NeuroOne Eyes Billion-Dollar Markets with New Neurological Devices

TL;DR

**NMTC is a high-risk, high-reward bet on innovative neurotech, but profitability and market penetration remain major hurdles.**

AI Summary

NeuroOne Medical Technologies Corp (NMTC) is a medical technology company focused on diagnostic, ablation, and deep brain stimulation technologies for neurological conditions and pain management. For the fiscal year ended September 30, 2025, the company reported a market value of common stock held by non-affiliates at $25.5 million as of March 31, 2025, with 50,413,148 shares outstanding as of December 12, 2025. NMTC has received 510(k) clearance from the FDA for four devices: Evo Cortical, Evo sEEG, OneRF Brain Ablation System, and OneRF TN Ablation System. A distribution agreement with Zimmer, Inc. covers the commercialization of Evo Cortical, Evo sEEG, and OneRF Brain Ablation System. The OneRF TN Ablation System initiated a limited market release in December 2025. Key risks include the ability to successfully commercialize technology, maintain regulatory clearance, achieve profitability, and raise additional capital. The strategic outlook involves developing 'all-in-one solutions' for epilepsy, Parkinson's, and chronic pain, with a drug delivery system already ordered for preclinical research, targeting a market potentially over $1 billion.

Why It Matters

NeuroOne's pursuit of 'all-in-one solutions' for neurological disorders like epilepsy and Parkinson's disease, alongside chronic pain management, could significantly disrupt existing treatment paradigms. By offering less invasive diagnostic and therapeutic options, NMTC aims to address underpenetrated markets, such as the epilepsy surgery market, where only 5,000 surgeries are performed annually despite 3 million patients. Success in commercialization and regulatory approvals, especially for its drug delivery system, could position NMTC as a key innovator, potentially impacting competitors like Medtronic and Boston Scientific in the neurostimulation and ablation space, and offering improved outcomes for patients.

Risk Assessment

Risk Level: high — The company explicitly states risks including its 'ability to achieve and sustain profitability' and 'ability to raise additional capital and to fund our operations.' Furthermore, the aggregate market value of shares held by non-affiliates was only $25.5 million as of March 31, 2025, indicating a small market capitalization and potential volatility. Many products are still 'under development,' adding significant uncertainty to future revenue streams.

Analyst Insight

Investors should approach NMTC with extreme caution, recognizing its early-stage commercialization and significant capital needs. Monitor closely for updates on FDA clearances for products in development, especially the drug delivery system, and any new distribution agreements beyond Zimmer, Inc. as these will be critical indicators of future growth potential.

Key Numbers

• $25.5M — Market Value of Non-Affiliate Shares (As of March 31, 2025, indicating a relatively small market capitalization.)
• 50.4M — Outstanding Shares (As of December 12, 2025, reflecting the company's share count.)
• 4 — FDA 510(k) Clearances (Number of devices cleared by the FDA, including Evo Cortical, Evo sEEG, OneRF Brain Ablation, and OneRF TN Ablation Systems.)
• 3M — Epilepsy Patients in US (Estimated annual patients suffering from epilepsy in the United States, highlighting a large target market.)
• 5,000 — Epilepsy Surgeries Annually (Estimated number of epilepsy surgeries performed each year in the United States, indicating an underpenetrated market.)
• $10,000 — Average Diagnostic Technology Cost (Per procedure, which NMTC aims to reduce with its 'all-in-one' solutions.)
• $15,000 — Average Ablation Device Cost (Per procedure, another cost NMTC's integrated solutions could impact.)
• 150,000 — Trigeminal Neuralgia Patients in US (Number of people living with TN in the US, representing another significant market.)
• $2.5B-$3B — Global SCS Market Value (Estimated value of the global Spinal Cord Stimulation market, a target for NMTC's products in development.)
• $1B+ — Potential Drug Delivery Market (Estimated full market commercial opportunity for NMTC's drug delivery application.)

Key Players & Entities

• NeuroOne Medical Technologies Corporation (company) — Registrant
• Zimmer, Inc. (company) — Distribution partner for Evo Cortical, Evo sEEG, and OneRF Brain Ablation System
• Food and Drug Administration (regulator) — Granted 510(k) clearance for four devices
• Evo Cortical (company) — FDA-cleared cortical electrode technology
• Evo sEEG (company) — FDA-cleared sEEG electrode technology
• OneRF Brain Ablation System (company) — FDA-cleared radiofrequency ablation system for brain procedures
• OneRF TN Ablation System (company) — FDA-cleared radiofrequency ablation system for pain treatment, limited market release in December 2025
• $25.5 million (dollar_amount) — Aggregate market value of common stock held by non-affiliates as of March 31, 2025
• 50,413,148 (dollar_amount) — Outstanding shares of common stock as of December 12, 2025
• $1 billion (dollar_amount) — Potential full market commercial opportunity for drug delivery application

FAQ

Risk Factors

• Commercialization and Market Adoption [high — market]: The company's success is heavily dependent on its ability to successfully commercialize its diagnostic, ablation, and deep brain stimulation technologies. This includes gaining market acceptance for its Evo Cortical, Evo sEEG, and OneRF Brain Ablation System through its distribution agreement with Zimmer, Inc., and the limited release of the OneRF TN Ablation System. Failure to achieve widespread adoption could materially impact revenue and growth prospects.
• Maintaining Regulatory Clearances [high — regulatory]: NMTC has obtained FDA 510(k) clearance for four key devices. However, maintaining these clearances and obtaining future approvals for new or expanded indications is critical. Any adverse regulatory actions, recalls, or changes in regulatory requirements could disrupt product availability and sales, posing a significant risk.
• Need for Additional Capital [high — financial]: As a development-stage medical technology company, NMTC faces the ongoing risk of needing to raise additional capital to fund its operations, research and development, and commercialization efforts. The market value of common stock held by non-affiliates was $25.5 million as of March 31, 2025, indicating a relatively small market capitalization. Inability to secure necessary funding could hinder its ability to execute its strategic plans.
• Achieving Profitability [medium — financial]: The company has not yet achieved profitability. The ability to transition from development to profitable commercialization is a key risk. Factors such as market penetration, pricing strategies, and cost management will be crucial in achieving sustainable profitability.
• Dependence on Distribution Partners [medium — operational]: The commercialization of Evo Cortical, Evo sEEG, and OneRF Brain Ablation System relies on a distribution agreement with Zimmer, Inc. The company's performance is therefore significantly tied to the effectiveness of this partnership. Any disputes, changes in the relationship, or underperformance by Zimmer could negatively impact sales and market reach.
• Competition in Neurological Therapies [medium — market]: The markets for epilepsy, Parkinson's disease, and pain management are competitive, with established players and emerging technologies. NMTC's success will depend on its ability to differentiate its 'all-in-one solutions' and demonstrate superior clinical and economic value compared to existing treatments.

Industry Context

NeuroOne Medical Technologies operates in the highly competitive and regulated medical device sector, specifically focusing on neurological disorders and pain management. The industry is characterized by significant R&D investment, long product development cycles, and stringent FDA approval processes. Key trends include the development of minimally invasive technologies, integrated diagnostic and therapeutic solutions, and the increasing demand for treatments for conditions like epilepsy, Parkinson's, and chronic pain.

Regulatory Implications

NMTC's business is heavily reliant on FDA regulatory approvals, particularly 510(k) clearances for its devices. Maintaining these clearances and navigating the evolving regulatory landscape are critical. Any delays, recalls, or changes in FDA requirements could significantly impact the company's ability to market and sell its products, posing a substantial risk to its commercialization strategy.

What Investors Should Do

1. Monitor commercialization progress and Zimmer partnership performance.
2. Evaluate the company's ability to secure future funding.
3. Assess progress towards profitability.
4. Track new product development and regulatory milestones.

Key Dates

• 2025-12-01: Limited market release of the OneRF TN Ablation System initiated. — Marks the beginning of commercialization efforts for a new pain management device, targeting the Trigeminal Neuralgia patient population.
• 2025-12-12: 50,413,148 shares outstanding. — Provides an updated share count, relevant for per-share calculations and market capitalization assessments.
• 2025-03-31: Market value of common stock held by non-affiliates was $25.5 million. — Indicates the company's market capitalization as of this date, reflecting investor valuation and its relatively small size.

Glossary

510(k) clearance

A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. (NMTC has obtained this clearance for four of its key devices, signifying FDA approval for marketing in the US.)

Evo Cortical

NMTC's thin film electrode technology for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain. (A key commercialized product with FDA 510(k) clearance, part of the distribution agreement with Zimmer, Inc.)

Evo sEEG

NMTC's thin film electrode technology for temporary (less than 30 days) use for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. (Another FDA-cleared product, crucial for diagnosing neurological disorders and part of the Zimmer distribution agreement.)

OneRF Brain Ablation System

NMTC's system for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures, featuring bedside monitoring, mapping, and ablation. (An FDA-cleared device for brain ablation, included in the distribution agreement with Zimmer, Inc.)

OneRF TN Ablation System

NMTC's system for creating radiofrequency lesions for the treatment of pain or lesioning nerve tissue for functional neurosurgical procedures, specifically for Trigeminal Neuralgia. (Recently initiated limited market release, targeting a specific pain management indication.)

Functional Neurosurgery

A type of surgery that aims to modify brain function to alleviate symptoms of neurological or psychiatric disorders. (The OneRF systems are indicated for use in these types of procedures.)

iEEG

Intracranial Electroencephalography, a method of recording brain activity directly from the surface of the brain. (The Evo Cortical electrodes are used in iEEG surgeries.)

Year-Over-Year Comparison

Information comparing key metrics to the previous year, such as revenue growth, margin changes, and new risks, is not available from the provided text. The 10-K filing itself would contain this comparative analysis within the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' section.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 par value per share NMTC The Nasdaq Sto
• $15.5 billion — e that epilepsy costs the United States $15.5 billion per year. Approximately 30-40% of these
• $10,000 — technology per procedure could be over $10,000, with ablation devices costing >$15,000
• $15,000 — $10,000, with ablation devices costing >$15,000. We believe our technology, once develo
• $2.5 — ith an estimated value of approximately $2.5 to $3 billion. The chronic back pain m
• $3 billion — stimated value of approximately $2.5 to $3 billion. The chronic back pain market includes
• $100 million — d in the United States is approximately $100 million per year (>10,000 procedures per year),
• $50 million — rch in drug development is greater than $50 million. Additionally, we are in early conversa
• $1 billion — e of application to be potentially over $1 billion. Parkinson's Disease The Parkinson's

Filing Documents

• ea0268749-10k_neuroone.htm (10-K) — 1252KB
• ea026874901ex19-1_neuroone.htm (EX-19.1) — 157KB
• ea026874901ex23-1_neuroone.htm (EX-23.1) — 2KB
• ea026874901ex31-1_neuroone.htm (EX-31.1) — 8KB
• ea026874901ex31-2_neuroone.htm (EX-31.2) — 8KB
• ea026874901ex32-1_neuroone.htm (EX-32.1) — 4KB
• ea026874901ex32-2_neuroone.htm (EX-32.2) — 4KB
• ex19-1_001.jpg (GRAPHIC) — 11KB
• 0001213900-25-122390.txt ( ) — 6544KB
• nmtc-20250930.xsd (EX-101.SCH) — 61KB
• nmtc-20250930_cal.xml (EX-101.CAL) — 45KB
• nmtc-20250930_def.xml (EX-101.DEF) — 279KB
• nmtc-20250930_lab.xml (EX-101.LAB) — 564KB
• nmtc-20250930_pre.xml (EX-101.PRE) — 304KB
• ea0268749-10k_neuroone_htm.xml (XML) — 625KB

BUSINESS

BUSINESS 1 ITEM 1A.

RISK FACTORS

RISK FACTORS 20 ITEM 1B. UNRESOLVED STAFF COMMENTS 51 ITEM 1C. CYBERSECURITY 51 ITEM 2.

PROPERTIES

PROPERTIES 52 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 52 ITEM 4. MINE SAFETY DISCLOSURES 52 PART II 53 ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 53 ITEM 6. [RESERVED] 53 ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 54 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 63 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA F-1 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 65 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 65 ITEM 9B. OTHER INFORMATION 66 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 66 PART III 67 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 67 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 67 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 67 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 67 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 67 PART IV 68 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 68 ITEM 16. FORM 10-K SUMMARY 71

SIGNATURES

SIGNATURES 72 i NeuroOne Medical Technologies Corporation FORM 10-K 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 successfully commercialize our technology in the United States; the results of our development and distribution relationship with Zimmer, Inc. ("Zimmer") and other future partnerships and collaborations; the performance and relia

Forward-looking statements are based on management's

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 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 I

BUSINESS

ITEM 1. BUSINESS Overview We are a medical technology company focused on (i) diagnostic, ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson's disease; (ii) ablation and stimulation for pain management throughout the body; and (iii) drug delivery including diagnostic and stimulation capabilities. We have received 510(k) clearance for four of our devices from the Food and Drug Administration ("FDA"), including: (i) our Evo cortical electrode technology for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain ("Evo Cortical"), (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain ("Evo sEEG"), (iii) our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures ("OneRF Brain Ablation System"), and (iv) our OneRF TN ablation system for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures ("OneRF TN Ablation System"). We have a distribution agreement with Zimmer, Inc. ("Zimmer") providing Zimmer Biomet Holdings, Inc. with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and OneRF Brain Ablation System in the brain. We initiated a limited market release of the OneRF TN Ablation System in December 2025. The Company's other products and indications are still under development. 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 Pr

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