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FDA grants emergency use authorization for portable negative pressure tent developed at Michigan Medicine

The device can now be distributed to hospitals across the country.

A negative pressure tent designed by Michigan Medicine researchers in response to the COVID-19 pandemic recently received emergency use authorization from the FDA.

The portable device, called the AerosolVE Tent, works to contain and filter aerosols using a foldable canopy and motorized filtration system. It was developed by the Michigan Center for Integrative Research in Critical Care, also known as MCIRCC, in collaboration with FlexSys, Inc., a Michigan-based mechanical systems engineering company.

“The tent helps patients by allowing more liberal use of proven therapies while protecting health care workers and other patients in the process,” said Nate Haas, M.D., assistant professor of emergency medicine at Michigan Medicine and one of the clinicians who led the tent’s development and testing. “The device can turn any hospital bed, stretcher or operating room into a portable negative pressure room. The light weight, collapsibility and inexpensive materials also make it ideal for use in non-traditional settings such as field hospitals.”

In clinical testing, physicians successfully performed tracheostomies on three intubated COVID-19 patients while using the negative pressure tent. Tents were also used on 20 emergency department patients, either with unknown COVID status or known to be COVID positive, for several procedures, including endotracheal intubations with 100% first-pass success, high-flow nasal cannula, non-invasive ventilation and electrocardiograms. It generated up to 600 air exchanges per hour, of which only 12 are required by the Centers for Disease Control and Prevention for negative pressure rooms.

“Throughout the testing, the tents were well-tolerated by patients and received positive feedback from health care workers,” Haas said. “The patients were able to easily communicate with their providers and family members, and no serious adverse events occurred. I am excited about the potential of these devices to help more patients and health care workers at other institutions moving forward.”

During a public health emergency, the FDA can issue emergency use authorization for unapproved medical devices to diagnose, treat and prevent conditions if approved alternatives are not available. The AerosolVE Tent is licensed to FlexSys, Inc., who has formed InspireRx, a Michigan Medicine spinoff company that can now, with the authorization, bring the product to the market.

“We have had requests for this product coming in from hospitals around the country,” said Sridhar Kota, Ph.D., CEO of InspireRx and Herrick Professor of Engineering at U-M. “We have partnered with an approved manufacturer with a scalable manufacturing capacity and are ready to begin distribution.”

The team is also in talks with the U.S. Department of Health and Human Services regarding stockpiling the tents for future pandemics, as well as for countries who are still inundated with critically ill COVID patients.

“Many health systems in the U.S. have very limited negative pressure infrastructure,” said Ben Bassin, M.D., CMO of InspireRx and associate professor of emergency medicine at Michigan Medicine.“In most developing countries, it doesn’t even exist. We think [the AerosolVE Tent] is a scalable solution with great utility that can also allow the provision of early non-invasive respiratory therapies as well as life-saving procedures. This could possibly alleviate the need for a ventilator or allow for earlier weaning of infected patients from ventilators, enabling them to be returned to the supply chain to help alleviate critical medical equipment shortages.”

The AerosolVE Tent is one of two portable negative pressure systems currently in development from InspireRx and MCIRCC. The other is a helmet that works to enable the isolated use of heated high-flow nasal cannula or nebulized medications.

“This is a fantastic example of MCIRCC’s innovative and integrated team science model,” said Kevin Ward, M.D, executive director of MCIRCC and professor of emergency medicine at U-M. “It allowed for the rapid development, testing and regulatory approval of a potential game-changing technology for the COVID-19 pandemic and possible future pandemics.”

 

Disclosure: Kota, Ward, Bassin and Haas are inventors of the tent and other negative pressure technology. They also have equity positions in InspireRx.

About Inspire Rx

InspireRx LLC. was established to develop, test, and patent the AerosolVE negative pressure Tent and Helmet systems. The team is comprised of clinicians and engineers from the University of Michigan and the Ann Arbor, Michigan-based mechanical systems developer FlexSys, Inc. Sridhar Kota is also the founder of FlexSys. For more information, please visit https://www.aerosolvedevices.com.

About MCIRCC

The team at the Michigan Center for Integrative Research in Critical Care (MCIRCC) is dedicated to pushing the leading edge of research to develop new technologies and novel therapies for the most critically ill and injured patients. Through a unique formula of innovation, integration and entrepreneurship, their multi-disciplinary teams of health providers, basic scientists, engineers, and data scientists, commercialization coaches, donors and industry partners are taking a boundless approach on re-imagining every aspect of critical care medicine. For more information, visit www.mcircc.umich.edu.

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