Imaging Device for the Assessment of Airways in Combat Casualties with Inhalation Injury due to Burns, Smoke, or Toxic Gases

Inhalation airway injury is a major cause of morbidity and mortality for soldiers in modern combat. In inhalation burn victims, certain pathophysiological changes occur at a very small length scales in airway tissues immediately following exposure. Measuring these changes from within the lumen of airway during bronchoscopy is difficult because these changes occur in sub-mucosa at microscopic level. To solve above problems, OCT Medical Imaging Inc (OCTMI), proposes to develop and test an advanced light-based, fiber-optic imaging system using a platform imaging technology known as Optical Coherence Tomography (OCT). In Phase II, we will extend our successful Phase I results and develop an advanced compact real-time 3D-OCT system incorporating advanced light source. By consulting with clinicians, we pan to develop user-friendly software and test our 3D-OCT probes and OCT systems using an animal smoke inhalation model developed at our collaborators laboratory. Based on above studies, we will refine our 3D-OCT probe, systems and software and evaluate them in bronchoscopic airway detection sensitivity and specificity to gold standard histologic imaging in patients. After successful Phase II, we plan to apply for IDE and seek 510k FDA approval to enter the market.