Novel medical device for treatment of fungal nail infection

描述（由申请方提供）：本提案继续对一种新型、安全、有效的甲真菌病（指甲真菌感染）治疗器械进行概念验证开发和测试。虽然甲真菌病被认为是一个美容问题，但感染的指甲也成为感染性微生物的持久储存库，可能导致其他重大医疗问题。超过3500万美国人患有甲癣，在美国医疗保健系统中直接花费超过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，而没有毒副作用，不像目前的口服药物可能会导致肝损伤，或局部乳膏和激光具有低或未经证实的疗效。在这个项目中，我们将开发一种基于我们正在申请专利的技术的医疗设备原型，以证明通过人体指甲杀死真菌感染的可行性。我们对这个第一阶段项目的关键成功指标是证明杀菌剂 该仪器对两种T.红色毛癣菌和须癣菌通过人的指甲生长这是一个必要的步骤，以减少技术风险，在最终开发的FDA批准的医疗器械治疗甲真菌病。为了支持我们的产品目标，我们建议回答与这种新型设备的实用性相关的三个关键问题：1）使用改进的仪器原型同时进行超声和等离子体治疗是否可以增加治疗的抗真菌特性？2)与平面相比，人体尸体指甲的三维曲率是否改变了所需的治疗方案？3)这种治疗的抗真菌效果是否会随着其他真菌种类的增加而持续？ 提出治疗？

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?