A Real Time Monitoring System to Measure IOP in Glaucoma

描述（由申请人提供）：Assenti LLC是一家由路易斯维尔大学速度工程学院和眼科与视觉科学系沿着与主要行业合作伙伴合作的研究团队组成的10人初创公司。Assenti的SBIR第二阶段应用程序将使我们能够继续我们的重大进展和势头，成为第一家将MEMS（微机电系统）为基础的设备推向市场，用于治疗青光眼患者的公司。这项革命性的技术有可能通过提供连续的、非侵入性的眼内压（IOP）监测来消除青光眼患者失明的根本原因。我们的短期商业化目标是开发第一代“智能眼压”监测仪，该监测仪将严格监测眼压，因此患者可以自行滴眼液以降低压力，这将导致消除视神经损伤，从而预防青光眼失明。然而，我们最终的长期目标是开发一个独立的系统，该系统将释放消肿药物以降低IOP或使用开关控制的MEMS阀，以创建一个完全自主的系统，无需患者干预。最近的研究表明，应用局部眼部消肿药物可有效延迟或预防原发性开角型青光眼的发作[1，2]。Assenti已经达到或超过了我们资助的SBIR第一阶段的所有三个具体目标，我们热切期待在第二阶段取得进展。我们确定了第二阶段要实现的三个具体目标：1.使用超微型MEMS压力传感器和遥测1C开发一种可靠、生产就绪、无电池的IOP监测系统，其组合尺寸小于2mm x 2mm x 0.5mm（与I期器械相比体积减少75%），用于FDA动物试验和最终的人体试验。2.实施由Arkios LLC制定的FDA战略测试计划，以获得IDE，并引导Assenti获得Smart IOP监护仪的PMA。研究我们的长期目标，将Assenti的智能IOP监测仪与体内IOP降低机制相结合，可以实现整个系统的自主控制，完全消除患者干预。

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.