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What changed in NEUROONE MEDICAL TECHNOLOGIES Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of NEUROONE MEDICAL TECHNOLOGIES Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+375 added−508 removedSource: 10-K (2025-12-17) vs 10-K (2024-12-17)

Top changes in NEUROONE MEDICAL TECHNOLOGIES Corp's 2025 10-K

375 paragraphs added · 508 removed · 267 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

92 edited+37 added−146 removed93 unchanged
Biggest changeIn 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. ● Facilitating partnerships for drug delivery : Partner with biotech, pharmaceutical or biopharma companies to provide a drug delivery sEEG electrode capable of delivering the therapy and recording before, during and after the therapy is delivered for up to 30 days. ● Investigate the potential applications associated with artificial intelligence : We have been informed by some of our corporate advisors that the ability to offer scale-able electrode technology that can provide thousands of electrodes in the brain may be helpful in treating medical conditions that may benefit from using artificial intelligence.
Biggest changeNeuroOne’s platform thin film technology has the capability to increase the number of contacts in a similar footprint that has fewer contacts. ● 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. ● 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.
Under the terms of the Distribution Agreement, we are responsible for all costs and expenses related to developing the Strip/Grid Products, the Electrode Cable Assembly Products, the sEEG Products and the OneRF Products (collectively the “Products”), and Zimmer is responsible for all costs and expenses related to the commercialization of the Products.
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 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.
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.
If an FDA evaluation of a PMA application is favorable, the FDA will either issue an approval letter, or approvable letter, which usually contains a number of conditions that must be met in order to secure final approval of the PMA.
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.
Although the currently available systems provide diagnosis and treatment for patients, they have certain inherent limitations and shortcomings that we believe limit their use and validate the need for improved technology in the market.
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.
Termination of this partnership would harm our business, and even if this partnership continues, it may not be successful.” Commercialization, Sales and Marketing Zimmer 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 “Original Distribution Agreement”) with Zimmer, pursuant to which we granted Zimmer exclusive global rights to distribute NeuroOne’s strip and grid cortical electrodes (the “Strip/Grid Products”) and electrode cable assembly products (the “Electrode Cable Assembly Products”), including to approximately 188 Level 4 epilepsy centers.
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.
The back pain market includes the following indications: FBSS, Ischemic Limb Pain, and Complex Regional Pain Syndrome. Over half of this market is comprised of patients with FBSS. Studies have indicated a benefit for some patients suffering from chronic back and lower limb pain when they have been treated with electrical stimulation.
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.
This causes significant patient inconvenience, use of precious hospital resources and tremendous cost to the system. ● Limited number of contacts on an electrode : Paddle electrodes currently are available in a variety of sizes and number of contacts.
This causes significant patient inconvenience, use of precious hospital resources and tremendous cost to the system. ● Limited number of contacts on an electrode : SCS electrodes currently are available in a variety of sizes and number of contacts.
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 govern product design and development, pre-clinical and clinical testing, premarket clearance or approval, risk management, product manufacturing, quality systems, import and export, product labeling, product storage, recalls and field safety corrective actions, advertising and promotion, product sales and distribution, and post-market clinical surveillance.
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.
The Zimmer Distribution Agreement will expire on September 30, 2034, unless terminated earlier pursuant to its terms. Either party may terminate the Amended and Restated Distribution Agreement (x) with written notice for the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.
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.
To be “substantially equivalent,” the proposed device must have the same intended use, indications for use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence.
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.
These include: ● establishment registration and device listing; ● QSR, which requires manufacturers, including third party manufacturers, to follow stringent design, testing, risk management, production control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process; ● labeling regulations that prohibit the promotion of products for uncleared, unapproved or “off-label” uses, and impose other restrictions on labeling, advertising and promotion; 22 NeuroOne Medical Technologies Corporation FORM 10-K ● 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.
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.
This future device is intended to deliver neurological drugs or gene therapy that are FDA approved or that are currently planned for clinical trials or in development to allow for monitoring, recording and stimulation and drug delivery for less than 30 days.
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.
Clinical trials must be entered into the clinical trials registry at clinicaltrials.gov. 21 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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. 17 NeuroOne Medical Technologies Corporation FORM 10-K Other Regulatory Requirements Even after a device receives clearance or approval and is placed in commercial distribution, numerous regulatory requirements apply.
Research and Development Our research and development team, which includes our Director of Electrode Development, utilizes advice from leading experts in the neurotech field on our scientific advisory board and is focused on the development of thin film cortical grid and strip electrodes and depth electrodes for recording, ablation and chronic stimulation for brain related disorders as well as stimulation for spinal cord stimulation for back related pain.
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.
Approximately 30-40% of these patients are not receptive to pharmaceutical treatment and therefore are appropriate for surgical treatment of this disorder. In addition to poor 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.
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.
Human Capital As of September 30, 2024, we had 17 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, 2024, we also retained the services of approximately 8 regular consultants.
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.
Since October 1, 2023, a 510(k) premarket notification is submitted as an electronic submission using the FDA eStar program through the CDRH Porta. 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.
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.
If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a De Novo or PMA application is obtained.
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.
If a patent or patents are issued on our additional pending patent applications, the resulting patents are projected to expire between 2040 and 2043. 17 NeuroOne Medical Technologies Corporation FORM 10-K Our patent applications may not result in issued patents, and any patents that have been issued or may be issued in the future may not protect the commercially important aspects of our technology.
If a patent or patents are issued on our additional pending patent applications, the resulting patents are projected to expire between 2040 and 2045. 12 NeuroOne Medical Technologies Corporation FORM 10-K 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.
The licensed issued patents expire between 2025 and 2030, subject to any patent extensions that may be available for such patents. The issued patents owned by NeuroOne expire between 2040 and 2041.
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.
Patents As of September 30, 2024, our patent estate consists of three issued United States patents licensed from WARF covering a neural probe array and thin-film micro electrode array and method, a U.S. patent issued in October 2022 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 and a pending European patent application published in 2020 relating to minimally invasive electrodes, a U.S. patent issued in February 2024 and a pending European patent application published in 2021 relating to spinal cord stimulation systems and devices, pending U.S. and European patent applications 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 and a PCT application filed or published in 2024 relating to spinal cord stimulation device implantation methods, and pending U.S. and PCT patent applications published in 2024 relating to ablation probe and temperature sensing device systems.
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.
In 2024, we completed the development of a percutaneous delivery system and conducted benchtop, animal and cadaver studies of both the percutaneous delivery system and various design iterations of paddle electrodes. This device is in early stages of development.
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.
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.
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.
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.
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.
In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite application(s). The PMA approval process Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review.
In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite application(s). 15 NeuroOne Medical Technologies Corporation FORM 10-K 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.
These pre-clinical tests have demonstrated that the technology is capable of recording, ablation and acute stimulation. 26 NeuroOne Medical Technologies Corporation Form 10-K Corporate Information Our principal executive offices are located at 7599 Anagram Drive, Eden Prairie, Minnesota 55344, and our telephone number is 952-426-1383.
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.
Based on FDA classifications, our diagnostic cortical strip, grid and depth electrode and RF ablation technology are categorized by the FDA as Class II devices that do not require clinical testing and can be filed as a 510(k), similar to existing competitive technology.
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 federal Physician Payment Sunshine Act requires most medical device manufacturers to report annually to the Secretary of Human Health Services financial arrangements, payments, or other transfers of value made by that entity to physicians and teaching hospitals. The payment information is made publicly available in a searchable format on a CMS website.
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.
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.
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.
CMS. Regulations cover virtually every critical aspect of a medical device company’s business operations, including research activities, product development, quality, manufacturing, supplier management, risk management, contracting, reimbursement, medical communications, sales and marketing.
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.
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.
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.
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. 18 NeuroOne Medical Technologies Corporation FORM 10-K Government Regulation Our cortical strip, grid and depth electrodes are medical devices subject to extensive and ongoing regulation by the FDA and the U.S.
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. 13 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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.
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.
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.
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.
In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), we have a period of 180 calendar days from July 11, 2024, or until January 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
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.
We have received 510(k) clearance for three of our devices from the Food and Drug Administration (“FDA”), including: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days, (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and (iii) our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
We have 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”).
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.
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. 16 NeuroOne Medical Technologies Corporation FORM 10-K Clinical Trials Clinical trials are typically required to support a PMA application and are sometimes required for a 510(k) clearance.
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; ● 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. 15 NeuroOne Medical Technologies Corporation FORM 10-K We believe that many of the indications we are pursuing with our technologies are currently reimbursed on a widespread basis by Medicare, Medicaid and private insurance companies.
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; 10 NeuroOne Medical Technologies Corporation FORM 10-K ● 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.
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.
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.
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.
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.
Nasdaq Nasdaq Minimum Bid Price Notification On July 11, 2024, we received a letter (the “Notice”) from the Listing Qualifications Department (the “Staff”) of Nasdaq Stock Market (“Nasdaq”) notifying that because the closing bid price of the our common stock was below $1.00 per share for the prior 30 consecutive business days, we are not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
Net proceeds to the Company were approximately $8.2 million. 9 NeuroOne Medical Technologies Corporation FORM 10-K 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”).
Over the next several years, we will need to dedicate significant resources to establish and maintain systems and processes in order to comply with these regulations. Failure to comply with the reporting requirements can result in significant civil monetary penalties. Similar laws have been enacted or are under consideration in foreign jurisdictions.
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.
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” and “EVO.” We have a pending U.S. trademark application for the trademark OneRF.
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.
Minimally invasive and percutaneously placed technologies have become almost a requirement for adoption with patients and physicians. In addition, our technology in the future offers the ability to increase the number of contacts on a film that traditionally offers fewer contacts.
Minimally invasive and percutaneously placed technologies have become almost a requirement for adoption with patients and physicians. ● 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.
Our website address is www.nmtc1.com Information on our website is not part of this Annual Report.
Our website address is www.nmtc1.com Information on our website is not part of this Annual Report. 19 NeuroOne Medical Technologies Corporation FORM 10-K
Many of the companies against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
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.
Epilepsy can be caused by a variety of conditions that affect a person’s brain, some of which are: stroke, brain tumor, traumatic brain injury and central nervous system infections.
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.
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. 13 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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.
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.
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. 14 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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. 23 NeuroOne Medical Technologies Corporation FORM 10-K The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and Similar Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Health Information We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
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. 18 NeuroOne Medical Technologies Corporation FORM 10-K 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 intend to expand our product offerings to include less invasive means and all-in-one solutions, thus providing both patients and physicians better options to treat epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological disorders.
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.
We will also compete against other companies in early stages of development of thin film technologies. 16 NeuroOne Medical Technologies Corporation FORM 10-K In the neuro-ablation market, we expect to compete with Medtronic’s Visualase guided-laser ablation technology and Monteris Medical’s NeuroBlate technology, which use MRI guided laser surgical ablation for use to ablate, necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
We will also compete against other companies in early stages of development of thin film technologies. 11 NeuroOne Medical Technologies Corporation FORM 10-K 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.
Parkinson’s Disease The Parkinson’s Disease Foundation estimates that as many as 1,000,000 patients in the United States live with Parkinson’s disease with an additional 60,000 patients diagnosed per year. Over 10,000,000 patients worldwide are living with Parkinson’s disease. There have not been any drugs introduced that have been effective at treating all patients with Parkinson’s disease.
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.
We believe our technology, once developed, will offer an all-in-one solution with diagnostic and therapeutic capabilities. 1 Epilepsy surgery in the United States: Analysis of data from the National Association of Epilepsy Centers 2015 Epilepsy Research. 2 NeuroOne Medical Technologies Corporation FORM 10-K Many leading neurologists believe that the limits of today’s current technologies are the reason the exact affected area of the brain causing epileptic seizures is not well-determined.
We believe our technology, 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.
Our Evo sEEG electrode technology has received FDA 510(k) clearance from the FDA for use (less than 30 days) with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
Our Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes. ● 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.
We believe our technology provides a number of advantages over other commercially available technologies, including the following: ● Our proprietary thin film technology has a smaller footprint with many more electrodes. ● We expect that our technology will eventually be able to be implanted using a minimally invasive procedure utilizing a dime sized burr hole rather than a full craniotomy. ● Our technology provides more accurate detection of irregular brain activity over other currently available technology.
We believe our technology provides a number of advantages over other commercially available technologies, including the following: ● We expect that our technology may be implanted using a less invasive procedure utilizing a burr hole rather than a full craniotomy. ● Our technology provides accurate detection of irregular brain activity and may be used for the treatment of the condition.
Currently, we are preparing a combination recording, stimulation and RF ablation technology that will perform both diagnostic and therapeutic functions for commercialization. ● Percutaneous placement of spinal cord stimulation paddle electrodes with scalability options : 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.
The innovative multi-contact probe may enable stimulation/mapping and ablation in fewer cycles, and may significantly reduce patient discomfort and procedure complexity. ● 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.
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.
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.
ARF 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.
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. 7 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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. 19 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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.
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 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.
A predicate device is a legally marketed device that was previously found substantially equivalent through the 510(k) process.
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.
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.
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 intend to submit a new 510(k) application for a facial pain ablation system which leverages the existing RF ablation generator. ● Develop percutaneous placed electrodes for spinal cord and peripheral stimulation for pain management with scalable contact configurations : Given that many surgically placed technologies have become less invasive due to patient and physician demands, we believe that our flexible thin film technology will allow for percutaneous placement of “paddle” shaped electrodes, thus potentially eliminating the need to make a more invasive surgical procedure.
This system may also allow for reduced procedural time, as well as improved patient comfort and safety. ● 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.
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.
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.
This pertains 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.
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.
Ablation and stimulation for pain management throughout the body ● Spinal Cord Stimulation (“SCS”), under development : This method under our development addresses chronic back pain from failed back surgery syndrome (“FBSS”) by placing electrodes in the spine connected to an implantable pulse generator.
We also intend to offer drug delivery devices for pre-clinical animal models. Recording, Ablation and stimulation for pain management throughout the body ● Spinal Cord Stimulation (“SCS”) : This system addresses chronic back pain (CBP) by placing electrodes in the spine connected to an implantable pulse generator.
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. 12 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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.
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. Diagnostic, ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson’s disease ● cEEG Recording : This involves a continuous recording of the brain’s electrical activity to identify irregularities.
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.
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.
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).
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”).
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.
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. 20 NeuroOne Medical Technologies Corporation FORM 10-K 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.
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.
Unlike ablative technologies, DBS effects are reversible. 1 NeuroOne Medical Technologies Corporation FORM 10-K Drug delivery including diagnostic and stimulation capabilities ● Future neurological drugs delivery : We are also researching and developing the capability to use our sEEG electrode technology to deliver drugs or gene therapy while being able to record brain activity before, during, and after delivery.
This system may allow for reduced procedural time, improved patient comfort and improved patient safety. 1 NeuroOne Medical Technologies Corporation FORM 10-K Products in Development Drug delivery including diagnostic and stimulation capabilities ● 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.
The invasiveness, procedural times and possible surgical complications have limited the growth of surgical treatment of epilepsy. 4 NeuroOne Medical Technologies Corporation FORM 10-K ● 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.
These limitations include: ● 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.
As previously mentioned, we are actively evaluating the potential to offer electrodes that can be implanted for long term stimulation applications, but such use will require that we pursue additional approvals from the FDA and any international regulatory bodies where we seek to commercialize our technology. 6 NeuroOne Medical Technologies Corporation FORM 10-K ● 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.
We established an advisory board for our BVNA development program in October 2025. ● 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.
But we hope to change that paradigm by creating “paddle” electrodes that can be implanted percutaneously (less invasively) through a “needle hole incision”. By leveraging our existing FDA cleared cortical electrode and sEEG technology, we may also be able to offer the ability to improve precision of where the stimulation is delivered.
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.
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.
Additionally, we granted Zimmer the exclusive right and license to distribute certain depth electrodes developed by the Company (the “sEEG Products”).
Despite the large market opportunity, it is estimated that there are only less than 5,000 epilepsy surgeries performed each year in the United States. 1 These numbers represent an underpenetrated market due to the invasiveness of diagnostic procedures. After the diagnostic procedure, a second therapeutic procedure is required and at times even a third surgery if the seizures persist.
Despite the large market opportunity, it is estimated only about 5,000 epilepsy surgeries performed each year in the United States. 1 1 Epilepsy surgery in the United States: Analysis of data from the National Association of Epilepsy Centers 2015 Epilepsy Research. 2 NeuroOne Medical Technologies Corporation FORM 10-K These numbers represent an underpenetrated market due to the invasiveness of diagnostic procedures.
We have a distribution agreement with Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute these three products in the brain. The Company’s other products and indications are still under development. Products We are focused on developing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectroencephalography (“sEEG”) recording.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our products, including: ● regulators may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● the failure to successfully complete pre-clinical testing requirements required by the FDA; ● we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts with third parties or clinical trial protocols with prospective trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different trial sites; ● clinical trials of our technology under development may produce negative or inconclusive results, including failure to demonstrate statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon our development programs; ● the number of people with brain related disorders required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or people may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our products may have unanticipated adverse events, undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials; ● our third-party contractors conducting the clinical trials may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; ● regulators may require that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our products may be greater than we anticipate; ● the supply or quality of our products or other materials necessary to conduct clinical trials of our products may be insufficient or inadequate; and ● delays from our suppliers and manufacturers could impact clinical trial completion and impact revenue. 33 NeuroOne Medical Technologies Corporation Form 10-K If we are required to conduct additional clinical trials or other testing of our cortical strip, grid electrode and depth electrode technology under development beyond those that we contemplate, if we are unable to successfully complete clinical trials, if the results of these trials or tests are not favorable or if there are safety concerns, we may: ● not obtain marketing approval at all; ● be delayed in obtaining marketing approval for our cortical strip, grid electrode and depth electrode technology under development in a jurisdiction; ● be subject to additional post-marketing testing requirements; or ● have our cortical strip, grid electrode and depth electrode technology removed from the market after obtaining marketing approval.
Biggest changeWe have limited resources to complete the expensive process of medical device development, pre-clinical testing and clinical trials, putting us at a disadvantage, particularly compared to some of our larger and established competitors, and we may not have sufficient resources to commercialize our products under development in a timely fashion, if ever. 25 NeuroOne Medical Technologies Corporation FORM 10-K We may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our products, including: ● regulators may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● the failure to successfully complete pre-clinical testing requirements required by the FDA; ● we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts with third parties or clinical trial protocols with prospective trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different trial sites; ● clinical trials of our technology under development may produce negative or inconclusive results, including failure to demonstrate statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon our development programs; ● the number of people with brain or central nervous system related disorders required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or people may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our products may have unanticipated adverse events, undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials; ● our third-party contractors conducting the clinical trials may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; ● regulators may require that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our products may be greater than we anticipate; ● the supply or quality of our products or other materials necessary to conduct clinical trials of our products may be insufficient or inadequate; and ● delays from our suppliers and manufacturers could impact clinical trial completion and impact revenue.
In order for us to sell cortical strip, grid electrode and depth electrode technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, we must convince them, their caregivers and healthcare providers that our technology offers meaningful advantages over existing solutions for neuromodulation, cEEG and sEEG recording, ablation, and brain stimulation.
In order for us to sell cortical strip, grid electrode and depth electrode technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, we must convince them, their caregivers and healthcare providers that our technology offers meaningful advantages over existing solutions for neuromodulation, cEEG and sEEG recording, ablation, and stimulation.
Our failure to comply with applicable Medicare rules could result in discontinuing the ability for physicians to receive reimbursement as they will likely utilize our cortical strip, grid electrode and depth electrode technology under the Medicare payment program, civil monetary penalties, and/or criminal penalties, any of which could have a material adverse effect on our business and revenues. 37 NeuroOne Medical Technologies Corporation Form 10-K If our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that are safer, more effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted.
Our failure to comply with applicable Medicare rules could result in discontinuing the ability for physicians to receive reimbursement as they will likely utilize our cortical strip, grid electrode and depth electrode technology under the Medicare payment program, civil monetary penalties, and/or criminal penalties, any of which could have a material adverse effect on our business and revenues. 31 NeuroOne Medical Technologies Corporation FORM 10-K If our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that are safer, more effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted.
Our development costs will also increase if we experience delays in testing or marketing approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.
Our development costs will also increase if we experience delays in testing or marketing clearance/approvals. We do not know whether any of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.
In fact, the original license and development agreement entered into with Mayo in 2014 required that, upon the Merger with the LLC, we make certain payments and issue shares of Common Stock to Mayo, which we failed to do at such time. 40 NeuroOne Medical Technologies Corporation Form 10-K We contract with third parties for the manufacture of our cortical strip, grid electrode and depth electrode technology and for our future products and technology under development, and expect to continue to do so for clinical trials and commercialization.
In fact, the original license and development agreement entered into with Mayo in 2014 required that, upon the Merger with the LLC, we make certain payments and issue shares of Common Stock to Mayo, which we failed to do at such time. 33 NeuroOne Medical Technologies Corporation FORM 10-K We contract with third parties for the manufacture of our cortical strip, grid electrode and depth electrode technology and for our future products and technology under development, and expect to continue to do so for clinical trials and commercialization.
Healthcare fraud and abuse and health information privacy and security laws potentially applicable to our operations include, but are not limited to: ● the Anti-Kickback Statute, which will apply to our marketing practices, educational programs, pricing policies and relationships with healthcare providers, by prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare or Medicaid programs.
Healthcare fraud and abuse and health information privacy and security laws potentially applicable to our operations include, but are not limited to: ● the Anti-Kickback Statute, which may apply to our marketing practices, educational programs, pricing policies and relationships with healthcare providers, by prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare or Medicaid programs.
None of our other products have received clearance or approval for commercial sale. Our ability to generate revenue from our developed products, if any, will depend heavily on their successful development and regulatory approval.
None of our other products have received clearance or approval for commercial sale. Our ability to generate revenue from our developed products, if any, will depend heavily on their successful development and regulatory approval for commercialization.
In addition, even though we have obtained FDA clearance to market two of our products, and even if we obtain the proper regulatory approval or clearance to market any additional products under development, the FDA has the power to require us to conduct post-market surveillance studies, which are designed to identify adverse events, device malfunctions or complaints from patients implanted with the device during a specified period after the commencement of commercial use in the U.S.
In addition, even though we have obtained FDA clearance to market four of our products, and even if we obtain the proper regulatory approval or clearance to market any additional products under development, the FDA has the power to require us to conduct post-market surveillance studies, which are designed to identify adverse events, device malfunctions or complaints from patients implanted with the device during a specified period after the commencement of commercial use in the U.S.
If we are unable to maintain strong relationships with these institutions and professionals, the development and marketing of our products could suffer, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows. 35 NeuroOne Medical Technologies Corporation Form 10-K Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products and technology.
If we are unable to maintain strong relationships with these institutions and professionals, the development and marketing of our products could suffer, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows. 29 NeuroOne Medical Technologies Corporation FORM 10-K Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products and technology.
If our competitors are more successful than us in these matters, our business may be harmed. 38 NeuroOne Medical Technologies Corporation Form 10-K The size and future growth in the market for our cortical strip, grid electrode and depth electrode technology and for other future products and technology under development have not been established with precision and may be smaller than we estimate, possibly materially.
If our competitors are more successful than us in these matters, our business may be harmed. 32 NeuroOne Medical Technologies Corporation FORM 10-K The size and future growth in the market for our cortical strip, grid electrode and depth electrode technology and for other future products and technology under development have not been established with precision and may be smaller than we estimate, possibly materially.
Although we will not provide healthcare services, submit claims for third-party reimbursement, or receive payments directly from government health insurance programs or other third-party payors for our cortical strip, grid electrode and depth electrode technology, we are subject to healthcare fraud and abuse regulation and enforcement by federal, state and foreign governments, which could adversely impact our business.
Although we do not provide healthcare services, submit claims for third-party reimbursement, or receive payments directly from government health insurance programs or other third-party payors for our cortical strip, grid electrode and depth electrode technology, we are subject to healthcare fraud and abuse regulation and enforcement by federal, state and foreign governments, which could adversely impact our business.
Generally, worldwide economic conditions remain uncertain, particularly due to the effects of the war, terrorism, military conflicts on global markets, the conflict and instability such as between Russia and Ukraine and potentially Eastern Europe, Israel, Lebanon, Iran, the Gaza Strip and the Middle East and Asia, disruptions in the banking system and financial markets, new and ongoing challenges relating to current supply chain constraints, the impact of natural disasters or global pandemics, such as the COVID-19 pandemic, increased inflation and rising interest rates.
Generally, worldwide economic conditions remain uncertain, particularly due to the effects of the war, terrorism, military conflicts on global markets, the conflict and instability such as between Russia and Ukraine and potentially Eastern Europe, Israel, Lebanon, Iran, the Gaza Strip and the Middle East and Asia, disruptions in the banking system and financial markets, new and ongoing challenges relating to current supply chain constraints, the impact of natural disasters or global pandemics, increased inflation and rising interest rates.
We expect to continue to incur significant expenses and increasing operating costs resulting in net losses for the foreseeable future, and management has raised substantial doubt about our ability to continue as a going concern. There was also substantial doubt about the Company’s ability to continue as a going concern as of and for the year ended September 30, 2023.
We expect to continue to incur significant expenses and increasing operating costs resulting in net losses for the foreseeable future, and management has raised substantial doubt about our ability to continue as a going concern. There was also substantial doubt about the Company’s ability to continue as a going concern as of and for the year ended September 30, 2025.
Our independent registered public accounting firm included an explanatory paragraph in the report on our financial statements as of and for the years ended September 30, 2024 and 2023, respectively, noting the existence of substantial doubt about our ability to continue as a going concern.
Our independent registered public accounting firm included an explanatory paragraph in the report on our financial statements as of and for the years ended September 30, 2025 and 2024, respectively, noting the existence of substantial doubt about our ability to continue as a going concern.
We do not maintain “key person” insurance for any of our executives or employees. 55 NeuroOne Medical Technologies Corporation FORM 10-K Recruiting and retaining qualified scientific and clinical personnel will also be critical to our success.
We do not maintain “key person” insurance for any of our executives or employees. 49 NeuroOne Medical Technologies Corporation FORM 10-K Recruiting and retaining qualified scientific and clinical personnel will also be critical to our success.
The trading price of our Common Stock may be volatile and subject to wide price fluctuations in response to various factors, including: ● actual or anticipated fluctuations in our quarterly financial and operating results; ● our progress toward developing our cortical strip and sheet electrode technology; ● the commencement, enrollment and results of our future clinical trials; ● adverse results from, delays in or termination of our clinical trials; ● adverse regulatory decisions, including failure to receive regulatory approval; ● publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts, if any; ● perceptions about the market acceptance of our products and the recognition of our brand; ● adverse publicity about our products or industry in general; ● overall performance of the equity markets; ● introduction of products, or announcements of significant contracts, licenses or acquisitions, by us or our competitors; ● legislative, political or regulatory developments; 50 NeuroOne Medical Technologies Corporation Form 10-K ● additions or departures of key personnel; ● threatened or actual litigation and government investigations; ● third-party promotional activities, which are subject to ongoing regulatory obligations; ● sale of shares of our Common Stock by us or members of our management; and ● general economic conditions.
The trading price of our Common Stock may be volatile and subject to wide price fluctuations in response to various factors, including: ● actual or anticipated fluctuations in our quarterly financial and operating results; ● our progress toward developing our cortical strip and sheet electrode technology; ● the commencement, enrollment and results of our future clinical trials; ● adverse results from, delays in or termination of our clinical trials; ● adverse regulatory decisions, including failure to receive regulatory approval; ● publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts, if any; ● perceptions about the market acceptance of our products and the recognition of our brand; ● adverse publicity about our products or industry in general; ● overall performance of the equity markets; ● introduction of products, or announcements of significant contracts, licenses or acquisitions, by us or our competitors; ● legislative, political or regulatory developments; ● additions or departures of key personnel; ● threatened or actual litigation and government investigations; ● third-party promotional activities, which are subject to ongoing regulatory obligations; ● sale of shares of our Common Stock by us or members of our management; and ● general economic conditions.
From our inception through September 30, 2024, we have generated limited revenue from the commercial sales of our products. Because we have generated very limited revenues from commercialization, our operations to date have been principally financed through public and private offerings of our Common Stock and convertible debt and exercises of options and warrants.
From our inception through September 30, 2025, we have generated limited revenue from the commercial sales of our products. Because we have generated limited revenues from commercialization, our operations to date have been principally financed through public and private offerings of our Common Stock and convertible debt and exercises of options and warrants.
Both before and after a product is commercially released, we will have ongoing responsibilities under FDA regulations. We will also be subject to periodic inspections by the FDA and comparable foreign authorities to determine compliance with regulatory requirements, such as the Quality System Regulation, or QSR, of the FDA, medical device reporting regulations and regulations regarding notification, corrections, and recalls.
Both before and after a product is commercially released, we will have ongoing responsibilities under FDA regulations. We will also be subject to periodic inspections by the FDA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations and regulations regarding notification, corrections, and recalls.
In addition, regardless of merit or eventual outcome, product liability claims may result in: ● litigation; ● distraction of management’s attention from our primary business; ● the inability to commercialize our cortical strip, grid electrode and depth electrode technology; ● decreased demand; ● damage to our business reputation; ● product recalls or withdrawals from the market; ● withdrawal of clinical trial participants; ● substantial monetary awards or settlements to patients or other claimants; or ● loss of revenue.
In addition, regardless of merit or eventual outcome, product liability claims may result in: ● litigation; ● distraction of management’s attention from our primary business; ● the inability to commercialize our cortical strip/grid electrode system, depth electrode system, RF probes and/or RF generator ablation system technology; ● decreased demand; ● damage to our business reputation; ● product recalls or withdrawals from the market; ● withdrawal of clinical trial participants; ● substantial monetary awards or settlements to patients or other claimants; or ● loss of revenue.
Our future capital requirements will depend on many factors, including: ● the cost of further developing our cortical strip, grid electrode and depth electrode technology; ● obtaining and maintaining regulatory clearance or approval for our cortical strip, grid electrode and depth electrode technology; ● the costs associated with commercializing our cortical strip, grid electrode and depth electrode technology; ● any change in our development priorities; ● the revenue generated by sales of our cortical strip, grid electrode and depth electrode technology; ● the costs associated with expanding our sales and marketing infrastructure for commercialization of our cortical strip grid electrode and depth electrode technology; ● any change in our plans regarding the manner in which we choose to commercialize any approved product in the United States; ● the cost of ongoing compliance with regulatory requirements; ● expenses we incur in connection with potential litigation or governmental investigations; ● expenses and costs we incur in connection with changes in the economy and regulatory process; ● the costs to develop additional intellectual property; ● anticipated or unanticipated capital expenditures; and ● unanticipated general and administrative expenses.
Our future capital requirements will depend on many factors, including: ● the cost of further developing our cortical strip, grid electrode and depth electrode technology; ● obtaining and maintaining regulatory clearance or approval for our cortical strip, grid electrode and depth electrode technology; ● the costs associated with commercializing our cortical strip, grid electrode and depth electrode technology; ● any change in our development priorities; ● the revenue generated by sales of our cortical strip, grid electrode and depth electrode technology; ● the costs associated with expanding our sales and marketing infrastructure for commercialization of our cortical strip grid electrode and depth electrode technology; ● any change in our plans regarding the manner in which we choose to commercialize any approved product in the United States; ● the cost of ongoing compliance with regulatory requirements; 23 NeuroOne Medical Technologies Corporation FORM 10-K ● expenses we incur in connection with potential litigation or governmental investigations; ● expenses and costs we incur in connection with changes in the economy and regulatory process; ● the costs to develop additional intellectual property; ● anticipated or unanticipated capital expenditures; and ● unanticipated general and administrative expenses.
We cannot assure you that use, even for a limited time, would not result in unanticipated complications, even after the device is removed. 41 NeuroOne Medical Technologies Corporation Form 10-K Undetected errors or defects in our cortical strip, grid electrode and depth electrode technology under development or future versions thereof could harm our reputation, decrease the market acceptance of our cortical strip, grid electrode and depth electrode technology or expose us to product liability claims adversely affecting our financial condition and results of operations or liquidity.
We cannot assure you that use, even for a limited time, would not result in unanticipated complications, even after the device is removed. 27 NeuroOne Medical Technologies Corporation FORM 10-K Undetected errors or defects in our cortical strip/grid electrode system, depth electrode system, RF probes and RF generator ablation system technologies under development or future versions thereof could harm our reputation, decrease the market acceptance of cortical strip/grid electrode system, depth electrode system, RF probes and RF generator ablation system technology or expose us to product liability claims adversely affecting our financial condition and results of operations or liquidity.
The success of any products that we develop will depend on several factors, including: ● receipt of timely commercialization approvals from applicable regulatory authorities; ● our ability to procure and maintain suppliers and manufacturers of the components of our current cortical strip, grid electrode and depth electrode technology and future versions; ● market acceptance of our cortical strip, grid electrode and depth electrode technology by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, the medical community and third-party payors; ● our success in educating healthcare providers and people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders about the benefits, administration and use of our cortical strip, grid electrode and depth electrode technology and future versions; ● the prevalence and severity of adverse events and public health emergencies such as the COVID-19 pandemic; ● the perceived advantages, cost, safety, convenience and accuracy of alternative therapies; ● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our cortical strip, grid electrode and depth electrode technology and otherwise protecting our rights in our intellectual property portfolio; ● maintaining compliance with regulatory requirements, including current good manufacturing practices; and ● obtaining and maintaining a continued acceptable performance and safety profile of our cortical strip, grid electrode and depth electrode technology.
The success of any products that we develop will depend on several factors, including: ● receipt of timely commercialization approvals from applicable regulatory authorities; ● our ability to procure and maintain suppliers and manufacturers of the components of our current cortical strip, grid electrode and depth electrode technology and future versions; ● market acceptance of our cortical strip, grid electrode and depth electrode technology by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, the medical community and third-party payors; ● our success in educating healthcare providers and people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders about the benefits, administration and use of our cortical strip, grid electrode and depth electrode technology and future versions; ● the perceived advantages, cost, safety, convenience and accuracy of alternative therapies; ● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our cortical strip, grid electrode and depth electrode technology and otherwise protecting our rights in our intellectual property portfolio; ● maintaining compliance with regulatory requirements, including current good manufacturing practices; and ● obtaining and maintaining a continued acceptable performance and safety profile of our cortical strip, grid electrode and depth electrode technology.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation; ● federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation; 41 NeuroOne Medical Technologies Corporation FORM 10-K ● federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government.
We are an early-stage medical technology company which continues to develop and commercialize comprehensive neuromodulation cEEG and sEEG monitoring, ablation, and brain stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.
We are an early-stage medical technology company which continues to develop and commercialize comprehensive neuromodulation sEEG monitoring, ablation, and stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic back pain and other related neurological disorders.
The Company has incurred losses since inception, negative cash flows from operations, and an accumulated deficit of $75.0 million as of September 30, 2024. To date, the Company’s revenues have not been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt and sale of equity securities.
The Company has incurred losses since inception, negative cash flows from operations, and an accumulated deficit of $78.6 million as of September 30, 2025. To date, the Company’s revenues have not been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt and sale of equity securities.
These governmental authorities enforce laws and regulations that are meant to assure product safety and effectiveness, including the regulation of, among other things: ● product design and development; ● pre-clinical studies and clinical trials; ● product safety; ● establishment registration and product listing; ● labeling, content and language of instructions for use and storage; ● marketing, manufacturing, sales and distribution; ● pre-market clearance or approval; ● servicing and post-market surveillance; ● record-keeping procedures; ● product import and export; ● advertising and promotion; and ● recalls and field safety corrective actions.
These governmental authorities enforce laws and regulations that are meant to assure product safety and effectiveness, including the regulation of, among other things: ● product design and development; ● pre-clinical studies and clinical trials; ● product safety; ● establishment registration and product listing; ● labeling, content and language of instructions for use and storage; ● marketing, manufacturing, sales and distribution; ● pre-market clearance or approval; ● servicing and post-market surveillance; 40 NeuroOne Medical Technologies Corporation FORM 10-K ● record-keeping procedures; ● product import and export; ● advertising and promotion; and ● recalls and field safety corrective actions.
Our limited experience in medical device development may make it more difficult for us to complete these tasks. 29 NeuroOne Medical Technologies Corporation Form 10-K Even if we successfully develop and market such technology, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and cause you to lose all of your investment.
Our limited experience in medical device development may make it more difficult for us to complete these tasks. Even if we successfully develop and market such technology, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and cause you to lose all of your investment.
At September 30, 2024, we had cash and cash equivalents in the aggregate of approximately $1.5 million. Our existing cash, cash equivalents and short-term investments will not be sufficient to fund our operating expenses. To continue to fund operations, we will need to secure additional funding.
At September 30, 2025, we had cash and cash equivalents in the aggregate of approximately $6.6 million. Our existing cash, cash equivalents and short-term investments will not be sufficient to fund our operating expenses. To continue to fund operations, we will need to secure additional funding.
Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations and when the cost inflation is incurred. 30 NeuroOne Medical Technologies Corporation Form 10-K We will need to raise substantial additional funds in the future, and these funds may not be available on acceptable terms or at all.
Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations and when the cost inflation is incurred. We will need to raise substantial additional funds in the future, and these funds may not be available on acceptable terms or at all.
If we fail to maintain our strong working relationships with healthcare and academic institutions and their professionals such as the Mayo Clinic, the Cleveland Clinic and Emory University, many of our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support our products, which could cause a decline in our earnings and profitability.
If we fail to maintain our strong working relationships with healthcare and academic institutions and their professionals, many of our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support our products, which could cause a decline in our earnings and profitability.
It may not be possible for us to manufacture these products at a cost or in quantities sufficient to make any future versions of our cortical strip, grid electrode and depth electrode technology commercially viable. Potential complications from our cortical strip, grid electrode and depth electrode technology that are currently unknown may come to light.
It may not be possible for us to manufacture these products at a cost or in quantities sufficient to make any future versions of our cortical strip, grid electrode and depth electrode technology commercially viable. 34 NeuroOne Medical Technologies Corporation FORM 10-K Potential complications from our cortical strip, grid electrode and depth electrode technology that are currently unknown may come to light.
For our current products under continued development, clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing.
For our current products under development clinical studies in humans may be required, clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing.
Significant clinical trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully commercialize our products. Even if we obtain regulatory clearance and/or approval for all of our products, we will remain subject to extensive regulatory scrutiny and compliance obligations.
Significant clinical trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully commercialize our products. 26 NeuroOne Medical Technologies Corporation FORM 10-K Even if we obtain regulatory clearance and/or approval for all of our products, we will remain subject to extensive regulatory scrutiny and compliance obligations.
We have incurred losses since inception, and as of September 30, 2024, we had an accumulated deficit of $75.0 million primarily as a result of expenses incurred in connection with our operations and from our research and development programs.
We have incurred losses since inception, and as of September 30, 2025, we had an accumulated deficit of $78.6 million primarily as a result of expenses incurred in connection with our operations and from our research and development programs.
The following examples are illustrative: ● others may be able to make devices that are the same as or similar to our cortical strip, grid electrode and depth electrode technology but that are not covered by the claims of the patents that we own; ● we or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own; ● we might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; ● we might enforce our patent rights or defend a challenge to our issued patents or pending application, putting the patents and patent applications at risk of being invalidated or interpreted narrowly; ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and ● we may not develop additional proprietary technologies that are patentable. 46 NeuroOne Medical Technologies Corporation Form 10-K Risks Related to our Legal and Regulatory Environment Our products and operations are subject to extensive governmental regulation, and any adverse regulatory action may materially adversely affect our financial condition and business operations.
The following examples are illustrative: ● others may be able to make devices that are the same as or similar to our various electrode technologies but that are not covered by the claims of the patents that we own; ● we or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own; ● we might not have been the first to file patent applications covering certain of our inventions; 39 NeuroOne Medical Technologies Corporation FORM 10-K ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; ● we might enforce our patent rights or defend a challenge to our issued patents or pending application, putting the patents and patent applications at risk of being invalidated or interpreted narrowly; ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and ● we may not develop additional proprietary technologies that are patentable.
Further, we cannot assure you that competitors will not infringe upon our trademarks, or that we will have adequate resources to enforce our trademarks. 44 NeuroOne Medical Technologies Corporation Form 10-K We also rely on trade secrets, know-how and technology, which are not protectable by patents, to maintain our competitive position.
Further, we cannot assure you that competitors will not infringe upon our trademarks, or that we will have adequate resources to enforce our trademarks. We also rely on trade secrets, know-how and technology, which are not protectable by patents, to maintain our competitive position.
The large number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent litigation. In the future, we could receive communications from various industry participants alleging our infringement of their intellectual property rights.
The large number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent litigation. 38 NeuroOne Medical Technologies Corporation FORM 10-K In the future, we could receive communications from various industry participants alleging our infringement of their intellectual property rights.
Product liability lawsuits and claims, safety alerts or product recalls, with or without merit, could cause us to incur substantial costs, delay our product development efforts, place a significant strain on our financial resources, divert the attention of management from our core business, harm our reputation, increase our product liability insurance rates, once we obtain such insurance, or prevent us from securing such insurance coverage in the future and adversely affect our ability to attract and retain customers, if approved, any of which could harm our business, financial condition and operating results.
Product liability lawsuits and claims, safety alerts or product recalls, with or without merit, could cause us to incur substantial costs, delay our product development efforts, place a significant strain on our financial resources, divert the attention of management from our core business, harm our reputation, increase our product liability insurance rates, once we obtain such insurance, or prevent us from securing such insurance coverage in the future and adversely affect our ability to attract and retain customers, if approved, any of which could harm our business, financial condition and operating results. 28 NeuroOne Medical Technologies Corporation FORM 10-K We currently maintain commercial product liability insurance with an aggregate limit of $5,000,000.
The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board, on committees of our Board or as members of senior management. 56 NeuroOne Medical Technologies Corporation FORM 10-K ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board, on committees of our Board or as members of senior management. 50 NeuroOne Medical Technologies Corporation FORM 10-K
This could delay completion of pre-clinical testing or clinical trials, increase costs, delay approval of our future products and jeopardize our ability to commence sales and generate revenue. 32 NeuroOne Medical Technologies Corporation Form 10-K We have three products which have each received 510(k) clearance from the FDA.
This could delay completion of pre-clinical testing or clinical trials, increase costs, delay approval of our future products and jeopardize our ability to commence sales and generate revenue. We have four products which have each received 510(k) clearance from the FDA.
Any potential intellectual property litigation could force us to do one or more of the following: ● stop selling our products or using technology that contains the allegedly infringing intellectual property; ● incur significant legal expenses; ● pay substantial damages to the party whose intellectual property rights we are allegedly infringing; ● redesign those products that contain the allegedly infringing intellectual property; or ● attempt to obtain a license to the relevant intellectual property from third-parties, which may not be available on reasonable terms or at all, and if available, may be non-exclusive, thereby giving our competitors access to the same technology. 45 NeuroOne Medical Technologies Corporation Form 10-K Patent litigation can involve complex factual and legal questions, and its outcome is uncertain.
Any potential intellectual property litigation could force us to do one or more of the following: ● stop selling our products or using technology that contains the allegedly infringing intellectual property; ● incur significant legal expenses; ● pay substantial damages to the party whose intellectual property rights we are allegedly infringing; ● redesign those products that contain the allegedly infringing intellectual property; or ● attempt to obtain a license to the relevant intellectual property from third-parties, which may not be available on reasonable terms or at all, and if available, may be non-exclusive, thereby giving our competitors access to the same technology.
On July 11, 2024, we received a letter (the “Notice”) from the Listing Qualifications Department (the “Staff”) of 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 Nasdaq, as set forth in Nasdaq Marketplace Rule 5550(a)(2), the Minimum Bid Price Requirement.
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”).
Any litigation or claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business and harm our reputation.
Patent litigation can involve complex factual and legal questions, and its outcome is uncertain. Any litigation or claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business and harm our reputation.
Further, these outcomes could damage investor confidence in the accuracy and reliability of our financial statements. Our management has concluded that our internal controls over financial reporting were, and continue to be, effective as of September 30, 2024.
In that case, we could become subject to regulatory sanction or investigation. Further, these outcomes could damage investor confidence in the accuracy and reliability of our financial statements. Our management has concluded that our internal controls over financial reporting were, and continue to be, effective as of September 30, 2025.
Any of these changes could cause our products to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered device. Such changes may also require additional testing, regulatory notification or regulatory approval.
Any changes we make carry the risk that they will not achieve the intended objectives. Any of these changes could cause our products to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered device. Such changes may also require additional testing, regulatory notification or regulatory approval.
Within and outside the United States, reimbursement is obtained from a variety of sources, including government-sponsored and private health insurance plans. These third-party payors determine whether to provide coverage and reimbursement for specific products and procedures.
Healthcare providers may choose not to order a product unless third-party payors pay a substantial portion of the product. Within and outside the United States, reimbursement is obtained from a variety of sources, including government-sponsored and private health insurance plans. These third-party payors determine whether to provide coverage and reimbursement for specific products and procedures.
In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), we have a period of 180 calendar days from July 11, 2024, or until January 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
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.
The collaboration with Zimmer may not be successful due to several factors, including the following: ● Zimmer may not be able to obtain from us or manufacture our products in a timely or cost-effective manner; ● Zimmer may not timely perform its obligations under the Zimmer Amended and Restated Distribution Agreement or to achieve certain net sales milestones; ● Zimmer may fail to effectively commercialize our products; or ● contractual disputes or other disagreements between us and Zimmer, including those regarding the development, manufacture, and commercialization of our products, interpretation of the Zimmer Amended and Restated Distribution Agreement, and ownership of proprietary rights.
The collaboration with Zimmer may not be successful due to several factors, including the following: ● Zimmer may not be able to obtain from us or manufacture our products in a timely or cost-effective manner; ● Zimmer may not timely perform its obligations under the Zimmer Amended and Restated Distribution Agreement or to achieve certain net sales milestones; ● Zimmer may fail to effectively commercialize our products; or ● contractual disputes or other disagreements between us and Zimmer, including those regarding the development, manufacture, and commercialization of our products, interpretation of the Zimmer Amended and Restated Distribution Agreement, and ownership of proprietary rights. 22 NeuroOne Medical Technologies Corporation FORM 10-K Any of the foregoing could adversely impact the likelihood and timing of any payments we are eligible to receive under the Zimmer Amended and Restated Distribution Agreement.
Third parties also may oppose our trademark applications, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote additional resources to marketing new brands.
In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote additional resources to marketing new brands.
However, any changes that lower reimbursements for either our products or procedures using our products, reduce medical procedure volumes, increase cost containment pressures on us or others in the healthcare sector, or impose additional or heightened regulatory requirements could adversely affect our business and results of operations.
However, any changes that lower reimbursements for either our products or procedures using our products, reduce medical procedure volumes, increase cost containment pressures on us or others in the healthcare sector, or impose additional or heightened regulatory requirements could adversely affect our business and results of operations. 43 NeuroOne Medical Technologies Corporation FORM 10-K Risks Related to our Common Stock The price of our Common Stock might fluctuate.
Due to differences between foreign and U.S. patent laws, our patented intellectual property rights may not receive the same degree of protection in foreign countries as they would in the United States. Even if patents are granted outside the United States, effective enforcement in those countries may not be available.
Due to differences between foreign and U.S. patent laws, our patented intellectual property rights may not receive the same degree of protection in foreign countries as they would in the United States.
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.
Any overestimation of the market opportunity could adversely impact our projected sales growth and overall business performance. 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.
Manufacturers must submit reports by the 90th day of each subsequent calendar year; ● federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of certain health information, many of which differ from each other in significant ways and often are not preempted by HIPAA. 48 NeuroOne Medical Technologies Corporation Form 10-K The risk of our being found in violation of these laws and regulations is increased by the fact that the scope and enforcement of these laws is uncertain, many of them have not been fully interpreted by the regulatory authorities or the courts, their provisions are open to a variety of interpretations, or they vary country by country.
Manufacturers must submit reports by the 90th day of each subsequent calendar year; ● federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of certain health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.
Promoting and positioning our brand, and increasing market awareness of our technology, will depend largely on the success of our marketing efforts and our ability to provide physicians with a reliable product for successful treatment of brain-related disorders.
Promoting and positioning our brand, and increasing market awareness of our technology, will depend largely on the success of our marketing efforts and our ability to provide physicians with a reliable product for successful treatment of brain-related disorders. Additionally, we believe the quality and reliability of our product is critical to building physician support in the United States.
Failure to conduct required surveillance or studies in a timely manner could result in the revocation of the approved PMA product that is subject to such a requirement and could also result in the recall or withdrawal of the product, which would prevent us from generating sales from that product in the United States. 34 NeuroOne Medical Technologies Corporation Form 10-K We may not be successful in commercializing our technology.
Failure to conduct required surveillance or studies in a timely manner could result in the revocation of the approved PMA product that is subject to such a requirement and could also result in the recall or withdrawal of the product, which would prevent us from generating sales from that product in the United States.
Our information technology systems are vulnerable to damage or interruption from earthquakes, fires, floods, other natural disasters, terrorist attacks, attacks by computer viruses or hackers, power losses, and computer system or data network failures.
In the future, we may rely on our information technology systems for inventory management and technical support functions. Our information technology systems are vulnerable to damage or interruption from earthquakes, fires, floods, other natural disasters, terrorist attacks, attacks by computer viruses or hackers, power losses, and computer system or data network failures.
Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual submission.
Failureto submit required information may result in civil monetary penalties, for all payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual submission.
Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities and negatively affect the value and liquidity of our Common Stock.
There is no assurance that we will remain in compliance with these standards. Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities and negatively affect the value and liquidity of our Common Stock.
Risks Related to our Common Stock The price of our Common Stock might fluctuate significantly, and you could lose all or part of your investment. Volatility in the market price of our Common Stock may prevent you from being able to sell your shares of our Common Stock at or above the price you paid for your shares.
Volatility in the market price of our Common Stock may prevent you from being able to sell your shares of our Common Stock at or above the price you paid for your shares.
Risks associated with the manufacturing of our products could reduce our gross margins and negatively affect our operating results; ● if we or our third-party suppliers or manufacturers fail to comply with the FDA’s good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner; ● potential complications from our products and technology that are currently unknown may come to light; ● if there are significant disruptions in our information technology systems, our business, financial condition and operating results could be adversely affected; ● we have entered into, and may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues; ● our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel; ● we have been the victim of a cyber-related crime and our controls may not be successful in avoiding further cyber-related crimes in the future; ● our ability to protect our intellectual property and proprietary technology is uncertain; ● we may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors; ● our products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer; ● the price of our Common Stock might fluctuate significantly, and you could lose all or part of your investment; and ● we intend to issue more shares to raise capital, which will result in substantial dilution.
Termination of this partnership would harm our business, and even if this partnership continues, it may not be successful; ● we may not be successful in commercializing our cortical strip, grid electrode and depth electrode technology in the United States or gaining market acceptance for our products and technology; ● risks associated with the manufacturing of our products could reduce our gross margins and negatively affect our operating results; ● if we or our third-party suppliers or manufacturers fail to comply with the FDA’s good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner; ● potential complications from our products and technology that are currently unknown may come to light; 20 NeuroOne Medical Technologies Corporation FORM 10-K ● if there are significant disruptions in our information technology systems, our business, financial condition and operating results could be adversely affected; ● we have entered into, and may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues; ● our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel; ● we have been the victim of a cyber-related crime and our controls may not be successful in avoiding further cyber-related crimes in the future; ● our ability to protect our intellectual property and proprietary technology is uncertain; ● our products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer; and ● the price of our Common Stock might fluctuate significantly.
An inability to obtain such components and raw material products could have a material adverse impact on our business, financial condition and results of operations. 31 NeuroOne Medical Technologies Corporation Form 10-K We depend on a limited number of third-party suppliers for the components of our cortical strip, grid electrode and depth electrode technology, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials, could harm our business.
We depend on a limited number of third-party suppliers for the components of our cortical strip, grid electrode and depth electrode technology, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials, could harm our business.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any product; ● changes in the configuration of our cortical strip, grid electrode and depth electrode technology under development may result in additional costs or delay; ● if we are unable to successfully develop, receive regulatory clearance/approval for and commercialize our technology and other products under development, or if we experience significant delays in doing so, our business will be harmed; ● failure to secure or retain coverage or adequate reimbursement for our cortical strip, grid electrode and depth electrode technology or future versions thereof, including the implantation procedures, by third-party payors could adversely affect our business, financial condition and operating results; ● if our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that are safer, more effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted; ● the size and future growth in the market for our cortical strip, grid electrode and depth electrode technology or our future neurological drugs delivery under development has not been established with precision and may be smaller than we estimate, possibly materially; ● we depend on intellectual property licensed from WARF for our technology under development, and the termination of this license would harm our business; ● we depend on our partnership with Mayo to license certain know how for the development and commercialization of our technology.
A failure to obtain this necessary capital when needed could force us to delay, limit, scale back or cease some or all operations; ● an inability to obtain a supply of components and raw material products could have a material adverse effect on our business, financial condition and results of operations; ● we depend on a limited number of third-party suppliers for the components of our cortical strip, grid electrode and depth electrode technology, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials, could harm our business; ● changes in the configuration of our cortical strip, grid electrode and depth electrode technology under development may result in additional costs or delay; ● if we are unable to successfully develop, receive regulatory clearance/approval for and commercialize our products under development, or if we experience significant delays in doing so, our business will be harmed; ● failure to secure or retain coverage or adequate reimbursement for our cortical strip, grid electrode and depth electrode technology or future versions thereof, including the implantation procedures, by third-party payors could adversely affect our business, financial condition and operating results; ● if our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic back pain and other related neurological disorders that are safer, more effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted; ● we depend on our partnership with Mayo to license certain know how for the development and commercialization of our technology.
Additionally, we may not be in a position to exercise sole decision making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on decisions, and our future collaborators may have economic or business interests or goals that are, or that may become, inconsistent with our business interests or goals.
In particular, these collaborations may not result in the development of products that achieve commercial success or result in significant revenues and could be terminated prior to developing any products. 36 NeuroOne Medical Technologies Corporation FORM 10-K Additionally, we may not be in a position to exercise sole decision making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on decisions, and our future collaborators may have economic or business interests or goals that are, or that may become, inconsistent with our business interests or goals.
If we are unable to successfully develop, and receive regulatory clearance/approval for our other products under development, or if we experience significant delays in doing so, our business will be harmed.
If we are unable to successfully develop and receive regulatory clearance/approval for our other products under development, or if we experience significant delays in doing so, our business will be harmed. Four of our products have received 510(k) clearance from the FDA: our Evo ® Cortical, Evo ® sEEG, OneRF ® Ablation System, and OneRF ® TN Ablation System.
As products are developed through pre-clinical testing and clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and configuration, are altered along the way in an effort to optimize processes and results. Any changes we make carry the risk that they will not achieve the intended objectives.
Changes in the configuration of our technology under development may result in additional costs or delay. As new products are developed through pre-clinical testing and clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and configuration, are altered along the way in an effort to optimize processes and results.
The IRA includes a 15% corporate alternative minimum tax and a 1% excise tax on share repurchases. 54 NeuroOne Medical Technologies Corporation Form 10-K We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our Common Stock.
For example, in August 2022, the Inflation Reduction Act of 2022 (“IRA”) was enacted into law. The IRA includes a 15% corporate alternative minimum tax and a 1% excise tax on share repurchases. We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our Common Stock.
Additionally, we granted Zimmer the exclusive right and license to distribute certain depth electrodes developed by the Company. We are reliant on Zimmer to drive the commercialization and sales of our products until 2034 under the Zimmer Amended and Restated Distribution Agreement for the exclusive distribution, marketing and sales license provided to Zimmer.
The Company granted Zimmer an exclusive global right to distribute our Evo Cortical, Evo sEEG, and OneRF Ablation System in the brain. We are reliant on Zimmer to drive the commercialization and sales of these products until 2034 under the Zimmer Amended and Restated Distribution Agreement for the exclusive distribution, marketing and sales license provided to Zimmer.
Certain provisions of this law, including comparative effectiveness research, pilot programs to evaluate alternative payment methodologies and other changes to the payment systems, have started changing the way healthcare is delivered, reimbursed and funded.
For example, the ACA and Health Care and Education Affordability Reconciliation Act of 2010 were enacted into law in the U.S. in March 2010. Certain provisions of this law, including comparative effectiveness research, pilot programs to evaluate alternative payment methodologies and other changes to the payment systems, have started changing the way healthcare is delivered, reimbursed and funded.
Healthcare providers may use our products, if approved, off-label, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine.
Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of our products. Healthcare providers may use our products, if approved, off-label, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine.
Access to adequate coverage and reimbursement for our cortical strip, grid electrode and depth electrode technology by third-party payors is essential to the acceptance of our products by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders. 36 NeuroOne Medical Technologies Corporation Form 10-K In the United States, a third-party payor’s decision to provide coverage for our products does not imply that an adequate reimbursement rate will be obtained.
Access to adequate coverage and reimbursement for our cortical strip, grid electrode and depth electrode technology by third-party payors is essential to the acceptance of our products by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.
Further, one third-party payor’s decision to cover our products does not assure that other payors will also provide coverage for the products or will provide coverage at an adequate reimbursement rate. Healthcare providers may choose not to order a product unless third-party payors pay a substantial portion of the product.
In the United States, a third-party payor’s decision to provide coverage for our products does not imply that an adequate reimbursement rate will be obtained. Further, one third-party payor’s decision to cover our products does not assure that other payors will also provide coverage for the products or will provide coverage at an adequate reimbursement rate.
We have limited institutional knowledge and experience with respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement. In particular, these collaborations may not result in the development of products that achieve commercial success or result in significant revenues and could be terminated prior to developing any products.
We have limited institutional knowledge and experience with respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement.
Further, these transactions and arrangements will be contractual in nature and will generally be terminable under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium. 43 NeuroOne Medical Technologies Corporation Form 10-K If we enter into in-bound intellectual property license agreements, we may not be able to fully protect the licensed intellectual property rights or maintain those licenses.
Further, these transactions and arrangements will be contractual in nature and will generally be terminable under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium.
Moreover, we have committed in connection with the sale of securities to use commercially reasonable efforts to maintain the listing of its Common Stock during such time that certain warrants are outstanding. 51 NeuroOne Medical Technologies Corporation Form 10-K Any failure to maintain an effective system of internal controls over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could result in material misstatements of our financial statements or cause us to fail to meet our reporting obligations or fail to prevent fraud in which case, our stockholders could lose confidence in our financial reporting, which would harm our business and could negatively impact the price of our stock.
Any failure to maintain an effective system of internal controls over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could result in material misstatements of our financial statements or cause us to fail to meet our reporting obligations or fail to prevent fraud in which case, our stockholders could lose confidence in our financial reporting, which would harm our business and could negatively impact the price of our stock.
Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of SOX until the date we have a public float of $75 million or greater.
Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 of SOX until the date we are no longer a “smaller reporting company” as defined by applicable SEC rules.
To date, we have financed our operations primarily through debt and equity financings, and our primary activities have been limited to, and our limited resources have been dedicated to, performing business and financial planning, raising capital, recruiting personnel, negotiating with business partners and the licensors of our intellectual property and conducting development activities. 28 NeuroOne Medical Technologies Corporation Form 10-K To implement our business strategy we need to, among other things, continue to develop all-in-one diagnostic and therapeutic solution, gain approval for other brain or motor related disorders such as Parkinson’s with the therapeutic technologies developed for epilepsy, convince physicians and patients that our technology represents an improvement over existing diagnostic or treatment options, hire direct experienced sales representatives to market our technology, and engage in beneficial partnerships that can leverage our core technology.
To implement our business strategy we need to, among other things, continue to develop all-in-one diagnostic and therapeutic solution, gain approval for other brain or motor related disorders such as Parkinson’s with the therapeutic technologies developed for epilepsy, convince physicians and patients that our technology represents an improvement over existing diagnostic or treatment options, hire direct experienced sales representatives to market our technology, and engage in beneficial partnerships that can leverage our core technology.
Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Dealing with investigations can be time and resource consuming and can divert management’s attention from our core business. Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.
We may not have long term supply agreements with our suppliers and, in many cases, we may make our purchases on a purchase order basis. Our ability to purchase adequate quantities of components or our products may be limited and we may not be able to convince suppliers to make components and products available to us.
Our ability to purchase adequate quantities of components or our products may be limited and we may not be able to convince suppliers to make components and products available to us.
This could harm our ability to market our products and generate sales. 49 NeuroOne Medical Technologies Corporation Form 10-K In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.
This could harm our ability to market our products and generate sales. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our products.
Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results. 47 NeuroOne Medical Technologies Corporation Form 10-K Any adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.
Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeDepending on the nature of the services provided, the sensitivity and quantity of information processed, and the identity of the service provider, our vendor management process may include reviewing the cybersecurity practices of such provider, contractually imposing obligations on the provider, conducting security assessments, and conducting periodic reassessments during their engagement.
Biggest changeDepending on the nature of the services provided, the sensitivity and quantity of information processed, and the identity of the service provider, our vendor management process may include reviewing the cybersecurity practices of such provider, contractually imposing obligations on the provider, conducting security assessments, and conducting periodic reassessments during their engagement. 51 NeuroOne Medical Technologies Corporation FORM 10-K We are not aware of any risks from cybersecurity threats, including as a result of any cybersecurity incidents, which have materially affected or are reasonably likely to materially affect our Company, including our business strategy, results of operations, or financial condition.
Our Chief Financial Officer leads our information security organization (overseeing work done by a third party IT services company) and reports to the Chief Executive Officer and Board of Directors of any material information regarding such cybersecurity matters.
Our Chief Administrative Officer leads our information security organization (overseeing work done by a third party IT services company) and reports to the Chief Executive Officer and Board of Directors of any material information regarding such cybersecurity matters.
Removed
We are not aware of any risks from cybersecurity threats, including as a result of any cybersecurity incidents, which have materially affected or are reasonably likely to materially affect our Company, including our business strategy, results of operations, or financial condition.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe following table summarizes our share repurchase activity during the fourth quarter of 2024: Period Total number of shares purchased Average price paid per share Total number of shares purchased as part of publicly announced plans or programs Maximum number of shares that may yet be purchased under the plans or programs July 1 - July 31, 2024 6,879 $ 0.80 - - August 1 - August 31, 2024 2,794 $ 0.75 - - September 1 - September 30, 2024 2,794 $ 0.80 - - TOTAL 12,467 - -
Biggest changeThe following table summarizes our share repurchase activity during the fourth quarter of 2025: Period Total number of shares purchased Average price paid per share Total number of shares purchased as part of publicly announced plans or programs Maximum number of shares that may yet be purchased under the plans or programs July 1 - July 31, 2025 4,085 $ 0.68 - - August 1 - August 31, 2025 - $ - - - September 1 - September 30, 2025 - $ - - - TOTAL 4,085 - -
The transfer agent and registrar for our Common Stock is Equiniti Trust Company LLC. Share Repurchases During the three months ended September 30, 2024, we repurchased 12,467 common shares surrendered by employees to satisfy income tax withholding obligations of employees in connection with the administration of employee share-based compensation plans.
The transfer agent and registrar for our Common Stock is Equiniti Trust Company LLC. Share Repurchases During the three months ended September 30, 2025, we repurchased 4,085 common shares surrendered by employees to satisfy income tax withholding obligations of employees in connection with the administration of employee share-based compensation plans.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our Common Stock commenced trading on the Nasdaq Capital Market on May 26, 2021 under the ticker symbol “NMTC.” Stockholders On December 13, 2024, there were 116 record holders of our Common Stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our Common Stock commenced trading on the Nasdaq Capital Market on May 26, 2021 under the ticker symbol “NMTC.” Stockholders On December 12, 2025, there were 111 record holders of our Common Stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWhile we have begun to generate revenue from the sale of products based on our cEEG and sEEG technology, and OneRF System, and through milestone and other payments from our current collaboration with Zimmer, we expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate a higher level of revenue from commercial sales, and we will need to obtain substantial additional funding in connection with our continuing operations through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources.
Biggest changeWhile we have begun to generate revenue from the sale of our Evo Cortical, Evo sEEG, OneRF Ablation System, and OneRF TN Ablation System, and through milestone and other payments from our current collaboration and distribution arrangement with Zimmer, we expect to continue to incur significant expenses and may incur increasing operating and net losses for the foreseeable future until we generate a higher level of revenue from commercial sales. 54 NeuroOne Medical Technologies Corporation FORM 10-K Recent Developments Corporate Updates 510(k) Clearance for Trigeminal Facial Pain On August 15, 2025 we received FDA 510(k) clearance to market its OneRF® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.
Under the WARF License, 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 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect.
Under the WARF License, we have agreed to pay WARF a royalty equal to a single-digit percentage of certain of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect.
Financing Costs Financing costs during the year ended September 30, 2024 consisted of the amortization of the deferred issuance costs associated with the debt facility (described further below) in the amount of $0.1 million and issuance costs attributed to the warrants issued in connection with the 2024 Private Placement (described further below) in the amount of $0.1 million.
Financing costs during the year ended September 30, 2024 of $0.2 million consisted of the amortization of the deferred issuance costs associated with the debt facility (described further below) in the amount of $0.1 million and issuance costs attributed to the warrants issued in connection with the 2024 Private Placement (described further below) in the amount of $0.1 million.
Under the Amended and Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement.
Under the Amended and Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty equal to a single-digit percentage of certain of our product sales pursuant to the Mayo Development Agreement.
We were permitted to borrow loans under the Debt Facility Agreement from time to time, for general corporate purposes and subject to certain specified conditions, until the earliest of: (i) November 30, 2024, (ii) the occurrence of any Monetization Event (as defined below) or Change of Control (as defined in the Debt Facility Agreement), or (iii) at the Lender’s option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement.
We were permitted to borrow loans under the Debt Facility Agreement from time to time, for general corporate purposes and subject to certain specified conditions, until the earliest of: (i) November 30, 2024, (ii) the occurrence of any Monetization Event as defined in the Debt Facility Agreement or a change of control, or (iii) at the Lender’s option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement.
August 2024 Private Placement On August 1, 2024, we entered into a Securities Purchase Agreement with certain Purchasers, pursuant to which we, in a private placement, agreed to issue and sell an aggregate of (i) 2,944,446 shares of our Company’s common stock (the “Shares”), par value $0.001 per share and (ii) warrants to purchase an aggregate of 2,208,333 shares of common stock (the “PIPE Warrants”) at a purchase price of $0.90 per unit, consisting of one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately $2.65 million before deducting estimated expenses.
August 2024 Private Placement On August 1, 2024, we entered into a Securities Purchase Agreement with certain purchasers, pursuant to which we, in a private placement, agreed to issue and sell an aggregate of (i) 2,944,446 shares of our Company’s common stock (the “Shares”), par value $0.001 per share and (ii) warrants to purchase an aggregate of 2,208,338 shares of common stock (the “PIPE Warrants”) at a purchase price of $0.90 per unit, consisting of one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately $2.65 million before deducting expenses.
Our existing cash and cash equivalents may not be sufficient to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need to secure additional funding through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources.
Our existing cash and cash equivalents may not be sufficient to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need to secure additional funding through public or private equity or debt financing, through collaborations or partnerships with other companies, or other sources.
Additionally, our independent registered public accounting firm included an explanatory paragraph in the report on our financial statements as of and for the years ended September 30, 2024 and 2023, respectively, noting the existence of substantial doubt about our ability to continue as a going concern.
Additionally, our independent registered public accounting firm included an explanatory paragraph in the report on our financial statements as of and for the years ended September 30, 2025 and 2024, respectively, noting the existence of substantial doubt about our ability to continue as a going concern.
Research and development expenses include compensation and benefits for research and development employees including stock-based compensation, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses.
Research and development expenses include compensation and benefits for research and development employees including stock-based compensation, overhead expenses, laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses.
Even though we have received regulatory clearance to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial sales of the sEEG electrodes and OneRF Products are expected to take some time to be a significant source of liquidity.
Even though we have received regulatory clearance to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial sales of the sEEG electrodes and OneRF Ablation System are expected to take some time to be a significant source of liquidity.
On October 2024, we entered into an Amended and Restated Distribution Agreement with Zimmer to provide Zimmer with the exclusive right and license to distribute also our OneRF Ablation System for an upfront payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
In October 2024, we entered into an Amended and Restated Distribution Agreement with Zimmer to provide Zimmer with the exclusive right and license to distribute our OneRF Ablation System in the brain for an upfront payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
Funding Requirements As noted above, certain of our cash requirements relate to the funding of our ongoing product development and commercialization operations and our milestone and royalty obligations under our intellectual property licenses with WARF and Mayo.
Funding Requirements Certain of our cash requirements relate to the funding of our ongoing product development and commercialization operations and our milestone and royalty obligations under our intellectual property licenses with WARF and Mayo.
Prior to FDA clearance of certain of our products, our main sources of cash, cash equivalents and short-term investments were proceeds from the issuances of notes, common stock, warrants and unsecured loans. See “Liquidity and Capital Resources—Capital Resources” below.
Prior to FDA clearance of certain of our products, our main sources of cash, cash equivalents and short-term investments were proceeds from the issuances of notes, common stock, warrants and unsecured loans. See “ Liquidity and Capital Resources—Capital Resources ” below.
On August 16, 2024, we increased the amount of common stock that can be sold pursuant to the Sales Agreement by $3.0 million.
On August 16, 2024, we increased the amount of common stock that can be sold pursuant to the Sales Agreement by $3.0 million. On April 3, 2025, we decreased the amount of common stock that can be sold pursuant to the Sales Agreement to zero.
As of September 30, 2024, we had an accumulated deficit of $75.0 million, primarily as a result of expenses incurred in connection with our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by collaborations and product revenues.
As of September 30, 2025, we had an accumulated deficit of $78.6 million, primarily as a result of expenses incurred in connection with our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by license and product revenues.
As of September 30, 2024, we had cash and cash equivalents in the aggregate of approximately $1.5 million. Management has noted the existence of substantial doubt about our ability to continue as a going concern.
At September 30, 2025, we had cash and cash equivalents in the aggregate of approximately $6.6 million. Management has noted the existence of substantial doubt about our ability to continue as a going concern.
The 2024 Private Placement closed on August 2, 2024. Issuance costs attributed to the 2024 Private Placement amounted to $0.2 million. The PIPE Warrants are exercisable beginning on the date of issuance, have an exercise price of $1.19 per share, subject to adjustment, and will expire on the third anniversary of the date of issuance .
The 2024 Private Placement closed on August 2, 2024. Issuance costs attributed to the 2024 Private Placement amounted to $0.2 million. The PIPE Warrants are exercisable beginning on the date of issuance and had an initial exercise price of $1.19 per share, subject to adjustment.
For additional information, see “Note 4 — Commitments and Contingencies” included in “Item 8 — Financial Statements and Supplementary Data” in this Report. Recent Accounting Pronouncements See “Note 3 — Summary of Significant Accounting Policies” included in “Item 8 — Financial Statements and Supplementary Data” in this Report regarding the impact of certain recent accounting pronouncements on our financial statements.
Recent Accounting Pronouncements See “Note 3 — Summary of Significant Accounting Policies” included in “Item 8 — Financial Statements and Supplementary Data” in this Report regarding the impact of certain recent accounting pronouncements on our financial statements.
If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and the development of our technology, or we may have to cease operations altogether.
If we are unable to obtain the necessary capital in the future from operating results or future financing, it may have a material adverse effect on our operations and the development of our technology, or we may have to cease operations altogether.
For discussions about the application of fair value associated with the warrants, see “Note 9 – Stockholders’ Equity” included in “Item 8 — Financial Statements and Supplementary Data” in this Report. Income Tax Assets and Liabilities Income tax assets and liabilities include income tax valuation allowances.
For discussions about the application of fair value associated with the warrants, see “Note 9 – Stockholders’ Equity” included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. Fair Value Change in Warrant Liability The net change in fair value line item is attributed to the warrant liability while outstanding.
Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. 56 NeuroOne Medical Technologies Corporation FORM 10-K Fair Value Change in Warrant Liability The net change in the fair value line item is attributed to the warrant liability while outstanding.
Research and Development Expenses Research and development expenses were approximately $5.1 million for the year ended September 30, 2024, compared to $6.9 million for the year ended September 30, 2023.
Research and Development Expenses Research and development expenses were approximately $5.0 million for the year ended September 30, 2025, compared to $5.1 million for the year ended September 30, 2024.
We expect to satisfy our short term and long term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales to cover expenses, if ever, from future equity and debt financings. 67 NeuroOne Medical Technologies Corporation FORM 10-K Liquidity Outlook For a discussion of potential fee payments under the Zimmer Distribution Agreement, see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue” included in our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
We expect to satisfy our short-term and long-term obligations through cash on hand and revenue from commercial sales to cover expenses. 60 NeuroOne Medical Technologies Corporation FORM 10-K Liquidity Outlook For a discussion of potential fee payments under the Amended and Restated Zimmer Development Agreement, see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue” included in our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
The $1.9 million decrease period over period was attributed to the net reduction in development activities associated with our sEEG Products, Strip/Grid Products and OneRF Products given the commercialization of these products. Activity associated with new technology development partially offset the overall net decrease in research and development costs during the current period.
The $0.1 million decrease period over period was attributed to the net reduction in development activities associated with our Evo Cortical, Evo sEEG, and OneRF Ablation System, given the commercialization of these products. Activity associated with new technology development largely offset the overall net decrease in research and development costs during the current period.
Partially offsetting the net cash operating use during the period was a decrease in our accounts receivable, prepaid expenses and by an increase in our accrued expenses, on a net basis, resulting from timing of payments and fluctuations in our operations.
Partially offsetting the net cash operating use during the period was a decrease in our inventory and prepaid expenses as well as a net increase in our accounts payable and accrued expenses resulting from timing of payments and fluctuations in our operations.
Overview We are a medical technology company focused on the development and commercialization of thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography (“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.
We are developing and commercializing thin film electrode technology for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography (“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions for patients suffering from epilepsy, trigeminal neuralgia, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological disorders.
We anticipate that our selling, general and administrative expenses will increase in the future to support our continued research and development activities, further commercialization of our cortical strip and grid technology, ablation system and our depth electrode technology, and the increased costs of operating as a public company.
We anticipate that our selling, general and administrative expenses will increase in the future to support our continued research and development activities, further commercialization of our technology, and the increased costs of operating as a public company. Research and Development Research and development expenses consist of expenses incurred in performing research and development activities in developing our technology.
Net cash (used in) provided by investing activities Net cash used in investing activities was $0.1 million for the year ended September 30, 2024 and consisted of outlays for purchases of property and equipment.
Net cash used in investing activities Net cash used in investing activities was $0.1 million for each of the years ended September 30, 2025 and 2024 consisting of outlays for purchases of property and equipment.
Other significant costs include legal and litigation costs relating to corporate matters, intellectual property costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with the commercial sale of cEEG strip/grid, sEEG depth electrode, OneRF ablation system and electrode cable assembly products.
Other significant costs include legal and litigation costs relating to corporate matters, intellectual property costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with the commercial sale of our Evo Cortical, Evo sEEG, and OneRF Ablation Systems.
We have 510(k) clearance for three of our devices from the FDA, including: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days, (ii) our Evo sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and (iii) our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
We have received 510(k) clearance for four of our devices from the Food and Drug Administration (“FDA”), including: (i) our Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days (“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 Ablation System”), (iv) our OneRF TN ablation system for use in procedures to create radiofrequency (RF) lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures (“OneRF TN Ablation System”).
Cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products and OneRF Products, and outside supplier materials costs in connection with the Electrode Cable Assembly Products.
Our cost of product revenue consists of the manufacturing and materials costs incurred by our third-party contract manufacturers in connection with our Evo Cortical, Evo sEEG, and OneRF Ablation Systems, and outside supplier costs of producing our electrode cable assembly products.
For the Years Ended September 30, 2024 2023 Net cash used in operating activities $ (11,011,840 ) $ (12,886,874 ) Net cash (used in) provided by investing activities (120,197 ) 2,649,964 Net cash provided by financing activities 7,269,586 7,399,074 Net decrease in cash and cash equivalents $ (3,862,451 ) $ (2,837,836 ) 68 NeuroOne Medical Technologies Corporation FORM 10-K Net cash used in operating activities Net cash used in operating activities was $11.0 million for the year ended September 30, 2024, which consisted of a net loss of $12.3 million partially offset by non-cash stock-based compensation, depreciation, amortization related to intangible assets and deferred financing costs, operating lease expense, fair value change in warrant liability and the proceeds from the issuance of warrants in connection with the 2024 Private Placement totaling approximately $2.3 million in the aggregate.
For the Years Ended September 30, 2025 2024 Net cash used in operating activities $ (2,837,272 ) $ (11,011,840 ) Net cash used in investing activities (81,742 ) (120,197 ) Net cash provided by financing activities 8,029,354 7,269,586 Net increase (decrease) in cash and cash equivalents $ 5,110,340 $ (3,862,451 ) 61 NeuroOne Medical Technologies Corporation FORM 10-K Net cash used in operating activities Net cash used in operating activities was $2.8 million for the year ended September 30, 2025, which consisted of a net loss of $3.6 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets and deferred issuance costs, operating lease expense, fair value change in warrant liability totaling approximately $1.1 million in the aggregate.
Development activities primarily included salary-related expenses and costs related to consulting services, materials and supplies. Fair Value Change in Warrant Liability The net change in fair value of the warrant liability during the year ended September 30, 2024 was $0.3 million. The change was due primarily to fluctuations in our common stock fair value.
Development activities primarily included salary-related expenses and costs related to consulting services, testing, materials and supplies. Fair Value Change in Warrant Liability The net change in fair value of the warrant liability during the year ended September 30, 2025 resulted in a $0.8 million benefit compared to an expense of $0.3 million during the year ended September 30, 2024.
The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described in “Note 3 — Summary of Significant Accounting Policies” to our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report. 69 NeuroOne Medical Technologies Corporation FORM 10-K Of these policies, the following are considered critical to an understanding of our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report that require the application of the most subjective and the most complex judgments: Revenues: For discussion about the determination of collaborations revenue, product revenue and cost of product revenue, see “Note 7 — Zimmer Amended and Restated Distribution Agreement and Other Product Revenue” included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
Of these policies, the following are considered critical to an understanding of our financial statements included in “Item 8 — Financial Statements and Supplementary Data” in this Report that require the application of the most subjective and the most complex judgments: Revenues: For discussion about the determination of collaborations revenue, product revenue and cost of product revenue, see “Note 7 — Zimmer Amended and Restated Distribution Agreement and Other Product Revenue” included in “Item 8 — Financial Statements and Supplementary Data” in this Report.
Debt Facility Financing On August 2, 2024, we entered into the Debt Facility Agreement with Growth Opportunity Funding, LLC, as the Lender, which provided for a delayed draw term loan facility in an aggregate principal amount not to exceed $3.0 million.
We incurred issuance costs in connection with the ATM Program in the amount of $0.6 million through September 30, 2025. 59 NeuroOne Medical Technologies Corporation FORM 10-K Debt Facility Financing On August 2, 2024, we entered into the Debt Facility Agreement with Growth Opportunity Funding, LLC, as the Lender, which provided for a delayed draw term loan facility in an aggregate principal amount not to exceed $3.0 million.
If economic conditions continue to decline, our future cost of equity or debt capital and access to the capital markets could be adversely affected. Our operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors.
If economic conditions continue to decline, our future cost of equity or debt capital and access to the capital markets could be adversely affected.
To date, we have not had, nor expect to have in the future, significant variable consideration adjustments related to product revenue, such as chargebacks, sales allowances and sales returns.
To date, we have not had, nor expect to have in the future, significant variable consideration adjustments related to product revenue, such as chargebacks, sales allowances and sales returns. Fair Value of Warrant liability We issued warrants in connection with our August 2024 Private Placement.
Net cash provided by financing activities Net cash provided by financing activities was $7.3 million for the year ended September 30, 2024, which consisted of net proceeds from the ATM of $4.8 million and net proceeds from the 2024 Private Placement of $2.6 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount of $81,000 and debt facility issuance costs of approximately $75,000.
Net cash provided by financing activities was $7.3 million for the year ended September 30, 2024, which consisted of net proceeds from the ATM Program of $4.8 million and net proceeds from the 2024 Private Placement of $2.6 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount of $81,000 and debt facility issuance costs of approximately $75,000. 62 NeuroOne Medical Technologies Corporation FORM 10-K Critical Accounting Policies and Significant Judgments and Estimates Our financial statements are prepared in accordance with U.S. generally accepted accounting principles.
Results of Operations Comparison of the Fiscal Years Ended September 30, 2024 and 2023 The following table sets forth our results of operations for the fiscal years ended September 30, 2024 and 2023.
Other Income Other income primarily consists of interest income related to our cash and cash equivalents, Results of Operations Comparison of the Fiscal Years Ended September 30, 2025 and 2024 The following table sets forth our results of operations for the fiscal years ended September 30, 2025 and 2024.
We are also developing the capability to use our sEEG electrode technology to deliver drugs or gene therapy while being able to record brain activity before, during, and after delivery. Additionally, we are investigating the potential applications of our technology associated with artificial intelligence.
The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while being able to record activity before, during, and after delivery.
The OneRF ablation system is not covered by the Zimmer Distribution Agreement. The parties agreed to collaborate with respect to development activities under the Zimmer Distribution Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
In addition, under the prior EDDAs, we agreed to collaborate with respect to development activities through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $1.0 million.
Our net loss was further adjusted to account for the reclassification of debt and equity facility termination costs to financing activities in the amount of $0.1 million. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $1.0 million.
Capital Resources Our sources of cash, cash equivalents and short-term investments to date have been limited to collaboration and product revenues, along with proceeds from the issuances of notes with warrants, common stock with and without warrants and unsecured loans with the terms of our more recent financings described below.
Liquidity and Capital Resources Overview As of September 30, 2025, our principal source of liquidity consisted of cash and cash equivalents in the aggregate of approximately $6.6 million. 58 NeuroOne Medical Technologies Corporation FORM 10-K Capital Resources Our sources of cash and cash equivalents to date have been limited to license, collaboration and product revenues, along with proceeds from the issuances of notes with warrants, common stock with and without warrants and unsecured loans with the terms of our more recent financings described below.
In connection with the 2024 Private Placement, we agreed to file a registration statement with the SEC covering the resale of the Shares and the shares of common stock issuable upon exercise of the PIPE Warrants which became effective on September 13, 2024. 65 NeuroOne Medical Technologies Corporation FORM 10-K At-The-Market Offering On December 21, 2022, we entered into a Capital on Demand TM Sales Agreement (“Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”) to create an at-the-market offering program (“ATM”) under which we may offer and sell shares having an aggregate offering price of up to $14.5 million.
At-The-Market Offering On December 21, 2022, we entered into a Capital on Demand TM Sales Agreement (“Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”) to create an at-the-market offering program (“ATM Program”) under which we may offer and sell shares having an aggregate offering price of up to $14.5 million.
The $1.0 increase period over period was primarily due to an increase in payroll related costs of approximately $0.4 million, stock-based compensation of $0.2 million, professional and board fees of $0.3 million and marketing and sales costs of $0.2 million, offset slightly by a reduction in general operating costs of $0.1 million on a net basis.
The $0.5 million decrease period over period was primarily due to a decrease in both legal fees in the amount of $0.4 million and investor relations related expense of $0.6 million, offset in part by increases in payroll related costs of approximately $0.1 million, non-legal professional fees of $0.2 million, marketing and sales costs of $0.1 million and other operating cost increases of $0.1 million on a net basis.
Net cash used in operating activities was $12.9 million for the year ended September 30, 2023, which consisted of a net loss of $11.9 million partially offset by non-cash stock-based compensation, depreciation, amortization related to intangible assets and short term investment premiums and discounts, operating lease expense and loss on disposal of fixed assets, totaling approximately $1.4 million in the aggregate.
Net cash used in operating activities was $11.0 million for the year ended September 30, 2024, which consisted of a net loss of $12.3 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets and deferred issuance costs, operating lease expense, fair value change in warrant liability and the proceeds from the issuance of warrants in connection with the 2024 Private Placement totaling approximately $2.2 million in the aggregate.
We did not incur any financing costs during the year ended September 30, 2023. 64 NeuroOne Medical Technologies Corporation FORM 10-K Other Income, net Other income, net during the year ended September 30, 2024 consisted principally of interest income attributed to our cash and cash equivalents.
Other Income, net Other income, net during the year ended September 30, 2025 and 2024 consisted principally of interest income attributed to our cash and cash equivalents.
The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $2.4 million.
Our net loss was further adjusted to account for the reclassification of debt and equity facility termination costs to financing activities in the amount of $0.1 million. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $0.4 million.
One of the Purchasers in the 2024 Private Placement included Paul Buckman, a director on the Company’s Board of Directors. 60 NeuroOne Medical Technologies Corporation FORM 10-K Global Economic Conditions Generally, worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and financial markets, and increased inflation.
Global Economic Conditions Generally, worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and financial markets, and increased inflation.
Net cash provided by financing activities was $7.4 million for the year ended September 30, 2023, which consisted of net proceeds from the July 2023 Public Offering of $5.2 million and from the ATM of $2.3 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount of $0.1 million.
Net cash provided by financing activities Net cash provided by financing activities was $8.0 million for the year ended September 30, 2025, which consisted of net proceeds from the April 2025 Financing of approximately $8.2 million and from the ATM Program in the amount of approximately $0.3 million as well as from the exercise of warrants in the amount of $0.1 million.
For further discussion about the determination of collaborations revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under the Zimmer Distribution Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note 7 — Zimmer Distribution Agreement” included in our financial statements included in Item 8 — Financial Statements and Supplementary Data” in this Report. 62 NeuroOne Medical Technologies Corporation FORM 10-K Selling, General and Administrative Selling, general and administrative expenses consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with research and development activities.
For further discussion about the determination of license revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under the Zimmer Amended and Restated Distribution Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue” included in our financial statements included in Item 8 — Financial Statements and Supplementary Data” in this Report.
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 for an upfront fee of $3.0 million dollars and up to an additional $1.0 million dollars upon achievement of certain net sales milestone by Zimmer.
(“Zimmer”) pursuant to which we granted Zimmer the exclusive right and license to distribute our OneRF Ablation System for an upfront payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
In addition, under the terms of the July 2023 Public Offering, we granted Benchmark an option, exercisable for 30 days, to purchase up to an additional 787,500 shares of common stock on the same terms (“the Overallotment Option”).
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.
Financing Costs Financing costs consists of the amortization of the deferred issuance costs associated with the debt facility (as described further below) and issuance costs attributed to the warrants issued in connection with the 2024 Private Placement (as described further below).
Financing Costs Financing costs consists of the amortization of the deferred issuance costs and other lending and issuance costs in connection with the debt facility and at-the market offering facility (both described below).
In addition, cost of product revenue included royalty fees incurred of approximately $157,000 in connection with our license agreements during each of the years ended September 30, 2024 and 2023. Collaborations Revenue There was no collaborations revenue during the year ended September 30, 2024. Collaborations revenue was approximately $1.5 million during the year ended September 30, 2023.
In addition, cost of product revenue included royalty fees incurred of approximately $150,000 and $157,000 in connection with our license agreements during the years ended September 30, 2025 and 2024, respectively. 57 NeuroOne Medical Technologies Corporation FORM 10-K Collaborations Revenue License revenue was $3.0 million for the year ended September 30, 2025 which related to the distribution license granted to Zimmer for the OneRF Ablation System in October 2024.
The net cash use stemming from the change in operating assets and liabilities was primarily attributable to both a decrease in deferred revenue in connection with the completion of the remaining milestone performance obligation under the Zimmer Distribution Agreement and to an increase in inventory purchases, attributed to the timing of payments.
The net cash use stemming from the change in operating assets and liabilities was primarily attributable to an increase in our accounts receivable attributed largely to the timing of customer payments.
Our cost of product revenue consists of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products, OneRF Products and outside supplier materials costs of producing the Electrode Cable Assembly Products. In addition, cost of product revenue includes royalty fees incurred in connection with our license agreements.
The cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract manufacturers in connection with our Evo Cortical, Evo sEEG, and OneRF Ablation System.
Financial Overview Product Revenue Our product revenue was derived from the sale of our Strip/Grid Products, the sEEG Products and the Electrode Cable Assembly Products based on Evo cortical electrode technology and the OneRF Products, which are products based on our OneRF Ablation System.
Financial Overview Product Revenue Our product revenue was derived from the sale of our Evo Cortical, Evo sEEG, and OneRF Ablation System, which have each received FDA 510(k) clearance. Product Gross Profit Product gross profit represents our product revenue less our cost of product revenue.
For the years ended September 30, 2024 2023 Period to Period Change Product revenue $ 3,453,003 $ 1,952,441 $ 1,500,562 Cost of product revenue 2,373,336 1,495,924 877,412 Product gross profit 1,079,667 456,517 623,150 Collaborations revenue — 1,455,188 (1,455,188 ) Operating expenses: Selling, general and administrative 7,901,695 6,926,269 975,426 Research and development 5,065,181 6,940,686 (1,875,505 ) Total operating expenses 12,966,876 13,866,955 (900,079 ) Loss from operations (11,887,209 ) (11,955,250 ) 68,041 Fair value change in warrant liability (327,092 ) — (327,092 ) Financing costs (228,988 ) — (228,988 ) Other income, net 125,179 95,759 29,420 Loss before income taxes (12,318,110 ) (11,859,491 ) (458,619 ) Provision for income taxes — — — Net loss $ (12,318,110 ) $ (11,859,491 ) $ (458,619 ) 63 NeuroOne Medical Technologies Corporation FORM 10-K Product Revenue and Product Gross Profit Product revenue was $3.5 million during the year ended September 30, 2024 with a gross profit and gross profit percentage of $1.1 million and 31.3%, respectively.
For the years ended September 30, 2025 2024 Period to Period Change Product revenue $ 9,097,692 $ 3,453,003 $ 5,644,689 Cost of product revenue 3,956,286 2,373,336 1,582,950 Product gross profit 5,141,406 1,079,667 4,061,739 Collaborations revenue 3,000,000 — 3,000,000 Operating expenses: Selling, general and administrative 7,384,517 7,901,695 (517,178 ) Research and development 4,983,362 5,065,181 (81,819 ) Total operating expenses 12,367,879 12,966,876 (598,997 ) Loss from operations (4,226,473 ) (11,887,209 ) 7,660,736 Fair value change in warrant liability 784,670 (327,092 ) 1,111,762 Financing costs (334,063 ) (228,988 ) (105,075 ) Other income, net 170,492 125,179 45,313 Loss before income taxes (3,605,374 ) (12,318,110 ) 8,712,736 Provision for income taxes — — — Net loss $ (3,605,374 ) $ (12,318,110 ) $ 8,712,736 Product Revenue and Product Gross Profit Product revenue was $9.1 million during the year ended September 30, 2025 with a gross profit and gross profit percentage of $5.1 million and 56.5%, respectively.
Revenue during the prior year period was derived from the Zimmer Distribution Agreement in connection with the completion of the sEEG maintenance fee obligation as a result of securing FDA approval. Selling, General and Administrative Expenses Selling, general and administrative expenses were $7.9 million and $6.9 million for the years ended September 30, 2024 and 2023, respectively.
No license revenue was generated from the Zimmer Amended and Restated Development Agreement during the year ended September 30, 2024. Selling, General and Administrative Expenses Selling, general and administrative expenses were $7.4 million and $7.9 million for the years ended September 30, 2025 and 2024, respectively.
Product revenue was $2.0 million during the year ended September 30, 2023 with a gross profit and gross profit percentage of $0.5 million and 23.4%, respectively.
Product revenue was $3.5 million during the year ended September 30, 2024 with a gross profit and gross profit percentage of $1.1 million and 31.3%, respectively. The increase in gross profit percentage during the current period was largely due to the higher margin OneRF Ablation System being sold in the current period under the Amendment with Zimmer.
Through September 30, 2024, we have issued 5,188,590 shares of common stock under the ATM for gross proceeds in the amount of $7.6 million. We incurred issuance costs in connection with the ATM in the amount of $0.5 million through September 30, 2024 of which $41,000 was reflected as a deferred cost on our balance sheet.
On August 15, 2025, we increased the amount of common stock that can be sold pursuant to the Sales Agreement to $6,750,000. Through September 30, 2025, we have issued 5,544,489 shares of common stock under the ATM Program for gross proceeds in the amount of $8.0 million.
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Our other products are still under development. We distribute our cEEG strip/grid electrodes, cable assembly products and our OneRF Ablation System with Zimmer Biomet. We have incurred losses since inception.
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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.
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We may be unable to raise additional funds when needed on favorable terms or at all.
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We have a distribution agreement with Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and OneRF 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.
Removed
Our failure to raise such capital as and when needed would have a negative impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode technology and future products and our ability to pursue our business strategy. See “Liquidity and Capital Resources—Liquidity Outlook” below.
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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”).
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Recent Developments Corporate Updates OneRF Ablation System In March 2024, we announced a limited commercial launch of our OneRF ablation system.
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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.
Removed
In October 2024, we amended and restated our Distribution Agreement with Zimmer to provide exclusive right and license to distribute also our OneRF Ablation System. 59 NeuroOne Medical Technologies Corporation FORM 10-K Nasdaq Notice Since May 28, 2024, the closing price of our common stock has been below $1.00.
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Zimmer Amended and Restated Distribution Agreement On October 25, 2024, we entered into the Zimmer Amended and Restated Distribution Agreement (the “Amendment”) with Zimmer, Inc.
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On July 11, 2024, we received a letter from the Listing Qualifications Department of the Nasdaq informing us that because the closing bid price for our common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company was 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).
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We previously entered into an Exclusive Development and Distribution Agreement dated July 20, 2020 with Zimmer, related to the Evo Cortical and Evo sEEG products, which was subsequently amended pursuant to the terms and conditions of a letter agreement dated January 6, 2021, a Second Amendment to Exclusive Development and Distribution Agreement dated June 28, 2022, and a Third Amendment to Exclusive Development and Distribution Agreement dated August 2, 2022 (collectively, the “EDDA”).The EDDAs executed prior to the Amendment granted Zimmer exclusive global rights to distribute the Evo Cortical and Evo sEEG products.
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In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from July 11, 2024, or until January 7, 2025, to regain compliance with the Minimum Bid Price Requirement.
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Under the Amendment, Zimmer paid us $3.0 million for an exclusive RF Distribution License (the “RF Distribution License” and “License”) for commercialization of the OneRF Ablation System in the brain. In addition, we are eligible to receive a future milestone payment of $1.0 million upon reaching a one-time sales volume threshold. We do not anticipate receiving this milestone payment.
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If at any time before January 7, 2025, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days (which number days may be extended by Nasdaq), Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved.
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The revised term under the Amendment (the “Term”) began on the effective date and will remain in effect until October 31, 2034. Upon the expiration of the Term, it may be renewed upon the mutual written of the Parties.
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The Notice also disclosed that in the event we do not regain compliance with the Rule by January 7, 2025, we may be eligible for additional time.
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The Zimmer Amended and Restated Exclusive Development and Distribution Agreement may be terminated before the expiration of the Term only by the Parties in accordance with certain terms under the Amendment.

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