SBIR/STTR Research Award

Free-Breathing Dynamic Cardiopulmonary Function Imaging System to use with Xenon MRI

Award identifier 9f83e2fe3871c85aa15575ef88b7d03ac00bf34ee5c4a1e4e17f6dd8bb15e63cAwarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$306,530

Program and phase

SBIR · Phase I

Award year

2025

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
SPINHANCE LLC
Proposal award date
2025-02-01
Contract end date
2026-01-31
UEI
HLPDK4TK2J62
Solicitation number
PA23-230
Topic code
NHLBI

Research abstract

ABSTRACT This project seeks to build, qualify and evaluate clinical feasibility of a novel cardiopulmonary imaging device for continuous administration of the gaseous Magnetic Resonance Imaging contrast agent Hyperpolarized Xenon-129 (HPX), recently approved by the FDA. Paired with a clinically practical set of physiological monitoring measurements, we intend this development to support a new paradigm for functional lung imaging that is accessible to all patients regardless of age or disease state, removes sources of irreproducibility and bias associated with images acquired during extended breath-hold, and offers new opportunities for contrast associated with the dynamic aspects of gas- and blood-flow in an organ that during normal functioning is always in motion. We pursue this goal by first designing and building an automatic, MRI-compatible, piston-based set of syringe pumps that respond to subject breathing dynamics by injecting supplemental HPX or oxygen (or any other desired agent) into the inhaled gas stream. Based on an existing product used for HPX in ventilated small-animal studies, this device will accumulate and respond to passively-obtained pneumotach measures of airflow, allowing bolus or constant- concentration delivery as desired, as well as synchronization with the MR imaging data, the heartbeat, and exhaled gas concentrations, without the need for patient compliance with breathing maneuvers. The combined dataset will support identification of abnormal ventilation, perfusion or gas diffusion during physiologically relevant conditions. Subsequently synchronous monitoring and capturing of inhaled and exhaled O2, CO2 and xenon concentrations is incorporated throughout the breathing cycle. This project also aims to demonstrate feasibility of the dynamic lung HPX MRI in a small pilot study. Identifying key design issues, evaluating patient tolerance and collecting preliminary feedback from clinical support staff are essential at this design stage in order to inform key device validation activities in Phase II including device validation and human factors.

Technology keywords

Not reported

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Agency intelligence

Department of Health and Human Services

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