NeuroAudit

NeuroAudit developing an innovative Psychoacoustics neurostimulation technology steered for personalized treatment of brain disorders and the first neuro stim patch for daily use driving an instant cognitive boost.

Pre seed - “Go to market” stage

First market College and post college students, ages 19 to 29 are the
1rst market for the cognitive patch.
The numbers of students for 2018 are enrolled )in age 20-29(, which are the most consumers tend to drinking coffee, energy drinks, using alcohol, using drugs, in order to stimulate.

Dataset: Enrolment by age Age 20 to 29 years (Year 2018)
Country
Australia 1,314,465
Canada 1,079,600
France 1,714,316
Germany 3,379,181
Italy 1,534,719
Poland 1,380,533
Spain 1,501,547
United Kingdom 1,755,814
Korea 2,019,112
Turkey 5,354,274
United States 11,096,385
Russia 3,457,933

World health organization reported 2019 cognitive problems as a worldwide issue:
World population consumes chemicals, sugar or caffeine in order to improve focus and get high cognitive level.

The solution is first deep stimulation brain technology on attachable patch, for a daily use gives 8 hours of enhanced cognition to get the most out of your day.

Zing energy - Electrical impulses, TENS method
6.99$ / 5 minutes at start / Claim to be a Day with 2 uses
Electrical impulses, TENS / Tingling on skin during min stimulation
100% back (officially)

Retalin - Chemicals
3$ / 1/day / 8 hours / Diabetic Can be all below
A kind of addiction, can cause over reaction After, Lack of appetite during influence, over appetite after influence, getting nervous, sleeping disorder, sweat, dry mouth, hair lost, and more severe effects on minority
Heart disease, blood disease, psychological disorders

Energy drinks- Coffin & Sugar / 70-200Mg / (adjusting heart ratio and muscle functionality and body energy) / 0.8$
15 to 45 min / Diabetic Can be all below
Defined as dangerous by WHO, some people are sensitive to ginseng, High sugar effects and sugar level drop effects, raise adrenalin, high blood pressure, anxiety
Heart disease, blood disease, Blood pressure disease, Diabetes

There are many common methods of performing brain stimulation like:
vagus nerve stimulation (VNS)
repetitive transcranial magnetic stimulation (rTMS)
magnetic seizure therapy (MST)
deep brain stimulation (DBS)
transcranial Direct Current Stimulation (tDCS)
focused ultrasound (FUS)
and more...
We can try to speak about the pros and cons of each ,so to make it simple things we should ask few questions are:
1) Invasive / non-invasive
2) Regional effect / focused effect
3) Deep stimulation / upper layers of the brain

Most common methods are non-invasive and therefore have a regional effectTo achieve a focused effect the diffused method is focused ultrasound (FUS).
These are large machines and technology that also works in Israel.
The advantages we have achieved are the use of technology with acoustic beats (ultrasound) and the possibility of inserting in a very small way into the patch - this is the unique innovation.
So surely it isn't an electric current transmission technology ,the ultrasound pulses affect the brain oscillation.

Patient patch consumption and potential market:
• 24 days a month
• 8 Patches in package
• 3 Packages a month
• Up to 288 patches per person a year
• Price per patch (dealer) 3$
• 864$ per person a year
• 10,000 users a year are gross income of 8.64M$ a year
• 100,000 Users a year are gross income of 86.4M$ a year
• The whole potential world market for ages of 18 to 29 years old is 35,5 M people around the world in developed countries, together with the medical patch version.
• With medical approval we can also approach the grown ages and above also ages above 29 which are working ages with work cognitive demands and also geriatric ages with their own spectrum of cognitive problems.

Wellness cognitive patch
The Customers: Initial customers are large Pharma Networks which are also our initial potential dealers (we are trying not to downgrade prices too much); 2nd level are mid and local area pharma networks; Online sells will be established after giving advantage to the large Pharma networks; the issue is trying not to compete with our largest buyers as long as they are providing our target sales quantity.
The next 3 months will be used for initial campaign.

Production:
• 6 months from project ignition we will go out with initial quantity of 10,000 Pieces that will used for samples for customers and Limited areas introduction sales.
• After additional 3 months we'll get out with 1st batches of mass production in quantities of 200,000 to 350,000, quantities will be defined according to customer's request and re estimation of quantities needed for constant supply between productions in order not to dry the market.
• Next production will be millions of patches

Medical version:
FDA and other related regulatory processes will be initiated 5.5 to 6 months from project ignition; clinical trials will be initiated as soon as possible after, estimated up to 3 months; we are expecting to get approval within 1 year to 1 year and 3 months; this is also because we are not working above FDA limitations, not connected to line source and these facts are simplifying the regulation process significantly.
• We expect to go to market with the medical patch, not later than 2 years after project ignition.
• With approved medical patch we can clearly penetrate the medical market which is occupied now, mainly by drugs as Ritalin as the none-chemical efficient solution.

Production:
Since the medical version is almost identical to medical version, upon approval, mass production can be initiated at once.

Go to market

Separate discussion
1) First seed fund raising - 625,000$ (9 months)
2) Second seed fund raising - 625,000$ (14 months)
3) Grow Fund raising 1,000,000 $ (18 months)

Milestones time 18 \ 14 \ 9 months
First braking stage 9 months needs
Complete raise 5 million USD for period of 3 years

No risk situations are known.
NeuroAudit is not currently seeking FDA approval.
This means that the US FDA has not evaluated and approved a "marketing" request from a company.
The FDA does not read clinical trials and make decisions based on the literature, the US FDA only responds to "marketing" requests from specific companies.
The FDA does not regulate non-medical use of devices, including use for "health" purposes.
• Focus ultrasound targeted therapy for a variety of diseases in the field of the brain (The Big Brother of NeuroAudit Cognitive stim Patch is approved for medical treatment in a large part of the world 12 (including the EU 13, Israel and Singapore).
• FDA Standards for the Use of NeuroAudit Cognitive Stim Patch Technology - ITLE 21 Standard - FOOD AND DRUG

CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVIC
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3
https://www.fda.gov/media/71100/download
https://www.brainstimjrnl.com/article/S1935-861X(19)30338-9/pdf

• We completed the KGAP + program at ATR Keihanna Research Complex in Japan, which gave us the opportunity to meet Japanese companies, find partners for collaboration, and describe innovative Brain technologies from Israel.

• We were asked by Advanced Telecommunications Research Institute International in Japan, based on our practices and the knowledge of Dan Anzyo, to deliver a brain research seminar and showcase our technology capabilities.

Application Number:
63021776