Neonatal EEG MOnitor (NEMO) Phase IIb

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Abstract Neonatal seizures occur in over 14,000 newborns annually in the US, and are frequently associated with long-term deleterious consequences including intellectual disability, epilepsy, and other neurodevelopmental disabilities. Electroencephalography (EEG) is the only reliable means of detecting seizures; however, many Neonatal Intensive Care Units (NICUs) do not have the capability to do EEG recordings due to the lack of skilled EEG technicians to apply gel- based electrodes to delicate neonatal skin and acquire clean signals. Under NIH SBIR funding, Quantum Applied Science and Research (QUASAR), a leader in noninvasive sensor technology, in collaboration with Children’s National Hospital (CNH), a top ranked pediatric hospital, has been developing a Neonatal EEG MOnitor (“NEMO”) device intended as a reliable and easy-to-use EEG system that will increase availability of neonatal EEG monitoring to hospitals that typically lack this capability. The NEMO device takes advantage of QUASAR’s innovative dry sensing technology combined with a soft cap that is designed for minimal impact on the infants’ wellbeing and ease of use in the hospital environment. NEMO will lead to more neonates being screened and treated, and thus to shorter hospital stays and improved outcomes. Under Phase I and Phase II of this project, QUASAR and CNH have validated QUASAR’s dry electrodes for the neonatal monitoring application in a NICU environment, demonstrating their signal quality was comparable to that of wet electrodes, and built a prototype NEMO headset. The main goal of the proposed Phase IIb effort is to finalize the NEMO device, validate its performance on neonates in the NICU environment, and obtain 510(k) clearance for it. In order to accomplish this goal, QUASAR will work with ProPharma, a regulatory consultant firm, to establish current Good Manufacturing Practices (cGMP) and finalize the NEMO device under cGMP. QUASAR will then complete Safety Testing, and in collaboration with CNH will conduct a Clinical Validation to obtain the necessary data for a 510(k) submission. The final step in the project will be a product launch in partnership with medical device manufacturers and distributors.