Novel medical device for treatment of fungal nail infection

描述(由申请人提供)：该提案继续对一种新颖、安全和有效的甲真菌病(指甲真菌感染)治疗设备进行概念验证开发和测试。虽然甲真菌病被认为是一种美容问题，但受感染的指甲也成为感染微生物的持久宿主，这些微生物可能会导致其他重大的医疗问题。超过3500万美国人患有甲真菌病，在美国医疗体系中，这种疾病的直接成本超过40亿美元。正在开发的设备将为患者和医生提供一种可靠的方法来治疗指甲真菌感染，而不同于目前可能导致肝脏损害的口服药物，或者疗效较低或未经证实的局部乳膏和激光。在这个项目中，我们将开发一个基于我们正在申请专利的技术的医疗设备原型，以证明通过人类指甲杀死真菌感染的可行性。我们这个第一阶段项目的关键成功指标是示范杀菌剂 该仪器通过人指甲对红色毛霉菌和须根霉菌的生长抑制率均为99.9%。在FDA批准的治疗甲真菌病的医疗设备的最终开发中，这是降低技术风险的必要步骤。为了支持我们的产品目标，我们建议回答与这种新设备的实用性有关的三个关键问题：1)使用改进的仪器原型同时进行超声波和等离子治疗是否可以增加治疗的抗真菌性能？2)人体身体指甲的三维弯曲是否会改变所需的治疗方案而不是平面？3)这种治疗的抗真菌效果是否会像其他真菌物种一样继续下去 被送去接受治疗？

DESCRIPTION (provided by applicant): This proposal continues the proof-of-concept development and testing of a novel, safe, and effective treatment device for onychomycosis (nail fungal infection). While onychomycosis is considered a cosmetic problem, the infected nail also becomes a persistent reservoir for infectious microbes that could lead to other significant medical problems. Over 35 million Americans suffer from onychomycosis, which carries a direct cost of over $4 billion in the US healthcare system. The device under development would offer patients and doctors a reliable method to treat nail fungal infections without toxic side effects unlike current oral medications that may cause liver damage, or topical creams and lasers that have low or unproven efficacy. In this project, we will develop a medical device prototype based on our patent pending technology to prove the feasibility of killing fungal infections through a human nail. Our critical success metric for this Phase I project is demonstration of the fungicidal effect of the instrument by 99.9% growth inhibition of both T. rubrum and T. mentagrophytes fungus through a human nail. This is a necessary step to reduce technical risk in the ultimate development of an FDA- approved medical device for curing onychomycosis. In support of our product goal, we propose to answer three critical questions related to the utility of this novel device: 1) Can performing simultaneous ultrasound and plasma treatment with an improved instrument prototype increase the antifungal properties of the treatment?; 2) Does the three dimensional curvature of a human cadaver nail change the needed treatment protocol vs. a flat surface?; 3) Will the antifungal effect of this treatment continue as additional fungal species are presented for treatment?