Real-time Modulated Imaging for Assessment of Tissue Viability Prior to Skin Grafts

There is a lack of quantitative tools to accurately map tissue viability in a rapid and quantitative manner so a surgeon can properly excise tissue prior to grafting. Spatial Frequency Domain Imaging (SFDI) is an optical method that has been shown to be a reliable method for physiology assessment - particularly for burn depth. SFDI measures of tissue structure (scattering) and function (hemoglobin, oxygen saturation, edema) give unique insight into tissue health due to widefield diagnostic capabilities over large curved surfaces and different skin tones. Currently, our company has a FDA cleared cart-based system with indications for measuring oxygen levels in patients who have circulatory compromise. In Phase 1 of this effort, we will partner with University of California, Irvine and build a benchtop SFDI system that utilizes recent advances to test a compact, portable, lightweight version of the system suited for tissue viability measurement as burn surgeons excise tissue. We will directly compare the performance of our device to our FDA-cleared system in a series of validated phantom studies. Upon conclusion of Phase 1, we will be in position to build a clinic-ready system in Phase II for preclinical and clinical burn tissue viability studies.