VISTA, Calif. — JUNE 23, 2020 — Sommetrics , Inc., a company providing products and services to improve sleep quality, announced it filed an application with the FDA for Emergency Use Authorization to introduce its aerSleep® II product to treat obstructive sleep apnea in people at risk of COVID-19. The intent is to reduce transmission of SARS-CoV-2 by those with documented or suspected infection by replacing CPAP therapy for sleep apnea with aerSleep® II. The rationale is that positive pressure delivered by CPAP may contaminate the treatment environment with infectious aerosols and facilitate transmission of virus. By contrast, aerSleep II is a comfortable external vacuum pressure device applied to the upper neck with no foreseeable risk of producing infectious aerosols. CPAP units are produced by several companies, including Koninklijke Philips N.V. (NYSE: PHG) and ResMed Inc. (NYSE: RMD), whereas the patented aer+TM technology in the aerSleep II device is unique to Sommetrics.
“We believe that our noninvasive, untethered aerSleep II product can have a role in reducing infectious aersols from those using CPAP devices,” commented Richard Rose, M.D., President of Sommetrics. “Replacing CPAP devices with our aerSleep II product may have important public health implications, particularly in limiting viral spread among family members, care givers, and in residential settings with those at increased risk for severe COVID-19 disease, like nursing homes and other long-term care settings.”
Sommetrics’ Emergency Use Authorization request is supported by several published studies and the American Academy of Sleep Medicine (AASM) which states, “there may be increased risk of transmission of COVID-19 to others in the environment if CPAP is used” (https://aasm.org/covid-19-resources/covid-19-faq).
This concern is also highlighted in a recent issue of Health Essentials from the Cleveland Clinic, which states that “PAP therapy is an open system that can generate contact, droplet and airborne COVID-19 increasing the risk of transmission like other procedures such as tracheal intubation” (https://health.clevelandclinic.org/can-cpap-machines-increase-the-risk-of-spreading-the-coronavirus/).
About Sommetrics, Inc.
Sommetrics (Vista, CA) is a privately funded company focused on improving sleep quality by providing products and services that deal with disorders of the upper airway such as obstructive sleep apnea (OSA) and snoring. For more information, visit www.sommetrics.com. Sommetrics®, aerSleep® and aer+TM are trademarks of Sommetrics.