What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2024-12-17 compared with 2023-12-15 · 613 added, 568 removed, 797 unchanged (60% of the section changed)

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.

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.

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.

The purposes of the Merger were to:

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.

In December 2019, NeuroOne, Inc.

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.

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.

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.

are a medical technology company focused on (i) diagnostic, ablation and deep brain stimulation technology for brain related conditions

such as epilepsy and Parkinson’s disease;

(ii) ablation and stimulation for pain management throughout the body;

and (iii) drug

delivery including diagnostic and stimulation capabilities.

are developing and commercializing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography

(“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions for patients suffering from epilepsy,

Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological

The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while

being able to record brain activity before, during, and after delivery.

Additionally, we are investigating the potential applications

of its technology associated with artificial intelligence.

have received 510(k) clearance for three of our devices from the Food and Drug Administration (“FDA”), including:

Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days, (ii) 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, and (iii) our OneRF ablation system for creation of radiofrequency

lesions in nervous tissue for functional neurosurgical procedures.

We have a distribution agreement with Zimmer, Inc.

providing Zimmer with a license to commercialize and distribute these three products in the brain.

The Company’s other products

and indications are still under development.

are focused on developing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectroencephalography

(“sEEG”) recording.

These cortical sheet and depth electrode technologies are crucial for diagnosing neurological disorders

such as epilepsy, Parkinson’s disease, dystonia, essential tremors, and other related conditions.

ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson’s disease

This involves a continuous recording of the brain’s electrical activity to

identify irregularities.

The procedure requires a craniotomy, an invasive surgical method,

to access the brain.

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.

A less invasive technique where electrodes are placed in targeted brain areas

by drilling small holes through the skull.

Frequency (“RF”) Ablation :

This procedure uses radiofrequency to target and

destroy brain tissue.

The process involves delivering energy to the contacts, thereby heating

them, forming scar tissue (instead of tissue removal).

Known as brain lesioning, it causes

irreversible lesions.

We are also developing an ablation system for performing ablations in the face to treat debilitating facial pain

attributed to the trigeminal nerve.

We intend to submit this system for a 510(k) clearance in the first half of 2025.

Brain Stimulation (“DBS”), under development :

This therapy under our development

involves activating or inhibiting the brain with electrical impulses delivered by electrodes

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

Introduced in

1987, DBS is used to treat disorders like Parkinson’s disease, essential tremor, dystonia,

and chronic pain.

Unlike ablative technologies, DBS effects are reversible.

Medical Technologies Corporation

delivery including diagnostic and stimulation capabilities

neurological drugs delivery :

We are also researching and developing the capability to

use our sEEG electrode technology to deliver drugs or gene therapy while being able to record

brain activity before, during, and after delivery.

This future 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.

FDA clearance is not required for clinical studies of our future

neurological drug delivery technology, but we are pursuing 510(k) clearance with the FDA

for use with an approved brain cancer drug.

and stimulation for pain management throughout the body

Cord Stimulation (“SCS”), under development :

This method under our development

addresses chronic back pain from failed back surgery syndrome (“FBSS”) by placing

electrodes in the spine connected to an implantable pulse generator.

FBSS is a debilitating

condition that affects patients who have undergone multiple unsuccessful back surgeries,

who experience chronic lower back and leg pain, reduced quality of life, and significant

functional limitations.

completed an initial animal implant of novel thin film paddle leads for SCS, intended for treating chronic back pain.

Our SCS system

utilizes thin-film paddle leads to deliver precise electrical stimulation to the spinal cord, blocking pain signals and providing relief

to patients with FBSS.

During the second fiscal quarter of 2023, we achieved a significant milestone with the initial animal implant

of these novel leads.

Additionally, we are developing a percutaneous delivery system for paddle leads, which has shown promising results

in bench testing.

we are pursuing the development of “ all-in-one solutions ”.

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 pain-related neurological disorders.

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.

Market Opportunity

7 unchanged sentences

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.

Approximately 30-40% of these patients are

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

In addition to poor

1 unchanged sentence

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.

of approximately 1/1000 in epilepsy patients.

Despite the large market opportunity, it is estimated that there are only less than 5,000

epilepsy surgeries performed each year in the United States.

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

9 unchanged sentences

capabilities.

surgery in the United States:

Analysis of data from the National Association of Epilepsy

Centers 2015 Epilepsy Research.

Medical Technologies Corporation

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

We believe our technology provides a number of advantages over other commercially

available technologies, including the following:

proprietary thin film technology has a smaller footprint with many more electrodes.

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

technology provides more accurate detection of irregular brain activity over other 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

8 unchanged sentences

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.

surgery in the United States:

Analysis of data from the National Association of Epilepsy

Centers 2015 Epilepsy Research.

Medical Technologies Corporation

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.

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

28 unchanged sentences

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.

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.

Medical Technologies Corporation

Cord Stimulation

5 unchanged sentences

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.

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.

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 global market for SCS is substantial,

with an estimated value of approximately $2.5 to $3 billion.

back pain market includes the following indications:

17 unchanged sentences

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

of Other Currently Available Therapies

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

18 unchanged sentences

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

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 epilepsy.

Medical Technologies Corporation

● Requirement

14 unchanged sentences

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.

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.

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.

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.

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.

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.

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

to other 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:

diagnostic and therapeutic technology solution :

22 unchanged sentences

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.

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.

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.

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.

manufacturing :

Our electrode technology is cost competitive to its competitors due to

the scalable, automated manufacturing process.

This also increases the reliability and consistency

of the manufacturing process, and allows for faster fulfillment of product.

Medical Technologies Corporation

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

procedure from diagnosis through treatment.

The key elements of our strategy include:

3 unchanged sentences

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 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 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:

(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.

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.

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 (the “ Zimmer Distribution Agreement ”).

Zimmer actively promotes and sell these products.

Based on physician feedback, we believe

our technology is seen as a significant improvement for recording brain activity, particularly

in epilepsy, an underserved market with a quick commercialization path.

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.

is our primary target due

to a large market, strong reimbursement, robust pricing, and physician enthusiasm.

several institutions have already adopted our technology for diagnostic procedures.

electrodes for sEEG recording :

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.

This product is covered under the Zimmer Distribution Agreement, and

Zimmer actively promotes and commercializes our sEEG electrode technology.

our RF Ablation System :

The OneRF Ablation System is the only FDA cleared radiofrequency

ablation system in the United States for both diagnostic and therapeutic use.

used in a number of ablation cases since its limited launch in April 2024.

Cases were reported

as being successful using the same device to identify the brain tissue triggering seizure

activity and ablate the targeted tissue to reduce or eliminate brain-related seizure activity.

In addition, the technology has the potential to reduce hospital stays, number of surgeries

and adverse events while offering temperature control to enhance patient safety.

are initially placed in the operating room.

To date, all the ablations have been performed

at the patient’s bedside saving additional operating costs while allowing the patient

to be diagnosed and treated in one hospitalization instead of multiple visits.

2024, the Zimmer Distribution Agreement was expanded to include our OneRF Ablation System.

We intend to submit a new 510(k) application for a facial pain ablation system which leverages the existing RF

ablation generator.

percutaneous placed electrodes for spinal cord and peripheral stimulation for pain management

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.

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:

technologies developed for epilepsy through partnership and collaborations with a strategic

organizations in the field :

While we are developing our technology for the diagnosis

17 unchanged sentences

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.

● Facilitating

partnerships for drug delivery :

Partner 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

52 unchanged sentences

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.

sEEG Evo cortical electrode technology has received 510(k) clearance from the FDA in November 2019 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.

On December 6, 2023, we received 510(k) FDA clearance to market our OneRF

Ablation System for creation of radiofrequency lesion in nervous tissue for functional neurosurgical procedures.

Our other products have

not received any clearance for commercialization by any U.S.

or foreign regulatory body.

In the future, we are planning on submitting

additional 510(k) clearance with the FDA for other ablation applications, as well as for neurological drug delivery.

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

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

surgeries and other pain-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 as well as have hired additional employees with expertise in the respective

We license three critical patents from Wisconsin Alumni Research Foundation (“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 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.

In July 2022, we announced the first clinical case using the Evo

sEEG electrode was performed by Dr.

Robert Gross at Emory University.

Gross selected the Evo sEEG electrode for intraoperative brain

mapping at the subsurface level of the brain.

Medical Technologies Corporation

launched OneRF, demonstrating combined diagnostic and therapeutic technology for brain applications.

We have also performed bedside ablations,

which can offer savings in operating room time and additional hospitalizations.

the first half of 2025, we expect to submit a 510(k) clearance with the FDA for an additional applications leveraging our RF generator

for brain ablations.

are also developing a device for brain monitoring and drug delivery capabilities using the same product.

We have performed bench top

and animal experiments and successfully confirmed the proof of concept for this technology, which could be used to deliver drugs, genes,

or cell-based therapies to the brain.

We are pursuing a 510(k) clearance with the FDA for brain cancer.

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

1 unchanged sentence

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

of Development and Pre-Clinical

Testing to Date

Expected Steps for Regulatory

Clearance or Approval

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).

sEEG - 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 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

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

Commercial launch commenced utilizing Zimmer, our distribution partner.

sEEG - Depth electrodes for recording

(diagnostic) purposes

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

No clinical testing was required in order to obtain FDA clearance.

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.

distributing this product in May 2023.

NeuroOne Medical

Technologies Corporation

Drug Delivery and monitoring electrode

Actively developing;

benchtop testing and

component sourcing complete

The Company is pursuing a 510(k) clearance

with the FDA for brain cancer drug delivery system.

OneRF Ablation System - Depth 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

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.

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

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

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

Additional 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.

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.

animal or human clinical testing is anticipated for FDA submission since 510K predicate devices did

not perform such clinical testing.

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

for functional neurosurgical procedures on December 6, 2023.

Company is pursuing additional 510(k) clearance for additional applications leveraging our RF generator

for brain ablations

SCS - Spinal cord stim electrodes

design freeze.

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

2021/early 2022, we performed bench top testing of prototypes to demonstrate chronic performance and

In 2023, we continued to refine our chronic spinal cord electrode design based on SCS customer feedback and completed additional pre-clinical bench and/or animal tests to further validate our value proposition.

In 2024, we completed the development of a percutaneous delivery system and conducted benchtop, animal and cadaver studies of both the percutaneous delivery system and various design iterations of paddle electrodes.

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.

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.

As we continue to refine the product design, we will evaluate the necessary pre-clinical and clinical testing for regulatory approval.

To expedite market entry, we are actively seeking strategic partnerships and collaborations.

NeuroOne Medical

Technologies Corporation

Implantable stimulation

testing was successfully completed in 2021 and early 2022.

We announced the results of these studies in the first quarter of 2022.

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

this device is still in early development, we plan to collaborate with clinicians to refine our designs and continue testing in 2023.

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

to assess safety and performance.

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

The Company is pursuing

chronic animal studies and plan to follow up with a first-in-human test.

we have not yet sought or received FDA feedback on the specific clinical process for chronic stimulation, we anticipate that regulatory

approval may necessitate a more rigorous clinical process, potentially involving a pre-market approval (“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.

As we have not yet met with the FDA, we cannot definitively determine the exact clinical data and testing requirements.

However, based on industry experience with similar technologies, we estimate that clinical trials will be necessary, requiring an

investment of over $2,000,000.

Collaborations

and Partnerships

Clinic and University of Wisconsin-Madison Studies

38 unchanged sentences

Medical Technologies Corporation

and Marketing

Development Agreement

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.

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.

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.

Medical Technologies Corporation

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.”

Commercialization,

Sales and Marketing

Distribution 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

and distribution agreement (the “Original Distribution 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 (the

“sEEG Products”).

The parties have agreed to collaborate with respect to development activities under the Distribution Agreement

through a joint development committee composed of an equal number of representatives of Zimmer and the Company.

to the Distribution 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 Distribution 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,

$0.001 par value, with an exercise price of $3.00 per share.

October 2024, we amended and restated our development and distribution agreement with Zimmer to grant exclusive right and license to

distribute also our OneRF Ablation System (the “OneRF Products”) for an upfront fee of $3 million dollars and up to an additional

$1 million dollars upon achievement of certain net sales milestone by Zimmer (as amended, the “Zimmer Distribution Agreement”).

the terms of the Distribution Agreement, we are responsible for all costs and expenses related to developing the Strip/Grid Products,

the Electrode Cable Assembly Products, the sEEG Products and the OneRF Products (collectively the “Products”), and Zimmer

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

In addition to the Development Agreement,

In addition to the Distribution 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

as otherwise provided in the Zimmer Distribution 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.

to promote, market and sell each Product following the “Product Availability Date” (as defined in the Zimmer Distribution

Agreement) for such Products.

Zimmer Distribution Agreement will expire on September 30, 2034, unless terminated earlier pursuant to its terms.

Either party may terminate

the Amended and Restated Distribution 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 Zimmer Distribution

Agreement for any reason with 90 days’ written notice, and we may terminate the Zimmer Distribution Agreement if Zimmer acquires

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

Both Zimmer and the Company have agreed

to indemnify the other party against certain losses and expenses relating to the development or commercialization of a product by the

indemnifying party, the negligence or willful misconduct of the indemnifying party or its directors, officers, employees or agents or

a breach of the indemnifying party’s representations, warranties or covenants.

Medical Technologies Corporation

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

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

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

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

Facility Agreement

August 2, 2024, we entered into a loan and security agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding,

LLC, as the lender (the “Lender”), which provides for a delayed draw term loan facility in an aggregate principal amount

not to exceed $3.0 million (the “Debt Facility”).

We are permitted to borrow loans under the Debt Facility from time to time

(collectively, the “Loans”), for general corporate purposes and subject to certain specified conditions, until the earliest

(i) November 30, 2024, (ii) the occurrence of any monetization or change in control, or (iii) at the Lender’s option, upon

the occurrence and during the continuance of an event of default under the Debt Facility Agreement.

The Loan(s), upon issuance, will

be secured by substantially all of our assets, subject to certain exceptions set forth in the Debt Facility Agreement, and will be subject

to covenants.

Debt Facility matures on February 2, 2026.

The outstanding principal amount of any outstanding Loans will bear interest at a rate of

10% per annum, payable monthly in arrears and at the maturity date.

As of the closing date of the Debt Facility Agreement, no amounts

were drawn by us thereunder.

On November 7, 2024, we mutually agreed with the Lender to terminate the loan facility.

paid a one-time standby facility fee of $125,000 and on August 2, 2024, we issued 100,000 Lender Warrants to Lender to purchase shares

of the our Common Stock at exercise price of $0.66 per share.

The warrants are immediately exercisable and expire on August 2, 2029.

Lastly, a cash draw-fee of $50,000 is payable and a warrant draw-fee consisting of the issuance of an additional 50,000 warrants to the

Lender is required upon each additional funding tranche of $500,000 under the Debt Facility, for an aggregate potential issuance of 300,000

additional Lender Warrants.

The Lender Warrants issuable upon each future funding date will have an exercise price of $0.66 per share

and will have a five-year term.

Private Placement

August 1, 2024, we entered into a Securities Purchase Agreement which closed on August 2, 2024, with certain accredited investors (the

“Purchasers”), pursuant to which the we, in a private placement, agreed to issue and sell an aggregate of (i) 2,944,446 shares

of the our common stock, and (ii) warrants to purchase an aggregate of 2,208,338 shares of common stock at a purchase price of $0.90

per unit, consisting of one share and a warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately

$2.65 million before deducting estimated expenses (the “2024 Private Placement”).

In connection with the 2024 Private Placement,

we filed a registration statement with the SEC covering the resale of the securities issued in the 2024 Private Placement.

Minimum Bid Price Notification

July 11, 2024, we received a letter (the “Notice”) from the Listing Qualifications Department (the “Staff”) of

Nasdaq Stock Market (“Nasdaq”) notifying that because the closing bid price of the our common stock was below $1.00 per share

for the prior 30 consecutive business days, we are not in compliance with the minimum bid price requirement for continued listing on

The Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

In accordance

with Nasdaq Marketplace Rule 5810(c)(3)(A), we have a period of 180 calendar days from July 11, 2024, or until January 7, 2025, to regain

compliance with the Minimum Bid Price Requirement.

If at any time before January 7, 2025, the closing bid price of our common stock closes

at or above $1.00 per share for a minimum of 10 consecutive business days (which number days may be extended by Nasdaq), Nasdaq will

provide written notification that we have achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved.

Medical Technologies Corporation

Reimbursement

7 unchanged sentences

health insurance companies and accreditation organizations.

Medical Technologies Corporation

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

7 unchanged sentences

without excision of cerebral tissue (separate procedure);

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

Stereotactic implantation of depth electro1des into the cerebrum for long term seizure monitoring.

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

17 unchanged sentences

Epileptic spasms.

Medical Technologies Corporation

believe that many of the indications we are pursuing with our technologies are currently reimbursed on a widespread basis by Medicare,

12 unchanged sentences

and removal procedures, our financial performance will be negatively impacted.

Medical Technologies Corporation

Manufacturing,

8 unchanged sentences

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

24 unchanged sentences

against other companies in early stages of development of thin film technologies.

Medical Technologies Corporation

the neuro-ablation market, we expect to compete with Medtronic’s Visualase guided-laser ablation technology and Monteris Medical’s

13 unchanged sentences

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

8 unchanged sentences

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.

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