# Automated three-dimensional spinal navigation system for chronic pain therapy

> **NIH NIH R44** · RIVANNA MEDICAL, INC. · 2021 · $877,193

## Abstract

PROJECT SUMMARY/ABSTRACT
 An estimated 40 million Americans suffer from chronic back pain, costing the US economy >$250B/yr. Most
chronic back pain originates in the facet joints, and can be treated by targeted joint injections, nerve blocks,
and radiofrequency nerve ablation. However, the current standard of care relies on fluoroscopic needle
guidance during these interventional procedures, leading to high cumulative radiation doses among members
of this patient population, and limiting patient access to these procedures due to the infrastructure costs
associated with performing fluoroscopically guided procedures. One result of limited patient access to
interventional pain procedures is the ongoing reliance on long-term prescription opioid treatment for managing
chronic pain conditions, despite the known hazards to patient wellbeing associated with prolonged opioid use.
 During this project, a 3D ultrasound-based, fluoroscopy-replacement imaging system will be developed
under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key
technological innovations underpinning the development of this product include the following: 3D bone
reconstruction technologies enabling ‘fluoroscopy-like’ renderings of the spine, an application-specific 3D
ultrasound probe system to support real-time needle guidance to the facet joints, and automated visualization
of the therapeutic injectate to confirm accurate administration of the drug. The primary technical tasks during
the early stages of the project period include the execution of end-user clinical usability studies to guide
technical specification development and implementation of core ultrasound visualization algorithms. Successful
completion of these technical aims will result in the fabrication of pre-production systems for pre-clinical
validation studies that will be conducted later in the project period.
 Pre-clinical product validation activities will include cadaver and human-imaging studies performed in
collaboration with clinical experts who will verify that the system meets the requirements for the clinical
application. The primary endpoint for the pre-clinical cadaveric studies is a direct measurement of the accuracy
of needle placement to the facet joints, as confirmed by CT imaging. Additionally, a second pre-clinical study
using cadaveric specimens will characterize the learning curve required to reach competency with the system
by studying the needle placement accuracy achieved by 15 individual pain medicine physicians across multiple
simulated procedures.
 Completion of this research project will result in the development and fabrication of a human clinical-trial-
ready 3D ultrasound-imaging-based imaging system to support guidance of interventional procedures targeting
the facet joints.

## Key facts

- **NIH application ID:** 10384241
- **Project number:** 1R44AR080617-01
- **Recipient organization:** RIVANNA MEDICAL, INC.
- **Principal Investigator:** Frank William Mauldin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $877,193
- **Award type:** 1
- **Project period:** 2021-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10384241

## Citation

> US National Institutes of Health, RePORTER application 10384241, Automated three-dimensional spinal navigation system for chronic pain therapy (1R44AR080617-01). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10384241. Licensed CC0.

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