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VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS

Award Number: R43HL176331
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS - 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 compared to conventional ventilation. In Phase 2 we intend to develop a scalable, market- ready prototype for statistically significant modeling to justify moving to the clinic.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $288,855 )
2025	2025	LIBERANDUM TECHNOLOGIES, INC.	90 URBANO DR	SAN FRANCISCO	CA	94127	SAN FRANCISCO	USA	Lung Diseases Research	002	2	3/25/2025	NON-COMPETING CONTINUATION	$288,855
2025	2024	LIBERANDUM TECHNOLOGIES, INC.	90 URBANO DR	SAN FRANCISCO	CA	94127	SAN FRANCISCO	USA	Lung Diseases Research	000	1	10/11/2024	NEW	$0
2025	2024	LIBERANDUM TECHNOLOGIES, INC.	90 URBANO DR	SAN FRANCISCO	CA	94127	SAN FRANCISCO	USA	Lung Diseases Research	001	1	12/7/2024	NEW	$0
														Subtotal = $288,855

Issue Date FY: 2024 ( Subtotal = $290,434 )
2024	2024	LIBERANDUM TECHNOLOGIES, INC.	90 URBANO DR	SAN FRANCISCO	CA	94127	SAN FRANCISCO	USA	Lung Diseases Research	000	1	8/22/2024	NEW	$290,434
														Subtotal = $290,434

Grand Total All Awards = $579,289

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VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS

Award Number: R43HL176331

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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