To address the expected heightened demand for disposable medical products brought on by the COVID-19 pandemic, Brain Scientific is fast-tracking steps required for expedited commercialization of its FDA cleared NeuroCap, single-use, disposable EEG headset.
This year, three hospitals in New York City, Texas and New England successfully completed initial testing of the NeuroCap. Based on the initial results, these institutions placed expanded, non-commercial orders for additional units.
As the Company continues to make progress on its commercialization goals for the NeuroCap, it is also in the final stages of negotiations with ISO 9001/13485 contract manufacturers in the United States capable of meeting increased product demand while maintaining a high level of quality and reliability.
Patent applications for Brain Scientific’s disposable EEG sets pending
Patent applications for Brain Scientific’s disposable EEG sets are pending in the U.S. , Europe , and China. The primary target markets in these regions are among those that offer routine EEG testing: ER’s, ICU’s, urgent care clinics, ambulatory, and telehealth.
The Company believes that approximately 5 million patients in US emergency departments and ICUs are subject to seizures and could benefit from routine EEG tests and 1 in 26 people in the US will be diagnosed with epilepsy at some point in their life, while only 254 of 6,210 US hospitals are Level 4 epilepsy centers with 24/7 EEG services.
EEGs are among the most widely used tests to diagnose brain conditions, such as seizures, epilepsy, headaches, brain tumors, and sleeping problems. Current EEG procedures are often slow, expensive, and cumbersome.
COVID-19 related neurologic symptoms will increase demand for EEG headsets
Further, the Company believes that COVID-19 related neurologic symptoms, present in an estimated 35-45% of COVID patients, will drive the urgent incremental need for disposable EEG headsets such as the NeuroCap™.
NeuroCap is an FDA-cleared disposable EEG headset with 22 electrodes and 19 active EEG channels. Its single-use life span minimizes cross-contamination and optimizes sanitary practice. The diagnostic tool is compatible with 3rd party amplifiers, it is designed to be administered by clinical staff of any level, and it can be used in healthcare facilities or outpatient settings.
The American Clinical Neurophysiology Society COVD-19 EEG guidelines suggest technologists “Consider rapid application EEG with disposable, single use caps/ templates particularly if tech staffing is limited.”
BrainScientific’s NeuroCap™ Disposable Headset could protect hospital staff from Coronavirus
BrainScientific believes that the global coronavirus pandemic creates unprecedented complexities for EEG departments and EEG technicians in emergency rooms, ICU’s, and in clinical research.
During the pandemic, technicians and doctors could be at risk while performing EEG tests, which take up to 30 minutes to set up and require 8-inch proximity to the patient. Providers are faced with having to jury-rig plexiglass solutions to limit exposure to potentially infected patients.