Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy.

Several organizations have cautioned about the potential for CPAP to spread the coronavirus, which is primarily via droplets expelled by infected individuals. In an FAQs page for sleep clinicians, the American Academy of Sleep Medicine underscored that noninvasive ventilation, such as CPAP, “is a potential aerosol-generating device” that could accelerate the spread of COVID-19.

The Cleveland Clinic also warned 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.”

How it works

Unlike CPAP, which forces air into the airways via a tight-fitting mask on the face, Vista, Calif.-based Sommetrics’ Aer+ technology creates a gentle vacuum externally on the patient’s neck to keep the airway open.

“Basically, this works by pulling the base of the tongue forward and holding it while you’re asleep,” Richard Rose, Sommetrics’ president, told BioWorld. “Another way of thinking of it is if you have a tube like the airway that collapses, you can hold it open by pushing air into it or by putting a vacuum around it.

Aersleep II consists of a collar with an integrated pump, about the size of a quarter, which oscillates at a frequency above human hearing, eliminating any ambient noise. There are no connecting tubes, so patients are able to sleep in any position, including prone. Sensors in the module that holds the pump monitor various patient parameters, such as body position, heart rate and breath sounds.

“It really simple, it’s not over your face, it’s not part of the airway and it’s a lot easier to use” than CPAP, Rose said.

“We believe that our noninvasive, untethered Aersleep II product can have a role in reducing infectious aerosols from those using CPAP devices,” Rose said. “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.”

Clinical trials

Sommetrics has evaluated its sleep apnea device in eight clinical studies involving 155 patients, largely to determine the range of vacuum pressures that is effective in treating the disorder.

Overall, about 70% of people responded to Aersleep, Rose said. After three weeks of home use, 76% of subjects preferred Aersleep to their current or prior treatments.

Last summer, Sommetrics completed its SOM-014 clinical trial assessing the safety, tolerability and effectiveness of Aersleep in ethnic Japanese subjects with obstructive sleep apnea (OSA). The prospective, observational study was conducted at the American Academy of Sleep Medicine-accredited sleep lab in Kaneohe, Hawaii. Among subjects with moderate to severe OSA, Aersleep reduced the frequency of apneas and hypopneas by 75% from baseline in responsive individuals. No significant adverse events were observed.

“We don’t work in everyone, nor does CPAP,” Rose said, referring to the 70% overall response rate. “Our product works at the base of the tongue, so if you’re obstructed above that like in the nasal pharynx, we probably won’t help you.”

Regulatory status

Currently, Aersleep II is investigational in the U.S. A first-generation device has been approved by Health Canada, and Sommetrics is planning to launch it there later this year or in early 2021, with Australia to follow soon after.

“We’re just now submitting a dossier on the second-generation device to Health Canada,” Rose said.

Sommetrics hopes to make Aersleep II available in the U.S. sometime next year as well, Rose added, noting there is still some uncertainty over whether the regulatory pathway will be a 510(k) or de novo submission.

A similar device by Aerfree LLC, Sommetrics’ partially owned affiliate, was cleared via the de novo pathway in 2017 as an external pressure aid to maintain a patient’s upper airway during mild to moderate sedation.

In the event the FDA grants an EUA for Aersleep II, Sommetrics is ready to meet the demand. “We have a fairly decent inventory because we’re planning to go back to Canada, and we could reallocate that to the U.S.,” Rose said.

The company is financed through high net worth individuals and funds from a Japanese partner, he said, adding they’re close to securing partners in two other territories as well.

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