The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units. The Rapid Response EEG system is currently being used in the Montefiore Health System in New York and at Northwell Health’s North Shore University Hospital, providers at the epicenter of the U.S. COVID-19 crisis.

According to a recent review of research published in the Annals of Neurology, roughly half of all hospitalized COVID-19 patients display neurological symptoms, from dizziness, weakness and loss of smell and taste to seizures and stroke. With seizures, like stroke, the window to prevent permanent brain injury can be very short.

Easy to use and disinfect

Jane Chao, co-founder and CEO of Ceribell Inc.

Conventional EEGs require a large machine and specialized technicians to set them up. The process can take 30 minutes to an hour, increasing a technician’s risk of exposure to infectious diseases, such as the coronavirus. By contrast, “the same nursing team who’s taking care of the COVID-19 patient can set up the EEG within a few minutes,” Jane Chao, Ceribell’s co-founder and CEO, told BioWorld. “Once the EEG is set up, the data is streamed to an FDA-cleared portal, and the neurologist can easily review the data in real time.”

The Ceribell system is comprised of a brain stethoscope that turns brain data into sound, enabling nurses or doctors to literally listen to the organ, and a machine learning-based seizure detection algorithm that monitors the brain 24/7. If a patient goes into prolonged seizure – longer than five minutes – the device beeps to alert the clinician. Chao said the device’s accuracy is on par with a well-trained epileptologist.

Compared with conventional EEGs, the device is also easy to disinfect. At just a bit larger than a cellphone, it can be placed in a biohazard bag or disinfected with a sanitizing wipe. The headband worn by the patient is disposable.

‘Gamechanger’

“It’s a big game changer to make EEG accessible, and it really reduces the time for patients to potentially linger in seizure and, therefore, acquire secondary brain injury,” she said, adding the device is intended mainly as a triage tool.

In March, Ceribell launched a goodwill program to offer hospitals loaner EEG recorders and headbands on consignment, with virtual training and round-the-clock hotline support.

The potential for lasting damage is particularly acute with nonconvulsive seizures. Because patients don’t have any outward manifestations, such as jerks or twitching, they can be overlooked for hours or days without access to EEG. About 25-30% of neurological patients experience seizures, the majority of which are the nonconvulsive type, according to Chao. While there has not been a large study yet of the rate of seizures in COVID-19 patients, the possibility for undetected – and untreated – seizures is a serious concern.

Spun out of Stanford University in 2014, Ceribell won 510(k) clearance for the Rapid Response EEG in 2017. The company did a limited release in California the following year and began more widescale commercialization across the U.S. in 2019. The device also has the CE mark, and Chao said the company is considering expanding beyond the U.S. in the near future.

Currently, the system is being used in about 100 U.S. hospitals, including chains like HCA Healthcare and Kaiser Permanente, which are adopting the product at the system level.

Clinical evidence

The EEG has been validated in several studies, including a just-completed multicenter trial at U.S. hospitals with the top-rated conventional EEG capacity. “We were trying to demonstrate a couple of things,” Chao said. “One is how much is the delay for the conventional EEG, and how can Ceribell change that? And also, how can Ceribell change the diagnostic decisions for the physician?”

The results, based on about 150 cases, were “pretty astonishing,” she added. In the best centers, the median time from ordering a conventional EEG to performing the test was about four hours, compared with about five minutes for Ceribell’s device. Moreover, in about 40% of cases, Ceribell changed the doctor’s bedside decision.

“It really not only validated the device and the system itself, but it called out a big unmet need from the bedside,” Chao said.

Active pipeline

Ceribell recently secured a $20 million venture loan from Horizon Technology Finance Corp. The proceeds are earmarked to expand its U.S. footprint and for future product development.

“Our mission is to turn EEG into a vital sign,” Chao said. “EEG for seizure detection is 99% of the current clinical use, but nobody has really used, systematically, machine learning to look into EEG signals to see whether or not we can use EEG for other indications.”

The company is looking at several applications, including detection of stroke, for which an feasibility study is underway. If further studies pan out, Chao said, Ceribell’s EEG could be deployed by EMS teams to differentiate stroke from nonstroke victims, speeding time to triage and life-saving treatment.

That could be big opportunity for the startup.

“We’re the first EEG system that can be set up in the ambulance,” Chao said. “We don’t have FDA approval for using the system in the ambulance yet. We’re working on it. But we know in terms of feasibility, it’s very easy to do.”

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