Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance

PROJECT SUMMARY IntroductionPhotoniCareIncis a medical device company nearing commercializing the ClearViewa handheldoptical imaging device for improved diagnosis of middle ear healthThe purpose of this proposaldeveloped in conjunction with the affiliated FDA review committeeis to perform pivotal clinical studies and use the collected data to establish objective data analysis algorithms for FDAkclearance submission usingfor the first timeproduction equivalent PhotoniCare ClearView imaging devicesSignificanceEar infections affectof all childrenyet they are one of the most poorly diagnosed and managed diseases in all of medicineCorrectly identifying the absence or presence type of middle ear effusionfluidthrough the non transparent eardrum is critical to accurate diagnosisand the limited current diagnostic tools suffer poor diagnostic accuracydue to inherent subjectivity and dependence on user experienceThereforeobjectivequantitative metrics to enable improved diagnostic accuracy is sorely needed to finally provide children afflicted by this disease with the correct treatment the first timeHypothesisThe ClearView imaging system with image analysis algorithms will facilitate detection of the presence or absence of middle ear effusionas well as classification of the type of middle ear effusionwith greater thansensitivity and specificityregardless of user experienceSpecific AimsConduct a pivotalsubject clinical study to demonstrate the utility of ClearView M mode images for detecting the presence of fluid in the middle ear by correlating image data with physician visual assessment of fluid characteristics and tympanometry measurementsQuantitatively analyze collected middle ear effusions and demonstrate correlations between ClearView M mode image dataeffusion compositionand biomechanical propertiesand how these relate to effusion typeserouspurulentor mucoidDevelop a quantitative image analysis algorithm for effusion detection and fluid classification based on Mmode image data for implementation into the ClearView user interface for improved effusion detectionCommercial OpportunityThe ClearView device will provide physicians with newobjective informationenabling better decision making for antibiotic prescription and surgical interventionThis has the potential to impact the standard of care forB children worldwide that experience ear infectionsrepresenting a commercial opportunity of$B worldwidebased on our projections PROJECTNARRATIVE Ear infectionsotitis mediaare highly prevalent in the pediatric population and represent a significant clinical diagnostic challengeAccurate detection and classification of effusionfluidin the middle ear is a critical element for this diagnosisand for making informed medical treatment decisionsThe long term goal of this work is to reduce healthcare costs and improve patient outcomes by addressing the low diagnostic accuracy and user experience dependence of current subjective methodswith a novelnon invasive imaging tool capable of quantitative depth resolved measurements to not only visualize the underlying infection behind the eardrumbutalsowithautomatedcomputeralgorithmsminimizeuserexperiencedependenceandvariability