Development of a novel kit for reduction of aerosolized particles during endonasal surgeries: the PharynVac Device

Project Summary Sinonasal surgery is extremely common (>600,000 outpatient procedures annually). There are three issues that can be mitigated with a single device: surgical staff pathogen and toxin exposure, patient blood ingestion, and periodic obstructed endoscopic visualization. Only blood ingestion has a current solution: packing the pharynx with absorbent materials with regular associated adverse events. Here we propose the further development of PharynVac, a balloon aspiration catheter that simultaneously addresses all three of these problems passively. If successful, PharynVac will decrease surgical staff exposure, reduce post-procedure nausea, and minimize operative times, potentially becoming a standard sinonasal surgical tool. This Phase I application would allow for the implementation of GMP (SA1), demonstrated blood and particle aspiration in a bio-realistic oral/nasal model (SA2), and demonstrated device safety/feasibility in a large-animal sheep model (SA3). At this point, PharynVac will move into Phase II: FDA engagement and first-in-human clinical trials.