Exostat Medical, Inc.
ExoStat Medical is dedicated to developing innovative, non-invasive medical devices for critical care, focusing on early detection and monitoring of tissue hypoperfusion. Their mission is to improve patient outcomes through advanced microcirculatory monitoring technology, leveraging over 20 years of pioneering leadership in tissue pCO2 measurement and microcirculatory assessment.
Industries
Nr. of Employees
small (1-50)
Exostat Medical, Inc.
Prior Lake, Minnesota, United States, North America
Products
Oral mucosal tissue pCO2 point-of-care monitoring system
A bedside, non-invasive monitoring system that uses a disposable oral-mucosa sensor seated on buccal or sublingual tissue to measure tissue pCO2 in real time. The system implements an electro-conductance sensing approach with time-resolved sampling (reported every ~2 minutes) and is designed for multi-hour, hands-free monitoring to aid early detection of microcirculatory hypoperfusion.
Oral mucosal tissue pCO2 point-of-care monitoring system
A bedside, non-invasive monitoring system that uses a disposable oral-mucosa sensor seated on buccal or sublingual tissue to measure tissue pCO2 in real time. The system implements an electro-conductance sensing approach with time-resolved sampling (reported every ~2 minutes) and is designed for multi-hour, hands-free monitoring to aid early detection of microcirculatory hypoperfusion.
Services
Pre-market clinical study execution and clinical evaluation
Design and conduct of IRB‑approved ICU observational studies and pre-market clinical testing to evaluate oral mucosal pCO2 monitoring against standard perfusion metrics and generate clinical evidence.
Regulatory and quality systems support with demonstrated clearance experience
Consultative support for regulatory submissions, QMS development, labeling, and interactions with regulatory authorities; includes company experience achieving FDA 510(k) clearance for an oral tissue perfusion sensor system.
Manufacturing oversight and consumables production support
Management and oversight services for probe and sensor production, including coordination with contract manufacturers and support for manufacturing scale-up of disposable consumables and device hardware.
Pre-market clinical study execution and clinical evaluation
Design and conduct of IRB‑approved ICU observational studies and pre-market clinical testing to evaluate oral mucosal pCO2 monitoring against standard perfusion metrics and generate clinical evidence.
Regulatory and quality systems support with demonstrated clearance experience
Consultative support for regulatory submissions, QMS development, labeling, and interactions with regulatory authorities; includes company experience achieving FDA 510(k) clearance for an oral tissue perfusion sensor system.
Manufacturing oversight and consumables production support
Management and oversight services for probe and sensor production, including coordination with contract manufacturers and support for manufacturing scale-up of disposable consumables and device hardware.
Expertise Areas
- Point-of-care sensor and consumable development
- Microcirculation monitoring and critical care diagnostics
- Clinical trial design and execution for medical devices (ICU observational and pre-market studies)
- Regulatory strategy and 510(k) submissions with FDA clearance experience
Key Technologies
- Oral mucosal pCO2 monitoring (buccal/sublingual capnometry)
- Electro-conductance sensing for tissue gas measurement
- Micro-scale CO2 microsensors
- Disposable single-use sensor probes