Vesticon will develop and test a transtympanic drug delivery system for improved treatment of common vestibular disorders for applications in the office-based setting. The system includes a novel insertion system and microfluidic pump technology for precise and flexible control of vestibulo-active or cochleo-active drugs delivered to the middle ear for absorption to the inner ear. The Microfluidic Transtympanic Delivery System (MTDS) will be digitally-controlled, overcoming control-related and practical limitations of current methods/technologies, as well as technologies still under development. Today, transtympanic drug delivery is regularly used to treat a variety of common inner ear diseases such as Meniere's disease, chronic labyrinthitis, sudden sensorineural hearing loss and intractable tinnitus that impact millions of people worldwide. Meniere's disease affects approximately 12 in 1000 individuals worldwide, and it is estimated that 7.9 million individuals in the U.S. suffer from tinnitus. Although the advantages of transtympanic delivery are generally understood, control remains a major challenge to realizing optimal and consistent outcomes. Wide inter-subject, and even intra-subject, variability in outcomes has presented a major problem with current practice, introducing the potential of serious side effects, such as oto-toxicity, that can lead to permanent hearing loss and vestibular hypofunction, or dysfunction. Recent studies indicate these shortcomings can be largely overcome with precise, controlled, sustained, low-concentration delivery to the round window membrane. However, while research is underway to develop products for surgically-implanted controlled delivery, Vesticon believes there is significant value for exploring a non-surgical solution for controlled delivery. Vesticon's MTDS promises to overcome both the control-related limitations of existing technology as well as the practical limitations of surgically-implantable solutions now in development. In Phase I we will research and develop a breadboard prototype for controlled, transtympanic delivery that includes a) insertion technology and circulating system for improved drug perfusion; and b) a microfluidics technology to deliver drugs with the optimal protocol. We will evaluate feasibility with physician testers using both plastic ears and temporal bone cores. During Phase II, we will build on Phase I findings for more advanced prototype development and further testing. MTDS could be tested on animals or human subjects at the PI's clinic and two independent beta sites, which will prepare this technology for eventual follow-on Phase III development, FDA clearance and commercialization. ? ? Public Health Relevance: The Microfluidic Transtympanic Delivery System (MTDS) will overcome shortcomings of current drug delivery methods to the inner ear for treatment of common vestibular problems. MTDS addresses both the control-related limitations of existing technology as well as the practical limitations of surgically-implantable solutions now in development. Meniere's disease, chronic labyrinthitis, sudden sensorineural hearing loss and intractable tinnitus impact millions of people worldwide. ? ? ?
