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

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Device Description:

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

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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.

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Rationale:

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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.

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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.

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

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System Capabilities:

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The platform is designed to:

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  • 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

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Data and Interpretation:

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

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  • blood rheology

  • microcirculatory dynamics

  • systemic physiologic and inflammatory states

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

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Development Status:

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

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Current development activities include:

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  • 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

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

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Intended Development Pathway:

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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.

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

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Regulatory Status:

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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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