in its US pivotal trial, a prospective, single-arm, multi-center study evaluating the safety and performance of aXess in adults with end-stage renal disease needing dialysis.

Xeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in US Pivotal Trial

Xeltis' aXess vascular access conduit receives FDA Breakthrough Device Designation, expediting its development and review for hemodialysis patients.
The designation acknowledges aXess' potential to offer a more effective vascular access option, reducing reinterventions and complications for dialysis patients.

CereVasc's eShunt System Receives FDA Breakthrough Device Designation for Normal Pressure Hydrocephalus

CereVasc's eShunt System has been granted Breakthrough Device Designation by the FDA for treating Normal Pressure Hydrocephalus (NPH).
The designation facilitates priority review and enhanced communication with the FDA during clinical trials and premarket assessment.

Innovations and Trials in Medical Technology

Recent advancements in medical technology include the launch of the CrossWise RF transseptal access system by Circa Scientific, completion of enrollment in a pivotal trial for Inquis Medical's Aventus thrombectomy system, a distribution agreement between Medtronic and Contego Medical, a $12 million Series A round for Relief Cardiovascular, CE mark approval for Johnson & Johnson MedTech's dual-energy catheter, a temporary pause on Varipulse PFA system cases by Johnson & Johnson MedTech, and the completion of a first-in-human study by AerWave for its lung denervation therapy.

Reference News

[1]
ExoStat Medical Receives FDA Clearance For Novel, Real-Time, Oral Tissue Perfusion ...
morningstar.com · Nov 12, 2024

ExoStat Medical receives FDA clearance for MicroTREND, a real-time oral tissue perfusion sensor system for early detecti...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy