NextGenET

Highlights

• Mechanical ventilation for breathing support requires an endotracheal tube.
• Inflatable cuffs on these tubes, designed to prevent infectious bacteria from entering the lungs, do not create effective seals.
• Over 300,000 Americans die each year from ventilator-associated pneumonia, caused by poorly-sealing inflatable cuffs.
• NextGenET has created a simplified, inexpensive, disposable, and easy-to-use design with multiple panels that significantly outperforms inflatable cuffs.
• The NextGenET team has formed a new Pitt spinout company to develop this device - Respair, Inc.

Problem

Mechanical ventilation for breathing support requires an endotracheal tube. Current endotracheal tubes include an inflatable cuff to provide a seal for ventilation to prevent harmful bacteria from entering the lungs, causing infections and deadly pneumonia.

These inflatable tubes fail to create an effective seal because they: (1) deflate over time, (2) do not maintain constant contact with the airway, and (3) shift locations during the everyday movement.

As a result, pneumonia develops for 1 in 3 patients on ventilators in Intensive Care Units. Ventilator-associated pneumonia is the second most common hospital-acquired infection (after only surgical site infections) and has an average mortality rate of almost 50%, killing almost 300,000 Americans annually.

Due to these ineffective inflatable seals, ventilator-associated pneumonia is viewed as an inevitable consequence of longer-term ventilator support, rather than a preventable infection.

Hospitals utilize some simple steps (oral hygiene, head elevation) to prevent this pneumonia, but fails to address its root cause – ineffective long-term seal from inflatable cuffs on endotracheal tubes, leading bacteria to freely enter the lungs and cause infection.

Solution

NextGenET is a simplified, low-cost-disposable endotracheal tube designed to prevent this deadly infection at its root.

Our unique design uses a layer of panels that passively seal the airway, consistently outperforming current inflatable cuffs without requiring constant monitoring.

While specialized tubes exist, they are simply too expensive for most hospital systems to implement consistently. NextGenET produces leak-proof seals, is affordable, and is simple for healthcare specialists to use and maintain.

While our tube is currently designed to be single-use in modern US hospital ICUs, we believe it can be re-sterilization for repeated use without degrading effectiveness (as happens with current inflatable tubes) in underserved developing regions.

NextGenET has the potential to substantially reduce ventilator-associated pneumonia in the ICU, saving thousands of lives and billions of dollars in the US alone.

Path to Impact Plan

The PinCh award will allow us to produce an advanced NextGenET prototype, providing the basis for a new spin-out company founded by the core team members. Pursuing funding through an NIH SBIR/STTR award, in addition to dilutive capital, would allow us to complete final product development and perform required ISO testing to apply for a 510(k) for market access through the FDA. As a Class II medical device, we expect that we could have the tube on the market within three years.

Next steps include partnering with large health systems to trial the NextGenET to accrue clinical data, marketing and selling our tube into the receptive market, and partnering with larger-scale manufacturers within the endotracheal tube market.

Additionally, once we have traction in the US market, we also see an opportunity to improve standards of care in low-resource settings globally. Our unique design is more amenable to re-sterilization than traditional cuffed tubes, which could substantially reduce ventilator-associated pneumonia in developing regions. The global impact of potentially saving thousands of lives with NextGenET is enormous.

Team

• Carl Snyderman, MD, MBA (Co-Inventor, Pitt Professor of Bioengineering, Otolaryngology, and Neurological Surgery) leads our project's clinical and testing workflows with over 30 years of experience in evaluating clinical care.
• Garrett Coyan, MD, MS (Co-Inventor, UPMC Cardiothoracic Surgery Resident and Fellow) is a serial entrepreneur and previous PinCh winner (OneValve) serving as regulatory and entrepreneurial lead.
• Ross Beresford, MS leads the project management and operations with experience managing complex projects/products and securing early-stage funding.
• Lauren Grice (Pitt) and Garett Craig Duquesne) are Bioengineering graduate students supporting testing and prototype development.