# Refinement of Very Low Leakage Non-Invasive Ventilation Mask for Infectious Patients

> **NIH ALLCDC R44** · CREARE, LLC · 2024 · $643,238

## Abstract

PROJECT SUMMARY/ABSTRACT
 A large number of patients with infectious respiratory diseases such as COVID-19, influenza, and SARS
require respiratory support. Noninvasive Positive Pressure Ventilation (NPPV) via a mask is an appropriate
treatment for many patients that can lead to better outcomes than intubation. Additionally, the equipment used
for NPPV (such as CPAP machines) is widely available, making NPPV well suited for responding to outbreaks
and pandemics. Unfortunately, NPPV masks increase the risk of disease transmission by spreading
contaminated aerosols leaking from the mask seal. This exposes health care workers and other patients to
increased risk and can hamper efforts to contain outbreaks of infectious diseases. The objective of this program
is to develop an innovative NPPV patient interface that greatly reduces the leakage of contaminated aerosols
through the mask seal. The two key innovations are a purged dual seal and a mask integrated vacuum ejector.
The dual seal captures contaminated leakage across the primary mask seal and integrated ejector provides the
purge flow required by the dual seal. All the contaminated flow is then passed through to a viral filter before
exhausting to the room. Our device is a cost effective drop in replacement for existing masks that integrates
easily with NPPV equipment used in hospitals.
 In a prior program and Phase I, we developed and tested initial PDS mask prototypes. We demonstrated
far better sealing performance than a leading commercial mask in laboratory and human subject testing. In the
proposed Phase II program we will refine and productize our mask design, extensively test the performance,
publicize the results, and prepare for regulatory clearance and commercialization. This will enable our innovative
leak-prevention mask technology to be widely deployed in critical care settings—benefiting patients and
protecting health care workers.

## Key facts

- **NIH application ID:** 11007800
- **Project number:** 2R44OH012421-02
- **Recipient organization:** CREARE, LLC
- **Principal Investigator:** Daniel Micka
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2024
- **Award amount:** $643,238
- **Award type:** 2
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007800

## Citation

> US National Institutes of Health, RePORTER application 11007800, Refinement of Very Low Leakage Non-Invasive Ventilation Mask for Infectious Patients (2R44OH012421-02). Retrieved via AI Analytics 2026-07-10 from https://api.ai-analytics.org/grant/nih/11007800. Licensed CC0.

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