A Real Time Monitoring System to Measure IOP in Glaucoma

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DESCRIPTION (provided by applicant): Assenti LLC is a 10-person start-up company formed out of collaborative research teams from the University of Louisville's Speed School of Engineering and the Department of Ophthalmology & Visual Sciences along with key industry partners. Assenti's enclosed SBIR Phase II application will allow us to continue our significant progress and momentum towards becoming the first company to bring a MEMS (Micro-Electrical-Mechanical Systems) based device to market for treating glaucoma patients. This revolutionary technology has the potential to eliminate the root cause of blindness for patients with glaucoma by providing continuous, non-invasive monitoring of Intra-Ocular Pressure (IOP). Our near term goal for commercialization is to develop our Gen I "Smart IOP" monitor that will strictly monitor IOP, so patients can self-administer eye drops to reduce pressure, which will lead to the elimination of optic nerve damage and hence prevention of blindness from glaucoma. However, our eventual longer term goal is to develop a self contained system that will either release hypotensive medication to reduce IOP or use a switch controlled MEMS valve, to create a totally autonomous system requiring no patient intervention. Recent studies have shown that applying topical ocular hypotensive medication was effective in delaying or preventing the onset of primary open-angle glaucoma [1,2]. Assenti has met or exceeded all three specific aims from our funded SBIR Phase I and we anxiously look forward to build upon this progress in Phase II. We have identified the following three specific aims to accomplish for Phase II: 1. Develop a reliable, production ready, battery-free IOP monitoring system using an ultra-miniature MEMS pressure sensor as well as a telemetry 1C, whose combined size measures less than 2mm x 2mm x 0.5mm (75% volume reduction from the phase I device) for FDA animal and eventual human trials. 2.Implementation of our strategic FDA test plan developed by Arkios LLC to obtain our IDE and lead Assenti towards a PMA of our Smart IOP monitor. S.Research into our longer term goal of combining Assenti's Smart IOP monitor with an invivo IOP reducing mechanism that can lead to autonomous control of the entire system and completely eliminate patient intervention.