Each year, up to one million children with persistent ear infections (otitis media) or middle ear fluid collections (effusions) undergo placement of bilateral ear tubes to ventilate and drain the middle ear. This procedure, formally known as bilateral tympanostomy, is the most common pediatric surgical procedure in the United States. Up to 50% of patients require repeat surgery to remove the tubes once they are no longer needed or if they become dislodged and do not fall out of the ear canal on their own. Based on premium pricing and cost savings from replacing post-procedure antibiotic drops, we estimate an annual market opportunity for this device of $200-$300 million.
The current standard of care requires general anesthesia for placement and removal of tubes, along with 7-10 day difficult-to-administer post-procedure antibiotic ear drop regimen. When the tube dislodges into the ear canal, it can be embedded in wax, resulting in inflammation, obscured visualization of the ear drum, pain, and bleeding. Tube dislodgement into the middle ear is a rare but difficult problem, which can lead to long-term damage and hearing loss. As a result, as noted, up to 50% of patients require a second procedure.
In 2016, we entered into a licensing agreement with a group of leading academic institutions, which provided us with an exclusive worldwide license to develop and commercialize antibiotic-eluting resorbable ear tubes based on a proprietary aqueous silk technology conceived and developed at these institutions. We believe DisappEAR ear tubes will eliminate the need for a second general anesthesia procedure to remove retained or dislodged tubes in most patients. In addition, having the antibiotics eluded from the device will eliminate the difficult-to-administer post-procedure antibiotic ear drop regimen.