Phase II Amount
$1,001,136
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 forFDA 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.
Public Health Relevance Statement: NARRATIVE: Diabetic peripheral neuropathy (DPN) affects up to half of all people living with diabetes and contributes directly to lower-extremity amputations in 15% of diabetic patients. The identification of early stage DPN can lead to timely interventions and better long-term health outcomes for the many people affected by this disease, but current diagnostic tools are time-consuming and highly subjective. Our device, i-RxTherm, detects biomarkers of DPN quickly, accurately, and non-invasively, thus providing a new and better tool for the early detection and diagnosis of this disabling complication of diabetes.
Project Terms: Affect, Amputation, Artificial Intelligence, AI system, Computer Reasoning, Machine Intelligence, Physiologic Thermoregulation, Body Temperature Regulation, Body Thermoregulation, Thermoregulation, Centers for Disease Control and Prevention (U.S.), CDC, Centers for Disease Control, Centers for Disease Control and Prevention, United States Centers for Disease Control, United States Centers for Disease Control and Prevention, Clinical Research, Clinical Study, Clinical Trials, comorbidity, co-morbid, co-morbidity, Diabetes Mellitus, diabetes, Diagnosis, Disease, Disorder, Environment, Feedback, foot, Goals, Grant, Health, Health Personnel, Health Care Providers, Healthcare Providers, Healthcare worker, health care personnel, health care worker, health provider, health workforce, healthcare personnel, medical personnel, treatment provider, Interview, Lead, Pb element, heavy metal Pb, heavy metal lead, Lower Extremity, Lower Limb, Membrum inferius, Market Research, Marketing, Medical Device, Persons, Nerve Cells, Nerve Unit, Neural Cell, Neurocyte, neuronal, Neurons, Patents, Legal patent, Patients, PNS Diseases, Peripheral Nerve Diseases, Peripheral Nervous System Disorders, Peripheral Neuropathy, Peripheral Nervous System Diseases, Physicians, Primary Care, Primary Healthcare, Primary Health Care, Reference Standards, Risk, Safety, Sales, Sensation, Esthesia, Sensitivity and Specificity, Cell Communication and Signaling, Cell Signaling, Intracellular Communication and Signaling, Signal Transduction Systems, Signaling, biological signal transduction, Signal Transduction, Software, Computer software, Software Verification, Software Validation, Survey Instrument, Surveys, Temperature, Testing, Time, United States, Universities, Work, Measures, base, Image Analysis, Image Analyses, image evaluation, image interpretation, Clinical, Phase, Fiber, diabetic, Measurement, Funding, tool, Diabetes Complications, Diabetes-Related Complications, Diabetic Complications, Complications of Diabetes Mellitus, programs, Scientist, Clinic, Protocol, Protocols documentation, System, vibration, early detection, Early Diagnosis, experience, success, research study, Devices, Early identification, develop software, developing computer software, software development, portability, Intervention Strategies, interventional strategy, Intervention, Documentation, image-based method, imaging method, imaging modality, Preparedness, Readiness, Detection, device development, instrument development, Device or Instrument Development, Imaging Instrument, Imaging Tool, Imaging Device, Reproducibility, Validation, Process, Development, developmental, Image, imaging, Computer Assisted, computer aided, design, designing, Outcome, Consumption, innovation, innovate, innovative, tertiary care, person centered, commercialization, Biological Markers, bio-markers, biologic marker, biomarker, diabetic patient, verification and validation, Secure, screening, nerve conduction study, improved outcome, diagnostic tool
