SBIR Phase I: Feasibility of The Use of a Debris Cartridge in an External Drainage Device

SBIR 第一阶段：在外部排水装置中使用碎片盒的可行性

• 批准号: 1248632
• 负责人: Lucinda Camras
• 金额: $ 15万
• 依托单位: Camras Vision, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2013-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1248632&HistoricalAwards=false
• 关键词: SBIR; Phase; Feasibility; Use; Debris

This Small Business Innovation Research Phase I project will demonstrate the feasibility of the use of a debris cartridge in an implant to prevent obstruction in debris-releasing glaucomas, such as uveitic, pigment-dispersion, and pseudoexfoliation glaucomas. Glaucoma is a group of chronic eye diseases that result in permanent vision loss for millions of suffers in the US alone. The innovation of this device lies in its potential ability to provide predictable, adjustable and personalize care to minimize disease progression. However, the device requires a filter to prevent infection that may clog overtime, especially with debris-releasing glaucomas. This Phase I research project will test the feasibility of a novel filter to prevent clogging and its safety in an animal model for debris-releasing glaucoma. The validation of the cartridge will provide the option for glaucoma suffers that may have been otherwise excluded from the advantage that this implant would provide. The broader impact/commercial potential of this project will be, if successful, a more effective treatment for patients with an advanced, cumbersome and difficult to treat type of glaucomas. In 2015, the US glaucoma market is estimated to be over $2 billion and our addressable market, glaucoma surgical therapies, is estimated to be $534M. The incidence for glaucoma increases with age, and as the baby boomer population gets older, there will be a growing need for glaucoma treatments. Debris-releasing glaucomas are especially difficult to treat and can affect children. These patients often are required to endure invasive surgeries throughout their lives that are difficult to manage with current therapies. If successful, our novel device and cartridge would radically change the treatment paradigm of glaucoma, providing the first personalized, long lasting, and adjustable therapy that can treat the most advanced cases of glaucoma. Ultimately, the advancements with the filter will minimize the risk of blindness and improve the quality of life for glaucoma patients.

这个小企业创新研究第一阶段项目将展示在植入物中使用碎片盒防止碎片释放型青光眼阻塞的可行性，如青光眼、色素弥散性青光眼和假脱落性青光眼。青光眼是一组慢性眼病，仅在美国就有数百万患者永久性失明。该设备的创新之处在于其提供可预测、可调节和个性化护理的潜在能力，以最大限度地减少疾病进展。然而，该设备需要一个过滤器来防止感染，因为感染可能会长期阻塞，特别是对于释放碎片的青光眼。这个第一阶段的研究项目将测试一种新型过滤器防止堵塞的可行性及其在碎片释放型青光眼动物模型中的安全性。墨盒的验证将为青光眼患者提供选择，否则这些患者可能被排除在这种植入物所提供的优势之外。如果成功，该项目的更广泛影响/商业潜力将是更有效地治疗晚期，麻烦且难以治疗的青光眼患者。2015年，美国青光眼市场预计将超过20亿美元，而我们的青光眼手术治疗市场预计将达到5.34亿美元。青光眼的发病率随着年龄的增长而增加，随着婴儿潮一代年龄的增长，对青光眼治疗的需求也会越来越大。碎片释放型青光眼尤其难以治疗，并可影响儿童。这些患者在他们的一生中经常需要忍受侵入性手术，而目前的治疗方法很难控制这些手术。如果成功，我们的新设备和墨盒将从根本上改变青光眼的治疗模式，提供第一个个性化的、持久的、可调节的治疗方法，可以治疗最晚期的青光眼病例。最终，滤光器的进步将使失明的风险降到最低，并改善青光眼患者的生活质量。