Sarcos Research Corporation proposes a novel microinfusion system for administration of medications for treatment of middle ear and cochlear diseases, such as sudden hearing loss, Menieres disease, instances of tinnitus, and for providing pharmacological hearing protection in chemotherapy. Methods that are currently in use cause systemic toxicity, do not provide suffient dose control (injections, wicks) or are impractical (waist-mounted pumps) and expensive. The proposed system will be small size, light-weight, will fit safely and comfortably behind the patient's ear, and will deliver medications into the middle ear in precise, controlled programmable and convenient manner, increasing effectiveness, reducing side effects and improving compliance with the therapy. In the future, the system will evove into totally implantable unit for treatment of chronic and/or recurrent conditions. In addition to improving the existing treatment regimens, the system will enable application of chronotherapy and other temporal dose patterns to increase effectiveness and reduce side effects, and will allow administration of medications in the head-and-neck area for treament of cancer in both hospital and at-home settings. For this application, Sarcos will adapt its microinfusion pump and microcatheter technologies to create a system that will consist of a micropump, a programmer with a wireless data link, and a drug delivery catheter. Due to the significant advancement of the already developed technology base that is available at Sarcos for this project, and in order to accelerate the development of the commercial product, Sarcos proposes a joint Phase I/Il (Fast Track) effort that will result in a validated system ready for commercialization and clinical implementation. Phase I of this project will result in a definitive feasibiility prototype, wherease the projected Phase II will end with a commercial product and completed regulatory submission to the FDA. The proposed system will have significant health and economic impact as it it is estimated that more than 28 millions Americans suffer from preventable hearing loss, at least 3 million are affected by Menieres disease, and 40 to 45 million have life-impairing tinnitus, resulting in an estimated cost of lost productivity that exceeds 30 billion dollars per year.
