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

总结 糖尿病周围神经病变（DPN）影响多达一半的糖尿病患者， 美国疾病控制中心表示，目前美国有超过3700万人患有糖尿病。 大约20%的人在被诊断为糖尿病时已经患有DPN， 美国每年有82，000例下肢截肢。卫生保健提供者需要一个准确的 检测早期DPN的方法，以改善结果。 VisionQuest Biomedical组建了一个跨学科的科学家团队， 在自动热成像分析、糖尿病合并症诊断和DPN治疗中。 我们的目标是在CRP授权结束前获得FDA批准i-RxTherm， 该设备基于受糖尿病影响的神经元因素改变糖尿病的原理， DPN患者的体温调节过程。i-RxTherm的核心创新在于它能够 在早期阶段检测任何类型的DPN，小或大的纤维，这是其他单一产品无法实现的功能。 设备目前有。 在第二阶段成功的推动下，我们计划开始将我们的设备商业化， 完成文档和测试流程，使我们能够将i-RxTherm提交给 FDA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 设计控制（符合ISO 13485）并执行软件V& V。 目标2：在试点诊所实施i-RxTherm。我们将进行临床研究（而不是 临床试验），并在我们大学合作机构的初级诊所部署i-RxTherm 证明（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Covelocity负责编写I类药物的技术文件和其他文件 在第2个月和第12个月批准作为510（k）器械提交给FDA。 目标4：完成市场研究并最终确定推出战略。我们将与我们的 营销顾问，以建立我们的初步营销计划。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CRP拨款的第3个月结束时，我们将提交i-RxTherm I类产品以获得FDA批准。 随后在第12个月时获得II类清除。

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.