HLS Hand held advanced functional imager for assessing local tissue oxygenation

Summary We believe that our project is responsive to the HLS Small Business Topic of Special Interest for NHLBI Fiscal Year Here we will develop commercialization ready advanced functional imager to assess red blood cell RBC transfusion We successfully finished Phase I by developing the device s prototype and testing its functionality in the proof of principle experiments in scattering phantom and two dorsal window mice models In Phase II of the project the device will be verified with established functional microscopy in the dorsal window animal model next the RBC transfusion microcirculation endpoint markers will be correlated with established organ wellness markers in the cranial window mouse model and finally the design and software of the clinically ready imager will be finalized in a small study of volunteers The key features of the imager are the ability to quantify local microcirculation parameters including tissue oxygen supply and consumption with a handheld probe for easy tissue access Our market research and analysis indicates a strong demand for such instrument to help physicians effectively perform RBC transfusion which is the most common inpatient hospital procedure We estimate that our device can save annually up to $ million in health care costs in the US Currently there are no defined markers of the RBC transfusion efficiency evaluation except the hemoglobin and hematocrit level which do not address function Conventional optimization of macrocirculatory arterial blood pressure cardiac output etc and tissue perfusion acidosis lactate venous O saturation SvO organ function etc parameters do not demonstrate beneficial results We hypothesize that the microcirculation including capillary density blood oxygenation flow and oxygen extraction in arterioles and venules with diameters of m can provide crucial endpoints for optimization of the RBC transfusion To reduce the risk of infection or injury in vulnerable patients and to minimize number of blood draws a non invasive microcirculation assessment if validated would be highly preferred over invasive or minimally invasive methods We believe our approach provides the needed performance to solve a critical problem and a clear path to successful commercialization This project will have strong social impact by providing crucial clinical information to improve patient outcomes Quantitative imaging of local tissue oxygen delivery and consumption will not only improve outcomes with RBC transfusion but has great potential to decrease morbidity and mortality in many devastating diseases with vascular etiology including a variety of malignant inflammatory ischemic infectious and immune disorders Narrative The objective of this project is to test in relevant animal studies and a small cohort of human volunteers a commercialization ready innovative and cost effective advanced functional imager that was developed in Phase I to assess microcirculation tissue parameters in a clinical setting The advanced functional imager combines in a convenient hand held design Orthogonal Polarization Spectroscopy OPS with multimodal Optical Coherence Tomography OCT to provide differentiated D maps of arterioles and venules hemoglobin oxygen saturation SO blood flow and O extraction and consumption as well as functional capillary density FCD The broader commercial impact of this project will be to utilize the microcirculation parameters in order to inform patient specific decision on red blood cell RBC transfusion to improve outcome of transfusion therapy and lead to acceptance of the advanced functional imager as a reliable monitoring tool to assess RBC transfusion