PHOTONICARE INC — Department of Health and Human Services SBIR Phase II: NIDCD

Description

DESCRIPTION provided by applicant PhotoniCare Inc is a medical device company developing a handheld biophotonics imaging system suitable for use by otolaryngologists ear nose and throat specialists ENT and primary care physicians PCP to enable real time D assessment of sub surface tissue structure in the middle ear Significance ENTs and PCPs have limited tools with which to diagnose otitis media OM or middle ear infections OM affects the vast majority of children and accounts for more than million annual physician visits The current standard diagnostic tool for evaluating the middle ear the otoscope is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability The ability to provide physicians with unprecedented quantitative information about the middle ear will reduce diagnostic variability between physicians and provide a more accurate picture of middle ear health to optimize treatment strategies Hypothesis The presence of middle ear biofilms or highly purulent effusions will be indicative of long term chronic ear disease even in patients tha are early in the disease cycle providing an early indicator of long term disease and a non invasive observable metric by using our device Specific Aims Build a commercial prototype handheld OCT system designed for ENT specialists to non invasively image through the eardrum and into the middle ear Conduct a patient clinical utility study in ENT and primary care settings to determine the clinical value of quantifiable effusion purulence and presence of middle ear biofilms Conduct a patient clinical utility study in the ENT clinic o determine dependence upon clinical expertise required to extract meaningful data from the imaging system The long term goal of this project is to better understand the impact of bacterial biofilms and effusion purulence on disease progression and treatment strategies Commercial Opportunity This device will provide physicians with new and quantitative information related to middle ear disease enabling better decision making for interventional surgery more rapid intervention for children that need it and reduction of unnecessary surgeries Reduction of even of surgeries represents $ M in savings to the U S healthcare system each year Additionally the ability to shorten the cycle of repeat visits before surgery represents a large savings to payers and patients alike PUBLIC HEALTH RELEVANCE Otolaryngologists and primary care physicians are responsible for diagnosing and treating the general population for ear disease but they have limited tools with which to accomplish this The current standard diagnostic tool for evaluating the middle ear the otoscope is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability The long term goal of this work is to reduce healthcare costs and improve patient outcomes by giving physicians new imaging tools that for the first time allow them to see behind the eardrum in order to visualize an infection and take quantitative measurements of middle ear effusions and biofilms