Clinical validation of a novel handheld optical measurement system to enable 1-touch assessment of middle ear effusion in standard otoscopy

Broader ImpactsMore thanof children experience at least one ear infection before agemaking ear infections among the most common childhood conditionsFamily Physicians and Pediatricians see more thanmillion suspected ear infection cases per year in the USApproximatelyof these are misdiagnosed infections in healthy earsleading tomillion unnecessary antibiotic prescriptions annuallyIn factear infection is the leading cause of unnecessary antibiotic use in childrenresulting in hundreds of millions of dollars wasted and millions of children placed at undue risk for adverse side effectsOn a societal levelunnecessary antibiotic use and resultant resistant microorganisms adds $B in excess healthcare costs annuallyThe Centers for Disease Control and PreventionAmerican Academy of Pediatricsand American Academy of Family Physicians have identified improved ear infection diagnostics as necessary to slow the spread of resistant microorganismsUnfortunatelydespite updated clinical guidelines dating back tono significant reduction in unnecessary prescription rates has been achievedEven a modest improvement in ear infection diagnosis has the potential to positively affect millions of childrensave hundreds of millions in direct costsand slow the evolution of resistant bacteriaCactus invented Optical TympanometryOTtechnology to improve ear infection diagnosis in primary carewhere most cases are seenCactus technology isaccurate in a clinical study ofpediatric participantsand works in clean and waxy earsIntellectual MeritChildren affected with ear infection are most often too young to adequately describe their symptomsSigns of ear infections are numerousbut they are also very non specificClinical diagnosis is most commonly done by assessing a set of qualitative factors using an otoscope to provide a magnified view of the ear drumMost clinicians look for middle ear rednessHoweverredness alone is less thanaccuratematching accuracy statistics observed in primary careThe American Academy of Pediatrics and American Academy of Family Physicians recommend an objective quantitative assessment of the presence or absence of middle ear effusionMEEIn factKey Action StatementC in the AAP s most recent Acute Otitis Mediaactive ear infection requiring antibiotic treatmentAOMguideline statesClinicians should not diagnose AOM in children who do not have middle ear effusionMEECurrentlyMEE is often unassessed due to technology limitationsExisting acoustic and pneumatic devices are slowsubjective and can be painful to childrenAs a resultclinicians commonly prescribe a course of antibiotics out of a preponderance of cautionor to placate parentsCactus invented OT as a rapidseamless means of assessing MEE during otoscopyThis SBIR Phase I proposal validates a miniaturized embodiment of OTLED OTbuilt into the familiar otoscopeSpecific Aims AimMonthAssembly and Repeatability andampReproducibility Study of LED OT OtoscopesCactus has developed a patent pendingUSandampUSLED OT otoscope based on its innovative multiLED microchipwhich houses allwavelengths required for OT in ax mm form factorCactus will assembleLED OT otoscope units for rigorous measurement repeatability and reproducibility assessment followed by clinical validation in AimsAimMonthClinical Data Collection IRB approvedUCI HSdata collection will take place under the supervision of UC Irvine Professor Elliot Botvinick via a sub awardClinical data collection mirrors that used inkapplications for previously cleared acoustic devices and enables receiver operating characteristicROCanalysis of LED OT otoscopyAimMonthClinical Data Analysis Clinical data analysis will be concurrent with data collectionwith two specific goalsFirsttrain OT s statistical componentSecondvalidate performance of LED OT in pediatric participants using ROC analysisA successful outcome of this proposal will be validated LED OT technology andotoscopes prepared for a pivotal study in Phase II to compare LED OT and acoustic methods in an office settingTogetherPhase I and II will prepare LED OT for analytical and clinical trials necessary for akapplicationencourage adoption of our revolutionary technologyand facilitate private investment and relationships with strategic partners Project NarrativeCactus MedicalLLC is developing a rapidlow costnon invasive ear infection indicator to improve ear infection diagnosis in pediatric care settingsCactusSmartScope will provide physicians with an accurate indication of ear infection at the press of a button while they are performing their normal inspection of the ear drum through an otoscopeSmartScope technology has shownaccuracy in a pediatric clinical studyThis device has the potential to save $billion annually and reduce the rate at which anti bacterial resistance evolves by limiting unnecessary antibiotic prescriptions and protect millions of children from unnecessary antibiotic treatment