NASDAQ: NMTC

Products

We are focused on developing thin film electrode
technology for a variety of recording and therapeutic applications. 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.

Commercialized Products

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Evo® Cortical: Cortical or subdural electrodes are used in intracranial electroencephalography (iEEG) surgeries to monitor, record and stimulate the surface of the brain for less than 30 days. Our Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes.

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Evo sEEG: 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. Federal (USA) law restricts this device to sale by or on the order of a physician. Evo sEEG enhances the ability to identify the right foci zones to determine the best intervention for patients.

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OneRF® Brain Ablation System: Our OneRF Brain Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures. It provides bedside monitoring, mapping and ablation using the same device, giving physicians a less invasive, potentially safer way to gain improved bedside clarity of the therapeutic window for an epilepsy patient with the possibility of seizure reduction or freedom.

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OneRF® TN Ablation System: Our OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. Differentiated features of this system include a “first-of-its-kind” multi-contact RF probe that allows for both precise localization and tailored ablation of the pain-conducting nerve tissue – using the same RF probe, and under temperature-controlled conditions which enhance safety and accuracy. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.

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NeuroOne Medical Technologies Corporation

FORM 10-K

Products in Development

Drug delivery including diagnostic and stimulation
capabilities

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Drug
delivery: We are also researching and developing the capability to create a new type of combination device based on our sEEG
electrode technology to deliver drugs or gene or cell therapies while having the ability to record brain activity before, during,
and after delivery. This future device is intended to deliver neurological drugs or gene or cell therapies 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 pre-clinical studies although
we are pursuing a 510(k) clearance with the FDA for use with an approved brain cancer drug. We also intend to offer drug delivery
devices for pre-clinical animal models.

Recording, Ablation and stimulation for pain
management throughout the body

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Spinal
Cord Stimulation (“SCS”): This system addresses chronic back pain (CBP) by placing electrodes in the spine connected
to an implantable pulse generator. CBP is a debilitating condition that affects patients who experience chronic lower back and leg
pain, reduced quality of life, and significant functional limitations. Our SCS solution utilizes a percutaneously-placed
thin-film paddle electrode to deliver precise electrical stimulation to the spinal cord, blocking pain signals and providing relief
to patients. This capability opens the use and implantation of paddle electrodes to pain management doctors, who
currently only implant traditional percutaneous electrodes but perform the majority of these procedures in the United
States. Current paddle electrodes are predominantly implanted by surgeons.

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Basivertebral Nerve Ablation (“BVNA”): This system would target the basiverterbal nerve to address lower back pain and improve function. Our solution would leverage our existing ablation technology while taking advantage of our multi-contact sEEG probes to increase placement flexibility.

These products in development are examples of
our interest to pursue development of less invasive “all-in-one solutions”. We believe these technologies offer 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.

Our Market Opportunity

Epilepsy Market

Our initial disease target has included 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: genetics,
autoimmune responses, 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 30-40% of these patients are not receptive
to pharmaceutical treatment and may be candidates 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 approximately 1/1000
in epilepsy patients. Despite the large market opportunity, it is estimated only about 5,000 epilepsy surgeries performed each year in
the United States.1

1Epilepsy surgery in the United States: Analysis of data from
the National Association of Epilepsy Centers 2015 Epilepsy Research.

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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 over $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 cause of epileptic seizures is not well-determined. We believe our technology
provides a number of advantages over other commercially available technologies, including the following:

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We expect that our technology may be implanted using a less invasive procedure utilizing a burr hole rather than a full craniotomy.

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Our
technology provides accurate detection of irregular brain activity and may be used for the treatment of the condition.

Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a sudden and
intense pain in the case that drives thousands of people to seek treatment each year. TN related pain is described as a stabbing,
shooting, sharp or piercing sensation. It can occur anywhere between the jaw and forehead, including in the mouth. Vascular
compression of the trigeminal nerve root is a typical cause for TN. Over 150,000 people live with TN in the US, and approximately
15,000 are diagnosed each year.2

Back Pain – Spinal Cord Stimulation and
BVNA

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 global market for SCS is substantial, with an estimated value of approximately
$2.5 to $3 billion.

The chronic back pain market includes the following
indications: FBSS, Ischemic Limb Pain, and Complex Regional Pain Syndrome (among others). 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.

2
https://www.aans.org/patients/conditions-treatments/trigeminal-neuralgia/

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Basivertebral Nerve Ablation (BVNA) includes adults
with chronic low back pain (CLBP) (≥6 months), specifically vertebrogenic pain from inflamed vertebral endplates (Modic Type 1 or 2
changes on MRI), who haven’t found relief from at least 6 months of conservative treatments like PT, meds, or injections, targeting pain
in the vertebral bodies. We believe the total market for BVNA procedures currently performed in the United States is approximately $100
million per year (>10,000 procedures per year), and growing rapidly.

Drug Delivery

In the near term, our drug delivery system
in development has already been ordered by a large biopharmaceutical company planning to test NeuroOne’s system in preclinical
research, representing a completely new market for NeuroOne. We believe the market for the preclinical research in drug development
is greater than $50 million. Additionally, we are in early conversations with potential strategic partners related to the ongoing
development of specific drug delivery combinations. We believe the full market commercial opportunity for this type of application
to be potentially over $1 billion.

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

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.

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

Dystonia

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.

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Limitations of Other Currently Available Therapies

There are a limited number of other currently
available products for diagnosis and treatment for people with neurological disorders. Although the other 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:

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Requirement for multiple devices for diagnostic and therapeutic procedures: Today both interventional diagnostic and treatment procedures may require different device implants, surgeries and even hospitalizations for each procedure. This causes significant patient inconvenience, use of precious hospital resources and tremendous cost to the system.

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Limited number of contacts on an electrode: SCS electrodes currently are available in a variety of sizes and number of contacts. Physicians increasingly want to explore greater number of contacts on the same electrode in order to be able to be more precise in stimulating targeted areas. This is also true for existing BVNA systems, which are limited to probes with only two contacts, requiring extremely precise placement of the probes and limiting flexibility.

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No ability to record brain activity during drug delivery: Currently available drug delivery devices do not have the ability to record brain activity before, during or after delivery of the drug with the same device.

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More invasive: All existing spinal cord paddle electrodes are more invasive than our SCS paddle electrodes under development, and the electrode itself is 20 times bigger than our proposed design.

Our Solution

In comparison to other currently available technologies,
our existing products and products in development all have the goal of providing the following advantages (and expected advantages):

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All-in-one diagnostic and therapeutic technology solution: Our OneRF Brain Ablation System, indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures, provides bedside monitoring, mapping and ablation, giving physicians a less invasive, potentially safer way to gain improved bedside clarity of the therapeutic window for an epilepsy patient with the possibility of seizure reduction or freedom. It is the first and only FDA-cleared system capable of nervous tissue ablation using the same Evo® sEEG-RF Electrode for both diagnostic and therapeutic applications.

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Multi-contact probe for OneRF TN: With the OneRF TN Ablation System, surgeons could simplify the ablation process to a single decisive step. The innovative multi-contact probe may enable stimulation/mapping and ablation in fewer cycles, and may significantly reduce patient discomfort and procedure complexity.

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Percutaneous placement of spinal cord stimulation paddle electrode with scalability options: Due to the thin film nature of our electrode technology, we believe that it may allow for percutaneous placement of “paddle” (flat) shaped electrodes, thereby preventing the need to use more invasive surgical approaches to place the electrodes. Minimally invasive and percutaneously placed technologies have become almost a requirement for adoption with patients and physicians.

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Increased contacts: We believe that both our spinal cord stimulation electrode in development and our BBNA product in development will offer the ability to increase the number of contacts on a film that traditionally offers fewer contacts. Increasing the number of contacts may allow for more precise stimulation in the spine, potentially improving the therapeutic outcomes.

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Improved accuracy of diagnostic technologies: The Evo sEEG is engineered for accuracy, enhancing the ability to identify the right foci zones to determine the best intervention for patients.

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Ability to record during drug delivery: Our drug delivery product in development is designed to be able to record brain tissue before, during or after delivery of the drug.

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Automated manufacturing: Our electrode technology is cost competitive to 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.

Our Strategy

Our goal is to be the global leader in minimally
invasive all in one therapies for brain related and other neurological disorders that leverages our thin film electrode technology to
be used for recording, monitoring, deep brain and peripheral stimulation and ablation, drug delivery, owning the procedure from diagnosis
through treatment. The key elements of our strategy include:

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Expand the use of our Evo Cortical, Evo sEEG and OneRF Brain Ablation System in the United States and begin the process to commercialize expand into select international markets: In July 2020, we entered into a development relationship with Zimmer, pursuant to which we granted Zimmer exclusive global rights to distribute our Evo Cortical, which was ultimately expanded to include rights to our Evo sEEG and OneRF Brain Ablation System (the “Zimmer Distribution Agreement”). Zimmer actively promotes and sell these products. In fiscal 2025, we received product revenue from these products of approximately $9.1 million.

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Launch our OneRF TN Ablation System: In December 2025, we initiated a limited market release of our OneRF TN Ablation System. The OneRF Trigeminal Nerve Ablation System features a minimally invasive surgical technology to treat severe, chronic facial pain. The system delivers targeted RF energy to ablate trigeminal nerve fibers, interrupting pain signaling. Differentiated features of this system include a “first-of-its-kind” multi-contact RF probe that allows for both precise localization and targeted ablation of the pain-conducting nerve tissue - using the same RF probe - and under temperature-controlled conditions, which enhances safety and accuracy. This system may also allow for reduced procedural time, as well as improved patient comfort and safety.

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Continue to develop percutaneous placed paddle electrodes for spinal cord and peripheral stimulation for pain management with scalable contact configurations: 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”. This capability opens the use and implantation of paddle electrodes to pain management doctors, who currently only implant traditional percutaneous electrodes. Current paddle electrodes are predominantly implanted by surgeons. By leveraging our existing FDA-cleared technologies, 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.

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Facilitate 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.

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Develop BVNA System: We intend to leverage our existing FDA-cleared technologies to develop a BVNA system, and using our multi-contact probes to increase placement flexibility compared to existing cleared BVNA systems. We established an advisory board for our BVNA development program in October 2025.

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Explore partnerships with other companies that leverage our core technology: Given that our technology enables, complements and/or competes with a number of companies that are in the market or attempting to enter the market with diagnostic or therapeutic technologies to treat brain related disorders, we believe there may be opportunities to establish mutually beneficial relationships. In addition, our technology may have application in cardiovascular, orthopedic and pain related indications that could benefit from a high-fidelity thin film electrode product that can provide stimulation and/or ablation therapies.

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NeuroOne Medical Technologies Corporation

FORM 10-K

Clinical Development and Regulatory Pathway
for Products in Development

Clinical Experience, Future Development and
Clinical Trial Plans

Below we have summarized, for each of our products
in development, the current stage of development, our plans for further testing or clinical trials and our expectations regarding the
requirements for regulatory clearance or approval and timing of regulatory submissions.

Technology

Stage of Development and Pre-Clinical

Testing to Date

Additional Expected Steps for Regulatory

Clearance or Approval

Drug Delivery and monitoring electrode

Actively developing; Conducted benchtop and animal studies.

The Company may pursue a 510(k) clearance with the FDA for brain cancer drug delivery system.

SCS - Spinal cord stim electrodes

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.

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.

BVNA

Actively developing; Conducted benchtop and animal ex vivo studies.

The Company may pursue a 510(k) clearance with the FDA for its BVNA product in development.

Collaborations and Partnerships

Mayo Clinic and University of Wisconsin-Madison
Studies

In 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. Pursuant to the WARF License, WARF has granted to us an exclusive
license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array or thin-film
micro electrode array and method. We have agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant
to the WARF License, with a minimum annual royalty payment of $50,000 for calendar year 2020, $100,000 for calendar year 2021 and $150,000
for calendar year 2022 and each calendar year thereafter that the WARF License is in effect. 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.

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WARF may terminate this license on 30
days’ written notice, if we default on the payments of amounts due to WARF or fail to timely submit development reports,
actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or
in the event of certain bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’ notice if we
had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after
royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters. The first commercial
sale occurred on December 7, 2020, prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date
that no valid claims on the patents licensed thereunder remain. We expect the latest expiration of a licensed patent to occur in
2030.

In addition, WARF reserves the right to grant
non-profit research institutions and government agencies non-exclusive licenses to practice and use the inventions of the licensed patents
for non-commercial research purposes, and we grant WARF a non-exclusive, sub licensable, royalty-free right and license for non-commercial
research purposes to use improvements to the licensed patents. In the event that we discontinue use or commercialization of the licensed
patents or improvements thereon, we must grant WARF an option to obtain a non-exclusive, sub-licensable, royalty-bearing license to use
the improvements for commercial purposes.

See “Risk Factors-Risks Related to Our Business-We
depend on intellectual property licensed from WARF for our technology, including our technology under development, and the termination
of this license would harm our business” for additional information regarding the WARF License.

Mayo Foundation for Medical Education and Research
License and Development Agreement

In May 2017, we entered into 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.

We have agreed to pay Mayo a royalty equal to
a single-digit percentage of our product sales pursuant to the Mayo Development Agreement. Mayo may purchase any developed products licensed
under the Mayo Development Agreement at the best price offered by us to the end user in the prior year. The Mayo Development Agreement
generally will expire in October 2034, unless the Mayo know-how and improvements under the Mayo Development Agreement remain in use, and
the Mayo Development Agreement may be terminated by Mayo for cause or under certain circumstances.

For additional information regarding the Mayo
Development Agreement, see “Risk Factors-Risks Related to Our Business-We depend on our partnership with Mayo to license certain
know how for the development and commercialization of our technology. Termination of this partnership would harm our business, and even
if this partnership continues, it may not be successful.”

Commercialization, Sales and Marketing

Zimmer Biomet Distribution 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 “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.

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

In August 2022, we entered into an amendment to
the 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.

In 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”).

Under the terms of the Zimmer 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 Zimmer 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.

Except 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 Zimmer Distribution Agreement) for such Products.

The Zimmer Distribution Agreement will expire
on September 30, 2034, unless terminated earlier pursuant to its terms. Either party may terminate the Zimmer 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.

We will investigate markets outside of the U.S.
with the assistance of Zimmer and formulate a plan to enter those markets with the support of Zimmer.

For more information regarding the 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.

Financing

April
2025 Financing

On April
4, 2025, we entered into an underwriting agreement with Ladenburg Thalmann & Co. Inc. as underwriter ( “Ladenburg”), relating
to the issuance and sale of 16,000,000 shares of the Company’s common stock, at a price to the public of $0.50 per share (the “April
2025 Financing”). In addition, under the terms of the underwriting agreement, we granted Ladenburg an option, exercisable for 45
days, to purchase up to an additional 2,400,000 shares of common stock on the same terms as the offering, which was exercised in full.
Net proceeds to the Company were approximately $8.2 million.

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Nasdaq

Nasdaq Minimum Bid Price Notification

On May 6, 2025, we received a letter from the
Listing Qualifications Department of Nasdaq Stock Market (“Nasdaq”) notifying that because the closing bid price of 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 had a period of 180 calendar days, or until November
3, 2025, to regain compliance with the Minimum Bid Price Requirement.

On November 4, 2025, we received a letter from
Nasdaq notifying us that we have been granted a 180-day extension, until May 4, 2026, to regain compliance with the Minimum Bid Price
Requirement. We will continue to monitor the closing bid price of our common stock and seek to regain compliance with the Minimum Bid
Price Requirement within the extension period. If we do not regain compliance with the Minimum Bid Price Requirement within the extension
period, Nasdaq will provide written notification to us that our common stock will be subject to delisting, at which time we may appeal
Nasdaq’s delisting determination to a Nasdaq Hearing Panel. There can be no assurance that, if we do need to appeal a Nasdaq delisting
determination to the Nasdaq Hearings Panel, that such appeal would be successful.

Reimbursement

Coverage in the United States

Reimbursement from private third-party healthcare
payors and, to a lesser extent, Medicare will be an important element of our success. Although the Centers for Medicare and Medicaid Services
(“CMS”) and third-party payors have adopted coverage policies for our targeted indications, there is no guarantee this will
continue at the same levels or at all in the future. Current Procedural Terminology, or CPT, is a medical code set that is used to report
medical, surgical and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation
organizations.

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

●61531 Subdural implantation of strip electrodes through one or more burr or trephine (saw) hole(s) for
long term seizure monitoring;

●61533 Craniotomy with elevation of bone flap: for subdural implantation of an electrode array, for long
term seizure monitoring;

●61535 Craniotomy with elevation of bone flap; for removal of epidural or subdural electrode array, without
excision of cerebral tissue (separate procedure); and

●61760 Stereotactic implantation of depth electro1des into the cerebrum for long term seizure monitoring.

Regarding ICD-10 codes, the International Classification
of Diseases, Tenth Edition (ICD-10) is a clinical cataloging system that went into effect for the U.S. healthcare industry on October
1, 2015, after a series of lengthy delays. Accounting for modern advances in clinical treatment and medical devices, ICD-10 codes offer
many more classification options compared to those found in its predecessor, ICD-9. Within the healthcare industry, providers, coders,
IT professionals, insurance carriers, government agencies and others use ICD codes to properly note diseases on health records, to track
epidemiological trends and to assist in medical reimbursement decisions.

ICD-10 codes for epilepsy are as follows:

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

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

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

●G40.3 Generalized idiopathic epilepsy and epileptic syndromes;

●G40.A Absence epileptic syndrome;

●G40.4 Other generalized epilepsy and epileptic syndromes;

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

●G40.80 Other epilepsy; and

●G40.82 Epileptic spasms.

For our OneRF Ablation System, we use ICD-10-PCScode
00503Z4 Destruction of Brain Using Stereoelectroencephalographic Radiofrequency Ablation, Percutaneous Approach. This code allows hospital
reporting of inpatient procedures that are performed using the OneRF Ablation system,

For our OneRF TN Ablation System, the following
CPT Codes are available:

●61790 Creation of lesion by stereotactic method,
percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); gasserian ganglion

●61791 Creation of lesion by sterotactic method,
percutaneous, by neurolytic agent (eg, alcohol, thermal, electrical, radiofrequency); trigeminal medullary tract

Medicare, Medicaid, health maintenance organizations
and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement
of new medical devices, and, as a result, their coverage policies may be restrictive, or they may not cover or provide adequate payment
for our products. In order to obtain reimbursement arrangements, we may have to agree to a net sales price lower than the net sales price
we might charge in other sales channels. Our revenue may be limited by the continuing efforts of government and third-party payors to
contain or reduce the costs of healthcare through various increasingly sophisticated means, such as requiring prospective reimbursement
and second opinions, purchasing in groups, or redesigning benefits. Our future dependence on the commercial success of our technologies
makes us particularly susceptible to any cost containment or reduction efforts. Accordingly, if government and other third-party payors
do not provide adequate coverage and reimbursement for our products and the related insertion and removal procedures, our financial performance
will be negatively impacted.

Manufacturing, Supply and Quality Assurance

We currently outsource the supply and manufacture
of all components of our prototypes of our technology under development. We plan to continue with an outsourced manufacturing arrangement
for the foreseeable future. Our third-party manufacturers are recognized in their field for their competency to manufacture the respective
portions of our system and have quality systems established that meet FDA requirements. We believe at this time the manufacturers we currently
utilize have sufficient capacity to meet our requirements. We believe that as we increase our demand in the future, our per-unit costs
will decrease materially.

As a medical device developer, the facilities
of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and corresponding state and foreign agencies.
We believe that our quality systems and those of our suppliers are robust and achieve high product quality. We plan to audit our suppliers
periodically to ensure conformity with the specifications, policies and procedures for our devices.

Research and Development

Our research and development team, which includes
our Vice President of Engineering, utilizes advice from leading experts in the neurotech field on our scientific advisory board and is
focused on the development of thin film cortical grid and strip electrodes and depth electrodes for recording, ablation and chronic stimulation
for brain related disorders as well as stimulation for spinal cord stimulation for back related pain. Our research and development expenses
were $5.0 million and $5.1 million for the years ended September 30, 2025 and 2024, respectively.

Competition

Epilepsy

In the market for epilepsy diagnosis, our Evo
Cortical and Evo sEEG compete with Ad-Tech Medical Instrument Corporation, PMT Corporation and Dixi Medical seizure diagnostic products.
We will also compete against other companies in early stages of development of thin film technologies.

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In the neuro-ablation market, our OneRF Brain
Ablation System competes with Medtronic, Monteris Medical and Clearpoint’s LITT technology, which use MRI guided laser surgical
ablation for use to ablate, necrotize or coagulate soft tissue. There may be other products in development that will compete with us as
well.

Trigeminal Neuralgia

In the market for treating trigeminal neuralgia,
we expect to compete with Boston Scientific and Avanos RF ablation systems, and various companies that use balloon compression for the
treatment of trigeminal neuralgia.

BVNA

In BVNA, we expect to compete with Boston Scientific
and Stryker’s BVNA Systems.

Spinal Cord Stimulation

In spinal cord stimulation, we expect to compete
with Medtronic, Boston Scientific, Abbott, Globus, and Biotronik spinal cord stimulator leads and systems.

Drug Delivery

In Drug Delivery, we expect to compete primarily
with Clearpoint and Sophysa’s (CED) drug delivery system.

Although we will face potential competition from
many different sources, we believe that our technology, knowledge, experience and scientific resources will provide us with competitive
advantages. For a discussion of the key competitive factors that we believe will impact the success of our cortical strip, grid electrodes
under development, if successfully developed and approved, see “—Our Solution” above.

Many of the companies against which we compete
have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting
clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical,
biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel
and establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary
to, or necessary for, our development.

Intellectual Property

Protection of our intellectual property is a strategic
priority for our business. We rely on a combination of patents, trademarks, copyrights, and trade secrets as well as nondisclosure and
assignment of invention agreements, material transfer agreements, confidentiality agreements and other measures to protect our intellectual
property and other proprietary rights.

Patents

As of December 17, 2025, our patent estate consists
of two issued United States patents licensed from WARF covering a neural probe array and thin-film micro electrode array and method,
a U.S. patent issued in October 2022 relating to improved neural depth electrodes, a U.S. patent issued in January 2024 and a pending
U.S. patent application relating to agent-delivering neural electrodes, a U.S. patent issued in January 2024 relating to minimally invasive
electrodes, a U.S. patent issued in February 2024 and a European patent issued in October 2025 relating to spinal cord stimulation systems
and devices, a U.S. patent issued in October 2025 and a pending European patent application published in 2022 relating to methods of
making electrode probes, pending U.S. and European patent applications published in 2023 relating to devices having temperature sensors,
pending U.S. and PCT patent applications published in 2024 relating to deformable spinal cord stimulation devices, three pending U.S.
patent applications, a pending European application and two pending PCT applications filed or published in 2024 or 2025 relating to spinal
cord stimulation device implantation methods, pending U.S. and European patent applications published in 2024 relating to ablation probe
and temperature sensing device systems, and pending U.S. and PCT patent applications filed in 2025 relating to proximal connectors of
probe devices and related manufacturing methods. The licensed issued patents expire between 2028 and 2030, subject to any patent extensions
that may be available for such patents. The issued patents owned by NeuroOne expire between 2039 and 2041. If a patent or patents are
issued on our additional pending patent applications, the resulting patents are projected to expire between 2040 and 2045.

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Our patent applications may not result in issued
patents, and any patents that have been issued or may issue in the future may not protect the commercially important aspects of our technology.
Furthermore, the validity and enforceability of our issued patents may be challenged by third parties and our patents could be invalidated
or modified by the issuing governmental authority. Third parties may independently develop technology that is not covered by our patents
that is similar to, or competes with, our technology. In addition, our intellectual property may be infringed or misappropriated by third
parties, particularly in foreign countries where the laws and governmental authorities may not protect our proprietary rights as effectively
as those in the United States.

The medical device industry in general, and the
recording, ablation and neurostimulation sector of this industry in particular, are characterized by the existence of a large number of
patents and frequent litigation based on assertions of patent infringement. We are aware of numerous patents issued to third parties that
may relate to the technology used in our business, including the design and manufacture of electrodes and pulse generators, as well as
methods for device placement. Each of these patents contains multiple claims, any one of which may be independently asserted against us.
The owners of these patents may assert that the manufacture, use, sale or offer for sale of our cortical strip and grid electrodes infringe
one or more claims of their patents. Furthermore, there may be additional patents issued to third parties of which we are presently unaware
that may relate to aspects of our technology that such third parties could assert against us and materially and adversely affect our business.
In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and
unknown to us, which may later result in issued patents that third parties could assert against us and materially and adversely affect
our business.

Any adverse determination in litigations or post
grant trial proceedings at the Patent Office relating to intellectual property to which we are or may become a party could subject us
to significant liabilities to third parties or require us to seek licenses from third parties, and could result in the cancellation and/or
invalidation of our intellectual property. Furthermore, if a court finds that we have willfully infringed a third party’s intellectual
property, we could be required to pay treble damages and/or attorney fees for the prevailing party, in addition to other penalties. Although
intellectual property disputes in the medical device area are often settled through licensing or similar arrangements, costs associated
with such arrangements can be substantial and often require ongoing royalty payments. We may be unable to obtain necessary licenses on
satisfactory terms, if at all. If we do not obtain necessary licenses, we may not be able to redesign our products to avoid infringement;
if we are able to redesign our products to avoid infringement, we may not receive FDA approval in a timely manner. Adverse determinations
in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our
products, which could have a significant adverse impact on our business.

Trademarks

We have registered U.S. trademarks for the trademarks
“NEUROONE,” “EVO,” and “OneRF.” We also have registered trademarks in the United Kingdom and the European
Union for the trademark OneRF.

Trade Secrets

We also rely on trade secrets, technical
know-how and continuing innovation to develop and maintain our competitive position. We seek to protect such intellectual property
and proprietary information by generally requiring our employees, consultants, contractors, scientific collaborators and other
advisors to execute non-disclosure and assignment of invention agreements upon the commencement of their employment or engagement as
the case may be. Our agreements with our employees prohibit them from providing us with any intellectual property or proprietary
information of third parties. We also generally require confidentiality agreements or material transfer agreements with third
parties that receive or have access to our confidential information, data or other materials. Notwithstanding the foregoing, there
can be no assurance that our employees and third parties that have access to our confidential proprietary information will abide by
the terms of their agreements. Despite the measures that we take to protect our intellectual property and confidential information,
unauthorized third parties may copy aspects of our products or obtain and use our proprietary information.

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Government Regulation (US)

Our cortical strip/grid electrode system, depth
electrode system and radiofrequency (RF) probes and RF generator ablation system are medical devices subject to extensive and ongoing
regulation by the Food and Drug Administration (FDA) and the U.S. Centers for Medicare and Medicaid Services (CMS). Regulations cover
virtually every critical aspect of a medical device company’s business operations, including management responsibility, research
activities, product design and development, quality management system, manufacturing, supplier management, risk management, contracting,
reimbursement, medical communications, sales and marketing. In the United States, the Federal Food, Drug and Cosmetic Act (“FDCA”),
and the implementing regulations of the FDA (specifically, 21 Code of Federal Regulations (21 CFR Parts 801- labeling, 803 - medical device
reporting, 807 - registration and listing, subpart E premarket notification 510k, 812 - investigational device exemption, 814 - premarket
approval and 820 - quality system regulation) and applicable FDA issued guidance’s and regulations govern product design and development,
pre-clinical and clinical testing, premarket clearance or approval, risk management, electrical safety, cybersecurity, software, sterilization,
biocompatibility, product manufacturing, quality systems, import and export, product labeling, product storage, recalls and field safety
corrective actions, advertising and promotion, product sales and distribution, and post-market clinical surveillance. Our business is
subject to federal, state, local and harmonized standards, such as ISO 13485, ISO 14971, and FDA’s Quality System Regulation (“QSR”)
contained in 21 CFR Part 820.

Regulatory Framework in the United States

A product is regulated as a medical device by
the FDA if: 1) the product meets the definition of a medical device per Section 201(h) of the FDCA and 2) an appropriate product classification
exists.

Device classification

The FDA characterizes medical devices into one
of three classes, Class I, II, and III based on risks and regulatory controls necessary to provide a reasonable assurance of safety and
effectiveness. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements
for a general device type. Most Class I devices are exempt from Premarket Notification under 510(k); most Class II devices require Premarket
Notification under 510(k); and most Class III devices require Premarket Approval (“PMA”).

Class I devices are subject to general controls
including labeling. However, most such devices are exempt from pre-market notification. If a device is exempted from any of the general
controls, such exemption is stated in the classification regulation for that device. If an exemption is stated it may pertain to manufacturers’
FDA registration and device listing, methods and documentation of the design, testing, production, control quality assurance, labeling,
packaging, sterilization, storage, shipping of products and post market surveillance.

Class II devices are subject to the same general
controls but may be subject to special controls such as device specific performance standards, post-market surveillance, FDA guidance,
or particularized labeling, and may also require clinical testing prior to clearance.

Class III devices are those for which insufficient
information exists to assure safety and effectiveness solely through general or special controls, including devices that support or sustain
human life, are of substantial importance in preventing impairment of human health, present an unreasonable risk of illness or injury,
or are not well established and generally accepted as safe and effective. Premarket Approval is required for most Class III devices, unless
the device is a preamendments device and the FDA has not called for a PMA.

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Some Class I and Class II devices are exempted
by regulation from the pre-market notification requirement under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, but
must meet the requirement of compliance with substantially all of the QSR. However, a PMA application is required for devices deemed by
the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices, or those that are “not
substantially equivalent” either to a device previously cleared through the 510(k) process or to a “preamendment” Class
III device in commercial distribution before May 28, 1976 when PMA applications were not required. The PMA approval process is more comprehensive
than the 510(k) clearance process and typically takes multiple years to complete.

Based on FDA classifications, our diagnostic cortical
strip/grid electrode system, depth electrode system and RF probes and RF generator diagnostic/therapeutic ablation system technology are
categorized by the FDA as Class II devices that do not require clinical testing and can be filed as a 510(k), similar to existing competitive
technology under the same product classification/product code. The Company expects that indications for treating epilepsy, Parkinson’s
and other patients suffering from motor related neurological deficiencies via a permanent implant for chronic treatment will require a
PMA process to commercially distribute in the United States.

The 510(k) clearance process

Under the 510(k) clearance process, the manufacturer
must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent” to a legally
marketed predicate device. A predicate device is a legally marketed device that was previously found to be substantially equivalent through
the 510(k) process. To be “substantially equivalent,” the proposed device must have the same intended use, indications for
use (product classification/code) as the predicate device, and either have the same technological characteristics as the predicate device
or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device.
Clinical data is sometimes required to support substantial equivalence.

Since October 1, 2023, a 510(k) premarket notification
has been submitted as an electronic submission using the FDA eStar program through the CDRH Portal. The eStar Complete status needs to
be observed for a successful submission. eSTAR submissions are not anticipated to undergo a refuse to accept (“RTA”) process.
However, the FDA intends to employ a virus scanning and technical screening process for an eSTAR. If the eSTAR does not pass technical
screening (i.e., an eSTAR is provided where none of the attachments to a question are relevant to the question, or if an inaccurate response
is provided to any question), the submission may be put on an early Technical Screening hold for 180 days, until a complete replacement
eSTAR is submitted. If it is accepted for filing, the FDA begins a substantive review. The FDA goal is to complete its review of a 510(k)
notification within 90 calendar days of receiving the 510(k) notification. As a practical matter, clearance often takes longer, and clearance
is never assured. Although many 510(k) premarket notifications are cleared without clinical data, the FDA may require further information,
including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review process.
If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market the device.

If the FDA determines that the device is not “substantially
equivalent” to a predicate device, or if the device is automatically classified into Class III, the device sponsor must then fulfill
the more rigorous premarketing requirements of the PMA approval process or seek reclassification of the device through the De Novo process.
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special
controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate
device. De Novo classification is a risk-based classification process. The De Novo classification process is an alternate pathway to classify
medical devices that are automatically classified into Class III but which are low to moderate risk. A manufacturer can submit a Pre-submission
for De Novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device
presents a moderate or low risk.

After a device receives 510(k) clearance, any
modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended
use, will require a new 510(k) clearance or, depending on the modification, could require a De Novo device application and potentially
a PMA application. The FDA requires each manufacturer to determine whether the proposed change requires a new submission in the first
instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many minor modifications are
accomplished by a letter-to-file in which the manufacture documents the change in an internal letter-to-file based on adherence to FDA
guidance on changes to an existing 510(k) device. The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for such
change. The FDA can always review these letters to file in an inspection. If the FDA disagrees with a manufacturer’s determination
regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared device, the FDA can require
the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance is obtained. A De Novo grant or PMA application
approval may also be affected if changes to the initial grant/approval are not evaluated and documented in accordance with FDA regulations.
In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite
application(s).

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The PMA approval process

Following receipt of a PMA application, the FDA
conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it
is not, the agency will refuse to file the PMA. If it is, the FDA will accept the application for filing and begin its review. The FDA
has 180 days to review a filed PMA application, although the review of an application more often occurs over a significantly longer period
of time. During this review period, the FDA may request additional information or clarification of information already provided, and the
FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the
FDA.

Before approving or denying a PMA, an FDA advisory
committee may review the PMA at a public meeting and provide the FDA with the committee’s recommendation on whether the FDA should
approve the submission, approve it with specific conditions, or not approve it. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.

Prior to approval of a PMA, the FDA may conduct
inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes. Overall,
the FDA review of a PMA application generally takes between one and three years but may take significantly longer. The FDA can delay,
limit or deny approval of a PMA application for many reasons, including:

●the device may not be safe, effective, reliable or accurate
to the FDA’s satisfaction;

●the data from pre-clinical studies and clinical trials may
be insufficient to support approval;

●the manufacturing process or facilities may not meet applicable
requirements; and

●changes in FDA approval policies or adoption of new regulations
may require additional data.

If an FDA evaluation of a PMA application is favorable,
the FDA will either issue an approval letter or an approvable letter, which usually contains a number of conditions that must be met in
order to secure final approval of the PMA. When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency
will issue a PMA approval letter authorizing commercial marketing of a device, subject to the conditions of approval and the limitations
established in the approval letter. If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the
FDA will deny approval of the PMA or issue a not approvable letter. The FDA also may determine that additional tests or clinical trials
are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted
in an amendment to the PMA under review. The PMA process can be expensive, uncertain and lengthy and a number of devices for which FDA
approval has been sought by other companies have never been approved by the FDA for marketing.

New PMA applications or PMA supplements may be
required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that has been
approved through the PMA process. PMA supplements often require submission of the same type of information as was presented in the initial
PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved
PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel.

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Clinical Trials

Clinical trials are typically required to support
a PMA application and are sometimes required for a 510(k) clearance. These trials generally require submission of an application for an
Investigational Device Exemption (“IDE”), to the FDA. The IDE application must be supported by appropriate data, such as animal
and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.
The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant
risk device and eligible for abbreviated IDE requirements. Generally, clinical trials for a significant risk device may begin once the
IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards
at the clinical trial sites. The FDA’s approval of an IDE allows clinical testing to go forward, but it does not bind the FDA to
accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success
criteria. All clinical trials performed in the United States must be conducted in accordance with the FDA’s IDE regulations that
govern investigational device labeling, prohibit promotion, and specify an array of recordkeeping, reporting and monitoring responsibilities
of study sponsors and study investigators. Clinical trials must further comply with the FDA’s regulations for institutional review
board approval and for informed consent and other human subject protections. Required records and reports are subject to inspection by
the FDA. The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved,
may not be considered sufficient for the FDA to grant approval or clearance of a product. Clinical trials must be entered into the clinical
trials registry at clinicaltrials.gov.

The commencement or completion of any clinical
trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited
to, the following:

●the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial,
or place a clinical trial on hold;

●patients do not enroll in clinical trials at the rate expected;

●patients, sponsor (NeuroOne) or study sites do not comply with trial protocols;

●patient follow-up is not at the rate expected;

●patients experience unanticipated adverse event;

●the data safety monitoring board determines the study should be placed on hold;

●patients die during a clinical trial, even though their death may not be related to the products that
are part of our trial;

●institutional review boards and third-party clinical investigators may delay or reject the trial protocol;

●third-party clinical investigators decline to participate in a trial or do not perform a trial on the
anticipated schedule or consistent with the clinical trial protocol, good clinical practices or other FDA requirements;

●the sponsor (NeuroOne) or third-party organizations do not perform data collection, monitoring and analysis
in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans;

●third-party clinical investigators have significant financial interests related to the sponsor (NeuroOne)
or the study that the FDA deems to make the study results unreliable, or the Company or investigators fail to disclose such interests;

●regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things,
require us to undertake corrective action or suspend or terminate our clinical trials;

●changes in governmental regulations or administrative actions;

●the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or efficacy;
and

●the FDA concludes that our trial design is inadequate to demonstrate safety and efficacy.

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Other Regulatory Requirements

Even after a device receives clearance or approval
and is placed in commercial distribution, numerous regulatory requirements apply. These include:

●establishment registration and device listing;

●Quality System Regulation (QSR), which requires manufacturers, including third party manufacturers, to
follow stringent design, testing, risk management, production control, supplier/contractor selection, complaint handling, documentation
and other quality assurance procedures during all aspects of the manufacturing process;

●labeling regulations that prohibit the promotion of products for uncleared, unapproved or “off-label”
uses, and impose other restrictions on labeling, advertising and promotion;

●Medical Device Reporting (MDR) regulations, which require that manufacturers report to the FDA if their
device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to
a death or serious injury if the malfunction were to recur;

●voluntary and mandatory device recalls to address problems when a device is mislabeled or does not meet
specifications and could be a risk to health; and

●corrections and removals reporting regulations, which require that manufacturers report to the FDA field
corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the
FDCA that may present a risk to health.

Also, the FDA may require us to conduct post-market
surveillance studies or establish and maintain a system for tracking our products through the chain of distribution to the patient level.
The FDA enforces regulatory requirements by conducting periodic, unannounced inspections and market surveillance. Inspections may include
the manufacturing facilities of our subcontractors.

Failure to comply with applicable regulatory requirements
can result in enforcement actions by the FDA and other regulatory agencies. These may include any of the following sanctions or consequences:

●warning letters or untitled letters that require corrective action;

●fines and civil penalties;

●unanticipated expenditures;

●delays in approving or refusal to approve future products;

●FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries;

●suspension or withdrawal of FDA clearance or approval;

●product recall or seizure; interruption of production;

●operating restrictions;

●injunctions; and

●criminal prosecution.

Our contract manufacturers, specification developers
and some suppliers of components or device accessories, also are required to manufacture our products in compliance with current good
manufacturing practice requirements set forth in the QSR. The QSR requires a quality system for the design, risk management, manufacture,
packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality
management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process
controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.
The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our
subcontractors. If the FDA believes that any of our contract manufacturers or regulated suppliers are not in compliance with these requirements,
it can shut down such manufacturing operations, require a recall of our products, refuse to approve new marketing applications, institute
legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers
or other employees.

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State Fraud and Abuse Provisions

Many states have also adopted some form of anti-kickback
and anti-referral laws and a false claims act. We believe that we are in conformance to such laws. Nevertheless, a determination of liability
under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Physician Payment Sunshine Act

Transparency laws regarding payments or other
items of value provided to healthcare providers and teaching hospitals may also impact our business practices. The federal Physician Payment
Sunshine Act requires most medical device manufacturers to report annually to the Centers for Medicare & Medicaid Services (CMS) financial
arrangements, payments, or other transfers of value made by that entity to physicians and teaching hospitals.

The payment information is made publicly available
in a searchable format on the Open Payments database. In the coming years, we will invest significant resources to develop and maintain
robust systems and processes that enhance compliance with these regulations. Failure to comply with the reporting requirements can
result in significant monetary penalties. Similar laws may have been enacted or are under consideration in foreign jurisdictions.

Human Capital

As of September 30, 2025, we had 18 employees,
all of whom are full-time, eight of whom are engaged in research and development activities, and all of whom are located in the United
States. As of September 30, 2025, we also retained the services of approximately 8 regular consultants. None of our employees are represented
by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

Corporate Overview and History of NeuroOne,
Inc.

We were originally incorporated as Original Source
Entertainment, Inc. under the laws of the State of Nevada on August 20, 2009. 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, and we changed our name to
NeuroOne Medical Technologies Corporation and we reincorporated in Delaware.

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.

Over the years, our cortical sheet electrode and
depth electrode technology have been tested 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.

Corporate Information

Our principal executive offices are located at
7599 Anagram Drive, Eden Prairie, Minnesota 55344, and our telephone number is 952-426-1383. Our website address is www.nmtc1.com Information
on our website is not part of this Annual Report.

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