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Item 1. Business

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Corporate Overview of NeuroOne Medical Technologies

We were originally incorporated as Original Source

Entertainment, Inc.

Overview of NeuroOne Medical Technologies Corporation

were originally incorporated as Original Source Entertainment, Inc.

under the laws of the State of Nevada on August 20, 2009.

Prior to the closing of the Acquisition, as defined below,

we completed a series of steps contemplated by a Plan of Conversion pursuant to which we, among other things, changed our name to NeuroOne

Medical Technologies Corporation, increased our authorized number of shares of Common Stock from 45,000,000 to 100,000,000, increased

our authorized number of shares of preferred stock from 5,000,000 to 10,000,000 and reincorporated in Delaware.

On July 20, 2017, we acquired

NeuroOne, Inc.

the closing of the Acquisition, as defined below, we completed a series of steps contemplated by a Plan of Conversion pursuant to which

we, among other things, changed our name to NeuroOne Medical Technologies Corporation, increased our authorized number of shares of Common

Stock from 45,000,000 to 100,000,000, increased our authorized number of shares of preferred stock from 5,000,000 to 10,000,000 and reincorporated

On July 20, 2017, we acquired NeuroOne, Inc.

(the “Acquisition”).

Immediately following the closing of the Acquisition, the business of NeuroOne, Inc.

our sole focus.

Corporate Overview and History of NeuroOne,

NeuroOne, Inc.

was incorporated under the laws

of the State of Delaware on October 7, 2016.

Its predecessor entity, NeuroOne LLC (the “LLC”), was formed on December 13,

2013 and operated as a limited liability company until it was merged with and into NeuroOne, Inc.

on October 27, 2016, with NeuroOne,

Immediately following the closing of the Acquisition,

the business of NeuroOne, Inc.

became our sole focus.

Overview and History of NeuroOne, Inc.

was incorporated under the laws of the State of Delaware on October 7, 2016.

Its predecessor entity, NeuroOne LLC (the “LLC”),

was formed on December 13, 2013 and operated as a limited liability company until it was merged with and into NeuroOne, Inc.

27, 2016, with NeuroOne, Inc.

as the surviving entity (the “Merger”).

As a result of the Merger, all of the properties, rights, privileges and powers

of the LLC vested in NeuroOne, Inc., and all debts, liabilities and duties of the LLC became the debts, liabilities and duties of NeuroOne,

Inc., except for the Exclusive Start-up Company License Agreement, dated as of October 1, 2014, as amended on February 22, 2017, March

30, 2019 and September 18, 2019 (the “Original WARF License”), with the Wisconsin Alumni Research Foundation (“WARF”),

which was not legally transferred until May 2017.

As a result of the Merger, all of the properties, rights,

privileges and powers of the LLC vested in NeuroOne, Inc., and all debts, liabilities and duties of the LLC became the debts, liabilities

and duties of NeuroOne, Inc., except for the Exclusive Start-up Company License Agreement, dated as of October 1, 2014, as amended on

February 22, 2017, March 30, 2019 and September 18, 2019 (the “Original WARF License”), with the Wisconsin Alumni Research

Foundation (“WARF”), which was not legally transferred until May 2017.

The purposes of the Merger were to:

change the jurisdiction of incorporation from Minnesota

change the jurisdiction

of incorporation from Minnesota to Delaware;

change the ownership of the LLC’s underlying assets;

and convert from a limited liability company to a corporation.

and convert from a limited liability

company to a corporation.

In December 2019, NeuroOne, Inc.

was merged with and into the Company, with the Company remaining as the surviving entity.

We are a medical technology company focused on

the development and commercialization of thin film electrode technology for continuous electroencephalogram (cEEG) and stereoelectrocencephalography

(sEEG) recording, spinal cord stimulation, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.

Additionally,

we are investigating the potential applications of our technology associated with artificial intelligence.

Members of our management team

have held senior leadership positions at a number of medical technology and biopharmaceutical companies, including Boston Scientific,

was merged with and into the Company, with the Company remaining as the surviving

are a medical technology company focused on the development and commercialization of thin film electrode technology for continuous electroencephalogram

(“cEEG”) and stereoelectrocencephalography (“sEEG”) recording, spinal cord stimulation, brain stimulation and

ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to

failed back surgeries and other related neurological disorders.

Additionally, we are investigating the potential applications of our

technology associated with artificial intelligence.

Members of our management team have held senior leadership positions at a number

of medical technology and biopharmaceutical companies, including Boston Scientific, St.

Jude Medical, Stryker Instruments, C.R.

Bard, A-Med Systems, Sunshine Heart, Empi, Don-Joy and PMT.

We are developing our cortical, strip, grid and

depth electrode technology to provide solutions for diagnosis through cEEG recording and sEEG recording and treatment through brain stimulation

and ablation, all in one product.

A cEEG is a continuous recording of the electrical activity of the brain that identifies the location

of irregular brain activity, which information is required for proper treatment.

cEEG recording involves an invasive surgical procedure,

referred to as a craniotomy.

sEEG involves a less invasive procedure whereby doctors place electrodes in targeted brain areas by drilling

small holes through the skull.

Both methods of seizure diagnosis are used to identify areas of the brain where epileptic seizures originate

in order to precisely locate the seizure source for therapeutic treatment if possible.

Deep brain stimulation, or DBS, therapies involve

activating or inhibiting the brain with electricity that can be given directly by electrodes on the surface or implanted deeper in the

brain via depth electrodes.

Introduced in 1987, this procedure involves implanting a power source referred to as a neurostimulator, which

sends electrical impulses through implanted depth electrodes, to specific targets in the brain for the treatment of disorders such as

Parkinson’s disease, essential tremors, dystonia, and chronic pain.

The effects of DBS as a potential treatment for Alzheimer’s

is also being evaluated by researchers.

A-Med Systems, Nuwellis, Inc., formerly known as Sunshine Heart, Empi, Don-Joy and PMT.

are developing our cortical sheet and depth electrode technology to provide solutions for diagnosis through cEEG recording and sEEG recording

and treatment through spinal cord stimulation, brain stimulation and ablation, all in one product.

A cEEG is a continuous recording of

the electrical activity of the brain that identifies the location of irregular brain activity, which information is required for proper

cEEG recording involves an invasive surgical procedure, referred to as a craniotomy.

sEEG involves a less invasive procedure

whereby doctors place electrodes in targeted brain areas by drilling small holes through the skull.

Both methods of seizure diagnosis

are used to identify areas of the brain where epileptic seizures originate in order to precisely locate the seizure source for therapeutic

treatment if possible.

brain stimulation, or DBS, therapies involve activating or inhibiting the brain with electricity that can be given directly by electrodes

on the surface or implanted deeper in the brain via depth electrodes.

Introduced in 1987, this procedure involves implanting a power

source referred to as a neurostimulator, which sends electrical impulses through implanted depth electrodes, to specific targets in the

brain for the treatment of disorders such as Parkinson’s disease, essential tremor, dystonia, and chronic pain.

is another indication evaluating the effects of DBS.

Unlike ablative technologies, the effects of DBS are reversible.

NeuroOne Medical Technologies Corporation

Radio frequency (RF) ablation is a procedure that

uses radiofrequency under the electrode contacts which is directed to the site of the brain tissue that is targeted for ablation.

process involves delivering energy to the contacts, thereby heating them and creating a lesion in the brain tissue.

The ablation does

not remove the tissue.

Rather, it is left in place and typically scar tissue (lesion) forms in the place where the ablation occurs.

procedure is also known as brain lesioning as it causes irreversible lesions.

In August 2021, the Company announced a strategic partnership

with RBC Medical Innovations to develop a RF ablation generator.

The following month, our RF ablation technology was tested by representatives

from Emory University in Atlanta Georgia in an animal study.

The product remains in development.

Our cortical strip, grid electrode and depth electrode

technology has been tested over the years by both WARF, the owners of our licensed patents, and Mayo Clinic located in Rochester, Minnesota,

in both pre-clinical models as well as through an institutional review board (“IRB”) approval at Mayo Clinic for clinical

In December 2020, we announced the first human commercial use of our Evo cortical electrode in a procedure performed at the

Regarding our ablation electrode, the Cleveland Clinic and representatives from Emory University have performed testing in

bench top models and pre-clinical (or animal testing) models.

These pre-clinical tests have demonstrated that the technology is capable

of recording, monitoring, ablation and acute stimulation, although our ablation electrode technology remains in product development (meaning

that additional testing will be needed prior to it being submitted for clearance for commercial distribution by the U.S.

Food and Drug

Administration (the “FDA”) for recording (or diagnostic) and therapeutic modalities.

We received 510(k) FDA clearance for our Evo cortical

technology in November 2019,in September 2021 we received FDA clearance to market our Evo sEEG electrode technology for temporary (less

than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical

signals at the subsurface level of the brain, and in October 2022 we received FDA clearance to market our Evo sEEG electrode technology

for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation

of electrical signals at the subsurface level of the brain.

Our Market Opportunity

Epilepsy Market

We expect to initially target the diagnosis and

treatment of epilepsy.

Epilepsy can be caused by a variety of conditions that affect a person’s brain, some of which are:

brain tumor, traumatic brain injury and central nervous system infections.

According to the Centers for Disease Control and Prevention

(the “CDC”) and Citizens United for Research in Epilepsy (“CURE”), there are approximately 3,000,000 patients

annually suffering with epilepsy in the United States, with an additional 200,000 diagnosed every year.

The CDC and CURE also estimate

that epilepsy costs the United States $15.5 billion per year.

Approximately 720,000 of these patients are not receptive to pharmaceutical

treatment and therefore are appropriate for surgical treatment of this disorder.

In addition to poor quality of life, epilepsy also is

associated with fairly high mortality rates.

Sudden Unexpected Death in Epilepsy has an annual incidence of 1.16/1000 in epilepsy patients.

Despite the large market opportunity, it is estimated that there are only less than 5K epilepsy surgeries performed each year in the

United States.

These numbers represent an underpenetrated market

due to the invasiveness of diagnostic procedures.

After the diagnostic procedure, a second therapeutic procedure is required and at times

even a third surgery if the seizures persist.

We believe patients are unwilling to proceed due to the long diagnostic and treatment procedure

times (one to four weeks in the hospital after a potential craniotomy for diagnosis).

As detailed above, after the diagnosis is completed,

if successful, the patient must undergo an additional procedure to have the affected area of brain tissue ablated or removed.

cost for the diagnostic technology per procedure could be >$10,000, with ablation devices costing >$15,000.

We believe our technology,

once developed, will offer an all-in-one solution with diagnostic and therapeutic capabilities.

1 Epilepsy surgery in the United States:

Analysis of data from

the National Association of Epilepsy Centers 2015 Epilepsy Research

NeuroOne Medical Technologies Corporation

Many leading neurologists believe that the limits

of today’s current technologies are the reason the exact affected area of the brain causing epileptic seizures is not well-determined.

We believe our technology, which has been developed to date by physicians at WARF and Mayo Clinic, will provide a number of advantages

over the current commercially available technologies, including the following:

● Our proprietary thin film technology under development has a smaller footprint with many more electrodes.

● We expect that our technology will eventually be able to be implanted using a minimally invasive procedure

utilizing a dime sized burr hole rather than a full craniotomy.

● Our technology may provide more accurate detection of irregular brain activity over currently available

In limited clinical testing, doctors at Mayo Clinic have documented pre-seizure activity (micro-seizures) during their clinical

research with their patients using our cEEG technology.

We expect our technology can ablate through the

electrodes as well as perform brain recording, monitoring and stimulation, allowing for diagnosis and treatment through the same product

and in the same procedure.

Parkinson’s Disease

The Parkinson’s Disease Foundation estimates

that as many as 1,000,000 patients in the United States live with Parkinson’s disease with an additional 60,000 patients diagnosed

Medical Technologies Corporation

frequency (“RF”) ablation is a procedure that uses radiofrequency under the electrode contacts that is directed to the site

of the brain tissue that is targeted for removal.

The process involves delivering energy to the contacts, thereby heating them and destroying

the brain tissue.

The ablation does not remove the tissue.

Rather, it is left in place and typically scar tissue forms in the place where

the ablation occurs.

This procedure is also known as brain lesioning as it causes irreversible lesions.

In August 2021, the Company announced

a strategic partnership with RBC Medical Innovations to develop a RF ablation generator.

The following month, our OneRF ablation system

was tested by representatives from Emory University in Atlanta Georgia in an animal study.

During the second fiscal quarter of 2023,

we successfully completed summative usability testing for OneRF with 15 neurosurgeons, and completed execution of internal device verification/validation

protocols for the final OneRF ablation system.

back surgery syndrome (“FBSS”) is a condition that produces chronic lower back/leg pain due to one or more failed back surgeries.

Typically, it is related to patients that suffer with pain after surgery of the lumbar spine for degenerative disc disease.

Re-operations

are usually not recommended for these patients due to low success rates.

These patients experience greater levels of pain, a lower quality

of life, varying levels of disability and higher rate of unemployment.

Spinal cord stimulation works by placing one or more electrodes in

a targeted area of the spine and then connected to an implantable pulse generator that sends electrical stimulation to the electrode

to block the pain signals from reaching the brain.

During the second fiscal quarter of 2023, we completed an initial animal implant of

novel thin film paddle leads for spinal cord stimulation (“SCS”).

The devices are intended for the treatment of patients

with chronic back pain due to multiple failed back surgery syndrome, intractable low back, and leg pain.

A percutaneous (through a needle)

delivery system for paddle leads is also under development and has been successfully bench-tested.

According to a 2020 Market Insights

report, the total global addressable market for spinal cord stimulation is estimated to be greater than $3 billion.

cortical sheet electrode and depth electrode technology have been tested over the years by both WARF, the owners of our licensed patents,

and Mayo Clinic located in Rochester, Minnesota, in both pre-clinical models as well as through an institutional review board (“IRB”)

approval at Mayo Clinic for clinical research.

In December 2020, we announced the first human commercial use of our Evo cortical electrode

in a procedure performed at the Mayo Clinic.

Regarding our ablation electrode, the Cleveland Clinic and representatives from Emory University

have performed testing in bench top models and pre-clinical (or animal testing) models.

These pre-clinical tests have demonstrated that

the technology is capable of recording, ablation and acute stimulation.

received 510(k) FDA clearance for our Evo cortical technology in November 2019, in September 2021 we received FDA clearance to market

our Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the

recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and in October 2022 we received FDA

clearance to market our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation

equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

submitted a 510(k) application to the FDA for the OneRF ablation system in June 2023 and responded to FDA comments on November 6, 2023.

On December 6, 2023, we received 510(k) FDA clearance to market the OneRF ablation system for creation of radiofrequency lesion in nervous

tissue for functional neurosurgical procedures.

intend to develop our Evo sEEG electrode technology for drug delivery applications in the next 12 months.

This device is intended

to deliver neurological drugs or gene therapy that are FDA approved or that are currently planned for clinical trials or in development

to allow for monitoring, recording and stimulation and drug delivery for less than 30 days.

In addition to having the capability

of delivering a drug through the center lumen, it will also be able to record brain activity before, during, and after drug delivery.

Medical Technologies Corporation

Market Opportunity

expect to initially target the diagnosis and treatment of epilepsy.

Epilepsy can be caused by a variety of conditions that affect a person’s

brain, some of which are:

stroke, brain tumor, traumatic brain injury and central nervous system infections.

According to the Centers

for Disease Control and Prevention (the “CDC”) and Citizens United for Research in Epilepsy (“CURE”), there are

approximately 3,000,000 patients annually suffering with epilepsy in the United States, with an additional 200,000 diagnosed every year.

The CDC and CURE also estimate that epilepsy costs the United States $15.5 billion per year.

Approximately 720,000 of these patients

are not receptive to pharmaceutical treatment and therefore are appropriate for surgical treatment of this disorder.

In addition to poor

quality of life, epilepsy also is associated with fairly high mortality rates.

Sudden Unexpected Death in Epilepsy has an annual incidence

of 1.16/1000 in epilepsy patients.

Despite the large market opportunity, it is estimated that there are only less than 5K epilepsy surgeries

performed each year in the United States.

numbers represent an underpenetrated market due to the invasiveness of diagnostic procedures.

After the diagnostic procedure, a second

therapeutic procedure is required and at times even a third surgery if the seizures persist.

We believe patients are unwilling to proceed

due to the long diagnostic and treatment procedure times (one to four weeks in the hospital after a potential craniotomy for diagnosis).

As detailed above, after the diagnosis is completed, if successful, the patient must undergo an additional procedure to have the affected

area of brain tissue ablated or removed.

The average cost for the diagnostic technology per procedure could be >$10,000, with ablation

devices costing >$15,000.

We believe our technology, once developed, will offer an all-in-one solution with diagnostic and therapeutic

capabilities.

leading neurologists believe that the limits of today’s current technologies are the reason the exact affected area of the brain

causing epileptic seizures is not well-determined.

We believe our technology, which has been developed to date by physicians at WARF

and Mayo Clinic, will provide a number of advantages over the current commercially available technologies, including the following:

proprietary thin film technology under development has a smaller footprint with many more

expect that our technology will eventually be able to be implanted using a minimally invasive

procedure utilizing a dime sized burr hole rather than a full craniotomy.

technology may provide more accurate detection of irregular brain activity over currently

available technology.

In limited clinical testing, doctors at Mayo Clinic have documented

pre-seizure activity (micro-seizures) during their clinical research with their patients

using our cEEG technology.

expect our technology can ablate through the electrodes as well as perform brain recording, monitoring and stimulation, allowing for

diagnosis and treatment through the same product and in the same procedure.

Parkinson’s Disease Foundation estimates that as many as 1,000,000 patients in the United States live with Parkinson’s disease

with an additional 60,000 patients diagnosed per year.

Over 10,000,000 patients worldwide are living with Parkinson’s disease.

There have not been any drugs introduced that

have been effective at treating all patients with Parkinson’s disease.

The average onset is over 60 years old but some people have

been diagnosed as young as 40 years old.

Parkinson’s is a disorder of the central nervous system caused by loss of brain cells throughout

various regions of the brain.

Today’s primary treatment for Parkinson’s

disease involves medications that have not proven to be curative but rather ease symptoms.

One of the potential treatments for Parkinson’s

patients is Deep Brain Stimulation (DBS).

There have not been any drugs introduced that have been effective at treating all patients with Parkinson’s disease.

onset is over 60 years old, but some people have been diagnosed as young as 40 years old.

Parkinson’s is a disorder of the central

nervous system caused by loss of brain cells throughout various regions of the brain.

primary treatment for Parkinson’s disease involves medications that have not proven to be curative but rather ease symptoms.

of the potential treatments for Parkinson’s patients is DBS.

According to the Michael J.

Fox Parkinson’s Disease Research Foundation website, patients

that seem to do best with DBS are those that have had the disease for at least four years and have benefited from taking medications prescribed

to control the disease.

In addition, DBS seems to help with reducing the issues with motor functions such as tremors, stiffness and slowness

but not for balance issues.

Fox Parkinson’s Disease Research Foundation website, patients that seem to do best with DBS are those that have had the disease

for at least four years and have benefited from taking medications prescribed to control the disease.

In addition, DBS seems to help

with reducing the issues with motor functions such as tremors, stiffness and slowness but not for balance issues.

surgery in the United States:

Analysis of data from the National Association of Epilepsy

Centers 2015 Epilepsy Research.

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tremors are thought to be due to electrical irregularities in the brain that send abnormal signals to the muscles.

It is a progressive

condition that worsens over time and is linked to genetic disorders that typically appear in people who are over 40.

Essential tremors

Essential tremors are thought to be due to electrical

irregularities in the brain that send abnormal signals to the muscles.

It is a progressive condition that worsens over time and is linked

to genetic disorders that typically appear in people who are over 40.

Essential tremors usually occur alone and without any other neurological

symptoms or signs.

The tremors usually occur when the hands are raised and primarily affect the hands.

Muscles in the trunk, face and

neck may also experience symptoms.

Sometimes misdiagnosed as Parkinson’s disease, essential tremors are an involuntary rhythmic

shaking of the hands that is not present at rest.

It is apparent during activities such as drinking, writing and eating.

worsen due to stress, anxiety, smoking, caffeine, fatigue, etc.

Genetics Home Reference estimates that as many as 10,000,000 people in

the United States are affected by the disease.

Treatments for the disease include medical therapy, and DBS.

DBS, which unlike other therapies,

is reversible and programmable, helping to adjust the settings to maximize patient benefit.

Similar to Parkinson’s disease, the

ability to detect this irregular brain activity before it causes a tremor is highly desirable.

Dystonia is a neurological condition recognized

as a motion disorder that involves over activity of a variety of different muscles simultaneously that work against each other.

itself in a variety of symptoms but typically involves repetitive, patterned and often twisting involuntary muscle contractions resembling

According to the Dystonia Medical Research Foundation, over 300,000 people are affected in the United States and Canada alone.

usually occur alone and without any other neurological symptoms or signs.

The tremors usually occur when the hands are raised and primarily

affect the hands.

Muscles in the trunk, face and neck may also experience symptoms.

Sometimes misdiagnosed as Parkinson’s disease,

essential tremors are an involuntary rhythmic shaking of the hands that is not present at rest.

It is apparent during activities such

as drinking, writing and eating.

Symptoms can worsen due to stress, anxiety, smoking, caffeine, fatigue, etc.

Genetics Home Reference

estimates that as many as 10,000,000 people in the United States are affected by the disease.

Treatments for the disease include medical

therapy and DBS.

DBS, which unlike other therapies, is reversible and programmable, helping to adjust the settings to maximize patient

Similar to Parkinson’s disease, the ability to detect this irregular brain activity before it causes a tremor is highly

is a neurological condition recognized as a motion disorder that involves over activity of a variety of different muscles simultaneously

that work against each other.

It presents itself in a variety of symptoms but typically involves repetitive, patterned and often twisting

involuntary muscle contractions resembling tremors.

According to the Dystonia Medical Research Foundation, over 300,000 people are affected

in the United States and Canada alone.

Dystonia is the third most common problem seen in movement disorder clinics.

Because it has many different manifestations, it is often

misdiagnosed.

In addition, similar to Parkinson’s disease, there are no specific tests that can positively diagnose dystonia.

doctor typically will evaluate patient and family history, potentially do genetic testing, EEG testing, blood and urine tests.

several treatment options (including medication and Botox) for patients depending on the type of dystonia.

DBS may be also an alternative

for certain patient sub-types.

NeuroOne Medical Technologies Corporation

Spinal Cord Stimulation

Chronic back pain is one of the most prevalent

chronic conditions in the world.

Because it has many

different manifestations, it is often misdiagnosed.

In addition, similar to Parkinson’s disease, there are no specific tests that

can positively diagnose dystonia.

A doctor typically will evaluate patient and family history, potentially do genetic testing, electroencephalogram (“EEG”) testing,

blood and urine tests.

There are several treatment options (including medication and Botox) for patients depending on the type of dystonia.

DBS may be also an alternative for certain patient sub-types.

Cord Stimulation

back pain is one of the most prevalent chronic conditions in the world.

According to the CDC, “in 2016, an estimated 20.4% of U.S.

adults had chronic pain and 8.0% of

adults had chronic pain and 8.0% of U.S.

adults had high-impact chronic pain.

Chronic pain has been linked to numerous physical and mental conditions and contributes to high

health care costs and lost productivity”.

Failed back surgery syndrome (“FBSS”) is one of leading causes for chronic

lower back/leg pain due to one or more failed back surgeries.

Typically, it is related to patients that suffer with pain after surgery

of the lumbar spine for degenerative disc disease.

Re-operations are usually not recommended for these patients due to low success rates.

These patients experience greater levels of pain, a lower quality of life, varying levels of disability and higher rate of unemployment.

Spinal cord stimulation works by placing an electrode(s) in a targeted area of the spine which is then connected to an implantable pulse

generator that sends electrical stimulation to the electrode to block the pain signals from reaching the brain.

The back pain market includes the following indications:

Chronic pain has been linked to numerous physical and mental

conditions and contributes to high health care costs and lost productivity”.

is one of leading causes for chronic lower back/leg pain due to one or more failed back surgeries.

Typically, it is related to patients

that suffer with pain after surgery of the lumbar spine for degenerative disc disease.

Re-operations are usually not recommended for

these patients due to low success rates.

These patients experience greater levels of pain, a lower quality of life, varying levels of

disability and higher rate of unemployment.

Spinal cord stimulation works by placing an electrode(s) in a targeted area of the spine

which is then connected to an implantable pulse generator that sends electrical stimulation to the electrode to block the pain signals

from reaching the brain.

back pain market includes the following indications:

FBSS, Ischemic Limb Pain, and Complex Regional Pain Syndrome.

Over half of this market is comprised of patients with FBSS.

indicated a benefit for some patients suffering from chronic back and lower limb pain when they have been treated with electrical stimulation.

Prior to the patient receiving an implant, they undergo a trial period that allows them to determine if they are receiving relief from

the therapy while preventing a surgery to implant the pulse generator that provides the stimulation.

If the trial period is successful,

then the device is implanted in a follow-up procedure.

Artificial Intelligence

The brain consists of approximately 100 billion

nerve cells, which are small wires that pass electrical signals to control all of its functions.

There have been a number of successful

clinical trials in which small metal wires, known as electrodes, are implanted in the brain to correct nerve damage using wireless communication

between implanted wires to simulate functional nerve cells.

In addition to correcting damaged nerve cells, certain scientists have theorized

that if millions of wires could be implanted in the brain, these electrodes could present an opportunity to use artificial intelligence

to create infrared sight, increase hearing or perfect memory recall.

However, there currently is no commercially available manufacturing

platform capable of making thousands of wires that can be placed within or on the brain and work reliably for the lifetime of a subject,

and are soft enough to match the tissue of the brain, that avoid damage to the brain.

Limitations of Currently Available Therapies

There are a limited number of currently available

products for diagnosis and treatment for people with neurological disorders such as epilepsy.

Although the currently available systems

provide diagnosis and treatment for patients, they have certain inherent limitations and shortcomings that we believe limit their use

and validate the need for improved technology in the market.

Over half of this

market is comprised of patients with FBSS.

Studies have indicated a benefit for some patients suffering from chronic back and lower limb

pain when they have been treated with electrical stimulation.

Prior to the patient receiving an implant, they undergo a trial period

that allows them to determine if they are receiving relief from the therapy while preventing a surgery to implant the pulse generator

that provides the stimulation.

If the trial period is successful, then the device is implanted in a follow-up procedure.

brain consists of approximately 100 billion nerve cells, which are small wires that pass electrical signals to control all of its functions.

There have been a number of successful clinical trials in which small metal wires, known as electrodes, are implanted in the brain to

correct nerve damage using wireless communication between implanted wires to simulate functional nerve cells.

In addition to correcting

damaged nerve cells, certain scientists have theorized that if millions of wires could be implanted in the brain, these electrodes could

present an opportunity to use artificial intelligence to create infrared sight, increase hearing or perfect memory recall.

However, there

currently is no commercially available manufacturing platform capable of making thousands of wires that can be placed within or on the

brain and work reliably for the lifetime of a subject, and are soft enough to match the tissue of the brain, that avoid damage to the

Medical Technologies Corporation

of Currently Available Therapies

are a limited number of currently available products for diagnosis and treatment for people with neurological disorders such as epilepsy.

Although the currently available systems provide diagnosis and treatment for patients, they have certain inherent limitations and shortcomings

that we believe limit their use and validate the need for improved technology in the market.

These limitations include:

● Lengthy diagnostic times:

diagnostic times:

It takes several months for patients to go through the various phases

of diagnostic methods, including imaging and non-invasive EEGs.

If the source of seizures are still unknown, Patients spend one to four

weeks in the hospital after interventional diagnostic procedures (cortical and/or SEEG implants) waiting to have seizures that will allow

doctors to determine where the seizures are occurring.

● Lower Accuracy:

Historically, clinical electrode manufacturers primarily provided electrodes that

sample brain tissue at approximately centimeter spatial scales.

Advances in digital EEG acquisition have made recordings at sub-millimeter

spatial scales possible, but high-spatial resolution EEG has been slow to impact clinical practice.

Existing, higher spatial scales increase

the potential for missing data that may be critical in the removal of brain tissue causing the irregular activity.

NeuroOne Medical Technologies Corporation

● Need to perform a full craniotomy (invasiveness):

Currently available cortical electrode technology

is typically placed after a craniotomy, which may require removing the top part of the cranium and is a very painful and invasive procedure.

Procedural times for a craniotomy can be as high as eight hours.

A variety of complications can occur when a full craniotomy is performed,

including but not limited to:

stroke, bleeding, infection, seizures, swelling of the brain (which may require a second craniotomy), nerve

damage, which may cause muscle paralysis or weakness, cerebrospinal fluid (CSF) leak, which may require repair, loss of mental functions

and permanent brain damage with associated disabilities.

The invasiveness, procedural times and possible surgical complications have limited

the growth of surgical treatment of epilepsy.

● Requirement for multiple devices for diagnostic and therapeutic procedures :

If the source of seizures

are still unknown, patients spend one to four weeks in the hospital after interventional

diagnostic procedures (cortical and/or sEEG implants) waiting to have seizures that will

allow doctors to determine where the seizures are occurring.

Historically, clinical electrode manufacturers primarily provided electrodes

that sample brain tissue at approximately centimeter spatial scales.

Advances in digital

EEG acquisition have made recordings at sub-millimeter spatial scales possible, but high-spatial

resolution EEG has been slow to impact clinical practice.

Existing, higher spatial scales

increase the potential for missing data that may be critical in the removal of brain tissue

causing the irregular activity.

to perform a full craniotomy (invasiveness):

Currently available cortical electrode technology is typically placed after a craniotomy,

which may require removing the top part of the cranium and is a very painful and invasive procedure.

Procedural times for a craniotomy

can be as high as eight hours.

A variety of complications can occur when a full craniotomy is performed, including but not limited to:

stroke, bleeding, infection, seizures, swelling of the brain (which may require a second craniotomy), nerve damage, which may cause muscle

paralysis or weakness, cerebrospinal fluid leak, which may require repair, loss of mental functions and permanent brain damage with associated

disabilities.

The invasiveness, procedural times and possible surgical complications have limited the growth of surgical treatment of

● Requirement

for multiple devices for diagnostic and therapeutic procedures :

Today both interventional

diagnostic and treatment procedures may require different device implants, surgeries and even hospitalizations for each procedure.

causes significant patient inconvenience, use of precious hospital resources and tremendous cost to the system.

● Limited number of contacts on an electrode :

diagnostic and treatment procedures may require different device implants, surgeries and

even hospitalizations for each procedure.

This causes significant patient inconvenience,

use of precious hospital resources and tremendous cost to the system.

number of contacts on an electrode :

Paddle electrodes currently are available in a variety

of sizes and number of contacts.

Physicians increasingly want to explore greater number of contacts on the same electrode in order to

be able to be more precise in stimulating targeted areas.

As a result of the inherent limitations and inconvenience

of existing systems, we believe that there is a significant unmet need among people with neurological disorders for cortical strip, grid

and depth electrodes that provide diagnostic capabilities through cEEG and sEEG recording in addition to therapeutic modalities, such

as brain stimulation and ablation, offered as an all-in-one product.

In comparison to currently available technologies, we are continuing

to develop applications of our strip, grid and depth electrodes with the goal of providing the following expected advantages:

● Reduced time for diagnosis and treatment:

Physicians increasingly want to explore greater number of

contacts on the same electrode in order to be able to be more precise in stimulating targeted

a result of the inherent limitations and inconvenience of existing systems, we believe that there is a significant unmet need among people

with neurological disorders for cortical strip, grid and depth electrodes that provide diagnostic capabilities through cEEG and sEEG

recording in addition to therapeutic modalities, such as brain stimulation and ablation, offered as an all-in-one product.

In comparison

to currently available technologies, we are continuing to develop applications of our strip, grid and depth electrodes with the goal

of providing the following expected advantages:

time for diagnosis and treatment:

By offering a minimally invasive procedure and developing

an all-in-one solution, we expect our technology will reduce overall procedural times.

While our pre-clinical and clinical experience

to date is limited, our cortical grid technology has demonstrated the ability to provide high fidelity recordings that have allowed physicians

our pre-clinical and clinical experience to date is limited, our cortical grid technology

has demonstrated the ability to provide high fidelity recordings that have allowed physicians

to identify the affected brain tissue causing seizures.

This may provide the potential for meaningful cost savings for hospitals and patients

and improved quality of life for patients.

● Improved accuracy of diagnostic technologies:

This may provide the potential for

meaningful cost savings for hospitals and patients and improved quality of life for patients.

Medical Technologies Corporation

accuracy of diagnostic technologies:

Because we believe our thin film technology is capable

of recording at higher fidelity than current technologies used in EEG recording, we believe our technology may be able to more precisely

determine the brain tissue causing seizures.

of recording at higher fidelity than current technologies used in EEG recording, we believe

our technology may be able to more precisely determine the brain tissue causing seizures.

In December 2020, we announced the first human commercial use of our Evo cortical electrode

to perform recording, functional mapping, monitoring and stimulation of the brain.

In the procedure, performed at the Mayo Clinic, our

electrodes were used to record evidence of pre-seizure activity, which may be critical in developing treatments to prevent the onset of

Since then, several institutions around the country have successfully tried and adopted our devices for diagnostic procedures.

● Implantation via minimally invasive procedure with fewer post-procedure complications:

procedure, performed at the Mayo Clinic, our electrodes were used to record evidence of pre-seizure

activity, which may be critical in developing treatments to prevent the onset of seizures.

Since then, several institutions around the country have successfully tried and adopted our

devices for diagnostic procedures.

● Implantation

via minimally invasive procedure with fewer post-procedure complications:

We are currently

developing approaches to deliver the electrodes by minimizing the invasiveness of the procedures.

We expect that patients who have qualified

for diagnostic or treatment procedures will be more accepting of a minimally-invasive procedure.

We expect that patients who have qualified for diagnostic or treatment procedures will be

more accepting of a minimally-invasive procedure.

Such procedures may potentially reduce

the patient’s pain, bleeding and other adverse events.

For example, our cortical electrode technology is expected to also have fewer

wires, also referred to as tails, exiting the patient’s head, which can also reduce the potential for infections.

Furthermore, the

material we currently use in our cortical electrodes has shown in pre-clinical evaluations to cause less inflammation than current electrode

substrates as it appears more compatible with brain tissue.

As discussed under “Our Strategy” below, our technology has been

and will be implanted via a full craniotomy until such time, if ever, as we are able to develop our minimally invasive procedure.

NeuroOne Medical Technologies Corporation

● All-in-one diagnostic and therapeutic technology solution:

For example, our cortical electrode

technology is expected to also have fewer wires, also referred to as tails, exiting the patient’s

head, which can also reduce the potential for infections.

Furthermore, the material we currently

use in our cortical electrodes has shown in pre-clinical evaluations to cause less inflammation

than current electrode substrates as it appears more compatible with brain tissue.

under “Our Strategy” below, our technology has been and will be implanted via

a full craniotomy until such time, if ever, as we are able to develop our minimally invasive

diagnostic and therapeutic technology solution:

Due to the expected recording and treatment

capabilities of some of our technology under development, we have received feedback from physicians that they will attempt to perform

the diagnosis and treatment in a single procedure, thereby potentially eliminating the need for a second surgical procedure, reducing

the likelihood of patient infection, risks associated with surgical procedures and minimizing the diagnostic, procedural and hospital

As discussed under “Our Strategy” below, our initial product offering offers diagnostic-only capabilities while we

advance the development of our all-in-one approach.

Currently, we are developing a combination recording, stimulation and RF ablation

technology that will perform both diagnostic and therapeutic functions.

● Percutaneous placement of spinal cord stimulation paddle electrodes with scalability options:

to the thin film nature of our electrode technology, we believe that it may allow for percutaneous placement of “paddle” (flat)

shaped electrodes, thereby preventing the need to use more invasive surgical approaches to place the electrodes.

Minimally invasive and

percutaneously placed technologies have become almost a requirement for adoption with patients and physicians.

In addition, our technology

in the future offers the ability to increase the number of contacts on a film that traditionally offers fewer contacts.

Increasing the

number of contacts may allow for more precise stimulation in the spine, potentially improving the therapeutic outcomes.

Our goal is to be the global leader in cEEG and

sEEG recording, monitoring, deep brain stimulation and ablation, owning the procedure from diagnosis through treatment.

capabilities of some of our technology under development, we have received feedback from

physicians that they will attempt to perform the diagnosis and treatment in a single procedure,

thereby potentially eliminating the need for a second surgical procedure, reducing the likelihood

of patient infection, risks associated with surgical procedures and minimizing the diagnostic,

procedural and hospital costs.

As discussed under “Our Strategy” below, our initial

product offering offers diagnostic-only capabilities while we advance the development of

our all-in-one approach.

Currently, we are preparing a combination recording, stimulation

and RF ablation technology that will perform both diagnostic and therapeutic functions for

commercialization.

● Percutaneous

placement of spinal cord stimulation paddle electrodes with scalability options:

to the thin film nature of our electrode technology, we believe that it may allow for percutaneous

placement of “paddle” (flat) shaped electrodes, thereby preventing the need to

use more invasive surgical approaches to place the electrodes.

Minimally invasive and percutaneously

placed technologies have become almost a requirement for adoption with patients and physicians.

In addition, our technology in the future offers the ability to increase the number of contacts

on a film that traditionally offers fewer contacts.

Increasing the number of contacts may

allow for more precise stimulation in the spine, potentially improving the therapeutic outcomes.

goal is to be the global leader in cEEG and sEEG recording, monitoring, deep brain stimulation and ablation, owning the procedure from

diagnosis through treatment.

The key elements of our strategy include:

● Introduce cortical strip and grid electrodes for the diagnosis of epilepsy in United States :

December 2019, we announced that we received FDA 510(k) clearance to market our thin film cortical electrode technology for temporary

(less than 30 days) recording, monitoring, and stimulation on the surface of the brain.

cortical strip and grid electrodes for the diagnosis of epilepsy in United States :

December 2019, we announced that we received FDA 510(k) clearance to market our thin film

cortical electrode technology for temporary (less than 30 days) recording, monitoring, and

stimulation on the surface of the brain.

Our initial product offering has initially been

and will be placed through traditional surgical means involving a craniotomy until such time, if any, that we launch our minimally invasive

In July 2020, we entered into a development relationship with Zimmer, pursuant to which we granted Zimmer exclusive global

rights to distribute the cortical strip and grid electrodes, and Zimmer will use commercially reasonable efforts to promote, market and

sell the strip and grid electrodes.

We believe, due to physician feedback, that our technology represents a major improvement over existing

and will be placed through traditional surgical means involving a craniotomy until such time,

if any, that we launch our minimally invasive procedure.

In July 2020, we entered into a

development relationship with Zimmer, pursuant to which we granted Zimmer exclusive global

rights to distribute the cortical strip and grid electrodes, and Zimmer will use commercially

reasonable efforts to promote, market and sell the strip and grid electrodes.

due to physician feedback, that our technology represents a major improvement over existing

cortical electrodes for the recording of brain activity.

We are initially targeting epilepsy as we believe this is a clinical area of

great need and a market that is underserved with a quick path to commercialization.

We are initially targeting epilepsy

as we believe this is a clinical area of great need and a market that is underserved with

a quick path to commercialization.

We believe the largest and quickest-to-market geography

for our cortical strip and grid technology under development is the United States for a number of reasons, including the following:

many industry sources believe there is a large underserved U.S.

market, (ii) healthy procedural reimbursement exist for centers and physicians,

(iii) average selling prices are robust, and (iv) there is substantial physician enthusiasm for our technology under development.

several institutions around the country have successfully tried and adopted our cortical electrode technology for diagnostic procedures.

● Launch depth electrodes for sEEG recording:

In September 2021, we announced that we received FDA

510(k) clearance to market our Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation

equipment for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

We filed for 510(k) clearance

to expand the duration of use up to less than 30 days in November 2021.

On October 20, 2022, the Company received an FDA clearance to

market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for

the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Given the reluctance of patients

to undergo epilepsy surgery due to its invasiveness, a number of epilepsy centers have adopted the use of depth electrodes, which are

placed by drilling small holes into the patient’s cranium, thereby avoiding a craniotomy.

We believe our technology offers advantages

compared to current depth electrode technology in the market and will also enable us to offer a therapeutic solution using this same technology

for our cortical strip and grid technology under development is the United States for a number

of reasons, including the following:

(i) many industry sources believe there is a large underserved

market, (ii) healthy procedural reimbursement exist for centers and physicians, (iii)

average selling prices are robust, and (iv) there is substantial physician enthusiasm for

our technology under development.

To date, several institutions around the country have successfully

tried and adopted our cortical electrode technology for diagnostic procedures.

Medical Technologies Corporation

depth electrodes for sEEG recording:

In September 2021, we announced that we received

FDA 510(k) clearance to market our Evo sEEG electrode technology for temporary (less than

24 hours) use with recording, monitoring, and stimulation equipment for recording, monitoring,

and stimulation of electrical signals at the subsurface level of the brain.

510(k) clearance to expand the duration of use up to less than 30 days in November 2021.

On October 20, 2022, the Company received an FDA clearance to market its Evo sEEG electrode

technology for temporary (less than 30 days) use with recording, monitoring, and stimulation

equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface

level of the brain.

Given the reluctance of patients to undergo epilepsy surgery due to its

invasiveness, a number of epilepsy centers have adopted the use of depth electrodes, which

are placed by drilling small holes into the patient’s cranium, thereby avoiding a craniotomy.

We believe our technology offers advantages compared to current depth electrode technology

in the market and will also enable us to offer a therapeutic solution using this same technology

in the future.

As we continue to develop our technology, we plan to release further information about the expected advantages of our technology

over currently available therapies.

NeuroOne Medical Technologies Corporation

● Utilize these core technologies to develop all-in-one diagnostic and therapeutic solutions with the initial

focus on a combination diagnostic and ablation electrode:

For many patients who currently undergo one surgical procedure for diagnosis,

a second and different procedure or surgery is then required to treat the patient.

There is strong physician/surgeon interest to be able

to perform both the diagnostic and therapeutic procedure with the same implanted devices.

We are developing our technology with the goal

of being able to offer this benefit although there can be no assurance that we will be able to do so.

We are pursuing cortical grid, strip

and depth electrode technology that can record brain activity (diagnose) and also provide both acute and long term stimulation as well

as depth electrode technology that can ablate brain tissue.

The technology has demonstrated these functions in acute and short term animal

however, additional development is required to offer a device that has long term therapeutic application.

These therapeutic technologies

are expected to require more robust regulatory approvals for the United States, ranging from a 510(k) to potential for pre-market approvals

(“PMAs”) with human clinical data.

We will engage the FDA at the proper time to determine the most efficient regulatory path.

● Develop percutaneous placed electrodes for spinal cord stimulation with scalable contact configurations:

Given that many surgically placed technologies have become less invasive due to patient and physician demands, we believe that our

flexible thin film technology will allow for percutaneous placement of “paddle” shaped electrodes, thus potentially eliminating

the need to make a more invasive surgical procedure.

Spinal cord clinical literature over the years have shown that “paddle”

electrodes (flat shaped) require less energy for stimulation (thus saving neurostimulator battery life) and may be associated with lower

revision rates over time.

Even then, “paddle” shaped electrodes are used less often due to the more invasive surgical procedure

that is required for placement.

But we hope to change that paradigm by creating “paddle” electrodes that can be implanted

percutaneously (less invasively) through a “needle hole incision”.

By leveraging our existing FDA cleared cortical electrode

and sEEG technology, we may also be able to offer the ability to improve precision of where the stimulation is delivered.

platform thin film technology has the capability to increase the number of contacts in a similar footprint that has fewer contacts.

● Gain clearance for other brain or motor related disorders such as Parkinson’s with the therapeutic

As we continue to develop our technology, we plan to release further information

about the expected advantages of our technology over currently available therapies.

these core technologies to develop all-in-one diagnostic and therapeutic solutions with the

initial focus on a combination diagnostic and ablation electrode:

For many patients who

currently undergo one surgical procedure for diagnosis, a second and different procedure

or surgery is then required to treat the patient.

There is strong physician/surgeon interest

to be able to perform both the diagnostic and therapeutic procedure with the same implanted

We are developing our technology with the goal of being able to offer this benefit

although there can be no assurance that we will be able to do so.

We are pursuing cortical

grid, strip and depth electrode technology that can record brain activity (diagnose) and

also provide both acute and long term stimulation as well as depth electrode technology that

can ablate brain tissue.

The technology has demonstrated these functions in acute and short

term animal models;

however, additional development is required to offer a device that has

long term therapeutic application.

These long term therapeutic technologies are expected

to require more robust regulatory approvals for the United States, ranging from a 510(k)

to potential for pre-market approvals (“PMAs”) with human clinical data.

engage the FDA at the proper time to determine the most efficient regulatory path.

percutaneous placed electrodes for spinal cord stimulation with scalable contact configurations:

Given that many surgically placed technologies have become less invasive due to patient

and physician demands, we believe that our flexible thin film technology will allow for percutaneous

placement of “paddle” shaped electrodes, thus potentially eliminating the need

to make a more invasive surgical procedure.

Spinal cord clinical literature over the years

have shown that “paddle” electrodes (flat shaped) require less energy for stimulation

(thus saving neurostimulator battery life) and may be associated with lower revision rates

Even then, “paddle” shaped electrodes are used less often due to the

more invasive surgical procedure that is required for placement.

But we hope to change that

paradigm by creating “paddle” electrodes that can be implanted percutaneously

(less invasively) through a “needle hole incision”.

By leveraging our existing

FDA cleared cortical electrode and sEEG technology, we may also be able to offer the ability

to improve precision of where the stimulation is delivered.

NeuroOne’s platform thin

film technology has the capability to increase the number of contacts in a similar footprint

that has fewer contacts.

approval for other brain or motor related disorders such as Parkinson’s with the therapeutic

technologies developed for epilepsy:

While we are developing our technology for the diagnosis and treatment of epilepsy, we believe that

our technology has strong application and utilization for other brain or motor related disorders such as Parkinson’s disease, dystonia,

essential tremors and facial pain as these diseases are currently treated with DBS if medications are not effective.

As previously mentioned,

we are actively evaluating the potential to offer electrodes that can be implanted for long term stimulation applications, but such use

will require that we pursue additional approvals from the FDA and any international regulatory bodies where we seek to commercialize our

● Explore partnerships with other companies that leverage our core technology:

While we are developing our technology for the diagnosis

and treatment of epilepsy, we believe that our technology has strong application and utilization

for other brain or motor related disorders such as Parkinson’s disease, dystonia, essential

tremors and facial pain as these diseases are currently treated with DBS if medications are

not effective.

As previously mentioned, we are actively evaluating the potential to offer

electrodes that can be implanted for long term stimulation applications, but such use will

require that we pursue additional approvals from the FDA and any international regulatory

bodies where we seek to commercialize our technology.

Medical Technologies Corporation

partnerships with other companies that leverage our core technology:

Given that our technology

enables, complements and/or competes with a number of companies that are in the market or attempting to enter the market with diagnostic

or therapeutic technologies to treat brain related disorders, we believe there may be opportunities to establish mutually beneficial relationships.

In addition, our technology may have application in cardiovascular, orthopedic and pain related indications that could benefit from a

high fidelity thin film electrode product that can provide stimulation and/or ablation therapies.

NeuroOne Medical Technologies Corporation

● Investigate the potential applications associated with Artificial Intelligence:

enables, complements and/or competes with a number of companies that are in the market or

attempting to enter the market with diagnostic or therapeutic technologies to treat brain

related disorders, we believe there may be opportunities to establish mutually beneficial

relationships.

In addition, our technology may have application in cardiovascular, orthopedic

and pain related indications that could benefit from a high fidelity thin film electrode

product that can provide stimulation and/or ablation therapies.

with biotech, pharmaceutical or biopharma companies to provide a drug delivery sEEG electrode

capable of delivering the therapy and recording before, during and after the therapy is delivered

for up to 30 days.

● Investigate

the potential applications associated with Artificial Intelligence:

We have been informed

by some of our corporate advisors that the ability to offer scale-able electrode technology that can provide thousands of electrodes in

the brain may be helpful in treating medical conditions that may benefit from using artificial intelligence.

by some of our corporate advisors that the ability to offer scale-able electrode technology

that can provide thousands of electrodes in the brain may be helpful in treating medical

conditions that may benefit from using artificial intelligence.

The Company has formed an

advisory board that will provide guidance to the Company as we continue to explore the opportunities in this exciting field.

Our Technology

Epilepsy Mapping and Monitoring

Epileptic seizures occur when the neurons in the

brain miscommunicate.

This miscommunication typically results in involuntary muscle seizure activities and/or periods of perceptual disconnect

where the individual appears frozen.

Modern medical science has advanced the treatment of epileptic seizures by mapping the electrical

communication activity of neurons and understanding their special orientation in the brain.

This mapping is accomplished by access to

the cranium (through a craniotomy) and placing conductive contacts on the brain directly.

The craniotomy procedure is very invasive, traumatic

to the surrounding tissue, results in high patient down time, and increases the risk of infection.

We seek to leverage scale-able technology and

produce ultra-thin, or paper-thin electrodes that allow for high-resolution and high-definition recordings, which would improve mapping

resolution and signal acquisition.

If the Company is able to leverage scale-able technology, it would mean that our technology would be

able to incorporate smaller electrodes and thereby increase the number of electrodes on a given surface area.

We expect that this would

increase the imaging resolution so that brain activity is displayed in greater definition.

We also believe that the electrodes’

unique thinness and flexibility will provide a less invasive approach to electrode placement.

The electrodes would be able to be placed

through a small quarter size hole instead of by an invasive full craniotomy procedure.

The images under “Cortical Electrode,”

from bottom to top, are images of our cortical electrode strip, our grid electrode, and the placement of the grid electrode on the brain,

respectively.

The images under “High Density Interconnect” are both images of our product that connects our electrodes to

the head box, which is a piece of hardware that connects to electrodes to acquire, amplify, display, store and archive electrophysiological

signals, and is integrated as part of our manufactured electrode product.

The images under “Head Box” and “Signal Monitoring

and Mapping” are images of the device which processes information received through the high density interconnect, and a sample output

of data acquisition, respectively, neither of which is one of the Company’s products.

Our technology consists of three primary types

of cortical electrodes:

advisory board that will provide guidance to the Company as we continue to explore the opportunities

in this exciting field.

Mapping and Monitoring

seizures occur when the neurons in the brain miscommunicate.

This miscommunication typically results in involuntary muscle seizure activities

and/or periods of perceptual disconnect where the individual appears frozen.

Modern medical science has advanced the treatment of epileptic

seizures by mapping the electrical communication activity of neurons and understanding their special orientation in the brain.

is accomplished by access to the cranium (through a craniotomy) and placing conductive contacts on the brain directly.

The craniotomy

procedure is very invasive, traumatic to the surrounding tissue, results in high patient down time, and increases the risk of infection.

seek to leverage scale-able technology and produce ultra-thin, or paper-thin electrodes that allow for high-resolution and high-definition

recordings, which would improve mapping resolution and signal acquisition.

If the Company is able to leverage scale-able technology,

it would mean that our technology would be able to incorporate smaller electrodes and thereby increase the number of electrodes on a

given surface area.

We expect that this would increase the imaging resolution so that brain activity is displayed in greater definition.

We also believe that the electrodes’ unique thinness and flexibility will provide a less invasive approach to electrode placement.

The electrodes would be able to be placed through a small quarter size hole instead of by an invasive full craniotomy procedure.

images under “Cortical Electrode,” from bottom to top, are images of our cortical electrode strip, our grid electrode, and

the placement of the grid electrode on the brain, respectively.

The images under “High Density Interconnect” are both images

of our product that connects our electrodes to the head box, which is a piece of hardware that connects to electrodes to acquire, amplify,

display, store and archive electrophysiological signals, and is integrated as part of our manufactured electrode product.

under “Head Box” and “Signal Monitoring and Mapping” are images of the device which processes information received

through the high density interconnect, and a sample output of data acquisition, respectively, neither of which is one of the Company’s

Medical Technologies Corporation

technology consists of three primary types of cortical electrodes:

grid electrodes, strip electrodes and dual-sided electrodes.

These electrodes have a patented design that utilizes

proprietary processing and materials technology, which we believe will allow the electrodes to have improved features over the current

industry standard recording electrodes.

What sets our technology apart from others is

the integration of state of the art design leveraging the latest in flexible printed circuit technology.

We believe our patented designs

will provide the surgeon a higher tactile perspective on electrode placement allowing for ultra-precise neuron recording.

We expect the

benefits of our electrode designs to include the ability to detect better defined margins between healthy tissue and resect-able tissue,

less immune-response from the brain and surrounding tissue, better signal acquisition due to superior conformability of the electrode

over the brain, improved flexibility that physicians have requested, which we expect will enable a minimally invasive approach and the

electrodes unique thinness that is unmatched by current products being used.

NeuroOne Medical Technologies Corporation

The Future of Neurology Mapping with

We seek to develop superior “scale-able”

technology for future product system iterations in higher density contact placement.

This will open the doors to other brain related disease

recording procedures by providing high fidelity, more accurate diagnostic capabilities and also the ability to provide an all-in-one therapy

capable of diagnosis, ablation and/or stimulation.

Beyond the brain, we believe our technology under development has applications in other

neurological signal recording disease states related to voluntary or involuntary motor neuron abnormalities, understanding sensory neuro

behavior (pain), limb prosthetics and degenerative muscle disease.

Clinical Development and Regulatory Pathway

Clinical Experience, Future Development

and Clinical Trial Plans

Our Evo cortical electrode technology has received

510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for less than 30 days on the surface of the brain.

Our Evo sEEG electrode technology has received FDA 510(k) clearance from the FDA for use (less than 30 days) with recording, monitoring,

and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

other products have not received any clearance for commercialization by any U.S.

or foreign regulatory body.

To date, the Company has

performed a number of bench top (which includes feasibility testing) and pre-clinical tests (which include animal testing of device placement,

ergonomics, performance, ease of use, and other tests required by FDA regulations).

As described in “-Government Regulation”

below, the Company will be required to perform additional testing of its technology in connection with seeking additional regulatory clearances

or approvals.

We intend to expand our product offerings to include

less invasive means and all-in-one solutions, thus providing both patients and physicians better options to treat epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.

While we expect

to make modifications to our initial system, we believe that most of our future product development initiatives will involve unique and

transformational next generation technology that should drive further appeal of our products with both physicians and patients.

We are utilizing a number of resources to develop

these technologies.

We license three critical patents from WARF that are the foundation of the technology and we are developing and intend

to commercialize and benefit from the thin film technology know-how of Mayo Clinic doctors through our license and development agreement.

WARF, Mayo Clinic (cortical electrodes) and Cleveland Clinic (sEEG electrodes) have been responsible for all pre-clinical studies of our

technology under development to date.

See “-WARF License” and “-Mayo Foundation for Medical Education and Research License

and Development Agreement” below.

We announced in December 2020, Mayo Clinic doctors used our technology in the first human commercial

application of our Evo cortical electrode technology to perform recording, functional mapping and stimulation of the brain on a human

And more recently, in July 2022, we announced the first clinical case using the Evo sEEG electrode was performed by Dr.

Gross at Emory University.

Gross selected the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the brain.

NeuroOne Medical Technologies Corporation

Below we have summarized, for each component of

our technology, the current stage of development or commercial production, the pre-clinical testing done to date by WARF, the Cleveland

Clinic or Mayo Clinic on such component, if any, our plans for further testing or clinical trials and our expectations regarding the requirements

for regulatory clearance or approval and timing of regulatory submissions.

Stage of Development and Pre-Clinical Testing to Date

Additional Expected Steps for Regulatory

electrodes have a patented design that utilizes proprietary processing and materials technology, which we believe will allow the electrodes

to have improved features over the current industry standard recording electrodes.

sets our technology apart from others is the integration of state of the art design leveraging the latest in flexible printed circuit

We believe our patented designs will provide the surgeon a higher tactile perspective on electrode placement allowing for

ultra-precise neuron recording.

We expect the benefits of our electrode designs to include the ability to detect better defined margins

between healthy tissue and resect-able tissue, less immune-response from the brain and surrounding tissue, better signal acquisition

due to superior conformability of the electrode over the brain, improved flexibility that physicians have requested, which we expect

will enable a minimally invasive approach and the electrodes unique thinness that is unmatched by current products being used.

Future of Neurology Mapping with NeuroOne

seek to develop superior “scale-able” technology for future product system iterations in higher density contact placement.

This will open the doors to other brain related disease recording procedures by providing high fidelity, more accurate diagnostic capabilities

and also the ability to provide an all-in-one therapy capable of diagnosis, ablation and/or stimulation.

Beyond the brain, we believe

our technology under development has applications in other neurological signal recording disease states related to voluntary or involuntary

motor neuron abnormalities, understanding sensory neuro behavior (pain), limb prosthetics and degenerative muscle disease.

Development and Regulatory Pathway

Experience, Future Development and Clinical Trial Plans

Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue

for less than 30 days on the surface of the brain.

Our Evo sEEG electrode technology has received FDA 510(k) clearance from the FDA for

use (less than 30 days) with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical

signals at the subsurface level of the brain.

Our other products have not received any clearance for commercialization by any U.S.

foreign regulatory body.

To date, the Company has performed a number of bench top (which includes feasibility testing) and pre-clinical

tests (which include animal testing of device placement, ergonomics, performance, ease of use, and other tests required by FDA regulations).

As described in “—Government Regulation” below, the Company will be required to perform additional testing of its technology

in connection with seeking additional regulatory clearances or approvals.

intend to expand our product offerings to include less invasive means and all-in-one solutions, thus providing both patients and physicians

better options to treat epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and

other related neurological disorders.

While we expect to make modifications to our initial system, we believe that most of our future

product development initiatives will involve unique and transformational next generation technology that should drive further appeal

of our products with both physicians and patients.

are utilizing a number of resources to develop these technologies.

We license three critical patents from WARF that are the

foundation of the technology and we are developing and intend to commercialize and benefit from the thin film technology know-how of

Mayo Clinic doctors through our license and development agreement.

WARF, Mayo Clinic (cortical electrodes) and Cleveland Clinic

(sEEG electrodes) have been responsible for all pre-clinical studies of our technology under development to date.

License” and “—Mayo Foundation for Medical Education and Research License and Development Agreement” below.

announced in December 2020 that Mayo Clinic doctors used our technology in the first human commercial application of our Evo

cortical electrode technology to perform recording, functional mapping and stimulation of the brain on a human patient.

recently, in July 2022, we announced the first clinical case using the Evo sEEG electrode was performed by Dr.

Robert Gross at Emory

Gross selected the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the

Medical Technologies Corporation

we have summarized, for each component of our technology, the current stage of development or commercial production, the pre-clinical

testing done to date by WARF, the Cleveland Clinic or Mayo Clinic on such component, if any, our plans for further testing or clinical

trials and our expectations regarding the requirements for regulatory clearance or approval and timing of regulatory submissions.

of Development and Pre-Clinical Testing to Date

Expected Steps for Regulatory

Clearance or Approval

Cortical strip and grid electrodes for the diagnosis of epilepsy

The Company has finalized the design for the product

and there are no further expected changes to the device (“design freeze”).

Pre-clinical testing and clinical testing on the

final design has been conducted by Mayo Clinic and WARF (as described in “Mayo Clinic Studies” below).

The product is in commercial

The Company received FDA 510(k) clearance in the

fourth calendar quarter of 2019.

Commercial launch commenced utilizing Zimmer, our

distribution partner.

Cortical strip and grid electrodes for the diagnosis

has finalized the design for the product and there are no further expected changes to the device (“design freeze”).

testing and clinical testing on the final design has been conducted by Mayo Clinic and WARF (as described in “Mayo Clinic and

University of Wisconsin-Madison Studies” below).

The product is in commercial production.

received FDA 510(k) clearance in the fourth calendar quarter of 2019.

launch commenced utilizing Zimmer, our distribution partner.

Depth electrodes for recording (diagnostic) purposes

We have frozen this design and the product is in

commercial production.

No clinical testing was required in order to obtain

FDA clearance.

The Company filed for FDA 510(k) marketing clearance for sEEG electrodes in May 2021 and received a 510(k) clearance from FDA for recording, monitoring and stimulation of brain tissue for less than 24 hours in September 2021.

The Company filed for 510(k) clearance to expand the duration of use up to less than 30 days in November 2021.

On October 20, 2022, the Company received an FDA clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Zimmer has indicated its desire to distribute this product.

NeuroOne Medical Technologies Corporation

Depth electrode diagnostic and ablation devices

No design freeze.

We expect to conclude the design

phase by the end of 2022.

Pre-clinical testing, including benchtop and animal

testing, has been conducted on near-final designs.

Very early testing at the Cleveland Clinic was completed in the second calendar quarter

Pre-clinical (animal) feasibility testing was conducted

in September 2021 with representatives from Emory University in Atlanta Georgia.

We plan to do further pre-clinical animal testing of

our near-final and final designs in the coming months.

The Company announced a partnership with RBC Medical

Systems in August 2021 to develop an RF generator that will be used with the Company’s diagnostic and ablation electrode.

No animal or human clinical testing is anticipated

for FDA submission since 510K predicate devices did not perform such clinical testing.

Once the design is finalized, we will be required

to conduct additional pre-clinical testing, which may include additional benchtop or even animal testing for safety and performance.

We anticipate filing a 510(k) submission in the second

calendar quarter of 2023.

We expect that we will need to demonstrate design verification, biocompatibility, electrical safety and sterilization

validation and adoption, all of which we estimate will require >$300K to complete.

It is estimated the RF generator will cost approximately

$1.5 million to complete.

Future testing requirements for regulatory clearance

will continue to be evaluated as we develop the design and regulatory strategy for this product.

frozen this design and the product is in commercial production.

testing was required in order to obtain FDA clearance.

The Company filed for FDA 510(k) marketing clearance

for sEEG electrodes in May 2021 and received a 510(k) clearance from FDA for recording, monitoring and stimulation of brain tissue

for less than 24 hours in September 2021.

The Company filed for 510(k) clearance to expand the duration of use up to less than 30

days in November 2021.

On October 20, 2022, the Company received an FDA clearance to market its Evo sEEG Electrode technology for

temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation

of electrical signals at the subsurface level of the brain.

Zimmer began distributing this product in May 2023.

Medical Technologies Corporation

electrode diagnostic and ablation devices

phase was completed at the end of 2022, the verification phase was completed in June 2023, and the transfer to manufacturing phase

began in July 2023.

testing, including benchtop and animal testing, has been conducted on final designs.

early testing at the Cleveland Clinic was completed in the second calendar quarter of 2020.

(animal) feasibility testing was conducted in September 2021 with representatives from Emory University in Atlanta, Georgia.

pre-clinical animal testing of our final design was conducted at Emory University in April 2023 and invivo testing of our final design

was conducted in May 2023.

announced a partnership with RBC Medical Systems in August 2021 to develop an RF generator that will be used with the Company’s

diagnostic and ablation electrode.

or human clinical testing is anticipated for FDA submission since 510K predicate devices did not perform such clinical testing.

Company submitted a 510(k) application to the FDA for the OneRF ablation system in June 2023 and responded to FDA comments on November

The Company received 510(k) clearance from the FDA for creation of radiofrequency lesions in nervous tissue for functional neurosurgical

procedures on December 6, 2023.

Spinal cord stim electrodes

No design freeze.

We performed pre-clinical in-house bench top testing

in August 2020.

In 2021/early 2022, we performed bench top testing

of prototypes to demonstrate chronic performance and longevity.

In 2023, we will continue to refine our chronic spinal

cord electrode design based on SCS customer feedback and do additional pre-clinical bench and/or animal tests to further validate our

value proposition.

This device is in early stages of development.

Once the design is finalized, we will be required

to conduct additional pre-clinical testing, which may include additional benchtop or animal testing for safety and performance.

Additionally,

the FDA may require that we conduct human clinical studies.

No FDA feedback has been sought or received by us

to date on the regulatory/clinical process that may be required for spinal cord stimulation indication, but we expect regulatory PMA approval

will require a more robust clinical process, human clinical data for a PMA (implanted system), depending on proposed indications for use.

Future pre-clinical and clinical testing requirements

for regulatory submission will continue to be evaluated as we develop the design of this product.

NeuroOne Medical Technologies Corporation

Depth electrode chronic stimulation devices

No design freeze.

Bench top testing were successfully performed in

2021 and early 2022.

pre-clinical in-house bench top testing in August 2020.

In 2021/early

2022, we performed bench top testing of prototypes to demonstrate chronic performance and longevity.

we will continue to refine our chronic spinal cord electrode design based on SCS customer feedback and do additional pre-clinical

bench and/or animal tests to further validate our value proposition.

device is in early stages of development.

the design is finalized, we will be required to conduct additional pre-clinical testing, which may include additional benchtop or

animal testing for safety and performance.

Additionally, the FDA may require that we conduct human clinical studies.

feedback has been sought or received by us to date on the regulatory/clinical process that may be required for spinal cord stimulation

indication, but we expect regulatory PMA approval will require a more robust clinical process, human clinical data for a PMA (implanted

system), depending on proposed indications for use.

pre-clinical and clinical testing requirements for regulatory submission will continue to be evaluated as we develop the design of

this product.

Medical Technologies Corporation

electrode chronic stimulation devices

top testing were successfully performed in 2021 and early 2022.

We announced the results of these studies in the first quarter of

While this device remains in early development, we

expect to work with clinicians to further refine our designs and continue testing in 2023.

Following a design freeze, we will be required to

conduct additional pre-clinical testing, which may include additional benchtop or animal testing for safety and performance.

this device remains in early development, we expect to work with clinicians to further refine our designs and continue testing in

a design freeze, we will be required to conduct additional pre-clinical testing, which may include additional benchtop or animal

testing for safety and performance.

Additionally, FDA-approved human clinical studies will most likely be required.

feedback has been sought or received by us to date on the clinical process that will be required for chronic stimulation, but we

expect regulatory approval for chronic stimulation may require a more robust clinical process, which could include a PMA with human

clinical data.

Because we have not yet met with the FDA, we cannot yet determine what clinical data and testing we will need to complete

or what the testing will need to demonstrate.

However, we believe, based on the experience of competitors for similar technology,

that we will need to conduct clinical trials, which we estimate will require an investment of over $2,000,000.

Clinic and University of Wisconsin-Madison Studies

cortical technology for the diagnosis of epilepsy has been tested by doctors at Mayo Clinic in multiple pre-clinical tests conducted

from 2012 to 2017.

In pre-clinical models, doctors examined the biological impact on mammalian brains.

Polyimide substrate electrodes

(NeuroOne technology) were implanted on the pig’s brain for one week alongside standard competitive electrodes.

The tissue underneath

the two types of electrodes was removed, fixed, stained, and examined for immunological responses.

The results of a histological (evaluation

of brain tissue under a microscope) analysis showed reduced immunological reaction to prolonged polyimide substrate implants (NeuroOne

technology) compared to standard silicone substrate clinical electrodes.

Electrophysiological recordings showed data obtained from polyimide

electrodes which demonstrated the feasibility of high fidelity multi-scale electrophysiology while also displaying easier deployment

of polyimide electrodes (NeuroOne technology) through minimally invasive burr holes.

Additionally,

FDA-approved human clinical studies will most likely be required.

No FDA feedback has been sought or received by us

to date on the clinical process that will be required for chronic stimulation, but we expect regulatory approval for chronic stimulation

may require a more robust clinical process, which could include a PMA with human clinical data.

Because we have not yet met with the FDA,

we cannot yet determine what clinical data and testing we will need to complete or what the testing will need to demonstrate.

we believe, based on the experience of competitors for similar technology, that we will need to conduct clinical trials, which we estimate

will require an investment of over $2,000,000.

Mayo Clinic and University of Wisconsin-Madison

Our cortical technology for the diagnosis of epilepsy

has been tested by doctors at Mayo Clinic in multiple pre-clinical tests conducted from 2012 to 2017.

In pre-clinical models, doctors

examined the biological impact on mammalian brains.

Polyimide substrate electrodes (NeuroOne technology) were implanted on the pig’s

brain for one week alongside standard competitive electrodes.

The tissue underneath the two types of electrodes was removed, fixed, stained,

and examined for immunological responses.

The results of a histological (evaluation of brain tissue under a microscope) analysis showed

reduced immunological reaction to prolonged polyimide substrate implants (NeuroOne technology) compared to standard silicone substrate

clinical electrodes.

Electrophysiological recordings showed data obtained from polyimide electrodes which demonstrated the feasibility

of high fidelity multi-scale electrophysiology while also displaying easier deployment of polyimide electrodes (NeuroOne technology) through

minimally invasive burr holes.

Additionally, doctors implanted our polyimide

thin film electrodes on five human patients who were undergoing surgery to remove brain tissue for drug resistant epilepsy.

Electrophysiological

recordings from the polyimide thin film technology displayed in each of these patients demonstrated micro-seizure activity due to the

high fidelity multi-scale electrophysiology.

In December 2020, we announced the first human commercial use of our Evo cortical electrode

to perform recording, functional mapping and stimulation of the brain.

In the procedure, performed at the Mayo Clinic, our electrodes

were used to record evidence of pre-seizure activity which may be critical in developing treatments to prevent the onset of seizures.

Conclusions reached by the physicians at Mayo

Clinic were that thin, flexible polyimide electrodes (NeuroOne technology) provided recordings similar to standard clinical electrodes

with reduced immunological response.

In addition, Mayo Clinic physicians observed that the flexibility of polyimide electrodes may reduce

pain and swelling associated with implantation of the device, and the single wire exiting the skull may reduce infection risk.

to record micro-seizure and single neuron brain activity may also provide additional useful clinical data.

Combined, these properties

suggest that the replacement of current competitive silicone electrodes with polyimide substrate electrodes (NeuroOne technology) for

recording brain activity for epilepsy could provide enhanced clinical value with reduced cost, reduced infection risk, and improved patient

In addition, our thin film cortical implant technology

has been tested by researchers at the University of Wisconsin-Madison in multiple pre-clinical animal studies conducted from 2006 to 2016,

which included mice, rats and primates.

In these studies, our technology was able to record brain activity from different areas of the

brain, was implanted in a minimally invasive fashion, electrically provided brain stimulation and tissue ablation, and had increased flexibility

compared to existing commercially available technology, which allowed the grids to conform more easily to the brain surface (and may have

reduced pain and swelling, compared to less flexible devices).

NeuroOne Medical Technologies Corporation

Sales and Marketing

Zimmer Development Agreement

Based on the size and maturity of the U.S.

and our initial commercial focus, on July 20, 2020, we entered into an exclusive development and distribution agreement (the “Development

Agreement”) with Zimmer, pursuant to which we granted Zimmer exclusive global rights to distribute NeuroOne’s strip and grid

cortical electrodes (the “Strip/Grid Products”) and electrode cable assembly products (the “Electrode Cable Assembly

Products”), including to approximately 188 Level 4 epilepsy centers.

Additionally, we granted Zimmer the exclusive right and license

to distribute certain depth electrodes developed by the Company (“SEEG Products”, and together with the Strip/Grid Products

and Electrode Cable Assembly Products, the “Products”).

The parties have agreed to collaborate with respect to development

activities under the Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer

and the Company.

Under the terms of the Development Agreement,

we are responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and expenses

related to the commercialization of the Products.

In addition to the Development Agreement, Zimmer and the Company have entered into a

manufacturing and supply agreement (the “MS Agreement”) and a supplier quality agreement (the “Quality Agreement”)

with respect to the manufacturing and supply of the Products.

Except as otherwise provided in the Development

Agreement, we are responsible for performing all development activities, including non-clinical and clinical studies directed at obtaining

regulatory approval of each Product.

Zimmer has agreed to use commercially reasonable efforts to promote, market and sell each Product

following the “Product Availability Date” (as defined in the Development Agreement) for such Product.

Pursuant to the Development Agreement, Zimmer

made an upfront payment of $2.0 million to the Company in August 2020.

In August 2022, we entered into an amendment to

the Development Agreement with Zimmer that provided us with a $3.5 million accelerated payment relating to certain milestone events.

addition, Zimmer received a Warrant to purchase 350,000 shares of our Common Stock, with an exercise price of $3.00 per share.

The Development Agreement will expire on the tenth

anniversary of the date of the first commercial sale of the last of the Products to achieve a first commercial sale, unless terminated

earlier pursuant to its terms.

Either party may terminate the Development Agreement (x) with written notice for the other party’s

material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.

In addition, Zimmer

may terminate the Development Agreement for any reason with 90 days’ written notice, and we may terminate the Development Agreement

if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company.

We will investigate markets outside of the U.S.

with the assistance of Zimmer and formulate a plan to enter those markets with the support of Zimmer.

For more information regarding the Development

Agreement, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Financial Overview-Collaborations

Revenue” and “Note 7 - Zimmer Development Agreement” included in “Item 8 - Financial Statements and Supplementary

Data” in this Report.

NeuroOne Medical Technologies Corporation

doctors implanted our polyimide thin film electrodes on five human patients who were undergoing surgery to remove brain tissue for drug

resistant epilepsy.

Electrophysiological recordings from the polyimide thin film technology displayed in each of these patients demonstrated

micro-seizure activity due to the high fidelity multi-scale electrophysiology.

In December 2020, we announced the first human commercial

use of our Evo cortical electrode to perform recording, functional mapping and stimulation of the brain.

In the procedure, performed

at the Mayo Clinic, our electrodes were used to record evidence of pre-seizure activity which may be critical in developing treatments

to prevent the onset of seizures.

reached by the physicians at Mayo Clinic were that thin, flexible polyimide electrodes (NeuroOne technology) provided recordings similar

to standard clinical electrodes with reduced immunological response.

In addition, Mayo Clinic physicians observed that the flexibility

of polyimide electrodes may reduce pain and swelling associated with implantation of the device, and the single wire exiting the skull

may reduce infection risk.

The ability to record micro-seizure and single neuron brain activity may also provide additional useful clinical

Combined, these properties suggest that the replacement of current competitive silicone electrodes with polyimide substrate electrodes

(NeuroOne technology) for recording brain activity for epilepsy could provide enhanced clinical value with reduced cost, reduced infection

risk, and improved patient comfort.

addition, our thin film cortical implant technology has been tested by researchers at the University of Wisconsin-Madison in multiple

pre-clinical animal studies conducted from 2006 to 2016, which included mice, rats and primates.

In these studies, our technology was

able to record brain activity from different areas of the brain, was implanted in a minimally invasive fashion, electrically provided

brain stimulation and tissue ablation, and had increased flexibility compared to existing commercially available technology, which allowed

the grids to conform more easily to the brain surface (and may have reduced pain and swelling, compared to less flexible devices).

Medical Technologies Corporation

and Marketing

Development Agreement

on the size and maturity of the U.S.

market and our initial commercial focus, on July 20, 2020, we entered into an exclusive development

and distribution agreement (the “Development Agreement”) with Zimmer, pursuant to which we granted Zimmer exclusive global

rights to distribute NeuroOne’s strip and grid cortical electrodes (the “Strip/Grid Products”) and electrode cable

assembly products (the “Electrode Cable Assembly Products”), including to approximately 188 Level 4 epilepsy centers.

Additionally,

we granted Zimmer the exclusive right and license to distribute certain depth electrodes developed by the Company (“SEEG Products”,

and together with the Strip/Grid Products and Electrode Cable Assembly Products, the “Products”).

The parties have agreed

to collaborate with respect to development activities under the Development Agreement through a joint development committee composed

of an equal number of representatives of Zimmer and the Company.

the terms of the Development Agreement, we are responsible for all costs and expenses related to developing the Products, and Zimmer

is responsible for all costs and expenses related to the commercialization of the Products.

In addition to the Development Agreement,

Zimmer and the Company have entered into a Manufacturing and Supply Agreement (the “MS Agreement”) and a supplier quality

agreement (the “Quality Agreement”) with respect to the manufacturing and supply of the Products.

as otherwise provided in the Development Agreement, we are responsible for performing all development activities, including non-clinical

and clinical studies directed at obtaining regulatory approval of each Product.

Zimmer has agreed to use commercially reasonable efforts

to promote, market and sell each Product following the “Product Availability Date” (as defined in the Development Agreement)

for such Product.

to the Development Agreement, Zimmer made an upfront payment of $2.0 million to the Company in August 2020.

August 2022, we entered into an amendment to the Development Agreement with Zimmer that provided us with a $3.5 million accelerated payment

relating to certain milestone events.

In addition, Zimmer received a Warrant to purchase 350,000 shares of our Common Stock, with an

exercise price of $3.00 per share.

Development Agreement will expire on the tenth anniversary of the date of the first commercial sale of the last of the Products to achieve

a first commercial sale, unless terminated earlier pursuant to its terms.

Either party may terminate the Development Agreement (x) with

written notice for the other party’s material breach following a cure period or (y) if the other party becomes subject to certain

insolvency proceedings.

In addition, Zimmer may terminate the Development Agreement for any reason with 90 days’ written notice,

and we may terminate the Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors

of the Company.

will investigate markets outside of the U.S.

with the assistance of Zimmer and formulate a plan to enter those markets with the support

more information regarding the Development Agreement, see “Management’s Discussion and Analysis of Financial Condition and

Results of Operations-Financial Overview-Collaborations Revenue” and “Note 7—Zimmer Development Agreement” included

in “Item 8—Financial Statements and Supplementary Data” in this Report.

Reimbursement

Coverage in the United States

Reimbursement from private third-party healthcare

payors and, to a lesser extent, Medicare will be an important element of our success.

Although the Centers for Medicare and Medicaid Services

(“CMS”) and third-party payors have adopted coverage policies for our targeted indications, there is no guarantee this will

continue at the same levels or at all in the future.

Current Procedural Terminology, or CPT, is a medical code set that is used to report

medical, surgical and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation

organizations.

Applicable diagnostic CPT codes for mapping (diagnosing)

the brain for diagnostic procedures are as follows:

● 61531 Subdural implantation of strip electrodes through one or more burr or trephine (saw) hole(s) for

long-term seizure monitoring;

in the United States

Reimbursement

from private third-party healthcare payors and, to a lesser extent, Medicare will be an important element of our success.

Centers for Medicare and Medicaid Services (“CMS”) and third-party payors have adopted coverage policies for our targeted

indications, there is no guarantee this will continue at the same levels or at all in the future.

Current Procedural Terminology, or

CPT, is a medical code set that is used to report medical, surgical and diagnostic procedures and services to entities such as physicians,

health insurance companies and accreditation organizations.

Medical Technologies Corporation

diagnostic CPT codes for mapping (diagnosing) the brain for diagnostic procedures are as follows:

Subdural implantation of strip electrodes through one or more burr or trephine (saw) hole(s)

for long-term seizure monitoring;

Craniotomy with elevation of bone flap:

for subdural implantation of an electrode array, for long

term seizure monitoring;

for subdural implantation of an electrode array,

for long term seizure monitoring;

Craniotomy with elevation of bone flap;

for removal of epidural or subdural electrode array, without

excision of cerebral tissue (separate procedure);

for removal of epidural or subdural electrode array,

without excision of cerebral tissue (separate procedure);

Stereotactic implantation of depth electrodes into the cerebrum for long term seizure monitoring.

Regarding ICD-10 codes, the International Classification

of Diseases, Tenth Edition (ICD-10) is a clinical cataloging system that went into effect for the U.S.

healthcare industry on October

1, 2015, after a series of lengthy delays.

Accounting for modern advances in clinical treatment and medical devices, ICD-10 codes offer

many more classification options compared to those found in its predecessor, ICD-9.

Within the healthcare industry, providers, coders,

IT professionals, insurance carriers, government agencies and others use ICD codes to properly note diseases on health records, to track

epidemiological trends and to assist in medical reimbursement decisions.

ICD-10 codes for epilepsy are as follows:

● G40.0 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures

ICD-10 codes, the International Classification of Diseases, Tenth Edition (ICD-10) is a clinical cataloging system that went into effect

healthcare industry on October 1, 2015, after a series of lengthy delays.

Accounting for modern advances in clinical treatment

and medical devices, ICD-10 codes offer many more classification options compared to those found in its predecessor, ICD-9.

healthcare industry, providers, coders, IT professionals, insurance carriers, government agencies and others use ICD codes to properly

note diseases on health records, to track epidemiological trends and to assist in medical reimbursement decisions.

codes for epilepsy are as follows:

Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures

of localized onset;

● G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple

partial seizures;

● G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex

partial seizures;

● G40.3 Generalized idiopathic epilepsy and epileptic syndromes;

● G40.A Absence epileptic syndrome;

● G40.4 Other generalized epilepsy and epileptic syndromes;

● G40.50 Epileptic seizures related to external causes, not intractable;

● G40.80 Other epilepsy;

● G40.82 Epileptic spasms.

NeuroOne Medical Technologies Corporation

We believe that many of the indications we are

pursuing with our technologies are currently reimbursed on a widespread basis by Medicare, Medicaid and private insurance companies.

Medicare, Medicaid, health maintenance organizations

and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement

of new medical devices, and, as a result, their coverage policies may be restrictive, or they may not cover or provide adequate payment

for our products.

In order to obtain reimbursement arrangements, we may have to agree to a net sales price lower than the net sales price

we might charge in other sales channels.

Our revenue may be limited by the continuing efforts of government and third-party payors to

contain or reduce the costs of healthcare through various increasingly sophisticated means, such as requiring prospective reimbursement

and second opinions, purchasing in groups, or redesigning benefits.

Our future dependence on the commercial success of our technologies

makes us particularly susceptible to any cost containment or reduction efforts.

Accordingly, if government and other third-party payors

do not provide adequate coverage and reimbursement for our products and the related insertion and removal procedures, our financial performance

will be negatively impacted.

Manufacturing, Supply and Quality Assurance

We currently outsource the supply and manufacture

of all components of our prototypes of our technology under development.

We plan to continue with an outsourced manufacturing arrangement

for the foreseeable future.

Our third-party manufacturers are recognized in their field for their competency to manufacture the respective

portions of our system and have quality systems established that meet FDA requirements.

We believe the manufacturers we currently utilize

have sufficient capacity to meet our requirements;

however, see “Risk Factors-Risks Related to Our Business-The COVID-19 pandemic

has adversely impacted, and may continue to impact, our business”.

We believe that as we increase our demand in the future, our

per-unit costs will decrease materially.

We have also identified capable second source manufacturers and suppliers in the event of disruption

from any of our primary vendors.

Our suppliers meet the latest ISO 13485 certification,

which includes design control requirements.

As a medical device developer, the facilities of our sterilization and other critical suppliers

are subject to periodic inspection by the FDA and corresponding state and foreign agencies.

We believe that our quality systems and those

of our suppliers are robust and achieve high product quality.

We plan to audit our suppliers periodically to ensure conformity with the

specifications, policies and procedures for our devices.

Research and Development

Our research and development team, which includes

our Director of Electrode Development, utilizes advice from leading experts in the neurotech field on our scientific advisory board and

is focused on the development of thin film cortical grid and strip electrodes and depth electrodes for recording, ablation and chronic

stimulation for brain related disorders as well as stimulation for spinal cord stimulation for back related pain.

Our research and development

expenses were $4.9 million and $3.9 million for the years ended September 30, 2022 and 2021, respectively.

In the market for Epilepsy diagnosis, our cortical

strip, grid and depth electrode technology will likely compete with Integra Life Science’s Integra Epilepsy Strip, Grid and depth

electrodes, which provide a similar function to our diagnostic technologies.

These products are well established in the marketplace and

Integra has greater resources than us, which could allow them to innovate faster.

Ad-Tech Medical Instrument Corporation’s Epilepsy/LTM

(subdural grid, strip and depth) electrodes, which have become the market leaders for diagnostic mapping in epilepsy, and PMT’s

Cortac Strips and grid electrodes and Depthalon depth electrodes are used for recording brain activity similar to other competitive technologies.

In addition, Dixie Medical has launched a product line of depth electrodes and CorTec has launched a cortical electrode product line called

Today’s success rates for seizure free post-operative conditions remain at 50%, which has limited patients’ willingness

to undergo the currently highly invasive surgical procedure.

We will also compete against other companies in early stages of development

of thin film technologies.

In the neuro-ablation market, we expect to compete

with Medtronic’s Visualase guided-laser ablation technology and Monteris Medical’s NeuroBlate technology, which use MRI guided

laser surgical ablation for use to ablate, necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine

and surgery in the discipline of neurosurgery with 1064 nm lasers.

Their website claims it is used for ablation in the brain for soft

tissue and tumors.

We believe there are other laser-based systems in development that will compete with these technologies.

NeuroOne Medical Technologies Corporation

In the neurostimulation market, we expect to compete

with NeuroPace’s RNS system approved for epilepsy, Medtronic’s Activa system approved for Parkinson’s disease, Boston

Scientific Vercise (indicated for Parkinson’s, dystonia and essential tremors), Abbott/St.

Jude Medical’s Infinity DBS system

(approved for Parkinson’s disease and essential tremors), Liva Nova/Cyberonic’s VNS therapy intended for patients suffering

with epilepsy.

Although we will face potential competition from

many different sources, we believe that our technology, knowledge, experience and scientific resources will provide us with competitive

For a discussion of the key competitive factors that we believe will impact the success of our cortical strip, grid electrodes

under development, if successfully developed and approved, see “Our Solution” above.

Many of the companies against which we may compete

in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing,

conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Mergers and acquisitions in the

pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of

our competitors.

Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

These competitors also compete with us in recruiting and retaining qualified scientific and management

personnel and establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary

to, or necessary for, our development.

In January 2020, we entered into the Amended and

Restated Exclusive Start-Up Company License Agreement, dated as of January 21, 2020, as amended on June 15, 2020 (the “WARF License”)

with WARF, which amended and restated in full the Original WARF License.

Pursuant to the WARF License, WARF has granted to us an exclusive

license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array or thin-film

micro electrode array and method.

We have agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant

to the WARF License, with a minimum annual royalty payment of $50,000 for calendar year 2020, $100,000 for calendar year 2021 and $150,000

for calendar year 2022 and each calendar year thereafter that the WARF License is in effect.

The minimum annual royalty payment for calendar

year 2020 in the amount of $50,000 was paid in January 2021.

If we or any of our sublicensees contest the validity of any licensed patent,

the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to be valid and would be infringed

by us if not for the WARF License, the royalty rate will be tripled for the remaining term of the WARF License.

WARF may terminate this license on 30 days’

written notice, if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our

development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or in the event of certain

bankruptcy events involving us.

WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial

sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after royalties earned on sales begin to

be paid, such earned royalties cease for more than four calendar quarters.

The first commercial sale occurred on December 7, 2020, prior

to the June 30, 2021 deadline.

The WARF License otherwise expires by its terms on the date that no valid claims on the patents licensed

thereunder remain.

Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with

simple partial seizures;

Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with

complex partial seizures;

Generalized idiopathic epilepsy and epileptic syndromes;

Absence epileptic syndrome;

Other generalized epilepsy and epileptic syndromes;

Epileptic seizures related to external causes, not intractable;

Other epilepsy;

Epileptic spasms.

believe that many of the indications we are pursuing with our technologies are currently reimbursed on a widespread basis by Medicare,

Medicaid and private insurance companies.

Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting

both coverage and the level of reimbursement of new medical devices, and, as a result, their coverage policies may be restrictive, or

they may not cover or provide adequate payment for our products.

In order to obtain reimbursement arrangements, we may have to agree

to a net sales price lower than the net sales price we might charge in other sales channels.

Our revenue may be limited by the continuing

efforts of government and third-party payors to contain or reduce the costs of healthcare through various increasingly sophisticated

means, such as requiring prospective reimbursement and second opinions, purchasing in groups, or redesigning benefits.

Our future dependence

on the commercial success of our technologies makes us particularly susceptible to any cost containment or reduction efforts.

if government and other third-party payors do not provide adequate coverage and reimbursement for our products and the related insertion

and removal procedures, our financial performance will be negatively impacted.

Medical Technologies Corporation

Manufacturing,

Supply and Quality Assurance

currently outsource the supply and manufacture of all components of our prototypes of our technology under development.

We plan to continue

with an outsourced manufacturing arrangement for the foreseeable future.

Our third-party manufacturers are recognized in their field

for their competency to manufacture the respective portions of our system and have quality systems established that meet FDA requirements.

We believe at this time the manufacturers we currently utilize have sufficient capacity to meet our requirements.

We believe that as

we increase our demand in the future, our per-unit costs will decrease materially.

We have also identified capable second source manufacturers

and suppliers in the event of disruption from any of our primary vendors.

suppliers meet the latest ISO 13485 certification, which includes design control requirements.

As a medical device developer, the facilities

of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and corresponding state and foreign agencies.

We believe that our quality systems and those of our suppliers are robust and achieve high product quality.

We plan to audit our suppliers

periodically to ensure conformity with the specifications, policies and procedures for our devices.

and Development

research and development team, which includes our Director of Electrode Development, utilizes advice from leading experts in the neurotech

field on our scientific advisory board and is focused on the development of thin film cortical grid and strip electrodes and depth electrodes

for recording, ablation and chronic stimulation for brain related disorders as well as stimulation for spinal cord stimulation for back

related pain.

Our research and development expenses were $6.9 million and $4.9 million for the years ended September 30, 2023 and 2022,

respectively.

the market for Epilepsy diagnosis, our cortical strip, grid and depth electrode technology will likely compete with Integra Life Science’s

Integra Epilepsy Strip, Grid and depth electrodes, which provide a similar function to our diagnostic technologies.

These products are

well established in the marketplace and Integra has greater resources than us, which could allow them to innovate faster.

Ad-Tech Medical

Instrument Corporation’s Epilepsy/LTM (subdural grid, strip and depth) electrodes, which have become the market leaders for diagnostic

mapping in epilepsy, and PMT’s Cortac Strips and grid electrodes and Depthalon depth electrodes are used for recording brain activity

similar to other competitive technologies.

In addition, Dixie Medical has launched a product line of depth electrodes and CorTec has

launched a cortical electrode product line called AirRay.

Today’s success rates for seizure free post-operative conditions remain

at 50%, which has limited patients’ willingness to undergo the currently highly invasive surgical procedure.

We will also compete

against other companies in early stages of development of thin film technologies.

the neuro-ablation market, we expect to compete with Medtronic’s Visualase guided-laser ablation technology and Monteris Medical’s

NeuroBlate technology, which use MRI guided laser surgical ablation for use to ablate, necrotize or coagulate soft tissue through interstitial

irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

Their website claims it

is used for ablation in the brain for soft tissue and tumors.

We believe there are other laser-based systems in development that will

compete with these technologies.

the neurostimulation market, we expect to compete with NeuroPace’s RNS system approved for epilepsy, Medtronic’s Activa system

approved for Parkinson’s disease, Boston Scientific Vercise (indicated for Parkinson’s, dystonia and essential tremors),

Jude Medical’s Infinity DBS system (approved for Parkinson’s disease and essential tremors), Liva Nova/Cyberonic’s

VNS therapy intended for patients suffering with epilepsy.

we will face potential competition from many different sources, we believe that our technology, knowledge, experience and scientific

resources will provide us with competitive advantages.

For a discussion of the key competitive factors that we believe will impact the

success of our cortical strip, grid electrodes under development, if successfully developed and approved, see “—Our Solution”

Medical Technologies Corporation

of the companies against which we may compete in the future have significantly greater financial resources and expertise in research

and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved

products than we do.

Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more

resources being concentrated among a smaller number of our competitors.

Smaller or early stage companies may also prove to be significant

competitors, particularly through collaborative arrangements with large and established companies.

These competitors also compete with

us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and subject registration

for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our development.

January 2020, we entered into an Amended and Restated Exclusive Start-Up Company License Agreement, dated as of January 21, 2020, as

amended on June 15, 2020 (the “WARF License”) with WARF, which amended and restated in full the Original WARF License.

to the WARF License, WARF has granted to us an exclusive license to make, use and sell, in the United States only, products that employ

certain licensed patents for a neural probe array or thin-film micro electrode array and method.

We have agreed to pay WARF a royalty

equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000

for calendar year 2020, $100,000 for calendar year 2021 and $150,000 for calendar year 2022 and each calendar year thereafter that the

WARF License is in effect.

The minimum annual royalty payment for calendar year 2020 in the amount of $50,000 was paid in January 2021.

If we or any of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of

such contest and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty

rate will be tripled for the remaining term of the WARF License.

may terminate this license on 30 days’ written notice, if we default on the payments of amounts due to WARF or fail to timely submit

development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy such default

in 90 days or in the event of certain bankruptcy events involving us.

WARF may also terminate the WARF License (i) on 90 days’

notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii)

if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters.

The first commercial

sale occurred on December 7, 2020, prior to the June 30, 2021 deadline.

The WARF License otherwise expires by its terms on the date that

no valid claims on the patents licensed thereunder remain.

We expect the latest expiration of a licensed patent to occur in 2030.

In addition, WARF reserves the right to grant

non-profit research institutions and government agencies non-exclusive licenses to practice and use the inventions of the licensed patents

for non-commercial research purposes, and we grant WARF a non-exclusive, sub licensable, royalty-free right and license for non-commercial

research purposes to use improvements to the licensed patents.

In the event that we discontinue use or commercialization of the licensed

patents or improvements thereon, we must grant WARF an option to obtain a non-exclusive, sub-licensable, royalty-bearing license to use

the improvements for commercial purposes.

NeuroOne Medical Technologies Corporation

See “Risk Factors- Risks Related to Our

Business-We depend on intellectual property licensed from WARF for our technology, including our technology under development, and the

termination of this license would harm our business” for additional information regarding the WARF License.

Mayo Foundation for Medical Education and

Research License and Development Agreement

In May 2017, we entered into the Amended and Restated

License and Development Agreement, dated as of May 25, 2017 (the “Mayo Development Agreement”), with Mayo Foundation for Medical

Education and Research (“Mayo”) to license worldwide (i) certain know how for the development and commercialization of products,

methods and processes related to flexible circuit thin film technology for the recording of tissue and (ii) the products developed therefrom,

and to partner with Mayo to assist the Company in the investigation, research application, development and improvement of such technology.

Mayo has agreed to assist us by providing access to certain individuals at Mayo (the “Mayo Principal Investigators”), in developing

our cortical thin film flexible circuit technology, including prototype development, animal testing, protocol development for human and

animal use, abstract development and presentation and access to and license of any intellectual property that the Mayo Principal Investigators

develop relating to the procedure.

We have agreed to pay Mayo a royalty equal to

a single-digit percentage of our product sales pursuant to the Mayo Development Agreement.

Mayo may purchase any developed products licensed

under the Mayo Development Agreement at the best price offered by us to the end user in the prior year.

The Mayo Development Agreement

generally will expire in October 2034, unless the Mayo know-how and improvements under the Mayo Development Agreement remain in use, and

the Mayo Development Agreement may be terminated by Mayo for cause or under certain circumstances.

For additional information regarding the Mayo

Development Agreement, see “Risk Factors- Risks Related to Our Business-We depend on our partnership with Mayo to license certain

know how for the development and commercialization of our technology.

Termination of this partnership would harm our business, and even

if this partnership continues, it may not be successful.”

Intellectual Property

Protection of our intellectual property is a strategic

priority for our business.

We rely on a combination of patents, trademarks, copyrights, and trade secrets as well as nondisclosure and

assignment of invention agreements, material transfer agreements, confidentiality agreements and other measures to protect our intellectual

property and other proprietary rights.

As of September 30, 2022, our patent estate consists

of three issued United States patents licensed from WARF covering a neural probe array and thin-film micro electrode array and method,

a pending U.S.

patent application filed by us and published in 2018 covering our applications and additional devices used during the diagnostic

and therapeutic ablation and stimulation procedures, a U.S.

patent issued in October 2022 and pending European patent application filed

addition, WARF reserves the right to grant non-profit research institutions and government agencies non-exclusive licenses to practice

and use the inventions of the licensed patents for non-commercial research purposes, and we grant WARF a non-exclusive, sub licensable,

royalty-free right and license for non-commercial research purposes to use improvements to the licensed patents.

In the event that we

discontinue use or commercialization of the licensed patents or improvements thereon, we must grant WARF an option to obtain a non-exclusive,

sub-licensable, royalty-bearing license to use the improvements for commercial purposes.

“Risk Factors—Risks Related to Our Business-We depend on intellectual property licensed from WARF for our technology, including

our technology under development, and the termination of this license would harm our business” for additional information regarding

the WARF License.

Foundation for Medical Education and Research License and Development Agreement

May 2017, we entered into an Amended and Restated License and Development Agreement, dated as of May 25, 2017 (the “Mayo Development

Agreement”), with Mayo Foundation for Medical Education and Research (“Mayo”) to license worldwide (i) certain know

how for the development and commercialization of products, methods and processes related to flexible circuit thin film technology for

the recording of tissue and (ii) the products developed therefrom, and to partner with Mayo to assist the Company in the investigation,

research application, development and improvement of such technology.

Mayo has agreed to assist us by providing access to certain individuals

at Mayo (the “Mayo Principal Investigators”), in developing our cortical thin film flexible circuit technology, including

prototype development, animal testing, protocol development for human and animal use, abstract development and presentation and access

to and license of any intellectual property that the Mayo Principal Investigators develop relating to the procedure.

Medical Technologies Corporation

have agreed to pay Mayo a royalty equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement.

Mayo may purchase any developed products licensed under the Mayo Development Agreement at the best price offered by us to the end user

in the prior year.

The Mayo Development Agreement generally will expire in October 2034, unless the Mayo know-how and improvements under

the Mayo Development Agreement remain in use, and the Mayo Development Agreement may be terminated by Mayo for cause or under certain

circumstances.

additional information regarding the Mayo Development Agreement, see “Risk Factors—Risks Related to Our Business—We

depend on our partnership with Mayo to license certain know how for the development and commercialization of our technology.

of this partnership would harm our business, and even if this partnership continues, it may not be successful.”

of our intellectual property is a strategic priority for our business.

We rely on a combination of patents, trademarks, copyrights, and

trade secrets as well as nondisclosure and assignment of invention agreements, material transfer agreements, confidentiality agreements

and other measures to protect our intellectual property and other proprietary rights.

of September 30, 2023, our patent estate consists of three issued United States patents licensed from WARF covering a neural probe array

and thin-film micro electrode array and method, a U.S.

patent issued in October 2022 and a pending European patent application filed

by us and published in 2020 relating to improved neural depth electrodes, a pending U.S.

patent application filed by us and published

in 2020 relating to agent-delivering neural electrodes, pending U.S.

and European patent applications published in 2020 relating to minimally

invasive electrodes, pending U.S.

and European patent applications published in 2021 relating to spinal cord stimulation systems and devices,

a pending U.S.

patent application (and corresponding PCT application) published in 2022 relating to methods of making electrode probes,

a pending U.S.

patent application (and corresponding PCT application) filed in 2021 relating to devices having temperature sensors, a

patent application filed in 2022 relating to deformable spinal cord stimulation devices, a pending U.S.

patent application

filed in 2022 relating to spinal cord stimulation device implantation methods, and a pending U.S.

patent application filed in 2022 relating

to ablation probe and temperature sensing device systems.

The licensed issued patents expire between 2025 and 2030, subject to any patent

extensions that may be available for such patents.

in 2020 relating to agent-delivering neural electrodes in which a Notice of Allowance was issued in August 2023 (along with a second

patent application filed in 2023 relating to the same technology), pending U.S.

and European patent applications published

in 2020 relating to minimally invasive electrodes (with a Notice of Allowance issued in September 2023 in the U.S.

application), pending

and European patent applications published in 2021 relating to spinal cord stimulation systems and devices (with a Notice of Allowance

issued in October 2023 in the U.S.

application), pending U.S.

and European patent applications published in 2022 relating to methods

of making electrode probes, a pending U.S.

patent application (and corresponding PCT application) published in 2023 relating to devices

having temperature sensors, a pending U.S.

patent application (and corresponding PCT application) filed in 2023 relating to deformable

spinal cord stimulation devices, a pending U.S.

patent application (and corresponding PCT application) filed in 2023 relating to spinal

cord stimulation device implantation methods, and a pending U.S.

patent application (and corresponding PCT application) filed in 2023

relating to ablation probe and temperature sensing device systems.

The licensed issued patents expire between 2025 and 2030, subject

to any patent extensions that may be available for such patents.

The issued patent owned by NeuroOne expires in 2041.

If a patent or patents are issued

on our additional pending patent applications, the resulting patents are projected to expire between 2038 and 2043.

NeuroOne Medical Technologies Corporation

Our patent applications may not result in issued

patents, and any patents that have been issued or may be issued in the future may not protect the commercially important aspects of our

Furthermore, the validity and enforceability of our issued patents may be challenged by third parties and our patents could

be invalidated or modified by the issuing governmental authority.

Third parties may independently develop technology that is not covered

by our patents that is similar to, or competes with, our technology.

In addition, our intellectual property may be infringed or misappropriated

by third parties, particularly in foreign countries where the laws and governmental authorities may not protect our proprietary rights

as effectively as those in the United States.

The medical device industry in general, and the

recording, ablation and neurostimulation sector of this industry in particular, are characterized by the existence of a large number of

patents and frequent litigation based on assertions of patent infringement.

We are aware of numerous patents issued to third parties that

may relate to the technology used in our business, including the design and manufacture of electrodes and pulse generators, as well as

methods for device placement.

Each of these patents contains multiple claims, any one of which may be independently asserted against us.

The owners of these patents may assert that the manufacture, use, sale or offer for sale of our cortical strip and grid electrodes infringe

one or more claims of their patents.

Furthermore, there may be additional patents issued to third parties of which we are presently unaware

that may relate to aspects of our technology that such third parties could assert against us and materially and adversely affect our business.

In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and

unknown to us, which may later result in issued patents that third parties could assert against us and materially and adversely affect

our business.

Any adverse determination in litigations, post

grant trial proceedings, at the Patent Office relating to intellectual property to which we are or may become a party could subject us

to significant liabilities to third parties or require us to seek licenses from third parties, and result in the cancellation and/or invalidation

of our intellectual property.

Furthermore, if a court finds that we have willfully infringed a third party’s intellectual property,

we could be required to pay treble damages and/or attorney fees for the prevailing party, in addition to other penalties.

Although intellectual

property disputes in the medical device area are often settled through licensing or similar arrangements, costs associated with such arrangements

can be substantial and often require ongoing royalty payments.

We may be unable to obtain necessary licenses on satisfactory terms, if

If we do not obtain necessary licenses, we may not be able to redesign our products to avoid infringement;

if we are able to redesign

our products to avoid infringement, we may not receive FDA approval in a timely manner.

Adverse determinations in a judicial or administrative

proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products, which could have a significant

adverse impact on our business.

We have registered U.S.

trademarks for the trademarks

“NEUROONE” and “EVO.” The document(s) updating the owner’s name were filed with the U.S.

Trademark Office

on November 30, 2021, with an effective date of December 30, 2019.

If a patent or

patents are issued on our additional pending patent applications, the resulting patents are projected to expire between 2038 and 2043.

patent applications may not result in issued patents, and any patents that have been issued or may be issued in the future may not protect

the commercially important aspects of our technology.

Furthermore, the validity and enforceability of our issued patents may be challenged

by third parties and our patents could be invalidated or modified by the issuing governmental authority.

Third parties may independently

develop technology that is not covered by our patents that is similar to, or competes with, our technology.

In addition, our intellectual

property may be infringed or misappropriated by third parties, particularly in foreign countries where the laws and governmental authorities

may not protect our proprietary rights as effectively as those in the United States.

Medical Technologies Corporation

medical device industry in general, and the recording, ablation and neurostimulation sector of this industry in particular, are characterized

by the existence of a large number of patents and frequent litigation based on assertions of patent infringement.

We are aware of numerous

patents issued to third parties that may relate to the technology used in our business, including the design and manufacture of electrodes

and pulse generators, as well as methods for device placement.

Each of these patents contains multiple claims, any one of which may be

independently asserted against us.

The owners of these patents may assert that the manufacture, use, sale or offer for sale of our cortical

strip and grid electrodes infringe one or more claims of their patents.

Furthermore, there may be additional patents issued to third

parties of which we are presently unaware that may relate to aspects of our technology that such third parties could assert against us

and materially and adversely affect our business.

In addition, because patent applications can take many years to issue, there may be

patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert

against us and materially and adversely affect our business.

adverse determination in litigations or post grant trial proceedings at the Patent Office relating to intellectual property to which

we are or may become a party could subject us to significant liabilities to third parties or require us to seek licenses from third

parties, and could result in the cancellation and/or invalidation of our intellectual property.

Furthermore, if a court finds that

we have willfully infringed a third party’s intellectual property, we could be required to pay treble damages and/or attorney

fees for the prevailing party, in addition to other penalties.

Although intellectual property disputes in the medical device area

are often settled through licensing or similar arrangements, costs associated with such arrangements can be substantial and often

require ongoing royalty payments.

We may be unable to obtain necessary licenses on satisfactory terms, if at all.

obtain necessary licenses, we may not be able to redesign our products to avoid infringement;

if we are able to redesign our

products to avoid infringement, we may not receive FDA approval in a timely manner.

Adverse determinations in a judicial or

administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products,

which could have a significant adverse impact on our business.

have registered U.S.

trademarks for the trademarks “NEUROONE” and “EVO”.

We have a pending U.S.

trademark application for the trademark OneRF.

We also have pending trademark applications in the United Kingdom and the European Union for the trademark OneRF.

Trade Secrets

We also rely on trade secrets, technical know-how

and continuing innovation to develop and maintain our competitive position.

We seek to protect such intellectual property and proprietary

information by generally requiring our employees, consultants, contractors, scientific collaborators and other advisors to execute non-disclosure

and assignment of invention agreements upon the commencement of their employment or engagement as the case may be.

Our agreements with

our employees prohibit them from providing us with any intellectual property or proprietary information of third parties.

We also generally

require confidentiality agreements or material transfer agreements with third parties that receive or have access to our confidential

information, data or other materials.

Notwithstanding the foregoing, there can be no assurance that our employees and third parties that

have access to our confidential proprietary information will abide by the terms of their agreements.

Despite the measures that we take

to protect our intellectual property and confidential information, unauthorized third parties may copy aspects of our products or obtain

and use our proprietary information.

NeuroOne Medical Technologies Corporation

Government Regulation

Our cortical strip, grid and depth electrodes

are medical devices subject to extensive and ongoing regulation by the FDA and the U.S.

Regulations cover virtually every critical

aspect of a medical device company’s business operations, including research activities, product development, quality, manufacturing,

supplier management and risk management, contracting, reimbursement, medical communications, and sales and marketing.

In the United States,

the Federal Food, Drug and Cosmetic Act (“FDCA”), and the implementing regulations of the FDA (specifically, 21 Code of Regulations

(21 CFR Parts 801- labeling, 803 - medical device reporting, 807 - registration and listing, subpart E premarket notification 510k, 812

- investigational device exemption, 814 - premarket approval and 820 - quality system regulation) and applicable FDA issued guidance’s

govern product design and development, pre-clinical and clinical testing, premarket clearance or approval, risk management, product manufacturing,

quality systems, import and export, product labeling, product storage, recalls and field safety corrective actions, advertising and promotion,

product sales and distribution, and post-market clinical surveillance.

Our business is subject to federal, state, local and harmonized

standards, such as ISO 13485, ISO 14971, and FDA’s Quality System Regulation (“QSR”) contained in 21 CFR Part 820.

Regulatory Framework in the United

Device classification

The FDA characterizes medical devices into one

of three classes, Class I, II, and III.

Regulatory control increases from Class I to Class III.

The device classification regulation defines

the regulatory requirements for a general device type.

Most Class I devices are exempt from Premarket Notification under 510(k);

Class II devices require Premarket Notification under 510(k);

and most Class III devices require Premarket Approval.

Class I devices are subject to general controls

including labeling.

trademark application

for the trademark OneRF.

We also have registered trademarks in the United Kingdom and the European Union for the trademark OneRF.

also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position.

protect such intellectual property and proprietary information by generally requiring our employees, consultants, contractors, scientific

collaborators and other advisors to execute non-disclosure and assignment of invention agreements upon the commencement of their employment

or engagement as the case may be.

Our agreements with our employees prohibit them from providing us with any intellectual property or

proprietary information of third parties.

We also generally require confidentiality agreements or material transfer agreements with third

parties that receive or have access to our confidential information, data or other materials.

Notwithstanding the foregoing, there can

be no assurance that our employees and third parties that have access to our confidential proprietary information will abide by the terms

of their agreements.

Despite the measures that we take to protect our intellectual property and confidential information, unauthorized

third parties may copy aspects of our products or obtain and use our proprietary information.

cortical strip, grid and depth electrodes are medical devices subject to extensive and ongoing regulation by the FDA and the U.S.

Regulations cover virtually every critical aspect of a medical device company’s business operations, including research activities,

product development, quality, manufacturing, supplier management and risk management, contracting, reimbursement, medical communications,

and sales and marketing.

In the United States, the Federal Food, Drug and Cosmetic Act (“FDCA”), and the implementing regulations

of the FDA (specifically, 21 Code of Regulations (21 CFR Parts 801- labeling, 803 - medical device reporting, 807 - registration and

listing, subpart E premarket notification 510k, 812 - investigational device exemption, 814 - premarket approval and 820 - quality system

regulation) and applicable FDA issued guidance’s govern product design and development, pre-clinical and clinical testing, premarket

clearance or approval, risk management, product manufacturing, quality systems, import and export, product labeling, product storage,

recalls and field safety corrective actions, advertising and promotion, product sales and distribution, and post-market clinical surveillance.

Our business is subject to federal, state, local and harmonized standards, such as ISO 13485, ISO 14971, and FDA’s Quality System

Regulation (“QSR”) contained in 21 CFR Part 820.

Medical Technologies Corporation

Framework in the United States

classification

FDA characterizes medical devices into one of three classes, Class I, II, and III.

Regulatory control increases from Class I to Class

The device classification regulation defines the regulatory requirements for a general device type.

Most Class I devices are exempt

from Premarket Notification under 510(k);

most Class II devices require Premarket Notification under 510(k);

and most Class III devices

require Premarket Approval.

I devices are subject to general controls including labeling.

However, most such devices are exempt from pre-market notification.

is exempted from any of the general controls, such exemption is stated in the classification regulation for that device.

This pertains

to manufacturers’ methods and documentation of the design, testing, production, control quality assurance, labeling, packaging,

a device is exempted from any of the general controls, such exemption is stated in the classification regulation for that device.

pertains to manufacturers’ methods and documentation of the design, testing, production, control quality assurance, labeling, packaging,

sterilization, storage and shipping of products.

2 unchanged sentences

testing prior to clearance.

Class III devices are those for which insufficient information exists to assure safety and effectiveness solely

through general or special controls, including devices that support or sustain human life, are of substantial importance in preventing

Class III devices are those for which insufficient information exists to assure safety and effectiveness

solely through general or special controls, including devices that support or sustain human life, are of substantial importance in preventing

impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Premarket Approval is required for most

Class III devices.

Some Class I and Class II devices are exempted

by regulation from the pre-market notification requirement under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, but

must meet the requirement of compliance with substantially all of the QSR.

However, a pre-market approval (“PMA application”)

is required for devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices,

or those that are “not substantially equivalent” either to a device previously cleared through the 510(k) process or to a

“preamendment” Class III device in commercial distribution before May 28, 1976 when PMA applications were not required.

PMA approval process is more comprehensive than the 510(k) clearance process and typically takes multiple years to complete.

Based on FDA classifications, we believe our diagnostic

cortical strip, grid and depth electrode and RF ablation technology will be categorized by the FDA as Class II devices that do not require

clinical testing and can be filed as a 510(k), similar to existing competitive technology.

The Company expects that indications for treating

epilepsy, Parkinson’s and other patients suffering from motor related neurological deficiencies via a permanent implant for chronic

treatment will require a PMA process to commercially distribute in the United States.

NeuroOne Medical Technologies Corporation

The 510(k) clearance process

Under the 510(k) clearance process, the manufacturer

must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent” to a legally

marketed predicate device.

A predicate device is a legally marketed device that is not subject to a PMA, i.e., a device that was legally

marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class

III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process.

To be “substantially

equivalent,” the proposed device must have the same intended use, indications for use as the predicate device, and either have the

same technological characteristics as the predicate device or have different technological characteristics and not raise different questions

of safety or effectiveness than the predicate device.

Clinical data is sometimes required to support substantial equivalence.

After a 510(k) premarket notification is submitted,

the FDA determines whether to accept it for substantive review.

If it lacks necessary information for substantive review, the FDA will

refuse to accept the 510(k) notification.

If it is accepted for filing, the FDA begins a substantive review.

The FDA goal is to complete

its review of a 510(k) notification within 90 calendar days of receiving the 510(k) notification.

As a practical matter, clearance often

takes longer, and clearance is never assured.

Although many 510(k) premarket notifications are cleared without clinical data, the FDA

may require further information, including clinical data, to make a determination regarding substantial equivalence, which may significantly

prolong the review process.

If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market

If the FDA determines that the device is not “substantially

equivalent” to a predicate device, or if the device is automatically classified into Class III, the device sponsor must then fulfill

the more rigorous premarketing requirements of the PMA approval process, or seek reclassification of the device through the De Novo process.

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special

controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate

De Novo classification is a risk-based classification process.

The De Novo classification process is an alternate pathway to classify

medical devices that are automatically classified into Class III but which are low to moderate risk.

A manufacturer can submit a Pre-submission

(Q-Sub) for De Novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of

the device presents a moderate or low risk.

After a device receives 510(k) clearance, any

modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended

use, will require a new 510(k) clearance or, depending on the modification, could require a De Novo device application and potentially

a PMA application.

The FDA requires each manufacturer to determine whether the proposed change requires a new submission in the first

instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.

Many minor modifications are

accomplished by a letter-to-file in which the manufacture documents the change in an internal letter-to-file based on adherence to FDA

guidance on changes to an existing 510(k) device.

The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for such

Premarket Approval is required for

most Class III devices.

Class I and Class II devices are exempted by regulation from the pre-market notification requirement under Section 510(k) of the FDCA,

also referred to as a 510(k) clearance, but must meet the requirement of compliance with substantially all of the QSR.

However, a pre-market

approval (“PMA application”) is required for devices deemed by the FDA to pose the greatest risk, such as life-sustaining,

life-supporting or certain implantable devices, or those that are “not substantially equivalent” either to a device previously

cleared through the 510(k) process or to a “preamendment” Class III device in commercial distribution before May 28, 1976

when PMA applications were not required.

The PMA approval process is more comprehensive than the 510(k) clearance process and typically

takes multiple years to complete.

on FDA classifications, our diagnostic cortical strip, grid and depth electrode and RF ablation technology are categorized by the FDA

as Class II devices that do not require clinical testing and can be filed as a 510(k), similar to existing competitive technology.

Company expects that indications for treating epilepsy, Parkinson’s and other patients suffering from motor related neurological

deficiencies via a permanent implant for chronic treatment will require a PMA process to commercially distribute in the United States.

clearance process

the 510(k) clearance process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially

equivalent” to a legally marketed predicate device.

A predicate device is a legally marketed device that is not subject to a PMA,

i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device

that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the

510(k) process.

To be “substantially equivalent,” the proposed device must have the same intended use, indications for use

as the predicate device, and either have the same technological characteristics as the predicate device or have different technological

characteristics and not raise different questions of safety or effectiveness than the predicate device.

Clinical data is sometimes required

to support substantial equivalence.

a 510(k) premarket notification is submitted, the FDA determines whether to accept it for substantive review.

If it lacks necessary information

for substantive review, the FDA will refuse to accept the 510(k) notification.

If it is accepted for filing, the FDA begins a substantive

The FDA goal is to complete its review of a 510(k) notification within 90 calendar days of receiving the 510(k) notification.

As a practical matter, clearance often takes longer, and clearance is never assured.

Although many 510(k) premarket notifications are

cleared without clinical data, the FDA may require further information, including clinical data, to make a determination regarding substantial

equivalence, which may significantly prolong the review process.

If the FDA agrees that the device is substantially equivalent, it will

grant clearance to commercially market the device.

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the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically

classified into Class III, the device sponsor must then fulfill the more rigorous premarketing requirements of the PMA approval process,

or seek reclassification of the device through the De Novo process.

The De Novo request provides a marketing pathway to classify novel

medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness

for the intended use, but for which there is no legally marketed predicate device.

De Novo classification is a risk-based classification

The De Novo classification process is an alternate pathway to classify medical devices that are automatically classified into

Class III but which are low to moderate risk.

A manufacturer can submit a Pre-submission for De Novo review if the manufacturer is unable

to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk.

a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute

a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, could require a De

Novo device application and potentially a PMA application.

The FDA requires each manufacturer to determine whether the proposed change

requires a new submission in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.

Many minor modifications are accomplished by a letter-to-file in which the manufacture documents the change in an internal letter-to-file

based on adherence to FDA guidance on changes to an existing 510(k) device.

The letter-to-file is in lieu of submitting a new 510(k)

to obtain clearance for such change.

The FDA can always review these letters to file in an inspection.

If the FDA disagrees with a manufacturer’s determination

regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared device, the FDA can require

the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a De Novo or PMA application

In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the

requisite application(s).

The PMA approval process

Following receipt of a PMA application, the FDA

conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review.

is not, the agency will refuse to file the PMA.

If it is, the FDA will accept the application for filing and begin its review.

has 180 days to review a filed PMA application, although the review of an application more often occurs over a significantly longer period

During this review period, the FDA may request additional information or clarification of information already provided, and the

FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the

Before approving or denying a PMA, an FDA advisory

committee may review the PMA at a public meeting and provide the FDA with the committee’s recommendation on whether the FDA should

approve the submission, approve it with specific conditions, or not approve it.

The FDA is not bound by the recommendations of an advisory

committee, but it considers such recommendations carefully when making decisions.

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Prior to approval of a PMA, the FDA may conduct

inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes.

the FDA review of a PMA application generally takes between one and three years, but may take significantly longer.

The FDA can delay,

limit or deny approval of a PMA application for many reasons, including:

● the device may not be safe, effective, reliable or accurate to the FDA’s satisfaction;

● the data from pre-clinical studies and clinical trials may be insufficient to support approval;

● the manufacturing process or facilities may not meet applicable requirements;

● changes in FDA approval policies or adoption of new regulations may require additional data.

If an FDA evaluation of a PMA application is favorable,

the FDA will either issue an approval letter, or approvable letter, which usually contains a number of conditions that must be met in

order to secure final approval of the PMA.

When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency

will issue a PMA approval letter authorizing commercial marketing of a device, subject to the conditions of approval and the limitations

established in the approval letter.

If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the

FDA will deny approval of the PMA or issue a not approvable letter.

The FDA also may determine that additional tests or clinical trials

are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted

in an amendment to the PMA.

The PMA process can be expensive, uncertain and lengthy and a number of devices for which FDA approval has

been sought by other companies have never been approved by the FDA for marketing.

New PMA applications or PMA supplements may be

required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that has been

approved through the PMA process.

PMA supplements often require submission of the same type of information as an initial PMA application,

except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application

and may or may not require as extensive technical or clinical data or the convening of an advisory panel.

Clinical Trials

Clinical trials are typically required to support

a PMA application and are sometimes required for a 510(k) clearance.

These trials generally require submission of an application for an

Investigational Device Exemption (“IDE”), to the FDA.

The IDE application must be supported by appropriate data, such as animal

and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant

risk device and eligible for abbreviated IDE requirements.

Generally, clinical trials for a significant risk device may begin once the

IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards

at the clinical trial sites.

The FDA’s approval of an IDE allows clinical testing to go forward, but it does not bind the FDA to

accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success

All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device

labeling, prohibit promotion, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study

investigators.

Clinical trials must further comply with the FDA’s regulations for institutional review board approval and for informed

consent and other human subject protections.

Required records and reports are subject to inspection by the FDA.

The results of clinical

testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient

for the FDA to grant approval or clearance of a product.

Clinical trials must be entered into the clinical trials registry at clinicaltrials.gov.

The commencement or completion of any clinical

trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited

to, the following:

● the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial,

or place a clinical trial on hold;

NeuroOne Medical Technologies Corporation

● patients do not enroll in clinical trials at the rate expected;

● patients, sponsor (NeuroOne) or study sites do not comply with trial protocols;

● patient follow-up is not at the rate expected;

● patients experience unanticipated adverse event;

● the data safety monitoring board determines the study should be placed on hold:

● patients die during a clinical trial, even though their death may not be related to the products that

If the FDA disagrees with a manufacturer’s

determination regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared device, the

FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a De Novo

or PMA application is obtained.

In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for

failure to submit the requisite application(s).

approval process

receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete

to permit a substantive review.

If it is not, the agency will refuse to file the PMA.

If it is, the FDA will accept the application for

filing and begin its review.

The FDA has 180 days to review a filed PMA application, although the review of an application more often

occurs over a significantly longer period of time.

During this review period, the FDA may request additional information or clarification

of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response

to deficiencies communicated by the FDA.

approving or denying a PMA, an FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee’s

recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it.

The FDA is not

bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of

the manufacturing facility and processes.

Overall, the FDA review of a PMA application generally takes between one and three years, but

may take significantly longer.

The FDA can delay, limit or deny approval of a PMA application for many reasons, including:

device may not be safe, effective, reliable or accurate to the FDA’s satisfaction;

data from pre-clinical studies and clinical trials may be insufficient to support approval;

manufacturing process or facilities may not meet applicable requirements;

in FDA approval policies or adoption of new regulations may require additional data.

Medical Technologies Corporation

an FDA evaluation of a PMA application is favorable, the FDA will either issue an approval letter, or approvable letter, which usually

contains a number of conditions that must be met in order to secure final approval of the PMA.

When and if those conditions have been

fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of a device, subject

to the conditions of approval and the limitations established in the approval letter.

If the FDA’s evaluation of a PMA application

or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.

The FDA also may

determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or

years while the trials are conducted and data is submitted in an amendment to the PMA.

The PMA process can be expensive, uncertain and

lengthy and a number of devices for which FDA approval has been sought by other companies have never been approved by the FDA for marketing.

PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling, device specifications,

materials or design of a device that has been approved through the PMA process.

PMA supplements often require submission of the same

type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes

from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening

of an advisory panel.

trials are typically required to support a PMA application and are sometimes required for a 510(k) clearance.

These trials generally

require submission of an application for an Investigational Device Exemption (“IDE”), to the FDA.

The IDE application must

be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans

and that the testing protocol is scientifically sound.

The IDE application must be approved in advance by the FDA for a specified number

of patients, unless the product is deemed a non-significant risk device and eligible for abbreviated IDE requirements.

Generally, clinical

trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent

are approved by appropriate institutional review boards at the clinical trial sites.

The FDA’s approval of an IDE allows clinical

testing to go forward, but it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety

and efficacy, even if the trial meets its intended success criteria.

All clinical trials must be conducted in accordance with the FDA’s

IDE regulations that govern investigational device labeling, prohibit promotion, and specify an array of recordkeeping, reporting and

monitoring responsibilities of study sponsors and study investigators.

Clinical trials must further comply with the FDA’s regulations

for institutional review board approval and for informed consent and other human subject protections.

Required records and reports are

subject to inspection by the FDA.

The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success

criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product.

Clinical trials must

be entered into the clinical trials registry at clinicaltrials.gov.

commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application,

for numerous reasons, including, but not limited to, the following:

FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical

trial, or place a clinical trial on hold;

do not enroll in clinical trials at the rate expected;

sponsor (NeuroOne) or study sites do not comply with trial protocols;

follow-up is not at the rate expected;

experience unanticipated adverse event;

data safety monitoring board determines the study should be placed on hold;

die during a clinical trial, even though their death may not be related to the products that

are part of our trial;

● institutional review boards and third-party clinical investigators may delay or reject the trial protocol;

● third-party clinical investigators decline to participate in a trial or do not perform a trial on the

anticipated schedule or consistent with the clinical trial protocol, good clinical practices or other FDA requirements;

● the sponsor (NeuroOne) or third-party organizations do not perform data collection, monitoring and analysis

in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans;

● third-party clinical investigators have significant financial interests related to the sponsor (NeuroOne)

or the study that the FDA deems to make the study results unreliable, or the company or investigators fail to disclose such interests;

● regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things,

● institutional

review boards and third-party clinical investigators may delay or reject the trial protocol;

Medical Technologies Corporation

● third-party

clinical investigators decline to participate in a trial or do not perform a trial on the

anticipated schedule or consistent with the clinical trial protocol, good clinical practices

or other FDA requirements;

sponsor (NeuroOne) or third-party organizations do not perform data collection, monitoring

and analysis in a timely or accurate manner or consistent with the clinical trial protocol

or investigational or statistical plans;

● third-party

clinical investigators have significant financial interests related to the sponsor (NeuroOne)

or the study that the FDA deems to make the study results unreliable, or the company or investigators

fail to disclose such interests;

inspections of our clinical trials or manufacturing facilities, which may, among other things,

require us to undertake corrective action or suspend or terminate our clinical trials;

● changes in governmental regulations or administrative actions;

● the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or efficacy;

● the FDA concludes that our trial design is inadequate to demonstrate safety and efficacy.

Other Regulatory Requirements

Even after a device receives clearance or approval

and is placed in commercial distribution, numerous regulatory requirements apply.

These include:

● establishment registration and device listing;

● QSR, which requires manufacturers, including third party manufacturers, to follow stringent design, testing,

risk management, production control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures

during all aspects of the manufacturing process;

● labeling regulations that prohibit the promotion of products for uncleared, unapproved or “off-label”

in governmental regulations or administrative actions;

interim or final results of the clinical trial are inconclusive or unfavorable as to safety

FDA concludes that our trial design is inadequate to demonstrate safety and efficacy.

Regulatory Requirements

after a device receives clearance or approval and is placed in commercial distribution, numerous regulatory requirements apply.

● establishment

registration and device listing;

which requires manufacturers, including third party manufacturers, to follow stringent design,

testing, risk management, production control, supplier/contractor selection, complaint handling,

documentation and other quality assurance procedures during all aspects of the manufacturing

regulations that prohibit the promotion of products for uncleared, unapproved or “off-label”

uses, and impose other restrictions on labeling, advertising and promotion;

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● MDR regulations, which require that manufacturers report to the FDA if their device may have caused or

contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury

if the malfunction were to recur;

● voluntary and mandatory device recalls to address problems when a device is mislabeled or does not meet

specifications and could be a risk to health;

● corrections and removals reporting regulations, which require that manufacturers report to the FDA field

corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the

FDCA that may present a risk to health.

Also, the FDA may require us to conduct post-market

surveillance studies or establish and maintain a system for tracking our products through the chain of distribution to the patient level.

The FDA enforces regulatory requirements by conducting periodic, unannounced inspections and market surveillance.

Inspections may include

the manufacturing facilities of our subcontractors.

Failure to comply with applicable regulatory requirements

can result in enforcement actions by the FDA and other regulatory agencies.

These may include any of the following sanctions or consequences:

● warning letters or untitled letters that require corrective action;

● fines and civil penalties;

● unanticipated expenditures;

● delays in approving or refusal to approve future products;

● FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries;

● suspension or withdrawal of FDA clearance or approval;

● product recall or seizure;

regulations, which require that manufacturers report to the FDA if their device may have

caused or contributed to a death or serious injury or malfunctioned in a way that would likely

cause or contribute to a death or serious injury if the malfunction were to recur;

and mandatory device recalls to address problems when a device is mislabeled or does not

meet specifications and could be a risk to health;

● corrections

and removals reporting regulations, which require that manufacturers report to the FDA field

corrections and product recalls or removals if undertaken to reduce a risk to health posed

by the device or to remedy a violation of the FDCA that may present a risk to health.

the FDA may require us to conduct post-market surveillance studies or establish and maintain a system for tracking our products through

the chain of distribution to the patient level.

The FDA enforces regulatory requirements by conducting periodic, unannounced inspections

and market surveillance.

Inspections may include the manufacturing facilities of our subcontractors.

to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies.

include any of the following sanctions or consequences:

letters or untitled letters that require corrective action;

and civil penalties;

Medical Technologies Corporation

● unanticipated

expenditures;

in approving or refusal to approve future products;

refusal to issue certificates to foreign governments needed to export products for sale in

other countries;

or withdrawal of FDA clearance or approval;

recall or seizure;

interruption of production;

● operating restrictions;

restrictions;

● injunctions;

● criminal prosecution.

Our contract manufacturers, specification developers

and some suppliers of components or device accessories, also are required to manufacture our products in compliance with current good

manufacturing practice requirements set forth in the QSR.

The QSR requires a quality system for the design, risk management, manufacture,

packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality

management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process

controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our

subcontractors.

If the FDA believes that any of our contract manufacturers or regulated suppliers are not in compliance with these requirements,

it can shut down such manufacturing operations, require a recall of our products, refuse to approve new marketing applications, institute

legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers

or other employees.

NeuroOne Medical Technologies Corporation

The Health Insurance Portability and

Accountability Act of 1996 (“HIPAA”) and Similar Foreign and State Laws and Regulations Affecting the Transmission, Security

and Privacy of Health Information

We may also be subject to data privacy and security

regulation by both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information

Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified requirements

relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s

security standards directly applicable to business associates, defined as service providers of covered entities that create, receive,

maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity.

also created four new tiers of civil monetary penalties and gave state attorneys general new authority to file civil actions for damages

or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal

civil actions.

In addition, many state laws govern the privacy and security of health information in certain circumstances, many of which

differ from HIPAA and each other in significant ways and may not have the same effect.

Fraud and Abuse Laws

In addition to FDA restrictions, there are numerous

federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws.

relationships with healthcare providers and other third parties are subject to scrutiny under these laws.

Violations of these laws are

punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and

state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.

Federal Anti-Kickback and Self-Referral

The federal Anti-Kickback Statute (the “Anti-Kickback

Statute”) prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration (including any

kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce either the referral of an individual, or the furnishing,

recommending, or arranging of a good or service, for which payment may be made under a federal healthcare program such as Medicare and

Medicaid or other federal healthcare programs.

The term “remuneration” has been broadly interpreted to include anything of

value, including such items as gifts, discounts, the furnishing of supplies or equipment, credit arrangements, waiver of payments and

providing anything at less than its fair market value.

Although there are a number of statutory exceptions and regulatory safe harbors

protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly.

Practices that involve remuneration

that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify

for an exception or safe harbor.

Failure to meet all of the requirements of a particular applicable statutory exception or regulatory

safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

Instead, the legality of the arrangement will be

evaluated on a case-by-case basis based on a review of all its relevant facts and circumstances.

Several courts have interpreted the statute’s

intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of (or purchases, or

recommendations related to) federal healthcare covered business, the Anti-Kickback Statute has been implicated and potentially violated.

The penalties for violating the Anti-Kickback

Statute include imprisonment for up to five years, fines of up to $25,000 per violation and possible exclusion from federal healthcare

programs such as Medicare and Medicaid.

Many states have adopted prohibitions similar to the Anti-Kickback Statute, some of which do not

have the same exceptions and apply to the referral of patients for healthcare services reimbursed by any source, not only by the Medicare

and Medicaid programs.

Further, the Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act (“ACA”).

Specifically, as noted above, under the Anti-Kickback Statute, the government must prove the defendant acted “knowingly” to

prove a violation occurred.

The ACA added a provision to clarify that with respect to violations of the Anti-Kickback Statute, “a

person need not have actual knowledge” of the statute or specific intent to commit a violation of the statute.

This change effectively

overturns case law interpretations that set a higher standard under which prosecutors had to prove the specific intent to violate the

In addition, the ACA codified case law that a claim including items or services resulting from a violation of the Anti-Kickback Statute

constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (the “False Claims Act”).

NeuroOne Medical Technologies Corporation

We plan to provide the initial training to providers

and patients necessary for appropriate use of our technology either through our own educators or by contracting with outside educators

that have completed an appropriate training course.

Outside educators are reimbursed for their services at fair market value.

Noncompliance with the Anti-Kickback Statute could

result in our exclusion from Medicare, Medicaid or other governmental programs, restrictions on our ability to operate in certain jurisdictions,

and civil and criminal penalties.

The federal Physician Self-Referral Prohibition,

commonly known as the “Stark Law,” prohibits a physician from ordering “designated health services,” including

durable medical equipment, for Medicare and Medicaid patients from entities with which the physician (or an immediate family member) has

a “financial relationship.” Financial relationships include both compensation arrangements and investment and ownership interests.

Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received under a noncompliant arrangement,

civil penalties, and exclusion from Medicare, Medicaid or other governmental programs.

We believe that we have structured our provider

arrangements to comply with current Stark Law requirements.

Nevertheless, a determination of liability under

such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Additionally, as some of these laws are still

evolving, we lack definitive guidance as to the application of certain key aspects of these laws as they relate to our arrangements with

providers with respect to patient training.

We cannot predict the final form that these regulations will take or the effect that the final

regulations will have on us.

As a result, our provider and training arrangements may ultimately be found to be not in compliance with

applicable federal law.

False Claims Act

The False Claims Act provides, in part, that the

federal government may bring a lawsuit against any person whom it believes has knowingly presented, or caused to be presented, a false

or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim

In addition, amendments in 1986 to the False Claims Act have made it easier for private parties to bring “qui tam”

whistleblower lawsuits against companies under the False Claims Act.

Penalties include fines ranging from $5,500 to $11,000 for each false

claim, plus three times the amount of damages that the federal government sustained because of the act of that person.

Qui tam actions

have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action,

pay fines or be excluded from Medicare, Medicaid or other federal or state healthcare programs as a result of an investigation arising

out of such action.

There are other federal anti-fraud laws that prohibit,

among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program,

including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing

a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or

making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits,

items or services.

Additionally, HIPAA established two federal crimes

related to making false statements in relation to healthcare matters.

The healthcare fraud statute prohibits knowingly and willfully executing

a scheme to defraud any healthcare benefit program, including private payors.

A violation of this statute is a felony and may result in

fines, imprisonment or exclusion from government sponsored programs.

The false statements statute prohibits knowingly and willfully falsifying,

concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery

of or payment for healthcare benefits, items or services.

A violation of this statute is a felony and may result in fines or imprisonment.

NeuroOne Medical Technologies Corporation

Civil Monetary Penalties Law

In addition to the Anti-Kickback Statute and the

False Claims Act, the federal government has the authority to seek civil monetary penalties, or CMPs, assessments, and exclusion against

an individual or entity based on a wide variety of prohibited conduct.

For example, the Civil Monetary Penalties Law authorizes the imposition

of substantial CMPs against an entity that engages in activities including, but not limited to:

(1) knowingly presenting or causing to

be presented, a claim for services not provided as claimed or which is otherwise false or fraudulent in any way;

(2) knowingly giving

or causing to be given false or misleading information reasonably expected to influence the decision to discharge a patient;

or giving remuneration to any beneficiary of a federal health care program likely to influence the receipt of reimbursable items or services;

(4) arranging for reimbursable services with an entity which is excluded from participation from a federal health care program;

(5) knowingly

or willfully soliciting or receiving remuneration for a referral of a federal health care program beneficiary;

or (6) using a payment

intended for a federal health care program beneficiary for another use.

The government is authorized to seek different amounts of CMPs

and assessments based on underlying violation.

For false or fraudulent claims, the government may seek a penalty of up to $10,000 for

each item or service improperly claimed, and an assessment of up to three times the amount improperly claimed.

For kickback violations,

the government may seek a penalty of up to $50,000 for each improper act and damages of up to three times the amount of remuneration at

State Fraud and Abuse Provisions

Many states have also adopted some form of anti-kickback

and anti-referral laws and a false claims act.

We believe that we are in conformance to such laws.

Nevertheless, a determination of liability

under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Physician Payment Sunshine Act

Transparency laws regarding payments or other

items of value provided to healthcare providers and teaching hospitals may also impact our business practices.

The federal Physician Payment

Sunshine Act requires most medical device manufacturers to report annually to the Secretary of Human Health Services financial arrangements,

payments, or other transfers of value made by that entity to physicians and teaching hospitals.

The payment information is made publicly

available in a searchable format on a CMS website.

Over the next several years, we will need to dedicate significant resources to establish

and maintain systems and processes in order to comply with these regulations.

Failure to comply with the reporting requirements can result

in significant civil monetary penalties.

Similar laws have been enacted or are under consideration in foreign jurisdictions.

Human Capital

As of September 30, 2022, we had 15 employees,

all of whom are full-time, seven of whom are engaged in research and development activities, and all of whom are located in the United

As of September 30, 2022, we also retained the services of approximately seven regular consultants.

None of our employees are

represented by a labor union or covered by a collective bargaining agreement.

We consider our relationship with our employees to be good.

During our 2022 fiscal year, we did not experience any turnover among our employees.

Corporate Information

Our principal

executive offices are located at 7599 Anagram Drive, Eden Prairie, Minnesota 55344, and our telephone number is 952-426-1383.

address is www.n1mtc.com.

Information on our website is not part of this Annual Report.

NeuroOne Medical Technologies Corporation

contract manufacturers, specification developers and some suppliers of components or device accessories, also are required to manufacture

our products in compliance with current good manufacturing practice requirements set forth in the QSR.

The QSR requires a quality system

for the design, risk management, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and it includes

extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling

of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation,

complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QSR through periodic unannounced inspections

that may include the manufacturing facilities of our subcontractors.

If the FDA believes that any of our contract manufacturers or regulated

suppliers are not in compliance with these requirements, it can shut down such manufacturing operations, require a recall of our products,

refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess

civil and criminal penalties against us or our officers or other employees.

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and Similar Foreign and State Laws and Regulations

Affecting the Transmission, Security and Privacy of Health Information

may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing

regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s security standards directly applicable to business associates, defined as service providers

of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for

or on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties and gave state attorneys general new

authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’

fees and costs associated with pursuing federal civil actions.

In addition, many state laws govern the privacy and security of health

information in certain circumstances, many of which differ from HIPAA and each other in significant ways and may not have the same effect.

and Abuse Laws

addition to FDA restrictions, there are numerous U.S.

federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback

laws and physician self-referral laws.

Our relationships with healthcare providers and other third parties are subject to scrutiny under

Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion

from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.

Medical Technologies Corporation

Anti-Kickback and Self-Referral Laws

federal Anti-Kickback Statute (the “Anti-Kickback Statute”) prohibits persons from knowingly and willfully soliciting, receiving,

offering or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce

either the referral of an individual, or the furnishing, recommending, or arranging of a good or service, for which payment may be made

under a federal healthcare program such as Medicare and Medicaid or other federal healthcare programs.

The term “remuneration”

has been broadly interpreted to include anything of value, including such items as gifts, discounts, the furnishing of supplies or equipment,

credit arrangements, waiver of payments and providing anything at less than its fair market value.

Although there are a number of statutory

exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn

Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations

may be subject to scrutiny if they do not qualify for an exception or safe harbor.

Failure to meet all of the requirements of a particular

applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

the legality of the arrangement will be evaluated on a case-by-case basis based on a review of all its relevant facts and circumstances.

Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration

is to induce referrals of (or purchases, or recommendations related to) federal healthcare covered business, the Anti-Kickback Statute

has been implicated and potentially violated.

penalties for violating the Anti-Kickback Statute include imprisonment for up to five years, fines of up to $25,000 per violation and

possible exclusion from federal healthcare programs such as Medicare and Medicaid.

Many states have adopted prohibitions similar to the

Anti-Kickback Statute, some of which do not have the same exceptions and apply to the referral of patients for healthcare services reimbursed

by any source, not only by the Medicare and Medicaid programs.

Further, the Anti-Kickback Statute was amended by the Patient Protection

and Affordable Care Act (“ACA”).

Specifically, as noted above, under the Anti-Kickback Statute, the government must prove

the defendant acted “knowingly” to prove a violation occurred.

The ACA added a provision to clarify that with respect to

violations of the Anti-Kickback Statute, “a person need not have actual knowledge” of the statute or specific intent to commit

a violation of the statute.

This change effectively overturns case law interpretations that set a higher standard under which prosecutors

had to prove the specific intent to violate the law.

In addition, the ACA codified case law that a claim including items or services

resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False

Claims Act (the “False Claims Act”).

plan to provide the initial training to providers and patients necessary for appropriate use of our technology either through our own

educators or by contracting with outside educators that have completed an appropriate training course.

Outside educators are reimbursed

for their services at fair market value.

Noncompliance

with the Anti-Kickback Statute could result in our exclusion from Medicare, Medicaid or other governmental programs, restrictions on

our ability to operate in certain jurisdictions, and civil and criminal penalties.

federal Physician Self-Referral Prohibition, commonly known as the “Stark Law,” prohibits a physician from ordering “designated

health services,” including durable medical equipment, for Medicare and Medicaid patients from entities with which the physician

(or an immediate family member) has a “financial relationship.” Financial relationships include both compensation arrangements

and investment and ownership interests.

Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements

received under a noncompliant arrangement, civil penalties, and exclusion from Medicare, Medicaid or other governmental programs.

believe that we have structured our provider arrangements to comply with current Stark Law requirements.

Nevertheless,

a determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in these

jurisdictions.

Additionally,

as some of these laws are still evolving, we lack definitive guidance as to the application of certain key aspects of these laws as they

relate to our arrangements with providers with respect to patient training.

We cannot predict the final form that these regulations will

take or the effect that the final regulations will have on us.

As a result, our provider and training arrangements may ultimately be

found to be not in compliance with applicable federal law.

Medical Technologies Corporation

False Claims Act provides, in part, that the federal government may bring a lawsuit against any person whom it believes has knowingly

presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false

statement or used a false record to get a claim approved.

In addition, amendments in 1986 to the False Claims Act have made it easier

for private parties to bring “qui tam” whistleblower lawsuits against companies under the False Claims Act.

Penalties include

fines ranging from $5,500 to $11,000 for each false claim, plus three times the amount of damages that the federal government sustained

because of the act of that person.

Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare

companies to have to defend a false claim action, pay fines or be excluded from Medicare, Medicaid or other federal or state healthcare

programs as a result of an investigation arising out of such action.

are other federal anti-fraud laws that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a

scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing

from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully

falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection

with the delivery of or payment for healthcare benefits, items or services.

Additionally,

HIPAA established two federal crimes related to making false statements in relation to healthcare matters.

The healthcare fraud statute

prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors.

of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs.

The false statements

statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious

or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

A violation of this

statute is a felony and may result in fines or imprisonment.

Monetary Penalties Law

addition to the Anti-Kickback Statute and the False Claims Act, the federal government has the authority to seek civil monetary penalties,

or CMPs, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct.

For example, the Civil

Monetary Penalties Law authorizes the imposition of substantial CMPs against an entity that engages in activities including, but not

(1) knowingly presenting or causing to be presented, a claim for services not provided as claimed or which is otherwise false

or fraudulent in any way;

(2) knowingly giving or causing to be given false or misleading information reasonably expected to influence

the decision to discharge a patient;

(3) offering or giving remuneration to any beneficiary of a federal health care program likely to

influence the receipt of reimbursable items or services;

(4) arranging for reimbursable services with an entity which is excluded from

participation from a federal health care program;

(5) knowingly or willfully soliciting or receiving remuneration for a referral of a

federal health care program beneficiary;

or (6) using a payment intended for a federal health care program beneficiary for another use.

The government is authorized to seek different amounts of CMPs and assessments based on underlying violation.

For false or fraudulent

claims, the government may seek a penalty of up to $10,000 for each item or service improperly claimed, and an assessment of up to three

times the amount improperly claimed.

For kickback violations, the government may seek a penalty of up to $50,000 for each improper act

and damages of up to three times the amount of remuneration at issue.

Fraud and Abuse Provisions

states have also adopted some form of anti-kickback and anti-referral laws and a false claims act.

We believe that we are in conformance

to such laws.

Nevertheless, a determination of liability under such laws could result in fines and penalties and restrictions on our

ability to operate in these jurisdictions.

Medical Technologies Corporation

Payment Sunshine Act

laws regarding payments or other items of value provided to healthcare providers and teaching hospitals may also impact our business

The federal Physician Payment Sunshine Act requires most medical device manufacturers to report annually to the Secretary

of Human Health Services financial arrangements, payments, or other transfers of value made by that entity to physicians and teaching

The payment information is made publicly available in a searchable format on a CMS website.

Over the next several years, we

will need to dedicate significant resources to establish and maintain systems and processes in order to comply with these regulations.

Failure to comply with the reporting requirements can result in significant civil monetary penalties.

Similar laws have been enacted

or are under consideration in foreign jurisdictions.

of September 30, 2023, we had 16 employees, all of whom are full-time, eight of whom are engaged in research and development activities,

and all of whom are located in the United States.

As of September 30, 2023, we also retained the services of approximately 9 regular

None of our employees are represented by a labor union or covered by a collective bargaining agreement.

We consider our

relationship with our employees to be good.

During our 2023 fiscal year, we had one employee resign.

principal executive offices are located at 7599 Anagram Drive, Eden Prairie, Minnesota 55344, and our telephone number is 952-426-1383.

Our website address is www.nmtc1.com Information on our website is not part of this Annual Report.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business