Otitis media (OM) is the leading cause of healthcare visits in the world, affecting more than 700 million people worldwide1 and accruing a significant economic burden of over $5 billion annually in direct and indirectcosts in the US alone2. Children are particularly susceptible to this disease; 90% of children will contract OM by the age of five with 40% of cases eventually becoming recurrent or chronic5. The gold standard for treatmentof recurrent acute OM and chronic OM with effusion is myringotomy surgery with tympanostomy tube insertion,in which a small tube is inserted into the tympanic membrane to ventilate and drain fluids out of the middle ear. Nearly 700,000 children in the US are treated with tympanostomy tubes (TTs) annually. To help resolveinfection and prevent otorrhea, tube insertion is commonly supplemented with a regimen of topical antibiotics.However, due to their lumen geometry and material composition, existing TTs are not optimized forreliable delivery of drugs into the middle ear and frequently become occluded by cellular debris,pathogenic bacteria, blood, and pus. Such challenges hinder OM treatment and prompt invasive TTreplacement surgeries in up to 20% of children with TTs.6 To combat these challenges simultaneously, PionEar Technologies Inc. is developingtympanostomy tubes (PionEar TTs) with a patent-pending material design that synergistically reducesthe pressure barrier for drugs to penetrate into the middle ear and suppresses bioadhesion, thusmaximizing the therapeutic benefit of topical drugs and facilitating earlier eradication of infection. Novelbio-inspired PionEar TTs possess (1) precisely engineered lumen geometry that is optimized to promotespontaneous transport of therapeutics even without tragal pumping, and (2) slippery liquid-infused materialsthat further minimize contact line pinning while suppressing bioadhesion7-9. PionEar tubes are biocompatibleand non-ototoxic, minimally invasive, and simple-to-manufacture. They preserve critical functionality of existingtympanostomy tubes: to enable ventilation and drainage of the middle ear and prevent water from entering themiddle ear.10,11 In an SBIR Phase I, we propose to assess the in vivo performance of PionEar tubes forpromoting more efficient drug delivery and resolution of OM compared to commercial tubes in a gold-standardOM chinchilla model. Demonstration of proof-of-concept will prepare the technology for successful Phase IIapplication and future commercialization. If successful, PionEar TTs would alleviate the prevalent issue ofrecurrent ear infections and complications, and open up new avenues for the treatment of OM. PionEar Technologies Inc. was born out of three years of rigorous translational medicine research andcollaboration between Harvard's Wyss Institute, J.A. Paulson School of Engineering and Applied Sciences, andMassachusetts Eye and Ear. Its novel TT technology was awarded the Grand Prize at the Collegiate InventorsCompetition by NIHF and USPTO as well as five other prestigious awards.
Public Health Relevance Statement: Project Narrative
Middle ear infections, also known as otitis media, are the leading cause of healthcare visits in the world,
affecting more than 700M people globally, and accruing significant economic burden of over $5B in direct and
indirect costs each year in the US alone. The gold standard for treatment of recurrent acute ear infections and
chronic OM with effusion is myringotomy surgery with tympanostomy tube insertion, in which millimeter-scale
tubes are inserted into the eardrum to ventilate and drain fluids out of the middle ear; unfortunately, current
state-of-the-art tympanostomy tubes are not ideal for OM treatment, as they commonly become contaminated
by cells and pathogens and do not reliably promote delivery of topical therapeutic drugs into the middle ear. In
an SBIR Phase I, PionEar Technologies, Inc. will demonstrate a proof-of-concept for an innovative,
fluid-guiding tympanostomy tube that promotes rapid elution of therapeutic drugs into the middle ear,
thus enabling faster resolution of OM in vivo in a preclinical chinchilla model.
Project Terms: <0-11 years old>
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