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

> **NIH NIH SB1** · VISIONQUEST BIOMEDICAL INC · 2022 · $1,001,136

## Abstract

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.

## Key facts

- **NIH application ID:** 10601546
- **Project number:** 1SB1DK135209-01
- **Recipient organization:** VISIONQUEST BIOMEDICAL INC
- **Principal Investigator:** Peter N Soliz
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,001,136
- **Award type:** 1
- **Project period:** 2022-09-22 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10601546

## Citation

> US National Institutes of Health, RePORTER application 10601546, Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy (1SB1DK135209-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10601546. Licensed CC0.

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