A gel patch for replacing surgical eardrum repair with an office-based procedure

ABSTRACT Chronic perforations of the tympanic membraneTMaffect overpatients in the United States annuallyoften stemming from ventilation tubes inserted in the TM to drain fluid from middle ear infectionsLeft untreatedthese TM perforations can lead to significant morbidities that include recurrent ear infectionconductive and sensorineural hearing lossmastoid bone infectionand cholesteatoma developmentCurrentlyTM perforations are repaired with a graft applied to the TM via an invasive surgery that can takehours to completecost up to $per surgeryand carry significant anesthesia related risks for pediatric patientsA nonsurgical alternative to the existing procedure that can reduce procedure time and morbidities would be of economic benefit to patientsotolaryngologistsand payors alikeWe have developed a highly regenerative gel patchcalled Perf Fixfor nonsurgical TM repairPerf Fix can be applied to the TM through the ear canal without incisions or abrasion of the perforation marginthen cured via blue light into a stiff scaffold through which cells can migrateThe cells degrade the gel patch as they proliferate and migrateresulting in total replacement of Perf Fix with regenerated TM tissueIn this proposalwe aim to perform the necessary biocompatibility testing and applicator development ahead of FDA submissionWe will evaluate Perf Fix for safety in a series of biocompatibility testsfollowed by a capstone animal trial to ensure that the finalsterilized form of Perf Fix retains its regenerative capabilitiesThis will be followed by the development of an applicator for Perf Fix that is suitable for human patientsand additional mechanical testing to ensure that Perf Fix applied with the applicator retains the same properties seen in previous bench testingThe success of this proposal will allow Tympanogen to proceed with submission of Perf Fix to the FDAleading to a significant medical improvement over the current standard of care with a major reduction in healthcare costs NARRATIVE Chronic perforations of the tympanic membrane affect hundreds of thousands of patientsmostly childreneach year and can lead to infectionhearing lossnerve and brain damageCurrentlythe only treatment for this condition is a costlyhighly invasive surgery that can carry significant anesthesia related risks for pediatric patientsWe have developed a light curable gel patch as a nonsurgicaloffice based alternative for tympanic membrane repair that improves healing and eliminates surgical complicationsThis project proposes safety and efficacy testing to prepare the gel patch for submission to the FDA