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Ceribell™ Rapid Response EEG Significantly Improves Clinical Accuracy

Results from A Prospective, Multi-center Clinical Trial to Assess Ceribell™ Rapid Response EEG Impact on Clinical Decision-Making Published in Critical Care Medicine

News provided by

Ceribell, Inc.

Jun 30, 2020, 16:55 ET

MOUNTAIN VIEW, Calif., June 30, 2020 /PRNewswire/ -- Ceribell, Inc. announced the publication of a research study in Critical Care Medicinethat demonstrated the clinical impact of the Ceribell Rapid Response EEG system. The study found that without Ceribell Rapid Response EEG, top academic centers with 24/7 EEG capability experience a 4-hour wait-time for conventional EEG. Further, diagnostic accuracy of physicians relying on clinical judgement alone is only slightly better than chance when making empiric decisions. Having access to the Ceribell Rapid Response EEG system reduced the time to EEG to 5-minutes and had a significant impact on diagnostic accuracy and confidence.

Results from the study show that Ceribell Rapid Response EEG enabled physicians to easily make more accurate judgments regarding the presence or absence of seizure activity compared to clinical suspicion alone. Physicians with access to Ceribell EEG had 90% diagnostic accuracy versus just 65% when using clinical judgement alone.

Additionally, physician confidence in their own diagnostic decisions was significantly affected. With Ceribell EEG available, physicians rated their confidence as high and very high 86% of the time versus just 40% of the time when making decisions with EEG information.

According to Neurocritical Care Society (NCS) guidelines, an EEG is required within 15-60 minutes for the evaluation and management of status epilepticus. Prior clinical studies indicate that the wait time to conventional EEG is about 4-hours. This study confirms these long wait times occur both during and after hours with conventional EEG practice, even in facilities with 24/7 onsite EEG technologists. The Ceribell Rapid Response EEG system was delivered in under 10-minutes, providing clinicians with the diagnostic information they need when they need it so they can make informed treatment decisions quickly.

"The results from this trial demonstrate Ceribell Rapid Response EEG's dramatic impact for managing critically ill patients. It provides patients with more precise and accurate care, physicians with a reliable diagnostic tool, and hospitals with clear cost saving opportunities. We are excited to be able to bring this revolutionary technology to medical facilities across the United States. Our rapid adoption across so many medical centers in such a short time speaks for the great unmet need that we address with our technology," said Jane Chao, CEO, Ceribell.

This prospective, multi-center study was conducted at 5 top tier facilities in the United States, with 24/7 EEG access. 181 patients were evaluated by 37 physicians. The study objective was to understand the clinical impact of Ceribell Rapid Response EEG. Key measures included: diagnostic assessment, therapeutic plan to escalate anti-seizure medication, physicians' confidence in diagnosis, physicians' confidence in treatment plan, time to EEG, ease of use, and adverse events.

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ABOUT NON-CONVULSIVE STATUS EPILEPTICUS: TIME IS BRAIN
Non-convulsive seizures are common in critically ill patients. 90% of these seizures are non-convulsive and can only be detected using EEG. Prolonged seizures of this type lead to permanent brain injury, higher risk of morbidity and mortality, and longer hospital stay. As a result, guidelines from the Neurocritical Care Society recommend EEG should be initiated within 15-60 minutes of suspected status epilepticus. However, meeting this guideline has proven difficult due to limitations of conventional EEG systems. The Ceribell Rapid Response EEG system was developed to address limitations in EEG acquisition and interpretation so patients at risk of seizure can be triaged more quickly.

ABOUT THE CERIBELL RAPID RESPONSE EEG SYSTEM
The Ceribell Rapid Response EEG System consists of a 10-electrode (8-channel) headband, an EEG recorder with Brain Stethoscope feature, and a cloud portal for continuous seizure monitoring, EEG data storing and remote EEG reviewing. The simplified electrode configuration enables easy set-up of EEG within minutes without the need specialized training. With the Brain Stethoscope and Clarity features, EEG interpretation for spot-checking and continuous seizure detection are possible in just seconds.

The Ceribell EEG System received FDA 510(k) clearance in 2017 and is commercially available in the United States.

ABOUT CERIBELL
Ceribell, Inc. (www.ceribell.com), is headquartered in Mountain View, CA. Ceribell is focused on making EEG widely available, more efficient, and more cost-effective to improve the diagnosis and treatment of patients at risk for seizures.

SOURCE Ceribell, Inc.