PHARYNVAC SURGICAL TECHNOLOGY INCORPORATED

2024-08-20

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Department of Health and Human Services

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.

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