Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy

摘要 糖尿病周围神经病变(DPN)影响多达一半的糖尿病患者，中心 疾病控制中心表示，目前美国有超过3700万糖尿病患者。 约20%的人在被诊断为糖尿病时已经患有DPN，而DPN会导致 在美国，每年有8.2万例截肢手术。医疗保健提供者需要一个准确的 检测早期DPN以改善预后的手段。 VisionQuest Biomedical组建了一个由有经验的科学家组成的跨学科小组 在自动热成像分析、糖尿病合并症诊断和DPN治疗方面的应用。 我们的目标是在我们的专利I-RxTherm的CRP拨款结束前获得FDA的批准 一种基于受糖尿病影响的神经因子改变 DPN患者的体温调节过程。I-RxTherm的核心创新是它能够 在早期阶段检测任何类型的DPN，无论是大光纤还是小光纤-这一功能是其他任何单一 设备当前有。 在我们第二阶段的成功推动下，我们计划通过以下方式开始我们的设备的商业化 完成文档和测试流程，使我们能够提交i-RxTherm FDA的批准和。我们将通过以下具体目标实现这些目标： 目标1：执行软件验证和确认(V&V)。我们将把i-RxTherm纳入 设计控制(符合国际标准化组织13485)并执行软件V&V。 目的2：在试点诊所实施i-RxTherm。我们将进行一项临床研究(不是 临床试验)，并在我们大学合作者设施的初级诊所部署i-RxTherm 展示(1)有效的临床部署工作流程和(2)安全性和有效性。 目标3：获得监管许可。我们将与RTG和我们的监管合作伙伴合作， PharMalex和CoVeley，为I类编写技术文件和其他文档 在第2个月和第12个月批准作为510(K)设备提交给FDA。 目标4：完成市场研究并最终确定推广战略。我们将与我们的 营销顾问将根据我们的初步营销计划开展工作。最终的营销计划将 由VisionQuest工作人员在这些合作者的协助下实施。 在第三个月的CRP拨款结束前，我们将提交I-RxTherm Class I以获得FDA的批准 然后在12个月前获得二级许可。

SUMMARY Diabetic peripheral neuropathy (DPN) affects up to half of all diabetic people, and the Centers for Disease Control state that over 37 million people in the United States now live with diabetes. About 20% of people already have DPN when they are diagnosed with diabetes, and DPN causes 82,000 lower extremity amputations annually in the US. Health-care providers need an accurate means to detect early stage DPN in order to improve outcomes. VisionQuest Biomedical has assembled an interdisciplinary group of scientists with experience in automated thermal image analysis, diabetes comorbidity diagnosis; and treatment of DPN. Our goal is to have FDA clearance by the end of this CRP grant for i-RxTherm, our patented device based on the principle that neuronal factors affected by diabetes, alter the thermoregulation process in DPN patients. The core innovation of i-RxTherm is its ability to detect any type of DPN, small or large fiber, in the early stages—a capability that no other single device currently has. Driven by our Phase II success, we plan to begin the commercialization of our device by completing the documentation and testing process that will allow us to submit i-RxTherm for FDA clearance and. We will accomplish these goals through the following specific aims: Aim 1: Perform software verification and validation (V&V). We will bring i-RxTherm under design controls (compliance with ISO 13485) and perform software V&V. Aim 2: Implement i-RxTherm at pilot clinic. We will conduct a clinical research study (not a clinical trial) and deploy i-RxTherm at a primary clinic at our University collaborator’s facilities to demonstrate (1) effective clinical deployment workflow and (2) safety and efficacy. Aim 3: Gain regulatory clearance. We will work with RTG and our regulatory partners, Pharmalex and Covelocity, to compile the technical file and other documentation for Class I approval in month 2 and in the 12th month for a submission to the FDA as a 510(k) device. Aim 4: Complete market research and finalize a rollout strategy. We will work with our marketing consultants to build on our preliminary marketing plan. The final marketing plan will be implemented by VisionQuest staff with the assistance of these collaborators. By the end of Month 3 of the CRP grant, we will submit the i-RxTherm Class I for FDA clearance followed by a Class II clearance by Month 12.