Clinical study to enable commercialization of nonsurgical gel patch for eardrum repair

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ABSTRACT Chronic perforations of the tympanic membrane (TM) affect over 170,000 patients in the United States annually, often stemming from ventilation tubes inserted in the TM to drain fluid from middle ear infections. Left untreated, these TM perforations can lead to significant morbidities that include recurrent ear infection, conductive and sensorineural hearing loss, mastoid bone infection, and cholesteatoma development. Currently, TM perforations are repaired with a graft applied to the TM via an invasive surgery that can take 2-4 hours to complete, cost up to $18,000 per surgery, and carry significant anesthesia-related risks for pediatric patients. A nonsurgical alternative to the existing procedure that can reduce procedure time and morbidities would be of economic benefit to patients, otolaryngologists, and payors alike. We have developed a highly regenerative gel patch called Perf-Fix for nonsurgical TM repair that fits the existing clinical workflow for myringoplasty. Perf-Fix can be applied to the TM through the ear canal without incisions or abrasion of the perforation margin, then cured via blue light into a stiff scaffold through which cells can migrate. The cells degrade the gel patch as they proliferate and migrate, resulting in total replacement of Perf-Fix with regenerated TM tissue. In this proposal, we will conduct a human study in both adult and pediatric patients to evaluate the efficacy of Perf-Fix. This human study is the last milestone before submission of Perf- Fix to FDA for clearance as a class II medical device. During the study, patients will be evaluated for: perforation closure rate, application time, time to closure, changes in hearing scores, safety of device through adverse events and failure rates. The endpoints for this study include: TM closure rate at 3 weeks and 3 months, incidence of adverse events, procedural success, and functional hearing results. The data from this study will be compiled in a final report that will be included in the de novo submission to FDA. This SBIR project concludes with submission of the de novo application. The success of this proposal will supply the necessary data to market Perf-Fix successfully after product launch, leading to a significant medical improvement over the current standard-of-care with a major reduction in healthcare costs.