A Real Time Monitoring System to Measure IOP in Glaucoma

简介(申请人提供)：Asseni LLC是一家由10人组成的初创公司，由路易斯维尔大学斯皮德工程学院、眼科和视觉科学系以及主要行业合作伙伴组成的合作研究团队组成。Asseni的封闭式SBIR第二阶段应用程序将使我们能够继续取得重大进展，并朝着成为第一家将基于MEMS(微型机电系统)的设备推向市场的公司迈进。这项革命性的技术通过提供对眼压(IOP)的持续、非侵入性监测，有可能消除青光眼患者失明的根本原因。我们商业化的近期目标是开发我们的第一代“智能眼压”监测器，该监测器将严格监控眼压，这样患者就可以自行给药来降低眼压，从而消除视神经损伤，从而防止青光眼致盲。然而，我们最终的长期目标是开发一种自给自足的系统，既可以释放降压药物来降低眼压，也可以使用开关控制的MEMS阀门，创建一个完全自主的系统，不需要患者干预。最近的研究表明，局部应用降眼压药物能有效延缓或预防原发性开角型青光眼的发病[1，2]。Asseni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。我们已经确定了第二阶段要实现的以下三个具体目标：1.开发一种可靠的、可投入生产的、无电池的眼压监测系统，该系统使用超微型MEMS压力传感器和遥测1C，其组合尺寸小于2 mm x 2 mm x 0.5 mm(比第一阶段设备体积减少75%)，用于FDA动物和最终的人体试验。2.实施我们由Arkios LLC开发的战略FDA测试计划，以获得我们的集成开发环境，并领导Asseni实现我们的智能眼压监测器的PMA。我们的长期目标是将Asseni的智能眼压监测仪与体内眼压降低机制相结合，从而实现对整个系统的自主控制，并完全消除患者干预。

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.