Phonocath - An endovascular medical device to objectively evaluate Pulsatile Tinnitus

Project Summary This Phase I STTR project spearheaded by VDF Industries, in collaboration with UCSF, aims to radically improve the diagnosis of Pulsatile Tinnitus (PT). PT is a form of tinnitus characterized by the perception of a heartbeat-synchronous sound that can be incredibly distressing, often leading to severe depression or anxiety in 60% of sufferers. Accurately diagnosing PT is paramount as it can lead to effective treatment of the underlying vascular anomaly, thus alleviating the auditory symptoms, risks of the underlying vascular disease, and the profound associated psychiatric conditions. However, current diagnostic procedures are invasive, lengthy, and uncomfortable, necessitating 3-6 hours of testing by skilled neurointerventionalists (NIRs) and often resulting in significant pain and distress for patients who must remain conscious and communicative throughout the process. Recognizing the urgent need for a more patient-friendly diagnostic tool, VDF Industries has initiated the development of Phonocath, a novel, single-use, highly navigable, endovascular medical device designed to objectively assess PT. Preliminary development has produced Phonocath prototypes capable of localizing the PT source in benchtop models. The next phase is to refine these devices into a more practical lower profile microcatheter, integrating advanced microsensor technology for enhanced navigability and precision in human patients. The project encompasses three primary objectives: the design and production of a new microcatheter prototype, validation of the Phonocath device using in vitro patient-specific 3D printed flow models, and the validation of the PT evaluation procedure using hybrid models that combine 3D printed bodies and human cadaver heads. These steps are critical to producing a batch of Phonocath devices ready for regulatory verification and validation. Upon successful completion of these objectives, VDF Industries intends to engage with the FDA to discuss the design and regulatory pathway for a first-in-human study, with the ultimate goal of commercializing the Phonocath System. A subsequent STTR Phase II proposal will seek to fund biocompatibility testing for the microcatheter and safety testing for the user interface unit, paving the way for human trials to establish the safety and efficacy of the Phonocath device in clinical practice. The successful development of Phonocath has the potential to transform the standard of care for PT patients, offering a swift, accurate, and minimally invasive diagnostic alternative to the current arduous procedures.