UNITED

STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended September 30, 2023

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission file number 001-40439

NeuroOne Medical Technologies Corporation

(Exact name of Registrant as specified in its charter)

(Address of principal executive offices) (Zip Code)

952-426-1383

(Registrant’s telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol Name of each exchange on which registered

Common Stock, $0.001 par value per share NMTC The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registration

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatement that required a recovery analysis of incentive-based compensation

received by an of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

of March 31, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market

value of shares of the registrant’s common stock held by non-affiliates of the registrant based upon the March 31, 2023 price at

which the common equity was last sold was $24,807,523 million. The number of outstanding shares of the registrant’s common stock

as of December 13, 2023 was 23,962,847.

DOCUMENTS

INCORPORATED BY REFERENCE

Parts

of the Proxy Statement for the Registrant’s 2024 Annual Meeting of Stockholders to be filed subsequently are incorporated by reference

into Part III of this Annual Report on Form 10-K.

NeuroOne

Medical Technologies Corporation

FORM

10-K

FOR

THE FISCAL YEAR ENDED SEPTEMBER 30, 2023

TABLE

OF CONTENTS

PART I

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 26

ITEM 1B. UNRESOLVED STAFF COMMENTS 58

ITEM 2. PROPERTIES 58

ITEM 3. LEGAL PROCEEDINGS 58

ITEM 4. MINE SAFETY DISCLOSURES 58

PART II

ITEM 6. [RESERVED] 59

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 69

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA F-1

ITEM 9A. CONTROLS AND PROCEDURES 70

ITEM 9B. OTHER INFORMATION 71

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 71

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 72

ITEM 11. EXECUTIVE COMPENSATION 72

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 72

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 73

SIGNATURES 77

SPECIAL

NOTE REGARDING FORWARD-LOOKING STATEMENTS

Unless

the context requires otherwise, references in this Annual Report on Form 10-K (this “Annual Report” or “Report”)

to “we,” “us,” “the Company” and “our” refer to NeuroOne Medical Technologies Corporation

(the “Company”).

This

Annual Report contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are

contained principally in the sections entitled “Risk Factors,” “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” and “Business,” but are also contained elsewhere in this Annual Report. In some

cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,”

“would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”

“believe,” “estimate,” “predict,” “project,” “potential,” “target,”

“seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other

comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties

and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from

the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each

forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and

factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include

statements about:

● our ability to maintain regulatory clearance for our RF ablation system;

● our ability to successfully commercialize our technology in the United States;

● our ability to achieve or sustain profitability;

● our ability to raise additional capital and to fund our operations;

● our future development priorities;

● our ability to comply with applicable regulatory requirements;

● our ability to maintain our intellectual property position;

Forward-looking

statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry

in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve

known and unknown risks, uncertainties and other factors that are in some cases beyond our control. You should refer to the “Risk

Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially

from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking

statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the

inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these

statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time

frame, or at all.

These

forward-looking statements speak only as of the date of this Annual Report. Except as required by law, we assume no obligation to update

or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however,

review the factors and risks and other information we describe in the reports we will file from time to time with the Securities and

Exchange Commission (the “SEC”) after the date of this Annual Report.

iii

NeuroOne

Medical Technologies Corporation

FORM 10-K

PART

ITEM

1. BUSINESS

Overview

Corporate

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 “Acquisition”). Immediately following the closing of the Acquisition,

the business of NeuroOne, Inc. became our sole focus.

Corporate

Overview and History of NeuroOne, Inc.

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, 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

entity.

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, 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

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 tremor, dystonia, and chronic pain. Alzheimer’s

is another indication evaluating the effects of DBS. Unlike ablative technologies, the effects of DBS are reversible.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Radio

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.

Failed

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.

Our

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

Market Opportunity

Epilepsy

Market

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.1

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. 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.

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:

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 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 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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

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. 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

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. 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. 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.

Spinal

Cord Stimulation

Chronic

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

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

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. These limitations include:

Our

Solution

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:

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

Strategy

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. The key elements of our strategy include:

NeuroOne

Medical Technologies Corporation

FORM 10-K

NeuroOne

Medical Technologies Corporation

FORM 10-K

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.

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Our

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.

The

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.

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. Our 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.

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. 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. And more

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

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

brain.

NeuroOne

Medical Technologies Corporation

FORM 10-K

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

NeuroOne

Medical Technologies Corporation

FORM 10-K

Mayo

Clinic and University of Wisconsin-Madison Studies

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. The ability 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 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).

NeuroOne

Medical Technologies Corporation

FORM 10-K

Sales

and Marketing

Zimmer

Development Agreement

Based

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.

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.

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.

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.

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.

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

Applicable

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

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:

● G40.3 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; and

● G40.82 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.

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.

NeuroOne

Medical Technologies Corporation

FORM 10-K

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

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NMTC · 10-K · period ended 2023-09-30

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