# VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS

> **NIH NIH R43** · VENTSAFE, INC. · 2024 · $290,434

## Abstract

The goal of this Phase 1 SBIR project is to develop and test a bidirectional synchronous flow-controlled
ventilation system to improve oxygenation and ventilation in Acute Respiratory Distress Syndrome (ARDS).
Respiratory failure is a significant cause of mortality, leading to one million deaths annually worldwide1.
Respiratory pandemics are frequent and lead to profound mortality with conventional therapy alone.
Conventional ventilation (CV) induces and potentiates alveolar trauma through numerous well-established
mechanisms of ventilator-induced-lung-injury (VILI) including: volutrauma, barotrauma, and atelectatic-trauma.
We propose to develop a ventilation system that has a lower potential for trauma and reduced need for sedation
and paralysis. VENTSAFE™ has the potential to provide gentle lung ventilation without the damaging effects of
CV. Instead of artificially expanding and collapsing the lung, the system performs gas exchange at tightly
controlled, near-static pressures. VENTSAFE™ technology overcomes the shortcomings of existing high
frequency ventilation systems by employing a bidirectional synchronous flow-controlled ventilation system. Our
device allows for much higher frequencies than existing technologies creating a near-static low amplitude
pressure wave. Using a rudimentary device and a physical test system, along with results from computational
fluid dynamics (CFD) airflow analysis, we have preliminary data demonstrating that our system is able to deliver
bidirectional synchronous flow-controlled, ventilation from the Endotracheal tube inlet at a near-static pressure
while circumventing trauma that is common from conventional ventilators. This should translate into lower
sedation requirements and eliminate risk of breath stacking. We will test the hypothesis that a bidirectional
synchronous flow-controlled ventilation system will demonstrate improved oxygenation and ventilation in an
ARDS lung model. To test this hypothesis, we will conduct the following specific aims: Aim 1. Perform CFD
analysis. Milestone: Design demonstrates equivalent or improved ability to oxygenate and ventilate (simulated
expired CO2 and O2) compared to CV forces in a CFD lung model. Aim 2. Develop a robust experimental
prototype. Milestone: Device demonstrates ability to maintain and adjust mean airway pressure with the ability
to effectively clear CO2 on a physical lung model. Aim 3. Preclinical and benchtop test of VentSafe™
ventilation system in both native and damaged lung models compared to conventional ventilation.
Milestone: Demonstrate improved oxygenation (>5mmHG PaO2 increase) and improved ventilation (>5mmHG
PaCO2 decrease) with arterial blood gas analysis (ABG) at specific time intervals compared to convention
ventilation system (p<0.05). Acceptable lung tissue histology. At the conclusion of this Phase 1 SBIR we seek
to have a validated, robust experimental prototype that has demonstrated improved ability to oxygenate and
ventilate in ARDS c...

## Key facts

- **NIH application ID:** 11007305
- **Project number:** 1R43HL176331-01
- **Recipient organization:** VENTSAFE, INC.
- **Principal Investigator:** Dean Antony Barker
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $290,434
- **Award type:** 1
- **Project period:** 2024-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007305

## Citation

> US National Institutes of Health, RePORTER application 11007305, VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS (1R43HL176331-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/11007305. Licensed CC0.

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