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INTERview






Using AI and Machine Learning, Brain Scientific Inc is developing Technologies and Medical Devices to Diagnose and Treat Neurological Diseases


Stuart Bernstein

VP- Marketing


Brain Scientific Inc

(OTCQB: BRSF)

https://www.brainscientific.com/memorymd/


Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine


Published – December 7, 2020


CEOCFO: Mr. Bernstein, what is the concept behind Brain Scientific?

Mr. Bernstein: Brain Scientific is focused on everything related to the brain. We include medical devices for neurological diseases applying artificial intelligence (AI) and machine learning when possible. We are developing technologies that will help diagnose traumatic brain injuries and illnesses such as epilepsy and others early in the process.


CEOCFO: What is allowing you to come up with these new approaches?

Mr. Bernstein: We are continually researching and implementing new technologies that expand our ability to provide devices that will improve people's lives dealing with neurological illnesses. We currently have two of those devices FDA approved.


CEOCFO: What is available today?

Mr. Bernstein: We have several products. The first product we have is a NeuroCap, a 100% disposable device applied to a person’s head. It is a 22-channel pre-jelled electrode system, using the International 10-20 standard. Since the electrodes are prepositioned and gelled, they can be quickly and accurately applied to the head in five minutes or less. It typically takes thirty to forty-five minutes to apply it with a standard EEG setup. The device is FDA approved and can be used with any 3rd party EEG amplifier.

 

We also have a miniaturized version of an EEG amplifier called NeuroEEG, which fits in the palm of your hand and connects to the headset itself. This device is also FDA approved and is used for concussions in sports medicine and neurology practices.

 

CEOCFO: Would someone be doing this at home?

Mr. Bernstein: We would not be doing it at home. Typically, home use would be for long-term monitoring. You would use our devices in hospitals, neurology offices, and urgent care facilities. We will be introducing a long-term monitoring system in 2021.


CEOCFO: How big is the factor of disposability, the one-time use?

Mr. Bernstein: It was not as much of a factor before COVID, although more and more hospitals were interested in something disposable. It was not as prevalent as we see now. Because the device is disposable, we see a much bigger interest than previously.


We have a series of orders from hospitals where they have a concern over infection from COVID-19.  The device allows for quick application by any clinical staff. Once applied, the EEG technician can attach the device to an EEG amplifier and run the EEG scan. Once the scan is complete, the EEG technician disconnects the amplifier, and the headset is disposed of by the clinical staff. This approach results in a much safer method for performing EEG scans.


CEOCFO: Are people comfortable with this procedure?

Mr. Bernstein: Yes. Previous procedures required the EEG technician to place a set of electrodes on a patient's head, one electrode at a time. The EEG technician must place the electrodes in the correct segments on the head. The EEG technician must gel each electrode, the scalp must be scrubbed with a sandpaper-like product where the electrodes are placed, and then they must be tested for connectivity. Each of the 22 electrodes must go through this process. It takes 45 minutes.


While the NeuroCap needs only to be placed on the head. The electrodes are precisely in the position they should be, and they are pre-gelled. Also, no scrubbing needs to take place. Any clinical staff can apply NeuroCap. The process takes 5-minutes.


CEOCFO: Is it reimbursable?

Mr. Bernstein: Yes, everything is absolutely reimbursable.


CEOCFO: Are you strictly in the US or in other countries, and do you see expansion?

Mr. Bernstein: We are currently only in the US but we are in the process of getting a CE approval from Europe. We should have that in the next couple of months.


CEOCFO: What us your new role at Brain Scientific?

Mr. Bernstein: My role is VP of Marketing.


CEOCFO: How are you reaching out to prospective customers?

Mr. Bernstein: We are reaching out to all hospital systems, neurology practices, and urgent care facilities across the US. The response has been terrific, and we hear from more and more hospital systems.


CEOCFO: Do you need to maintain much inventory or are you able to manufacture as needed?

Mr. Bernstein: We maintain quite a bit of inventory because you do not know when you will get an order for ten thousand units or ten units. We laid in a decent supply of products to respond as quickly as possible. When they call us for more caps, they needed them yesterday, so we try to get them out as soon as possible.


CEOCFO: About how many procedures are done annually that could potentially use the machine?

Mr. Bernstein: Brain Scientific 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. Simultaneously, only 254 of 6,210 US hospitals are Level 4 epilepsy centers with 24/7 EEG services. A level 4 center provides the more complex forms of intensive neurodiagnostic monitoring, as well as more extensive medical, neuropsychological and psychosocial treatment. EEGs are among the most widely used tests to diagnose brain conditions, such as seizures, epilepsy, headaches, brain tumors, and sleeping problems. 


Brain Scientific targets the aging Baby Boomer population (who often suffer from seizures, dementia, Parkinson’s, Alzheimer’s) and a younger/pediatric demographic (who can suffer from autism, ADHD, seizures). 


A recent report from three COVID-19-designated hospitals in Wuhan, China, indicated that more than one-third of coronavirus patients had some neurologic symptoms. The Company believes that COVID-19 related neurologic symptoms, presenting in an estimated 35-45% of COVID patients, will drive the urgent incremental need for disposable EEG headsets such as the NeuroCap. 


Furthermore, reusable EEG caps are a significant source of hospital-acquired infections. The disposable NeuroCap assists in decreasing the risk of hospital-acquired infections since its one-use life span minimize cross-contamination and optimizes sanitary practice.


CEOCFO: Are you seeking funding, partnerships, investments, as you move forward?

Mr. Bernstein: We are looking for investments and have a set of products that could move faster with additional funding. Partnerships are essential; we are working on a series of those. Anybody from a neurology group to a hospital that wants to form a partnership, or another manufacturer interested in using our technology, whether it is a white label project or whatever, can do it.


CEOCFO: What is the competitive landscape for Brain Scientific?

Mr. Bernstein: There are, there are only two. One is a company based in China, and they are not selling in the US. The second is also in China and is trading in the US but is manufactured in Wu Han, so it is not very popular to many people. I am not sure whether it is the same as what we call disposable, but they refer to it as a disposable cap.


CEOCFO: What does the next year look like for you?

Mr. Bernstein: We have a whole series of new products we will announce in 2021. We will introduce a cap with fewer channels that can be used for EEGs in the neurologist’s office. We will present a pediatric cap that can be used for babies and children. We will have a long-term monitoring product. Long-term monitoring is an important market. You have to be able to monitor for 24-72 hours. We will be introducing a new EEG amplifier to go along with that, which will support the same amount of time.

 

We have a product we call Brain E-Tattoo, a subcutaneous implantable graphene-based EEG Electrode. It is a minimally invasive 4-21 channels implant designed for long-term monitoring to detect epileptic seizures.


We have a forward-looking set of products.

 

CEOCFO: So, people should pay attention!

Mr. Bernstein: We think people will be impressed with our direction and interest in providing forward looking medical devices that will help reduce, prevent, and monitor neurologic illnesses.


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“We think people will be impressed with our direction and interest in providing forward looking medical devices that will help reduce, prevent, and monitor neurologic illnesses.”
Stuart Bernstein


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