FDA grants Emergency Use Authorization for portable negative pressure tent developed at Michigan Medicine
Full view of the Aerosolve Tent and air filtration system. Image courtesy of InspireRx.
ANN ARBOR, MI — The U.S. Food and Drug Administration (FDA) has approved an Emergency Use Authorization (EUA) for the Aerosolve negative pressure procedure tent built in response to the COVID-19 pandemic.
Produced in collaboration with FlexSys, Inc. and the Michigan Center for Integrative Research in Critical Care (MCIRCC), the Aerosolve Tent turns any hospital bed, stretcher or operating room table into a portable negative pressure room via its foldable canopy and motorized air filtration system. Development and testing included faculty and staff from Michigan Medicine (Emergency Medicine, Anesthesiology, Critical Care, Internal Medicine, Surgery, Nursing, and Respiratory Therapy), the College of Engineering (Mechanical Engineering) and Industry (FlexSys, Inc).
“The tent helps patients by allowing more liberal use of proven therapies while protecting healthcare workers and other patients in the process by containing and filtering aerosols,” said Nathan Haas, M.D., Assistant Professor of Emergency Medicine and one of the clinicians who led the tent’s development and testing. “The light weight, collapsibility, and inexpensive materials also make it ideal for use in non-traditional settings such as field hospitals.”
Under an Emergency Use Authorization, the FDA allows the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases or conditions during an emergency. The tent has subsequently been licensed to a Michigan Medicine spin-off company, InspireRx. With this recent EUA designation, the InspireRx team can officially move forward with getting the device into the hands of those who need it most.
“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 (HHS) regarding stockpiling the tents for future pandemics as well as for countries who are still inundated with critically ill COVID patients. Ben Bassin, M.D., CMO of InspireRx and Associate Professor of Emergency Medicine spoke on the critical need for devices such as the tent.
“Many health systems in the U.S. have very limited negative pressure infrastructure,” said Bassin. “In most developing countries, it doesn’t even exist. We think this [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. Together with the Aerosolve Helmet, these devices are poised to enhance patient care and provider safety well beyond the current health crisis. Kevin Ward, MD, Executive Director for MCIRCC said, “This is a fantastic example of MCIRCC’s innovative and integrated team science model that allowed for the rapid development, testing, and regulatory approval of a potential game changing technology for the COVID-19 pandemic and possible future pandemics.”
Dr. Haas mirrored Dr. Ward’s confidence. “Pre-clinical and clinical testing has yielded positive results,” said Haas. “I'm excited about the potential of these devices to help patients and healthcare workers at other institutions moving forward.”
Disclosures
Drs. Kota, Ward, Bassin, and Haas are inventors of the tent and other negative pressure technology and 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.