# Intravenous delivery of oxygen microbubbles for the treatment of hypoxia and ARDS

> **NIH NIH R43** · AGITATED SOLUTIONS, LLC · 2022 · $305,538

## Abstract

PROJECT SUMMARY
The goal of this Phase 1 project is to develop the AS-O2-001 System for intravenous, gaseous oxygen
microbubble delivery for treatment of hypoxia. Hypoxia is a catastrophic illness that can result from acute
respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), pulmonary fibrosis,
COVID-19, congestive heart failure and myocardial infarction. Current treatment options for severely affected
patients include extracorporeal membrane oxygenation (ECMO) and mechanical ventilation, which are both
invasive, expensive, and have iatrogenic sequalae. Agitated Solutions Inc. is developing a novel, minimally
invasive alternative: the AS-O2-001 system delivers gaseous oxygen microbubbles into the inferior vena cava to
delay or prevent mechanical ventilation or ECMO.
Gaseous oxygen delivery has historically resulted in emboli formation; however, improved technology today
enables the delivery of microbubbles (<100 µm). Microbubbles have unique properties, including their shrinking
collapse, accelerated diffusion of gases, and negatively charged surface that prevents coalescence into emboli.
Supersaturated oxygen is one such therapy that utilizes microbubbles of oxygen and has seen success in acute
treatments (e.g. myocardial infarctions), but cannot readily be applied for chronic illness such as hypoxia due to
fluid overload. Other alternative treatments in development, such as chemically coated microbubbles or
intravascular respiratory assist catheters, have seen adverse metabolic effects or cardiac intolerance that
prevent their clinical adoption.
The AS-O2-001 system is promising because it utilizes the safety and efficacy of microbubbles in supersaturated
oxygen but removes the overburden of fluids which would be deleterious in severely ill patients with hypoxia.
Furthermore, the AS-O2-001 system is applied in the inferior vena cava and takes lessons learned from
intravascular respiratory assist catheters in order to prevent cardiac intolerance, including a small form factor, a
small insertion size, and the use of biocompatible materials.
In Aim 1, the AS-O2-001 System will be developed and tested in an in vitro model to characterize its safety in
preventing formation of air emboli and its effectiveness in delivering a therapeutic relevant dose. In Aim 2, the
System will be evaluated in vivo to demonstrate the safety and proof of concept of intravenous delivery of oxygen
in a porcine model of normoxemia and hyperoxemia. Successful completion of this project will demonstrate the
feasibility of this novel and innovative method of delivering therapeutic oxygen as intravenously injected
microbubbles.

## Key facts

- **NIH application ID:** 10384013
- **Project number:** 1R43HL158362-01A1
- **Recipient organization:** AGITATED SOLUTIONS, LLC
- **Principal Investigator:** Benjamin Arcand
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $305,538
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10384013

## Citation

> US National Institutes of Health, RePORTER application 10384013, Intravenous delivery of oxygen microbubbles for the treatment of hypoxia and ARDS (1R43HL158362-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10384013. Licensed CC0.

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