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The Biofluid Inflammometer™ - Advancing Physiologic Measurement to Improve Understanding of Human Disease:

Device Description:

The Biofluid Inflammometer™ is an investigational whole blood viscometry platform designed to characterize blood flow behavior across physiologically relevant shear conditions.

The system measures whole blood viscosity under controlled conditions to generate a quantitative profile of rheologic behavior. These measurements are intended to provide insight into how changes in blood properties may relate to microcirculatory function and systemic physiologic states.

Rationale:

Blood is a dynamic, non-Newtonian fluid whose behavior varies across the vascular system. Changes in viscosity and flow characteristics may influence tissue perfusion, oxygen delivery, and overall physiologic function.

Current clinical assessment of inflammatory and cardiometabolic conditions relies primarily on biochemical markers. These measurements do not directly assess the mechanical behavior of blood within the circulation.

The Biofluid Inflammometer™ is being developed to enable direct characterization of blood flow properties as a complementary dimension of physiologic assessment.

System Capabilities:

The platform is designed to:

  • Measure whole blood viscosity across a range of controlled shear conditions

  • Generate reproducible measurement outputs under defined laboratory settings

  • Operate with small sample volumes using fresh human whole blood

  • Produce data suitable for further analytical modeling and interpretation

Data and Interpretation:

Data generated by the system are intended to support ongoing research into the relationship between:

  • blood rheology

  • microcirculatory dynamics

  • systemic physiologic and inflammatory states

Future work may explore integration of these measurements with clinical and laboratory datasets to develop improved frameworks for interpretation.

Development Status:

The Biofluid Inflammometer™ is currently in a preclinical validation and risk-reduction phase.

Current development activities include:

  • characterization of measurement reproducibility and variability

  • evaluation of system performance across operating conditions

  • testing using fresh human whole blood samples

  • refinement of system design and data acquisition processes

These efforts are focused on establishing technical reliability and preparing the platform for subsequent clinical evaluation.

Intended Development Pathway:

The long-term objective of this technology is to support the development of tools that may contribute to improved understanding of physiologic changes associated with disease.

Further development, including clinical studies, will be required to evaluate potential clinical applications.

Regulatory Status:

The Biofluid Inflammometer™ is an investigational device and is not approved by the U.S. Food and Drug Administration or any regulatory authority for diagnostic or clinical use.

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